Clinical Diagnostics and Research

May 28-30, 2014
873
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34,758
 

This year will be our 5th annual Clinical Diagnostics & Research online conference. Attendees can earn free CME and CE Credits. The theme of this conference is a range of medical and clinical and research topics such as Personalized Healthcare, Pathology, Oncology, Infectious Disease, Laboratory Testing, Cardiology, Diabetes, Point of Care, Molecular Diagnostics, Hematology, Automation, Nutrition, Vitamin D, Allergy, Clinical Research, Mass Spectrometry, and much more.
This event will bring together clinicians, researchers, medical experts and professionals from around the world to learn about recent advances in clinical diagnostics, research and medicine. This conference offers an amazing opportunity as it is free to participants, and there will be no out-of-pocket expenses for travel. However, participants will still benefit from interacting with a global community of like-minded colleagues, without leaving the comfort of their office or home.
Conference participants will be able to:

  • Attend interactive live streaming video sessions
  • Have their questions answered in real-time by industry experts
  • Receive Free CME and CE Continuing Education Credits
  • Chat live with peers and speakers
  • Browse a virtual exhibit floor for solution providers

No crowded airports, delayed flights or expensive hotel rooms, but still the look and feel of a first-rate conference with world renowned experts. Participants also benefit from the fact that experts and vendors are more accessible, no more waiting in line to speak to someone. Think it is too good to be true? Checkout the venue and become a believer.

Here are continuing medical education (CME) learner objectives that attendees should be able to do as a result of participating in this activity.

  • Ability to contrast previous and newly released guidelines
  • Take action to increase partnership and collaboration with clinicians
  • Identify actions that can be taken to deliver quality results faster to clinicians
  • Better define personalized healthcare today and explain the role of companion diagnostics
  • Better describe diagnostic tools used in the patient workups
  • Better describe how the evolution of laboratory testing in health has impacted the patient
  • Identify the role of the clinical laboratory in contributing to or preventing diagnostic errors
  • Identify laboratory directed interventions that can reduce diagnostic errors
  • Describe analytical issues associated with various assays
  • Recognize the patient safety risks associated with misuse of the clinical laboratory
  • Identify several categories of commonly misused laboratory tests
  • Advise patients on the likely long term effects of certain surgery in patients with diseases
  • Explain levels of personalized medicine as it attempts to predict individual response to therapy

Speakers

(See Agenda)
Director, Clinical Cancer Genetics, Professor ...
Professor of Medicine and Pediatrics, Boston ...
Director of Global Scientific Affairs, Beckman ...
Chemistry Automation Supervisor Chemical Pathology ...
Director of Clinical Virology, Serology, and ...
Anesthesiology/Chronic Pain Management, Cleveland ...
President, AACC 2014, Professor of Pathology ...
Dr. Holick, is Professor of Medicine, Physiology ...
Distinguished Clinical Professor of Medicine ...
Chief Scientific Officer, Augurex Life Sciences ...
Senior Medical/Clinical Consultant, Siemens ...
Director, Scientific Affairs Cardiac, Roche ...
Clinical Associate Professor, Dept of ...
Kelli Bramlett, Senior Manager, R&D Thermo ...
Dr. Bowman is Medical Director, Enzo Clinical ...
Head of Molecular Microbiology Unit- Molecular ...
Professor, Department of Medicine, University of ...
Principal Officer, Healthcare Management and ...
Director, Translational Medicine, Thermo-Fisher ...
Associate Professor of Medicine, Division of ...
Assistant Professor of Medicine, Baylor College of ...
Attorney, Alston & Bird, LLP
Scientific Affairs Manager, Medical and Scientific ...
Head of the Flow-Cytometry Facility, Institute of ...
Senior Director of Scientific Affairs, Binding ...
Project Lead for the Clinical Laboratory ...
Scientific Director, Automation & Special ...
President, CEO and Laboratory Director ...
Laboratory Director, Millennium Laboratories, Inc ...
Director, Assay Development, Siemens Healthcare ...
Board Certified Diagnostic Radiologist, Clinical ...
Professor of Endocrine Bone Research Laboratory ...
Patrick Joseph, MD, Medical Director, Siemens ...
Assistant Manager Biochemistry, Sullivan ...
Network Operations & Research Manager, iCCnet ...

Clinical Diagnostics and Research

Agenda

All times are Pacific Time

Keynote-+

May 28, 9:00 AM - 10:00 AM PT

Keynote: Establishing an economic BRCA1 and BRCA2 (BRCA) gene analyses research workflow using custom AmpliSeq panel design and the Ion PGM System

Jeffrey N Weitzel, MD

Director, Clinical Cancer Genetics, Professor, Director, Cancer Screening & Prevention City of Hope

While the "Jolie effect" has refocused attention on the central role of BRCA gene analyses in the diagnosis and prevention of hereditary breast and ovarian cancer, there is a global disparity in access to affordable testing. The development of bench top NGS technologies holds promise for faster, more comprehensive and cost-effective methodologies than Sanger sequencing.

The goal of the study was to create a global consortium for developing and demonstrating the feasibility of a shared, dedicated workflow that may develop into a clinical grade BRCA gene analyses using Ion AmpliSeqTM multiplex PCR technology combined with the Ion PGMTM Sequencer.

May 28, 12:00 PM - 1:00 PM PT

Keynote

Barbara Van Der Pol, PhD, MPH

Associate Professor of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine

The CDC has recently released the Recommendations for Laboratory Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. As a result of advances in molecular diagnostics, the current recommendations are substantially different from the previous version published in 2002. Dr. Van Der Pol will provide data regarding the importance of chlamydia and gonorrhea screening and describe the process by which the current guidelines were developed. The application of the guidelines in both laboratories and in clinical settings will be described. Recommendations for testing non-genital (e.g. ano-rectal and oropharyngeal) samples will also be discussed. Adoption of the CDC recommendations will improve sexually transmitted infection control efforts and may help move screening toward a normative, sexual health maintenance practice.

LEARNER OBJECTIVES:
The learner will be able to choose the appropriate type of assay to use for chlamydia/gonorrhea screening.
The learner will be able to provide appropriate screening options for patients who report anal or oral sex.

May 29, 9:00 AM - 10:00 AM PT

Keynote Panel Discussion: Companion Diagnostics: Changing the Face of Healthcare, Doctors Hawkins, Joseph, and Frank

Patrick Joseph, MD and Richard Frank, MD

Patrick Joseph, MD, Medical Director, Siemens Clinical Laboratory (SCL), Siemens Healthcare Diagnostics Richard Frank, MD, Chief Medical Officer, Clinical Strategy and Policy, Siemens Healthcare

What is the future of personalized medicine? Featuring Dr. Trevor Hawkins (An Introduction to Companion Diagnostics), Dr. Patrick Joseph (Making It Personal for Patients), and Dr. Richard Frank (The Impact on Healthcare Policy), this lively panel discussion will highlight the many ways in which Companion Diagnostics are changing the face of healthcare.
As a patient-centric shift continues to sweep our healthcare system, pharmaceutical companies are increasingly seeing the value of targeting treatments to specific patient populations, making their therapies more personal. In the burgeoning age of personalized medicine, companies are looking for ways to develop more specific, efficacious, and cost-effective treatments that are tailored to a patients needs, rather than focusing solely on the blockbuster drugs that have dominated the industry over the past few decades. Some companies have found novel ways to accommodate this shift, including adjusting their business models to focus on healthcare outcomes and collaborating with payers and providers to simplify reimbursement and provide tools and technologies to increase medication adherence.
Join Drs. Hawkins, Joseph, and Frank and learn how companion diagnostics promises to change the way patients are treated, therapies may be prescribed, and tests are developed, and how this fast-moving evolution will impact all of healthcare.

Learning Objectives:

At the end of the presentation, attendees will be able to:


Understand how companion diagnostics may improve patient outcomes by personalizing medicine.
Appreciate the pathways for adoption and prescription of companion diagnostic tests.

May 30, 11:30 AM - 12:30 PM PT

Keynote: Biochemical Markers of Bone Turnover in the Management of Postmenopausal Osteoporosis

Paul D Miller, MD

Distinguished Clinical Professor of Medicine, University of Colorado Health Sciences Center Medical Director Colorado Center for Bone Research

Bone turnover markers (BTM) are biological markers of bone remodeling (turnover). The entire skeleton is replaced every 10 years by remodeling, a process constantly going on at different phases throughout the skeleton (Figure 1). The purposes of remodeling are to repair the microcracks that occur in the skeleton with daily mechanical loading.

From these bone remodeling cavities proteins (BTM) are released into the circulation and can be measured by radioimmunoassay or immunoassay. (Figure 2)

The clinical evidence is consistent that these markers are useful for:

1. Determining the rate of bone turnover (high bone turnover is an independent risk factor for osteoporotic fracture) and predicting the rate of bone loss.

2. Assessing response to osteoporosis treatments (both anti-resorptive as well as anabolic agents). The change in the BTM after the initiation of treatment occurs rapidly-within 3 months of starting therapy and, therefore, provide much earlier information on compliance, and a bone effect than bone mineral density (BMD) which requires 1-2 years to see a measureable change. A change in the BTM also predicts improvements in BMD and predicts fracture risk reduction

Two large international groups: The International Osteoporosis Foundation-International Federation of Clinical Chemistry and The National Bone Health Alliance-American Association of Clinical Chemistry both have both endorsed, based on evidence, that the preferred BTM for bone formation is the propeptide type I collagen (PINP) and for bone resorption the collagen cross-link, C-telopeptide (CTX).

Bioinformatics-+

May 29, 6:00 AM - 7:00 AM PT

Challenges for the Pathology Profession in the Age of the Electronic Health Record How Informatics and Standardisation Initiatives can Help

Robert Flatman, FAACB, MBA, B App Sc

Assistant Manager Biochemistry, Sullivan Nicolaides Pathology, Australia

Governments, pathology providers, and clients relying on pathology reports face increasing conflict between burgeoning costs versus demands for service innovation. The health industry has been generally slower than the financial industry to embrace the benefits of computerization in terms of portability and accessibility. There have however been good reasons including the requirements for privacy and security, together with the complexity of the information itself.

Many countries have embraced programs for electronic health records (EHRs), encouraging electronic requesting and reporting of health information, including pathology. Pathology providers have long focused on excellence within their own institution by embracing the best analytical instrumentation, information technology for laboratory information systems, and the best medical expertise for interpretation and reporting. Centralised reporting to EHRs will however highlight to clinicians and tech-savvy patients unnecessary, and sometimes unsafe, variations in the requesting and reporting of pathology. Examples include variations in test profiles, test naming, reference limits and units.

Pathology providers and clients must collaborate to create robust standards for the transmission and interpretation of health messages. There is an urgent need in most countries to standardize both requesting and reporting. Structured messaging and medical terminologies offers tools to assist.

This presentation will focus on developments in both medical terminologies and pathology harmonisation initiatives that will require greater awareness and support from the medical community to generate maximum benefit.

May 29, 7:30 AM - 8:30 AM PT

Identification of predictive biomarkers from high throughput drug combination screening data

Emma Bowden, PhD

Director, Translational Medicine, Thermo-Fisher Scientific

One of the major challenges to oncology based drug discovery and development has been the limited or incremental impact that many targeted agents have exhibited in the clinic. Understanding and overcoming tumor heterogeneity as well as inherent or emerging resistance are areas of significant ongoing research in both clinical and preclinical settings. Systematic approaches to support combination therapy clinical trial design are critical. Zalicus Inc. and Life Technologies have collaborated to develop a joint service offering that supports rationale design of cell line panels to inform and address the relevant genomic aberrations in disease subsequently enabling the identification of (1) potentially synergistic therapy combinations, (2) biomarkers of synergy, and (3) identification of potential clinical populations for hypothesis testing. During this segment, Dr. Bowden will discuss technical aspects of combination screening and biomarker discovery, major considerations required for success, provide examples of results, and offer potential impacts of this innovative service offering.

May 29, 10:30 AM - 11:30 AM PT

Adding Value in Healthcare Delivery: Uses for Clinical Laboratory Informatics in Decision Support

Elizabeth Kenimer Leibach, EdD, MS, MLS(ASCP), SBB

Principal Officer, Healthcare Management and Education Services (HMES), Education Editor for Clinical Laboratory Science and Expert Consultant for the US Centers for Disease Control and Prevention

Clinical laboratory information provides decision support for most healthcare

providers and impacts care processes and patient outcomes throughout the entire

health services delivery system. Evidence-based practice (EBP) describes

systematic, data-derived strategies employed by clinical laboratory

practitioners in production, interpretation, and communication of laboratory

information. EBP includes health outcomes and diagnostic studies, cost-

effectiveness analyses, practice guidelines development, and

provider/patient/consumer education systems development. Evidence from

analyses of these efforts is then used to measure the quality of and assign

value to services delivered.

Rapid advancements in technology, communications, and information analytics

have intersected producing unprecedented opportunity for measuring healthcare

effectiveness and efficiency for providers and individual patient/consumers.

These rapid advancements have also contributed to challenging economics and

heightened privacy concerns. How EBP strategies can be used to define value

(highest quality at lowest cost) for providers and individual patient/consumers

will be explored. Personalized healthcare delivery models will be discussed.

Learn how the discovery and documentation of evidence-based practices help to

promote quality and value in healthcare.

Learning Objectives:

At the end of the presentation, participants will be able to:

1. Define clinical laboratory science (CLS) evidence-based practice (EBP)

constructs linking clinical research, quality improvement, and

provider/patient/consumer education.

2. Describe CLS practices supporting evidence-based clinical decision-

making in personalized healthcare.

3. Present EBP models describing the current status of clinical decision

support systems and suggesting directions for further development.

May 29, 12:00 PM - 1:00 PM PT

Navigating the Complexities of the Human Oncoproteome with the SigNET KnowledgeBank

Steve Pelech, PhD

Professor, Department of Medicine, University of British Columbia, President & Chief Scientific Officer, Kinexus Bioinformatics Corporation

The human genome encodes ~21,500 proteins that are subject to reversible phosphorylation at nearly 1 million phosphosites by about 538 protein kinases and 156 protein phosphatases. Amongst other regulatory proteins, these classes of proteins play a central role in cancer as oncoproteins (OP), tumour-requiring proteins (TRP) or tumour suppressor proteins (TSP). They can be distinguished in part by their mutation patterns across thousands of tumour specimens. OP feature highly restricted mutations that produce a gain of function, commonly by loss of repression by inhibitory domains or mimicry of activating phosphorylation sites with acid amino acid residue substitutions. TSP typically feature an extensive range of mutation types and locations in their genes, which lead to their loss of function. By contrast, TRP display extremely low rates of mutation in human cancers, about 5 to 10-fold lower that the background mutation rates evident in bystander genes. TRP may serve as ideal targets for cancer drug development as they may be more commonly required for cancer development than OP, and they may be less tolerant to mutations that facilitate drug resistance. Interestingly, many OP are down-regulated and TSP are up-regulated in their protein levels in human tumours, which indicates that intracellular regulatory networks typically evoke compensatory mechanisms to restore growth control or induce apoptosis. Therefore, gene expression and mutation data has to be interpreted in the context of integrated signalling pathways. The open-access, on-line suite of SigNET KnowledgeBases offered by Kinexus provide extensive known and predictive information of human proteins, their gene expression, interactions and phosphorylation, and in the case of protein kinases, drug interactions. The new OncoNET website (www.onconet.ca) is a repository of detailed information about the mRNA expression and mutation patterns for nearly 3000 genes linked to diverse types of human cancers.

Cardiology-+

May 28, 6:00 AM - 7:00 AM PT

High Sensitivity Troponin as an Emerging Marker in Prediction of Cardiovascular Disease

Vijay Nambi, MD

Assistant Professor of Medicine, Baylor College of Medicine

Endocrine-+

May 29, 10:30 AM - 11:30 AM PT

Why are we unable to lose weight and keep it off? All about the connection between the gut and the brain

Caroline M Apovian, MD, FACP, FACN

Professor of Medicine and Pediatrics, Boston University School of Medicine Director, Center for Nutrition and Weight Management, Boston Medical Center

Obesity is a disease. It was once not considered to be a disease and to be a matter of will power and gluttony. It was also the case that we once thought that fat tissue had no metabolic function other than to be inert and store fat. We now know that adipose tissue is an endocrine organ that secretes adipokines that regulate metabolism and energy balance. There are several kinds of adipose tissue: white brown and beige. We used to think that brown fat was not present in adult humans, only in animals and human babies to generate heat. We now know that brown fat exists in the adult human and that white fat can undergo browning to become beige fat and burn more calories. We used to think that people who lost weight and regained it back and more had psychological disorders that made them eat. The overwhelming reason for weight regain is the body readjusting the energy regulation system and adjusting hormone levels so that a person feels preoccupied with food until they regain the weight. Other adjustments are made to resting metabolic rate so that it decreases to facilitate regain of weight. There is also some evidence to suggest that it may be our food supply that is creating this increase in the prevalence of obesity by interacting with pathways to appetite and satiety in the brain, thereby altering the signals to appetite and satiety. Foods high in fat cause obesity in animal models also cause inflammation in the hypothalamic area that controls food intake. These animals no longer regulate body fat and gain weight and eventually defend a high body set point weight. Human physiology may go through this same mechanism to defend a higher body weight in this toxic food environment.
How can we combat this new disease? Drugs devices and surgery and new methods in the pipeline are considered.

Healthcare reform-+

May 28, 1:30 PM - 2:30 PM PT

Legal and Regulatory Developments Affecting Molecular Testing

Peter M Kazon, JD

Attorney, Alston & Bird, LLP

The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by CMS. This session will discuss recent developments in these areas. While FDA has not acted to explicitly regulate molecular testing that is performed as a Laboratory Developed Test, the agency continues to suggest that new requirements will soon be forthcoming. In the meantime, FDA has acted to limit the use of tests labeled as Research Use Only or Investigational Use Only, and to increase its oversight of innovative Companion Diagnostics. Meanwhile, Medicare has developed new processes for determining whether or not to pay for developing molecular tests, such as the MolDx Program, created by Palmetto Government Services, one of the Medicare Administrative Contractors, which requires special coding of and technical assessment of new molecular tests. Finally, the payment for this testing has been in turmoil, as a result of Medicares year-long gapfilling process that occurred in 2013. As part of legislation passed in April, however, pricing will go through yet another major change, as the Medicare Program moves away from the current fee schedule approach to one that is designed to reflect market prices beginning in 2017. That legislation also includes special payment provisions affecting Advanced Diagnostic Laboratory Tests, which could affect many new molecular tests. Before any of that happens, however, there will need to be a complex regulatory approach to define what is to be reported to CMS and how that reporting will occur. This program will examine these developments and attempt to make some predictions about their likely impact

Hematology-+

May 29, 10:30 AM - 11:30 AM PT

Going Beyond Cell Counting and Solving Common Problems Faced by Laboratories

Fernando P Chaves, MD

Director of Global Scientific Affairs, Beckman Coulter, Inc.

Learn how technological advances with the DxH 800/DxH 600 analyzers are bringing practical solutions to problems faced by labs and their clinicians and patients. After the webinar you'll understand how this technology can help labs achieve optimal patient care with accurate counting, automated detection of important morphologic changes, while minimizing workload impact thanks to decreased false positive flagging rates.

Industry-+

May 28, 6:00 AM - 7:00 AM PT

The new role for HPV DNA testing: cobas HPV Test as a first-line cervical cancer screen

Julia Engstrom-Melnyk, PhD

Scientific Affairs Manager, Medical and Scientific Affairs, Roche Diagnostics

For the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology -- if it is negative, women are rescreen in three years and if positive, are referred to follow-up examinations. Although this strategy has led to a tremendous reduction in the incidence of cervical cancer, some significant limitations exist. Cytology has low sensitivity for cervical cancer pre-cursors, has low reproducibility, and does not adequately assess long-term risk. HPV testing added to cytology as a co-test for women 30 years and older increases the sensitivity of cytology and addresses many of its limitation, but also significantly contributes to the complexity of management. Additionally, it does not address the women 25-29 who are still screened with cytology alone. In ATHENA, 28% of all CIN3+ lesions detected were in women 25-29 -- more high-grade disease was found in these 6,647 women than in the 22,006 women 40 years and older. Further, cytology-based screening, the only other option for women 25-29, was negative in more than 57% of these cases, suggesting that current screening with cytology is inadequate in identifying underlying CIN3+ lesions in this age group. This is highly relevant when assessing data from the National Cancer Institute's SEER Tumor Registry, which shows a sharp rise in the incidence of invasive cervical cancer between the ages of 25 and 34 years. Since the goal of cervical cancer screening is to prevent cervical cancer from developing, it important to identify high-grade cervical cancer precursors in women 25-29 years, so that the precursors can be treated prior to this up rise in cervical cancer incidence and cervical cancer may be prevented. As a solution, HPV DNA testing can be used as a first-line primary screen in women 25 and older to not only enhance screening sensitivity but also reduce the complexity of a co-test.

May 28, 7:30 AM - 8:30 AM PT

Overview on ONE Study experience on standardization across multiple centers

Mathias Streitz, MS, Certified Biologist

Head of the Flow-Cytometry Facility, Institute of Medical Immunology, Charite - Universittsmedizin Berlin

May 28, 10:30 AM - 11:30 AM PT

Heavy/Light Chain Combination Assays: What Laboratories should know about M-Protein detection

Richard O'Hara, PhD

Senior Director of Scientific Affairs, Binding Site

Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed at diagnosis. Furthermore, difficulties in traditional methods of measuring monoclonal proteins have restricted the ability to measure M-proteins at low levels thereby limiting the laboratory and the clinician, particularly in identifying patients who have minimal residual disease.

In the past decade, assays which can measure immunoglobulin free light chains has improved detection of patients with Multiple Myeloma and related diseases, as well as providing a more sensitive tool for measuring a patients response to therapy. However, that assay is limited in that not all patients with monoclonal gammopathy show abnormal free light chain measurements. Within the last year, a novel assay which can identify and quantitate individual immunoglobulin heavy chain/light chain pairs has received FDA approval. Like Immunofixation, this assay has the ability to identify m-protein heavy chain and light chain isotypes. However, unlike Immunofixation, the heavy chain/light chain combination assay is quantitative and provides information which is independent of complicating factors such as changes in hematocrit. This heavy chain/light chain combination assay shares with the free light chain assay the ability to measure the analyte in normal individuals, providing exquisite sensitivity when measuring patients in relapse or with minimal residual disease.

The heavy chain/light chain combination assay is not intended to replace the free light chain assay but rather provides complementary information which enhances the laboratorys ability to provide quantitative information on M-protein production. Utilizing both assays,will enhance the ability of the laboratory and the clinician to evaluate patient tumor load at diagnosis and in response to therapy.

May 29, 7:30 AM - 8:30 AM PT

Ensuring Quality Using IT Algorithms

Eric Vasbinder, BS

Chemistry Automation Supervisor Chemical Pathology Laboratory, University of Michigan Health System

Case Example: University of Michigan Chemical Pathology Laboratory

Every laboratory wants to achieve the highest quality possible and meet its commitment to deliver timely results. However, managing Quality Control (QC) is frequently a manual and time-consuming process which may raise turnaround time and the risk of errors. In this session, Eric Vasbinder from University of Michigan Hospital will demonstrate proven techniques such as patient moving averages and Westgard rules to proactively manage QC issues. Over the past 7 years, the University of Michigan has been able to reduce errors by 73% and increase volume 97%, while holding headcount flat. Learn the tips and techniques that have worked for this progressive laboratory to optimize QC with the CentraLink Data Management System.

Learning Objectives:

Learn how to proactively manage QC and prevent problems before they occur
Evaluate the right batch size for patient moving averages
Explore the benefits of integrating QC with your data management process
Pinpoint the problem areas and redirect samples to minimize delay and reagent waste

May 30, 7:30 AM - 8:30 AM PT

The Role of Lactate in the Risk Assessment of Morbidity and Mortality

Monet Sayegh, MD

Senior Medical/Clinical Consultant, Siemens Healthcare Diagnostics

The value of measuring lactate levels is expanding. Though generally considered a nonspecific biomarker, knowing lactate levels early in a patients presentation can provide valuable information to help guide assessment and treatment. It can be particularly useful in ICU and ED settings where the presentation of symptoms may be inconclusive while diseases progress rapidly with severe pathology. Lactate testing can open a critical window for early intervention when treatment is most likely to be successful. This seminar provides a framework for understanding lactate and the role it can play as a prognostic indicator of morbidity and mortality.

Seminar Objectives
At the conclusion of the seminar, attendees should be able to:

Understand the role of lactate as a prognostic indicator for morbidity and mortality
Identify disease states where lactate testing can add significant clinical value
Understand the differences between the systemic inflammatory response (SIR) and sepsis, severe sepsis and septic shock
Understand the urgency associated with assessing lactate levels

May 30, 10:30 AM - 11:30 AM PT

Universal Definition of MI

Hans Loyda, PhD

Director, Scientific Affairs Cardiac, Roche Diagnostics Corporation

The program "The Universal Definition of MI & Troponin, Clearing the confusion" is intended to review the recently released Third Universal Definition of Myocardial Infarction and aims to familiarize clinicians and laboratory health care providers with the implications for current practice.

The focus will be on understanding the use of troponin in the Clinical Setting and my discussions will include:


The identification of pathological characteristics of myocardial ischemia and infarction,
The classification framework created by the 2007 Universal Definition of MI,
The biomarker preference and endorsement of cardiac troponins as preferred biomarker for each category of MI emphasizing that an increased troponin concentration is defined as a value exceeding the 99th percentile of a normal reference population, and
The differentiation of acute and chronic cTn elevations.

Infectious Disease-+

May 29, 7:30 AM - 8:30 AM PT

Is Cervical Cancer a preventable Disease in women? The role of HPV as a screening test.

Belinda Yen-Lieberman, PhD

Director of Clinical Virology, Serology, and Cellular Immunology, Cleveland Clinic

Human papillomavirus (HPV) is the primary cause of cervical cancer and more than 100 types of HPV have been identified. Detection of HPV from cervical samples is associated with a 250 times increased risk of high grade cervical neoplasm. Approximately 30 HPV types were reported to infect primarily the squamous epithelium of the lower anogenital tracts of men and women. Worldwide, Cervical Cancer is much more common particularly in countries without screening programs, with an estimated 530,000 new cases of the disease and 275,000 resultant deaths each year (Farlay J, et al. 2008 and Arbyn M, et al 2011). When cervical cancer screening programs have been introduced into communities, marked reductions in cervical cancer incidence have followed (Gustafsson L, et al 1997).

Human Papillomavirus is one of the most common sexually transmitted infections (STI) in the United States in women, with approximately 6.2 million cases diagnosed annually. The American Cancer Society estimates that there will be 12,170 new cases of cervical cancer in the United States in 2012, with 4,220 deaths from the disease ( Siegel R et al. 2012).

Learning Objectives:

At the completion of the presentation, the learners should know:
1. What is Human Papilloma virus (HPV)
2. HPV is the primary causal factor of cervical cancer and cervical disease in Women
3. HPV is one of the most common sexually transmitted infections the the USA
4. HPV vaccines are available for young men and young women
5. Why is HPV testing important in women?

Laboratory Automation & Testing-+

May 28, 6:00 AM - 7:00 AM PT

How to Improve Healthcare with More Effective Clinical Laboratory Test Utilization

Julie R Taylor, PhD, MS

Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC), Division of Laboratory Programs, Standards, and Services Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services Centers for Disease Control and Prevention

Due to the large increase in the number and complexity of clinical laboratory tests, optimal use of laboratory testing services has presented many challenges. The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, composed of expert physicians and laboratory professionals, and supported by the Division of Laboratory Programs, Standards and Services at CDC, is addressing these challenges with several approaches. The session will provide information and tools produced by CLIHCTM initiatives to improve laboratory test utilization, including development of test algorithms and mobile applications for test selection. Participants will learn about physicians challenges in laboratory test selection and result interpretation (http://www.jabfm.org/content/27/2/268.full) as well as gaps in laboratory medicine training in medical schools. Data presented on both topics are based on national surveys conducted by CDCs CLIHCTM program. In this session, tools will be provided to assist in managing clinical laboratory test utilization.

Learning Objectives:

1) Describe the challenges physicians face for laboratory test selection and result interpretation
2) Identify at least three tools that can be used to assist physicians in improving test utilization for better patient care
3) Define the gaps in medical school curricula that could be remedied to improve physicians knowledge of laboratory medicine.

May 28, 7:30 AM - 8:30 AM PT

How Automation is Required in Order for a Laboratory to Achieve Six-Sigma Quality in Non-Analytic Metrics

Charles D Hawker, PhD, MBA, FACB

Scientific Director, Automation & Special Projects, ARUP Laboratories, Professor (Adjunct) of Pathology, University of Utah

Six-Sigma quality is defined as 3.4 (or fewer) defects per million opportunities (DPMO). Achieving Six-Sigma quality in a clinical laboratory is extremely difficult. This presentation will show how the presenters laboratory has been able to achieve this level in lost specimens per 100,000 billed units, probably representing the first US laboratory to achieve Six-Sigma quality for any metric, analytic or nonanalytic. What has enabled this to happen is a 20-year continuum of process improvement and automation, especially using robotics and advanced software. Among the automation systems employed at the authors laboratory are an 1100 foot conveyor system that routes barcoded specimens to 8 high-speed sorters, a two story robotic freezer that holds up to 2.3 million specimens, 2 automated thawing & mixing workcells, and other systems, Further, with the invention and validation of an automated camera system that uses optical character recognition (OCR) technology to identify potentially mislabeled specimens, a second nonanalytic metric in the presenters laboratory now has the prospect of also reaching Six-Sigma quality levels. Using these developments as the background, this presentation will describe several activities that participants can undertake in their own laboratories that will improve nonanalytic quality without the major investments in automation that have happened in the presenters laboratory.

Learning objectives: Upon completion of this activity, participants will be able to: (1) define Six-Sigma quality, and (2) list three activities to improve non-analytic quality in ones own lab.

May 28, 1:30 PM - 2:30 PM PT

Lowering Blood Culture Contamination Rates Using an Evidence-Based Medicine Approach

Alice Weissfeld, PhD, D (ABMM), F(AAM)

President, CEO and Laboratory Director, Microbiology Specialists Incorporated

Blood culture contamination is a huge problem in the hospital. If strict aseptic technique is not used, patients can be treated unnecessarily, leading to complications from intravenous antimicrobial use. Unnecessary treatment costs hundreds of thousands of dollars per year. A number of changes in how blood cultures are collected have been shown to lower the percent contamination. These will be discussed in this presentation.

Learning Objectives:
After Completing this activity, the learner will be able to:

1. Discuss the three interventions that have been shown to lower blood culture contamination
2. Discuss what a PICO based evidence-review means
3. Discuss the target for lowering blood culture contamination at their own institution

May 30, 9:00 AM - 10:00 AM PT

How does the soluble mechanistic biomarker 14-3-3 eta assist in the management of Rheumatoid Arthritis?

Anthony Marotta, PhD

Chief Scientific Officer, Augurex Life Sciences Corp

RA is a chronic autoimmune disease that if left untreated results in severe joint destruction. It is estimated that 30-50% of patients will end up on workplace disability within 5 years of diagnosis. Early identification of RA, assessment of the severity of disease at presentation, together with a prompt and effective treatment strategy can significantly improve a patient's prognosis. To enable all of this, new markers are required 1) to improve the diagnosis of RA; 2) to efficiently stratify patients into different risk categories and 3) to guide treatment decisions.

The 14-3-3 family of proteins are ubiquitously expressed intracellular chaperonins. In 2007, Kilani et al. demonstrated that the eta isoform was abundantly expressed in the synovial fluid and serum of patients with RA. They also demonstrated that there was a significantly strong correlation with the levels of MMPs, and that extracellular 14-3-3η possesses ligand-like activity capable of inducing these degradative enzymes underscoring its role in the pathogenesis of joint damage in RA. Since 14-3-3 eta is not normally present extracellularly, the immune system sees soluble 14-3-3 eta as foreign. Using quantitative assays, we have reported that serum 14-3-3 eta and its auto-antibodies are highly specific RA markers which together identify greater than 90% of early RA patients. Patients who are 14-3-3 eta protein positive have worse disease outcomes over 5 years compared to the patients who are 14-3-3 eta negative. This is likely due to the role that 14-3-3 eta plays in inducing pro-inflammatory factors like TNF alpha that also perpetuate disease.

Learning Objectives

At the end of the presentation, participants will be able to:

1. Understand the how markers are used in the management of RA and what are the current needs.
2. Understand how the two 14-3-3 eta biomarkers assist with the management of RA

Lipids-+

May 30, 3:00 PM - 4:00 PM PT

Opportunities to simplify clinical lipid assessment

David R Sullivan, MBBS, FRACP, FRCPA

Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

Laboratory assessment of serum lipid and lipoprotein levels is essential for the management of the risk of atherothrombotic cardiovascular disease (CVD). Traditionally, this has involved the measurement of fasting levels of total and HDL cholesterol, as well as calculation or direct measurement of LDL cholesterol (LDL-C). Contemporaneous fasting triglyceride levels are required for calculation of LDL-C.

Several recent developments have created uncertainty concerning the current and future use of LDL-C as the main focus of CVD management. This presentation will examine the clinical and therapeutic insights that have prompted a reduction in the emphasis on LDL-C. It will also explore alternatives that may enhance laboratory CVD risk assessment, some of which are relatively simple.

Oncology-+

May 30, 7:30 AM - 8:30 AM PT

Multiplexed Fusion Gene Detection using Next Generation Sequencing

Kelli Bramlett and Jeoffrey Schageman

Kelli Bramlett, Senior Manager, R&D Thermo Fisher Scientific Jeoffrey Schageman, Staff Scientist, Thermo Fisher Corp.

As next-generation sequencing (NGS) platforms advance in their speed, ease-of-use, and cost-effectiveness, many translational researchers are transitioning from microarrays to RNA sequencing (or RNA-seq) for their gene expression analysis needs. RNA-seq goes beyond differential gene expression to provide fundamental insights into how genomes are organized and regulated. New RNA-seq solutions now offer higher sensitivity, increased sample number flexibility, and the ability to analyze highly degraded or rare samples from as little as 10 ng of input RNA. Dr. Bramlett will discuss how NGS and RNA-seq can be applied for the discovery of new tumor biomarkers in archived formalin-fixed, paraffin-embedded (FFPE) samples.

POCT-+

May 30, 9:00 AM - 10:00 AM PT

Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using conventional and molecular tests. Dr's Bowman and Wang

Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD

Dr. Bowman is Medical Director, Enzo Clinical Laboratories Dr. Wang is Chief of Microbiology and Molecular Diagnostics Westchester Medical Center, New York Medical College

Vaginitis and vaginosis, including Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV), are extremely common conditions, consuming many healthcare resources and having significant potential adverse consequences for women. Traditional diagnosis has relied on clinical signs and symptoms and a number of conventional diagnostic tests. The presentation of vaginitis and vaginosis is not always typical, and the usual diagnostic tests are not always straight forward, reproducible, or sensitive. Newer molecular techniques may be more sensitive and revealing about the conditions. They have also helped to re-shape our understanding about BV, VVC, and TV, but they are more complex and expensive. This presentation will discuss the spectrum of conventional and molecular tests currently available for BV, VVC, and TV and compare tests performance and utility in light of clinical indications.

Learner Objectives:

Attendee will be able to:

1. Describe the pertinent clinical characteristics of BV, VVC, and TV.

2. List the classic or conventional diagnostic criteria for BV, VVC, TV.

3. Identify the most common conventional tests for BV, VVC, TV.

4. List current and upcoming molecular tests for identifying BV, VVC, and TV.

5. Compare the advantages and disadvantages of conventional versus molecular tests for BV, VVC, and TV.

6.Distinguish when conventional tests or molecular tests might be indicated for BV, VVC, and TV.

May 30, 10:30 AM - 11:30 AM PT

Are we able to amplify single bacterial/viral/fungal genome equivalent?

Ivan Brukner, PhD

Head of Molecular Microbiology Unit- Molecular Biology, Jewish General Hospital - McGill University

There is growing pressure to implement new generation sequencing platform in hospital emergency rooms. The utility would be obvious: identifying unknown pathogens form cerebrospinal fluid/plasma/body fluids and guiding next step in therapy. What is exactly preventing us in taking this step, if we know that billions of dollars is/was spent on revealing cancer-relevant sequence-signatures using the same technology? And one vanishes from cancer much slower comparing to 24-48h time-window of life under unrelieved life-threatening infection. What went wrong in cashing in technological advance?

May 30, 3:00 PM - 4:00 PM PT

PoCT Integrated into Clinical Care Contributing to Improved Cardiac Outcomes in Rural Areas

Rosy Tirimacco BSc

Network Operations & Research Manager, iCCnet, Country Health SA Local Health Network Inc

Clinical networks link groups of professionals and organisations from primary, secondary and tertiary care, shifting emphasis from institutional to patient needs and outcomes. One of the main aims of clinical networks is to facilitate best practice health care.

The Integrated Cardiovascular Clinical Network, Country Health South Australia (iCCnet CHSA) provides an integrated solution to ensure patients presenting to rural health facilities receive access to appropriate cardiac care. Solutions include clinical tools, resources and systems designed to support the practice of evidence-based acute cardiac care by practitioners, including remote area nurses, from a diverse range of backgrounds and with varying levels of experience and training. Point of Care Testing (PoCT) incorporated into clinical care with appropriate clinical pathways linked with 24 hour technical and Cardiologist support has been deployed throughout country hospitals in South Australia.

PoCT is managed by a group of clinical scientists who are responsible for ensuring the service is run within a quality framework. All sites perform quality control and external quality assurance to ensure results generated do not compromise patient care.

To evaluate the impact of iCCnet CHSA on patient outcomes, 30-day mortality among patients with myocardial infarction (MI) was evaluated. Results have shown the interventions introduced have led to a 22% reduction in 30-day mortality for MI.

Pain Management-+

May 29, 6:00 AM - 7:00 AM PT

Chronic Pain Management and Laboratory Testing

Benjamin Abraham, MD

Anesthesiology/Chronic Pain Management, Cleveland Clinic

Chronic pain has continued to grow as a public health concern, now affecting more than 116 million people in the United States. It is the leading cause of disability among American workers. Laboratory testing has become increasingly important in order to care for these patients safely.

This presentation will review the history and new challenges for treatment inherent in this population

Personalized Medicine-+

May 28, 10:30 AM - 11:30 AM PT

Monitoring drugs and medications in pain and addiction patients

Amadeo J Pesce, PhD, DABCC

Laboratory Director, Millennium Laboratories, Inc.

Guidelines for physicians treating pain patients with chronic opioid therapy recommend the patients be monitored for the presence of their prescribed medications. In addition, it is often recommended that these patients be monitored for the possible presence of non-prescribed medications and drugs. Monitoring patients with substance abuse issues requires a similar testing menu that includes a wide spectrum of prescription medications and illicit agents. Analytical considerations in drug testing are important for health care providers to understand for optimal clinical decision-making. Point of care devices based on immunoassay principles have gained popularity for this type of testing. However, all immunoassays have limited ability to provide the required analytical sensitivity and specificity required for the clinician to make an accurate clinical assessment. Furthermore, the test menus are limited and do not include newer medications. Finally, immunoassay tests are readily deceived by the addition of small amounts of the medication tablet. The current method of choice for providing such testing is liquid chromatography tandem mass spectrometry. Because of its sensitivity and specificity for many drugs, testing can be performed with little sample preparation. Of additional benefit, it is possible to adjust cutoffs to meet clinical needs. Historically urine has been the fluid of choice for drug testing, but oral fluid is being used more frequently as it is an easily obtained witnessed collection. Interpretation of drug testing results should include quantitative evaluation of the inactive as well as the active metabolites of the administered medication.


Objectives
1. Understand why patients on chronic opioid therapy are monitored.
2. Be able to describe the range of drugs encountered
3. Be able to discuss the differnces in specificity betweem immunoassays and mass spectrometry ones
4. Bio, title, BioBe able to describe the detection of drugs in urine and oral fluid

May 29, 12:00 PM - 1:00 PM PT

Pharmacogenomics and Pharmacometabolomics for Personalized Medicine

Steven Wong, PhD, DABCC(TC), FACB

President, AACC 2014, Professor of Pathology, Director, Clinical Chemistry, Co-Director, Clinical and Translational Mass Spectrometry Center, Wake Forest University School of Medicine

Pharmcogenomics (PGx) is the 2nd potential clinical application of genomic medicine, preceded by genomic application for cancer. In the recently published, 2012 Institute of Medicine report on Evolution of Translational Omics: Lessons Learned and the Path Forward , 4 molecular disciplines included genomics, transcriptomics, proteomics and metabolomics. The proper application of genomics/PGx and other omics biomarkers requires development and evaluations, with clinical utilities performed in a CLIA certified laboratory. Further, there is emerging evidence of the bidirectional relationship, possibly modifying the central dogma of molecular biology. A subset of metabolomics - pharmacometabolomics complements PGx by assessing its effect on drug metabolism. Coupled with recent advances in molecular diagnostics such as Next Generation Sequencing, Genome Wide Association Studies, and high resolution LCMSMS, translational PGx and pharmacometabolomics are being rapidly explored to optimize drug therapies by offering the possible practice of Personalized Medicine in transplant, cancer, pain management, and other areas.

Vitamin D-+

May 28, 7:30 AM - 8:30 AM PT

Technical Challenges and Standardization of Vitamin D

James Freeman, BS

Director, Assay Development, Siemens Healthcare Diagnostics

Variability of vitamin D results remains a hot topic today as more options are available to laboratories. This webinar examines how clinical and analytical factors such as vitamin D binding protein (DBP), 3-epi-25(OH)vitamin D3, and vitamin D2 supplementation may impact vitamin D values, and how these in turn may impact clinical decisions. It also discusses how initiatives such as the NIH Office of Dietary Supplements Vitamin D Standardization Program (VDSP) will improve standardization of results.

Learning objectives:
Understand the clinical and analytical factors that influence the measurement of vitamin D by immunoassay and how they impact patient results.
Learn about the implementation of the Vitamin D Standardization Program and the next steps in vitamin D harmonization.

May 28, 10:30 AM - 11:30 AM PT

Early infantile rickets: A new look at an old disease and mimic of child abuse

David Ayoub, MD

Board Certified Diagnostic Radiologist, Clinical Radiologist, SC

Early infantile rickets is the least appreciated form of this ancient disease of children. Although it is usually subclinical, the high prevalence recently reported at autopsy (87% < 1 year age) suggests it is far more common than classical presentations and vastly underappreciated. In my experience with living subjects the disease is most often recognized in infants with unexplained fractures undergoing skeletal surveys for suspected child abuse. Classical signs of metaphyseal fraying and splaying are absent, but numerous additional radiographic signs of rickets and hyperparathyroidism are easily recognized. The most common radiographic finding is that of staged rachitic growth plate recovery indicating that extremity fractures occur after initiation of healing. The development of disease is associated with numerous maternal risk factors, particularly vitamin D deficiency and use of antacids. Biochemical testing in the infants is highly variable. Early infantile rickets closely resembles the clinical and radiographic findings of osteopathy of prematurity.

Objectives:
1) To recognize the clinical signs and risk factors of vitamin D deficiency during pregnancy and early infancy
2) Describe the range of radiographic changes of rickets in early infancy and how they differ from classical rickets.

May 28, 3:00 PM - 4:00 PM PT

Vitamin D Testing in the Clinical Laboratory: The Status in 2014

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor of Endocrine Bone Research Laboratory, Univ of South Australia

Interest in vitamin D status remains high amongst the public and medical profession alike stimulating a surge in requests for clinical laboratories to measure patient serum 25-hydroxyvitamin D levels. It is stimulated by reports that a low vitamin D status is common and is associated with an increased incidence of a variety of diseases. Questions facing the clinical laboratory providing this service include: How reliable are the various serum 25-hydroxyvitamin D assays that are available to the clinical laboratory and which patient groups benefit most from this test? In the past confidence in the quality of serum 25-hydroxyvitamin D assays has been questioned. An internationally accepted reference measurement procedure and reference standards for serum 25-hydroxyvitamin D assays are now available. Restandardization of routine automated assays has been implemented for a number of assays demonstrating considerable improvement in the accuracy of these assays for most patient groups. However recent data suggest that for some patient groups inaccuracy is still a significant clinical problem. The highest levels of evidence indicate that the elderly with a low vitamin D status benefit from vitamin D and dietary calcium supplementation to reduce risks of premature mortality, falls and fractures. There is no agreement that screening for vitamin D deficiency in the general population is cost effective. However there is agreement that a variety of patients groups can benefit by correcting their vitamin D deficiency. Interpretation of serum 25-hydroxyvitamin D levels remains highly controversial although considerable advances have been made elucidating the physiology of vitamin D metabolite homeostasis.

May 29, 6:00 AM - 8:00 AM PT

Panel Discussion: Vitamin D Requirements during Pregnancy and Lactation, Bio Available 25-HydroxyVitamin D, Doctors Holick, Thadhani, and Wagner

Michael Holick, MD, PhD, Ravi I Thadhani, MD, MPH, Carol Wagner, MD

Dr. Holick, is Professor of Medicine, Physiology and Biophysics, Director of the General Clinical Research Center, Director of the Vitamin D, Skin and Bone Research Laboratory, Director, Biologic Effects of Light Research Center, Boston University Medical Center Dr. Thadhani is Chief, Division of Nephrology Massachusetts General Hospital, Harvard Medical School Dr. Carol Wagner is Professor of Pediatrics, Associate Director, Clinical & Translational Research Center, Medical University Sout

Cardiology

6:00 AM - 7:00 AM PT

High Sensitivity Troponin as an Emerging Marker in Prediction of Cardiovascular Disease

Vijay Nambi, MD

Assistant Professor of Medicine, Baylor College of Medicine


Healthcare reform

1:30 PM - 2:30 PM PT

Legal and Regulatory Developments Affecting Molecular Testing

Peter M Kazon, JD

Attorney, Alston & Bird, LLP

The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by CMS. This session will discuss recent developments in these areas. While FDA has not acted to explicitly regulate molecular testing that is performed as a Laboratory Developed Test, the agency continues to suggest that new requirements will soon be forthcoming. In the meantime, FDA has acted to limit the use of tests labeled as Research Use Only or Investigational Use Only, and to increase its oversight of innovative Companion Diagnostics. Meanwhile, Medicare has developed new processes for determining whether or not to pay for developing molecular tests, such as the MolDx Program, created by Palmetto Government Services, one of the Medicare Administrative Contractors, which requires special coding of and technical assessment of new molecular tests. Finally, the payment for this testing has been in turmoil, as a result of Medicares year-long gapfilling process that occurred in 2013. As part of legislation passed in April, however, pricing will go through yet another major change, as the Medicare Program moves away from the current fee schedule approach to one that is designed to reflect market prices beginning in 2017. That legislation also includes special payment provisions affecting Advanced Diagnostic Laboratory Tests, which could affect many new molecular tests. Before any of that happens, however, there will need to be a complex regulatory approach to define what is to be reported to CMS and how that reporting will occur. This program will examine these developments and attempt to make some predictions about their likely impact

Industry

6:00 AM - 7:00 AM PT

The new role for HPV DNA testing: cobas HPV Test as a first-line cervical cancer screen

Julia Engstrom-Melnyk, PhD

Scientific Affairs Manager, Medical and Scientific Affairs, Roche Diagnostics

For the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology -- if it is negative, women are rescreen in three years and if positive, are referred to follow-up examinations. Although this strategy has led to a tremendous reduction in the incidence of cervical cancer, some significant limitations exist. Cytology has low sensitivity for cervical cancer pre-cursors, has low reproducibility, and does not adequately assess long-term risk. HPV testing added to cytology as a co-test for women 30 years and older increases the sensitivity of cytology and addresses many of its limitation, but also significantly contributes to the complexity of management. Additionally, it does not address the women 25-29 who are still screened with cytology alone. In ATHENA, 28% of all CIN3+ lesions detected were in women 25-29 -- more high-grade disease was found in these 6,647 women than in the 22,006 women 40 years and older. Further, cytology-based screening, the only other option for women 25-29, was negative in more than 57% of these cases, suggesting that current screening with cytology is inadequate in identifying underlying CIN3+ lesions in this age group. This is highly relevant when assessing data from the National Cancer Institute's SEER Tumor Registry, which shows a sharp rise in the incidence of invasive cervical cancer between the ages of 25 and 34 years. Since the goal of cervical cancer screening is to prevent cervical cancer from developing, it important to identify high-grade cervical cancer precursors in women 25-29 years, so that the precursors can be treated prior to this up rise in cervical cancer incidence and cervical cancer may be prevented. As a solution, HPV DNA testing can be used as a first-line primary screen in women 25 and older to not only enhance screening sensitivity but also reduce the complexity of a co-test.

7:30 AM - 8:30 AM PT

Overview on ONE Study experience on standardization across multiple centers

Mathias Streitz, MS, Certified Biologist

Head of the Flow-Cytometry Facility, Institute of Medical Immunology, Charite - Universittsmedizin Berlin


10:30 AM - 11:30 AM PT

Heavy/Light Chain Combination Assays: What Laboratories should know about M-Protein detection

Richard O'Hara, PhD

Senior Director of Scientific Affairs, Binding Site

Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed at diagnosis. Furthermore, difficulties in traditional methods of measuring monoclonal proteins have restricted the ability to measure M-proteins at low levels thereby limiting the laboratory and the clinician, particularly in identifying patients who have minimal residual disease.

In the past decade, assays which can measure immunoglobulin free light chains has improved detection of patients with Multiple Myeloma and related diseases, as well as providing a more sensitive tool for measuring a patients response to therapy. However, that assay is limited in that not all patients with monoclonal gammopathy show abnormal free light chain measurements. Within the last year, a novel assay which can identify and quantitate individual immunoglobulin heavy chain/light chain pairs has received FDA approval. Like Immunofixation, this assay has the ability to identify m-protein heavy chain and light chain isotypes. However, unlike Immunofixation, the heavy chain/light chain combination assay is quantitative and provides information which is independent of complicating factors such as changes in hematocrit. This heavy chain/light chain combination assay shares with the free light chain assay the ability to measure the analyte in normal individuals, providing exquisite sensitivity when measuring patients in relapse or with minimal residual disease.

The heavy chain/light chain combination assay is not intended to replace the free light chain assay but rather provides complementary information which enhances the laboratorys ability to provide quantitative information on M-protein production. Utilizing both assays,will enhance the ability of the laboratory and the clinician to evaluate patient tumor load at diagnosis and in response to therapy.

Keynote

9:00 AM - 10:00 AM PT

Keynote: Establishing an economic BRCA1 and BRCA2 (BRCA) gene analyses research workflow using custom AmpliSeq panel design and the Ion PGM System

Jeffrey N Weitzel, MD

Director, Clinical Cancer Genetics, Professor, Director, Cancer Screening & Prevention City of Hope

While the "Jolie effect" has refocused attention on the central role of BRCA gene analyses in the diagnosis and prevention of hereditary breast and ovarian cancer, there is a global disparity in access to affordable testing. The development of bench top NGS technologies holds promise for faster, more comprehensive and cost-effective methodologies than Sanger sequencing.

The goal of the study was to create a global consortium for developing and demonstrating the feasibility of a shared, dedicated workflow that may develop into a clinical grade BRCA gene analyses using Ion AmpliSeqTM multiplex PCR technology combined with the Ion PGMTM Sequencer.

12:00 PM - 1:00 PM PT

Keynote

Barbara Van Der Pol, PhD, MPH

Associate Professor of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine

The CDC has recently released the Recommendations for Laboratory Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. As a result of advances in molecular diagnostics, the current recommendations are substantially different from the previous version published in 2002. Dr. Van Der Pol will provide data regarding the importance of chlamydia and gonorrhea screening and describe the process by which the current guidelines were developed. The application of the guidelines in both laboratories and in clinical settings will be described. Recommendations for testing non-genital (e.g. ano-rectal and oropharyngeal) samples will also be discussed. Adoption of the CDC recommendations will improve sexually transmitted infection control efforts and may help move screening toward a normative, sexual health maintenance practice.

LEARNER OBJECTIVES:
The learner will be able to choose the appropriate type of assay to use for chlamydia/gonorrhea screening.
The learner will be able to provide appropriate screening options for patients who report anal or oral sex.

Laboratory Automation & Testing

6:00 AM - 7:00 AM PT

How to Improve Healthcare with More Effective Clinical Laboratory Test Utilization

Julie R Taylor, PhD, MS

Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC), Division of Laboratory Programs, Standards, and Services Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services Centers for Disease Control and Prevention

Due to the large increase in the number and complexity of clinical laboratory tests, optimal use of laboratory testing services has presented many challenges. The Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) TM, composed of expert physicians and laboratory professionals, and supported by the Division of Laboratory Programs, Standards and Services at CDC, is addressing these challenges with several approaches. The session will provide information and tools produced by CLIHCTM initiatives to improve laboratory test utilization, including development of test algorithms and mobile applications for test selection. Participants will learn about physicians challenges in laboratory test selection and result interpretation (http://www.jabfm.org/content/27/2/268.full) as well as gaps in laboratory medicine training in medical schools. Data presented on both topics are based on national surveys conducted by CDCs CLIHCTM program. In this session, tools will be provided to assist in managing clinical laboratory test utilization.

Learning Objectives:

1) Describe the challenges physicians face for laboratory test selection and result interpretation
2) Identify at least three tools that can be used to assist physicians in improving test utilization for better patient care
3) Define the gaps in medical school curricula that could be remedied to improve physicians knowledge of laboratory medicine.

7:30 AM - 8:30 AM PT

How Automation is Required in Order for a Laboratory to Achieve Six-Sigma Quality in Non-Analytic Metrics

Charles D Hawker, PhD, MBA, FACB

Scientific Director, Automation & Special Projects, ARUP Laboratories, Professor (Adjunct) of Pathology, University of Utah

Six-Sigma quality is defined as 3.4 (or fewer) defects per million opportunities (DPMO). Achieving Six-Sigma quality in a clinical laboratory is extremely difficult. This presentation will show how the presenters laboratory has been able to achieve this level in lost specimens per 100,000 billed units, probably representing the first US laboratory to achieve Six-Sigma quality for any metric, analytic or nonanalytic. What has enabled this to happen is a 20-year continuum of process improvement and automation, especially using robotics and advanced software. Among the automation systems employed at the authors laboratory are an 1100 foot conveyor system that routes barcoded specimens to 8 high-speed sorters, a two story robotic freezer that holds up to 2.3 million specimens, 2 automated thawing & mixing workcells, and other systems, Further, with the invention and validation of an automated camera system that uses optical character recognition (OCR) technology to identify potentially mislabeled specimens, a second nonanalytic metric in the presenters laboratory now has the prospect of also reaching Six-Sigma quality levels. Using these developments as the background, this presentation will describe several activities that participants can undertake in their own laboratories that will improve nonanalytic quality without the major investments in automation that have happened in the presenters laboratory.

Learning objectives: Upon completion of this activity, participants will be able to: (1) define Six-Sigma quality, and (2) list three activities to improve non-analytic quality in ones own lab.

1:30 PM - 2:30 PM PT

Lowering Blood Culture Contamination Rates Using an Evidence-Based Medicine Approach

Alice Weissfeld, PhD, D (ABMM), F(AAM)

President, CEO and Laboratory Director, Microbiology Specialists Incorporated

Blood culture contamination is a huge problem in the hospital. If strict aseptic technique is not used, patients can be treated unnecessarily, leading to complications from intravenous antimicrobial use. Unnecessary treatment costs hundreds of thousands of dollars per year. A number of changes in how blood cultures are collected have been shown to lower the percent contamination. These will be discussed in this presentation.

Learning Objectives:
After Completing this activity, the learner will be able to:

1. Discuss the three interventions that have been shown to lower blood culture contamination
2. Discuss what a PICO based evidence-review means
3. Discuss the target for lowering blood culture contamination at their own institution

Personalized Medicine

10:30 AM - 11:30 AM PT

Monitoring drugs and medications in pain and addiction patients

Amadeo J Pesce, PhD, DABCC

Laboratory Director, Millennium Laboratories, Inc.

Guidelines for physicians treating pain patients with chronic opioid therapy recommend the patients be monitored for the presence of their prescribed medications. In addition, it is often recommended that these patients be monitored for the possible presence of non-prescribed medications and drugs. Monitoring patients with substance abuse issues requires a similar testing menu that includes a wide spectrum of prescription medications and illicit agents. Analytical considerations in drug testing are important for health care providers to understand for optimal clinical decision-making. Point of care devices based on immunoassay principles have gained popularity for this type of testing. However, all immunoassays have limited ability to provide the required analytical sensitivity and specificity required for the clinician to make an accurate clinical assessment. Furthermore, the test menus are limited and do not include newer medications. Finally, immunoassay tests are readily deceived by the addition of small amounts of the medication tablet. The current method of choice for providing such testing is liquid chromatography tandem mass spectrometry. Because of its sensitivity and specificity for many drugs, testing can be performed with little sample preparation. Of additional benefit, it is possible to adjust cutoffs to meet clinical needs. Historically urine has been the fluid of choice for drug testing, but oral fluid is being used more frequently as it is an easily obtained witnessed collection. Interpretation of drug testing results should include quantitative evaluation of the inactive as well as the active metabolites of the administered medication.


Objectives
1. Understand why patients on chronic opioid therapy are monitored.
2. Be able to describe the range of drugs encountered
3. Be able to discuss the differnces in specificity betweem immunoassays and mass spectrometry ones
4. Bio, title, BioBe able to describe the detection of drugs in urine and oral fluid

Vitamin D

7:30 AM - 8:30 AM PT

Technical Challenges and Standardization of Vitamin D

James Freeman, BS

Director, Assay Development, Siemens Healthcare Diagnostics


Variability of vitamin D results remains a hot topic today as more options are available to laboratories. This webinar examines how clinical and analytical factors such as vitamin D binding protein (DBP), 3-epi-25(OH)vitamin D3, and vitamin D2 supplementation may impact vitamin D values, and how these in turn may impact clinical decisions. It also discusses how initiatives such as the NIH Office of Dietary Supplements Vitamin D Standardization Program (VDSP) will improve standardization of results.

Learning objectives:
Understand the clinical and analytical factors that influence the measurement of vitamin D by immunoassay and how they impact patient results.
Learn about the implementation of the Vitamin D Standardization Program and the next steps in vitamin D harmonization.

10:30 AM - 11:30 AM PT

Early infantile rickets: A new look at an old disease and mimic of child abuse

David Ayoub, MD

Board Certified Diagnostic Radiologist, Clinical Radiologist, SC

Early infantile rickets is the least appreciated form of this ancient disease of children. Although it is usually subclinical, the high prevalence recently reported at autopsy (87% < 1 year age) suggests it is far more common than classical presentations and vastly underappreciated. In my experience with living subjects the disease is most often recognized in infants with unexplained fractures undergoing skeletal surveys for suspected child abuse. Classical signs of metaphyseal fraying and splaying are absent, but numerous additional radiographic signs of rickets and hyperparathyroidism are easily recognized. The most common radiographic finding is that of staged rachitic growth plate recovery indicating that extremity fractures occur after initiation of healing. The development of disease is associated with numerous maternal risk factors, particularly vitamin D deficiency and use of antacids. Biochemical testing in the infants is highly variable. Early infantile rickets closely resembles the clinical and radiographic findings of osteopathy of prematurity.

Objectives:
1) To recognize the clinical signs and risk factors of vitamin D deficiency during pregnancy and early infancy
2) Describe the range of radiographic changes of rickets in early infancy and how they differ from classical rickets.

3:00 PM - 4:00 PM PT

Vitamin D Testing in the Clinical Laboratory: The Status in 2014

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor of Endocrine Bone Research Laboratory, Univ of South Australia

Interest in vitamin D status remains high amongst the public and medical profession alike stimulating a surge in requests for clinical laboratories to measure patient serum 25-hydroxyvitamin D levels. It is stimulated by reports that a low vitamin D status is common and is associated with an increased incidence of a variety of diseases. Questions facing the clinical laboratory providing this service include: How reliable are the various serum 25-hydroxyvitamin D assays that are available to the clinical laboratory and which patient groups benefit most from this test? In the past confidence in the quality of serum 25-hydroxyvitamin D assays has been questioned. An internationally accepted reference measurement procedure and reference standards for serum 25-hydroxyvitamin D assays are now available. Restandardization of routine automated assays has been implemented for a number of assays demonstrating considerable improvement in the accuracy of these assays for most patient groups. However recent data suggest that for some patient groups inaccuracy is still a significant clinical problem. The highest levels of evidence indicate that the elderly with a low vitamin D status benefit from vitamin D and dietary calcium supplementation to reduce risks of premature mortality, falls and fractures. There is no agreement that screening for vitamin D deficiency in the general population is cost effective. However there is agreement that a variety of patients groups can benefit by correcting their vitamin D deficiency. Interpretation of serum 25-hydroxyvitamin D levels remains highly controversial although considerable advances have been made elucidating the physiology of vitamin D metabolite homeostasis.

Bioinformatics

6:00 AM - 7:00 AM PT

Challenges for the Pathology Profession in the Age of the Electronic Health Record How Informatics and Standardisation Initiatives can Help

Robert Flatman, FAACB, MBA, B App Sc

Assistant Manager Biochemistry, Sullivan Nicolaides Pathology, Australia

Governments, pathology providers, and clients relying on pathology reports face increasing conflict between burgeoning costs versus demands for service innovation. The health industry has been generally slower than the financial industry to embrace the benefits of computerization in terms of portability and accessibility. There have however been good reasons including the requirements for privacy and security, together with the complexity of the information itself.

Many countries have embraced programs for electronic health records (EHRs), encouraging electronic requesting and reporting of health information, including pathology. Pathology providers have long focused on excellence within their own institution by embracing the best analytical instrumentation, information technology for laboratory information systems, and the best medical expertise for interpretation and reporting. Centralised reporting to EHRs will however highlight to clinicians and tech-savvy patients unnecessary, and sometimes unsafe, variations in the requesting and reporting of pathology. Examples include variations in test profiles, test naming, reference limits and units.

Pathology providers and clients must collaborate to create robust standards for the transmission and interpretation of health messages. There is an urgent need in most countries to standardize both requesting and reporting. Structured messaging and medical terminologies offers tools to assist.

This presentation will focus on developments in both medical terminologies and pathology harmonisation initiatives that will require greater awareness and support from the medical community to generate maximum benefit.

7:30 AM - 8:30 AM PT

Identification of predictive biomarkers from high throughput drug combination screening data

Emma Bowden, PhD

Director, Translational Medicine, Thermo-Fisher Scientific

One of the major challenges to oncology based drug discovery and development has been the limited or incremental impact that many targeted agents have exhibited in the clinic. Understanding and overcoming tumor heterogeneity as well as inherent or emerging resistance are areas of significant ongoing research in both clinical and preclinical settings. Systematic approaches to support combination therapy clinical trial design are critical. Zalicus Inc. and Life Technologies have collaborated to develop a joint service offering that supports rationale design of cell line panels to inform and address the relevant genomic aberrations in disease subsequently enabling the identification of (1) potentially synergistic therapy combinations, (2) biomarkers of synergy, and (3) identification of potential clinical populations for hypothesis testing. During this segment, Dr. Bowden will discuss technical aspects of combination screening and biomarker discovery, major considerations required for success, provide examples of results, and offer potential impacts of this innovative service offering.

10:30 AM - 11:30 AM PT

Adding Value in Healthcare Delivery: Uses for Clinical Laboratory Informatics in Decision Support

Elizabeth Kenimer Leibach, EdD, MS, MLS(ASCP), SBB

Principal Officer, Healthcare Management and Education Services (HMES), Education Editor for Clinical Laboratory Science and Expert Consultant for the US Centers for Disease Control and Prevention

Clinical laboratory information provides decision support for most healthcare

providers and impacts care processes and patient outcomes throughout the entire

health services delivery system. Evidence-based practice (EBP) describes

systematic, data-derived strategies employed by clinical laboratory

practitioners in production, interpretation, and communication of laboratory

information. EBP includes health outcomes and diagnostic studies, cost-

effectiveness analyses, practice guidelines development, and

provider/patient/consumer education systems development. Evidence from

analyses of these efforts is then used to measure the quality of and assign

value to services delivered.

Rapid advancements in technology, communications, and information analytics

have intersected producing unprecedented opportunity for measuring healthcare

effectiveness and efficiency for providers and individual patient/consumers.

These rapid advancements have also contributed to challenging economics and

heightened privacy concerns. How EBP strategies can be used to define value

(highest quality at lowest cost) for providers and individual patient/consumers

will be explored. Personalized healthcare delivery models will be discussed.

Learn how the discovery and documentation of evidence-based practices help to

promote quality and value in healthcare.

Learning Objectives:

At the end of the presentation, participants will be able to:

1. Define clinical laboratory science (CLS) evidence-based practice (EBP)

constructs linking clinical research, quality improvement, and

provider/patient/consumer education.

2. Describe CLS practices supporting evidence-based clinical decision-

making in personalized healthcare.

3. Present EBP models describing the current status of clinical decision

support systems and suggesting directions for further development.

12:00 PM - 1:00 PM PT

Navigating the Complexities of the Human Oncoproteome with the SigNET KnowledgeBank

Steve Pelech, PhD

Professor, Department of Medicine, University of British Columbia, President & Chief Scientific Officer, Kinexus Bioinformatics Corporation

The human genome encodes ~21,500 proteins that are subject to reversible phosphorylation at nearly 1 million phosphosites by about 538 protein kinases and 156 protein phosphatases. Amongst other regulatory proteins, these classes of proteins play a central role in cancer as oncoproteins (OP), tumour-requiring proteins (TRP) or tumour suppressor proteins (TSP). They can be distinguished in part by their mutation patterns across thousands of tumour specimens. OP feature highly restricted mutations that produce a gain of function, commonly by loss of repression by inhibitory domains or mimicry of activating phosphorylation sites with acid amino acid residue substitutions. TSP typically feature an extensive range of mutation types and locations in their genes, which lead to their loss of function. By contrast, TRP display extremely low rates of mutation in human cancers, about 5 to 10-fold lower that the background mutation rates evident in bystander genes. TRP may serve as ideal targets for cancer drug development as they may be more commonly required for cancer development than OP, and they may be less tolerant to mutations that facilitate drug resistance. Interestingly, many OP are down-regulated and TSP are up-regulated in their protein levels in human tumours, which indicates that intracellular regulatory networks typically evoke compensatory mechanisms to restore growth control or induce apoptosis. Therefore, gene expression and mutation data has to be interpreted in the context of integrated signalling pathways. The open-access, on-line suite of SigNET KnowledgeBases offered by Kinexus provide extensive known and predictive information of human proteins, their gene expression, interactions and phosphorylation, and in the case of protein kinases, drug interactions. The new OncoNET website (www.onconet.ca) is a repository of detailed information about the mRNA expression and mutation patterns for nearly 3000 genes linked to diverse types of human cancers.

Endocrine

10:30 AM - 11:30 AM PT

Why are we unable to lose weight and keep it off? All about the connection between the gut and the brain

Caroline M Apovian, MD, FACP, FACN

Professor of Medicine and Pediatrics, Boston University School of Medicine Director, Center for Nutrition and Weight Management, Boston Medical Center

Obesity is a disease. It was once not considered to be a disease and to be a matter of will power and gluttony. It was also the case that we once thought that fat tissue had no metabolic function other than to be inert and store fat. We now know that adipose tissue is an endocrine organ that secretes adipokines that regulate metabolism and energy balance. There are several kinds of adipose tissue: white brown and beige. We used to think that brown fat was not present in adult humans, only in animals and human babies to generate heat. We now know that brown fat exists in the adult human and that white fat can undergo browning to become beige fat and burn more calories. We used to think that people who lost weight and regained it back and more had psychological disorders that made them eat. The overwhelming reason for weight regain is the body readjusting the energy regulation system and adjusting hormone levels so that a person feels preoccupied with food until they regain the weight. Other adjustments are made to resting metabolic rate so that it decreases to facilitate regain of weight. There is also some evidence to suggest that it may be our food supply that is creating this increase in the prevalence of obesity by interacting with pathways to appetite and satiety in the brain, thereby altering the signals to appetite and satiety. Foods high in fat cause obesity in animal models also cause inflammation in the hypothalamic area that controls food intake. These animals no longer regulate body fat and gain weight and eventually defend a high body set point weight. Human physiology may go through this same mechanism to defend a higher body weight in this toxic food environment.
How can we combat this new disease? Drugs devices and surgery and new methods in the pipeline are considered.

Hematology

10:30 AM - 11:30 AM PT

Going Beyond Cell Counting and Solving Common Problems Faced by Laboratories

Fernando P Chaves, MD

Director of Global Scientific Affairs, Beckman Coulter, Inc.

Learn how technological advances with the DxH 800/DxH 600 analyzers are bringing practical solutions to problems faced by labs and their clinicians and patients. After the webinar you'll understand how this technology can help labs achieve optimal patient care with accurate counting, automated detection of important morphologic changes, while minimizing workload impact thanks to decreased false positive flagging rates.

Industry

7:30 AM - 8:30 AM PT

Ensuring Quality Using IT Algorithms

Eric Vasbinder, BS

Chemistry Automation Supervisor Chemical Pathology Laboratory, University of Michigan Health System

Case Example: University of Michigan Chemical Pathology Laboratory

Every laboratory wants to achieve the highest quality possible and meet its commitment to deliver timely results. However, managing Quality Control (QC) is frequently a manual and time-consuming process which may raise turnaround time and the risk of errors. In this session, Eric Vasbinder from University of Michigan Hospital will demonstrate proven techniques such as patient moving averages and Westgard rules to proactively manage QC issues. Over the past 7 years, the University of Michigan has been able to reduce errors by 73% and increase volume 97%, while holding headcount flat. Learn the tips and techniques that have worked for this progressive laboratory to optimize QC with the CentraLink Data Management System.

Learning Objectives:

Learn how to proactively manage QC and prevent problems before they occur
Evaluate the right batch size for patient moving averages
Explore the benefits of integrating QC with your data management process
Pinpoint the problem areas and redirect samples to minimize delay and reagent waste

Infectious Disease

7:30 AM - 8:30 AM PT

Is Cervical Cancer a preventable Disease in women? The role of HPV as a screening test.

Belinda Yen-Lieberman, PhD

Director of Clinical Virology, Serology, and Cellular Immunology, Cleveland Clinic

Human papillomavirus (HPV) is the primary cause of cervical cancer and more than 100 types of HPV have been identified. Detection of HPV from cervical samples is associated with a 250 times increased risk of high grade cervical neoplasm. Approximately 30 HPV types were reported to infect primarily the squamous epithelium of the lower anogenital tracts of men and women. Worldwide, Cervical Cancer is much more common particularly in countries without screening programs, with an estimated 530,000 new cases of the disease and 275,000 resultant deaths each year (Farlay J, et al. 2008 and Arbyn M, et al 2011). When cervical cancer screening programs have been introduced into communities, marked reductions in cervical cancer incidence have followed (Gustafsson L, et al 1997).

Human Papillomavirus is one of the most common sexually transmitted infections (STI) in the United States in women, with approximately 6.2 million cases diagnosed annually. The American Cancer Society estimates that there will be 12,170 new cases of cervical cancer in the United States in 2012, with 4,220 deaths from the disease ( Siegel R et al. 2012).

Learning Objectives:

At the completion of the presentation, the learners should know:
1. What is Human Papilloma virus (HPV)
2. HPV is the primary causal factor of cervical cancer and cervical disease in Women
3. HPV is one of the most common sexually transmitted infections the the USA
4. HPV vaccines are available for young men and young women
5. Why is HPV testing important in women?

Keynote

9:00 AM - 10:00 AM PT

Keynote Panel Discussion: Companion Diagnostics: Changing the Face of Healthcare, Doctors Hawkins, Joseph, and Frank

Patrick Joseph, MD and Richard Frank, MD

Patrick Joseph, MD, Medical Director, Siemens Clinical Laboratory (SCL), Siemens Healthcare Diagnostics Richard Frank, MD, Chief Medical Officer, Clinical Strategy and Policy, Siemens Healthcare

What is the future of personalized medicine? Featuring Dr. Trevor Hawkins (An Introduction to Companion Diagnostics), Dr. Patrick Joseph (Making It Personal for Patients), and Dr. Richard Frank (The Impact on Healthcare Policy), this lively panel discussion will highlight the many ways in which Companion Diagnostics are changing the face of healthcare.
As a patient-centric shift continues to sweep our healthcare system, pharmaceutical companies are increasingly seeing the value of targeting treatments to specific patient populations, making their therapies more personal. In the burgeoning age of personalized medicine, companies are looking for ways to develop more specific, efficacious, and cost-effective treatments that are tailored to a patients needs, rather than focusing solely on the blockbuster drugs that have dominated the industry over the past few decades. Some companies have found novel ways to accommodate this shift, including adjusting their business models to focus on healthcare outcomes and collaborating with payers and providers to simplify reimbursement and provide tools and technologies to increase medication adherence.
Join Drs. Hawkins, Joseph, and Frank and learn how companion diagnostics promises to change the way patients are treated, therapies may be prescribed, and tests are developed, and how this fast-moving evolution will impact all of healthcare.

Learning Objectives:

At the end of the presentation, attendees will be able to:


Understand how companion diagnostics may improve patient outcomes by personalizing medicine.
Appreciate the pathways for adoption and prescription of companion diagnostic tests.

Pain Management

6:00 AM - 7:00 AM PT

Chronic Pain Management and Laboratory Testing

Benjamin Abraham, MD

Anesthesiology/Chronic Pain Management, Cleveland Clinic

Chronic pain has continued to grow as a public health concern, now affecting more than 116 million people in the United States. It is the leading cause of disability among American workers. Laboratory testing has become increasingly important in order to care for these patients safely.

This presentation will review the history and new challenges for treatment inherent in this population

Personalized Medicine

12:00 PM - 1:00 PM PT

Pharmacogenomics and Pharmacometabolomics for Personalized Medicine

Steven Wong, PhD, DABCC(TC), FACB

President, AACC 2014, Professor of Pathology, Director, Clinical Chemistry, Co-Director, Clinical and Translational Mass Spectrometry Center, Wake Forest University School of Medicine

Pharmcogenomics (PGx) is the 2nd potential clinical application of genomic medicine, preceded by genomic application for cancer. In the recently published, 2012 Institute of Medicine report on Evolution of Translational Omics: Lessons Learned and the Path Forward , 4 molecular disciplines included genomics, transcriptomics, proteomics and metabolomics. The proper application of genomics/PGx and other omics biomarkers requires development and evaluations, with clinical utilities performed in a CLIA certified laboratory. Further, there is emerging evidence of the bidirectional relationship, possibly modifying the central dogma of molecular biology. A subset of metabolomics - pharmacometabolomics complements PGx by assessing its effect on drug metabolism. Coupled with recent advances in molecular diagnostics such as Next Generation Sequencing, Genome Wide Association Studies, and high resolution LCMSMS, translational PGx and pharmacometabolomics are being rapidly explored to optimize drug therapies by offering the possible practice of Personalized Medicine in transplant, cancer, pain management, and other areas.

Vitamin D

6:00 AM - 8:00 AM PT

Panel Discussion: Vitamin D Requirements during Pregnancy and Lactation, Bio Available 25-HydroxyVitamin D, Doctors Holick, Thadhani, and Wagner

Michael Holick, MD, PhD, Ravi I Thadhani, MD, MPH, Carol Wagner, MD

Dr. Holick, is Professor of Medicine, Physiology and Biophysics, Director of the General Clinical Research Center, Director of the Vitamin D, Skin and Bone Research Laboratory, Director, Biologic Effects of Light Research Center, Boston University Medical Center Dr. Thadhani is Chief, Division of Nephrology Massachusetts General Hospital, Harvard Medical School Dr. Carol Wagner is Professor of Pediatrics, Associate Director, Clinical & Translational Research Center, Medical University Sout


Industry

7:30 AM - 8:30 AM PT

The Role of Lactate in the Risk Assessment of Morbidity and Mortality

Monet Sayegh, MD

Senior Medical/Clinical Consultant, Siemens Healthcare Diagnostics

The value of measuring lactate levels is expanding. Though generally considered a nonspecific biomarker, knowing lactate levels early in a patients presentation can provide valuable information to help guide assessment and treatment. It can be particularly useful in ICU and ED settings where the presentation of symptoms may be inconclusive while diseases progress rapidly with severe pathology. Lactate testing can open a critical window for early intervention when treatment is most likely to be successful. This seminar provides a framework for understanding lactate and the role it can play as a prognostic indicator of morbidity and mortality.

Seminar Objectives
At the conclusion of the seminar, attendees should be able to:

Understand the role of lactate as a prognostic indicator for morbidity and mortality
Identify disease states where lactate testing can add significant clinical value
Understand the differences between the systemic inflammatory response (SIR) and sepsis, severe sepsis and septic shock
Understand the urgency associated with assessing lactate levels

10:30 AM - 11:30 AM PT

Universal Definition of MI

Hans Loyda, PhD

Director, Scientific Affairs Cardiac, Roche Diagnostics Corporation

The program "The Universal Definition of MI & Troponin, Clearing the confusion" is intended to review the recently released Third Universal Definition of Myocardial Infarction and aims to familiarize clinicians and laboratory health care providers with the implications for current practice.

The focus will be on understanding the use of troponin in the Clinical Setting and my discussions will include:


The identification of pathological characteristics of myocardial ischemia and infarction,
The classification framework created by the 2007 Universal Definition of MI,
The biomarker preference and endorsement of cardiac troponins as preferred biomarker for each category of MI emphasizing that an increased troponin concentration is defined as a value exceeding the 99th percentile of a normal reference population, and
The differentiation of acute and chronic cTn elevations.

Keynote

11:30 AM - 12:30 PM PT

Keynote: Biochemical Markers of Bone Turnover in the Management of Postmenopausal Osteoporosis

Paul D Miller, MD

Distinguished Clinical Professor of Medicine, University of Colorado Health Sciences Center Medical Director Colorado Center for Bone Research

Bone turnover markers (BTM) are biological markers of bone remodeling (turnover). The entire skeleton is replaced every 10 years by remodeling, a process constantly going on at different phases throughout the skeleton (Figure 1). The purposes of remodeling are to repair the microcracks that occur in the skeleton with daily mechanical loading.

From these bone remodeling cavities proteins (BTM) are released into the circulation and can be measured by radioimmunoassay or immunoassay. (Figure 2)

The clinical evidence is consistent that these markers are useful for:

1. Determining the rate of bone turnover (high bone turnover is an independent risk factor for osteoporotic fracture) and predicting the rate of bone loss.

2. Assessing response to osteoporosis treatments (both anti-resorptive as well as anabolic agents). The change in the BTM after the initiation of treatment occurs rapidly-within 3 months of starting therapy and, therefore, provide much earlier information on compliance, and a bone effect than bone mineral density (BMD) which requires 1-2 years to see a measureable change. A change in the BTM also predicts improvements in BMD and predicts fracture risk reduction

Two large international groups: The International Osteoporosis Foundation-International Federation of Clinical Chemistry and The National Bone Health Alliance-American Association of Clinical Chemistry both have both endorsed, based on evidence, that the preferred BTM for bone formation is the propeptide type I collagen (PINP) and for bone resorption the collagen cross-link, C-telopeptide (CTX).

Laboratory Automation & Testing

9:00 AM - 10:00 AM PT

How does the soluble mechanistic biomarker 14-3-3 eta assist in the management of Rheumatoid Arthritis?

Anthony Marotta, PhD

Chief Scientific Officer, Augurex Life Sciences Corp

RA is a chronic autoimmune disease that if left untreated results in severe joint destruction. It is estimated that 30-50% of patients will end up on workplace disability within 5 years of diagnosis. Early identification of RA, assessment of the severity of disease at presentation, together with a prompt and effective treatment strategy can significantly improve a patient's prognosis. To enable all of this, new markers are required 1) to improve the diagnosis of RA; 2) to efficiently stratify patients into different risk categories and 3) to guide treatment decisions.

The 14-3-3 family of proteins are ubiquitously expressed intracellular chaperonins. In 2007, Kilani et al. demonstrated that the eta isoform was abundantly expressed in the synovial fluid and serum of patients with RA. They also demonstrated that there was a significantly strong correlation with the levels of MMPs, and that extracellular 14-3-3η possesses ligand-like activity capable of inducing these degradative enzymes underscoring its role in the pathogenesis of joint damage in RA. Since 14-3-3 eta is not normally present extracellularly, the immune system sees soluble 14-3-3 eta as foreign. Using quantitative assays, we have reported that serum 14-3-3 eta and its auto-antibodies are highly specific RA markers which together identify greater than 90% of early RA patients. Patients who are 14-3-3 eta protein positive have worse disease outcomes over 5 years compared to the patients who are 14-3-3 eta negative. This is likely due to the role that 14-3-3 eta plays in inducing pro-inflammatory factors like TNF alpha that also perpetuate disease.

Learning Objectives

At the end of the presentation, participants will be able to:

1. Understand the how markers are used in the management of RA and what are the current needs.
2. Understand how the two 14-3-3 eta biomarkers assist with the management of RA

Lipids

3:00 PM - 4:00 PM PT

Opportunities to simplify clinical lipid assessment

David R Sullivan, MBBS, FRACP, FRCPA

Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

Laboratory assessment of serum lipid and lipoprotein levels is essential for the management of the risk of atherothrombotic cardiovascular disease (CVD). Traditionally, this has involved the measurement of fasting levels of total and HDL cholesterol, as well as calculation or direct measurement of LDL cholesterol (LDL-C). Contemporaneous fasting triglyceride levels are required for calculation of LDL-C.

Several recent developments have created uncertainty concerning the current and future use of LDL-C as the main focus of CVD management. This presentation will examine the clinical and therapeutic insights that have prompted a reduction in the emphasis on LDL-C. It will also explore alternatives that may enhance laboratory CVD risk assessment, some of which are relatively simple.

Oncology

7:30 AM - 8:30 AM PT

Multiplexed Fusion Gene Detection using Next Generation Sequencing

Kelli Bramlett and Jeoffrey Schageman

Kelli Bramlett, Senior Manager, R&D Thermo Fisher Scientific Jeoffrey Schageman, Staff Scientist, Thermo Fisher Corp.

As next-generation sequencing (NGS) platforms advance in their speed, ease-of-use, and cost-effectiveness, many translational researchers are transitioning from microarrays to RNA sequencing (or RNA-seq) for their gene expression analysis needs. RNA-seq goes beyond differential gene expression to provide fundamental insights into how genomes are organized and regulated. New RNA-seq solutions now offer higher sensitivity, increased sample number flexibility, and the ability to analyze highly degraded or rare samples from as little as 10 ng of input RNA. Dr. Bramlett will discuss how NGS and RNA-seq can be applied for the discovery of new tumor biomarkers in archived formalin-fixed, paraffin-embedded (FFPE) samples.

POCT

9:00 AM - 10:00 AM PT

Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using conventional and molecular tests. Dr's Bowman and Wang

Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD

Dr. Bowman is Medical Director, Enzo Clinical Laboratories Dr. Wang is Chief of Microbiology and Molecular Diagnostics Westchester Medical Center, New York Medical College

Vaginitis and vaginosis, including Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV), are extremely common conditions, consuming many healthcare resources and having significant potential adverse consequences for women. Traditional diagnosis has relied on clinical signs and symptoms and a number of conventional diagnostic tests. The presentation of vaginitis and vaginosis is not always typical, and the usual diagnostic tests are not always straight forward, reproducible, or sensitive. Newer molecular techniques may be more sensitive and revealing about the conditions. They have also helped to re-shape our understanding about BV, VVC, and TV, but they are more complex and expensive. This presentation will discuss the spectrum of conventional and molecular tests currently available for BV, VVC, and TV and compare tests performance and utility in light of clinical indications.

Learner Objectives:

Attendee will be able to:

1. Describe the pertinent clinical characteristics of BV, VVC, and TV.

2. List the classic or conventional diagnostic criteria for BV, VVC, TV.

3. Identify the most common conventional tests for BV, VVC, TV.

4. List current and upcoming molecular tests for identifying BV, VVC, and TV.

5. Compare the advantages and disadvantages of conventional versus molecular tests for BV, VVC, and TV.

6.Distinguish when conventional tests or molecular tests might be indicated for BV, VVC, and TV.

10:30 AM - 11:30 AM PT

Are we able to amplify single bacterial/viral/fungal genome equivalent?

Ivan Brukner, PhD

Head of Molecular Microbiology Unit- Molecular Biology, Jewish General Hospital - McGill University

There is growing pressure to implement new generation sequencing platform in hospital emergency rooms. The utility would be obvious: identifying unknown pathogens form cerebrospinal fluid/plasma/body fluids and guiding next step in therapy. What is exactly preventing us in taking this step, if we know that billions of dollars is/was spent on revealing cancer-relevant sequence-signatures using the same technology? And one vanishes from cancer much slower comparing to 24-48h time-window of life under unrelieved life-threatening infection. What went wrong in cashing in technological advance?

3:00 PM - 4:00 PM PT

PoCT Integrated into Clinical Care Contributing to Improved Cardiac Outcomes in Rural Areas

Rosy Tirimacco BSc

Network Operations & Research Manager, iCCnet, Country Health SA Local Health Network Inc

Clinical networks link groups of professionals and organisations from primary, secondary and tertiary care, shifting emphasis from institutional to patient needs and outcomes. One of the main aims of clinical networks is to facilitate best practice health care.

The Integrated Cardiovascular Clinical Network, Country Health South Australia (iCCnet CHSA) provides an integrated solution to ensure patients presenting to rural health facilities receive access to appropriate cardiac care. Solutions include clinical tools, resources and systems designed to support the practice of evidence-based acute cardiac care by practitioners, including remote area nurses, from a diverse range of backgrounds and with varying levels of experience and training. Point of Care Testing (PoCT) incorporated into clinical care with appropriate clinical pathways linked with 24 hour technical and Cardiologist support has been deployed throughout country hospitals in South Australia.

PoCT is managed by a group of clinical scientists who are responsible for ensuring the service is run within a quality framework. All sites perform quality control and external quality assurance to ensure results generated do not compromise patient care.

To evaluate the impact of iCCnet CHSA on patient outcomes, 30-day mortality among patients with myocardial infarction (MI) was evaluated. Results have shown the interventions introduced have led to a 22% reduction in 30-day mortality for MI.

Clinical Diagnostics and Research

Continuing Education (CME/CE/CEU) Credits

The speakers below have been approved for CME, CE, or CEU credits. To redeem your credits, locate the presentation you watched and click on the CME/CE/CEU buttons for further direction. For more general information regarding continuing education, the processes to receive credits, and the accreditation bodies, click here.

Click on the CME/CE/CEU credit buttons to get credits:

High Sensitivity Troponin as an Emerging Marker in Prediction of Cardiovascular Disease
05.28.2014 | 06:00:00 AM PT
Vijay Nambi, MD
Assistant Professor of Medicine, Baylor College of Medicine
How to Improve Healthcare with More Effective Clinical Laboratory Test Utilization
05.28.2014 | 06:00:00 AM PT
Julie R Taylor, PhD, MS
Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC), Division of Laboratory Programs, Standards, and Services Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services Centers for Disease Control and Prevention
CME
The new role for HPV DNA testing: cobas HPV Test as a first-line cervical cancer screen
05.28.2014 | 06:00:00 AM PT
Julia Engstrom-Melnyk, PhD
Scientific Affairs Manager, Medical and Scientific Affairs, Roche Diagnostics
How Automation is Required in Order for a Laboratory to Achieve Six-Sigma Quality in Non-Analytic Metrics
05.28.2014 | 07:30:00 AM PT
Charles D Hawker, PhD, MBA, FACB
Scientific Director, Automation &amp; Special Projects, ARUP Laboratories, Professor (Adjunct) of Pathology, University of Utah
CME
Overview on ONE Study experience on standardization across multiple centers
05.28.2014 | 07:30:00 AM PT
Mathias Streitz, MS, Certified Biologist
Head of the Flow-Cytometry Facility, Institute of Medical Immunology, Charite - Universittsmedizin Berlin
Technical Challenges and Standardization of Vitamin D
05.28.2014 | 07:30:00 AM PT
James Freeman, BS
Director, Assay Development, Siemens Healthcare Diagnostics
CE
Keynote: Establishing an economic BRCA1 and BRCA2 (BRCA) gene analyses research workflow using custom AmpliSeq panel design and the Ion PGM System
05.28.2014 | 09:00:00 AM PT
Jeffrey N Weitzel, MD
Director, Clinical Cancer Genetics, Professor, Director, Cancer Screening &amp; Prevention City of Hope
Early infantile rickets: A new look at an old disease and mimic of child abuse
05.28.2014 | 10:30:00 AM PT
David Ayoub, MD
Board Certified Diagnostic Radiologist, Clinical Radiologist, SC
CME
Heavy/Light Chain Combination Assays: What Laboratories should know about M-Protein detection
05.28.2014 | 10:30:00 AM PT
Richard O'Hara, PhD
Senior Director of Scientific Affairs, Binding Site
CE
Monitoring drugs and medications in pain and addiction patients
05.28.2014 | 10:30:00 AM PT
Amadeo J Pesce, PhD, DABCC
Laboratory Director, Millennium Laboratories, Inc.
CE
Keynote
05.28.2014 | 12:00:00 PM PT
Barbara Van Der Pol, PhD, MPH
Associate Professor of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine
CME
Legal and Regulatory Developments Affecting Molecular Testing
05.28.2014 | 13:30:00 PM PT
Peter M Kazon, JD
Attorney, Alston &amp; Bird, LLP
CME
Lowering Blood Culture Contamination Rates Using an Evidence-Based Medicine Approach
05.28.2014 | 13:30:00 PM PT
Alice Weissfeld, PhD, D (ABMM), F(AAM)
President, CEO and Laboratory Director, Microbiology Specialists Incorporated
CME
Vitamin D Testing in the Clinical Laboratory: The Status in 2014
05.28.2014 | 15:00:00 PM PT
Howard Morris, PhD, FAACB, FFSc(RCPA)
Professor of Endocrine Bone Research Laboratory, Univ of South Australia
CME
Challenges for the Pathology Profession in the Age of the Electronic Health Record How Informatics and Standardisation Initiatives can Help
05.29.2014 | 06:00:00 AM PT
Robert Flatman, FAACB, MBA, B App Sc
Assistant Manager Biochemistry, Sullivan Nicolaides Pathology, Australia
CME
Chronic Pain Management and Laboratory Testing
05.29.2014 | 06:00:00 AM PT
Benjamin Abraham, MD
Anesthesiology/Chronic Pain Management, Cleveland Clinic
CME
Panel Discussion: Vitamin D Requirements during Pregnancy and Lactation, Bio Available 25-HydroxyVitamin D, Doctors Holick, Thadhani, and Wagner
05.29.2014 | 06:00:00 AM PT
Michael Holick, MD, PhD, Ravi I Thadhani, MD, MPH, Carol Wagner, MD
Dr. Holick, is Professor of Medicine, Physiology and Biophysics, Director of the General Clinical Research Center, Director of the Vitamin D, Skin and Bone Research Laboratory, Director, Biologic Effects of Light Research Center, Boston University Medical Center Dr. Thadhani is Chief, Division of Nephrology Massachusetts General Hospital, Harvard Medical School Dr. Carol Wagner is Professor of Pediatrics, Associate Director, Clinical &amp; Translational Research Center, Medical University Sout
CE
Ensuring Quality Using IT Algorithms
05.29.2014 | 07:30:00 AM PT
Eric Vasbinder, BS
Chemistry Automation Supervisor Chemical Pathology Laboratory, University of Michigan Health System
CME
Identification of predictive biomarkers from high throughput drug combination screening data
05.29.2014 | 07:30:00 AM PT
Emma Bowden, PhD
Director, Translational Medicine, Thermo-Fisher Scientific
Is Cervical Cancer a preventable Disease in women? The role of HPV as a screening test.
05.29.2014 | 07:30:00 AM PT
Belinda Yen-Lieberman, PhD
Director of Clinical Virology, Serology, and Cellular Immunology, Cleveland Clinic
CE
Keynote Panel Discussion: Companion Diagnostics: Changing the Face of Healthcare, Doctors Hawkins, Joseph, and Frank
05.29.2014 | 09:00:00 AM PT
Patrick Joseph, MD and Richard Frank, MD
Patrick Joseph, MD, Medical Director, Siemens Clinical Laboratory (SCL), Siemens Healthcare Diagnostics Richard Frank, MD, Chief Medical Officer, Clinical Strategy and Policy, Siemens Healthcare
CE
Adding Value in Healthcare Delivery: Uses for Clinical Laboratory Informatics in Decision Support
05.29.2014 | 10:30:00 AM PT
Elizabeth Kenimer Leibach, EdD, MS, MLS(ASCP), SBB
Principal Officer, Healthcare Management and Education Services (HMES), Education Editor for Clinical Laboratory Science and Expert Consultant for the US Centers for Disease Control and Prevention
CME
Going Beyond Cell Counting and Solving Common Problems Faced by Laboratories
05.29.2014 | 10:30:00 AM PT
Fernando P Chaves, MD
Director of Global Scientific Affairs, Beckman Coulter, Inc.
CE
Why are we unable to lose weight and keep it off? All about the connection between the gut and the brain
05.29.2014 | 10:30:00 AM PT
Caroline M Apovian, MD, FACP, FACN
Professor of Medicine and Pediatrics, Boston University School of Medicine Director, Center for Nutrition and Weight Management, Boston Medical Center
CE
Navigating the Complexities of the Human Oncoproteome with the SigNET KnowledgeBank
05.29.2014 | 12:00:00 PM PT
Steve Pelech, PhD
Professor, Department of Medicine, University of British Columbia, President &amp; Chief Scientific Officer, Kinexus Bioinformatics Corporation
CE
Pharmacogenomics and Pharmacometabolomics for Personalized Medicine
05.29.2014 | 12:00:00 PM PT
Steven Wong, PhD, DABCC(TC), FACB
President, AACC 2014, Professor of Pathology, Director, Clinical Chemistry, Co-Director, Clinical and Translational Mass Spectrometry Center, Wake Forest University School of Medicine
CE
Multiplexed Fusion Gene Detection using Next Generation Sequencing
05.30.2014 | 07:30:00 AM PT
Kelli Bramlett and Jeoffrey Schageman
Kelli Bramlett, Senior Manager, R&amp;D Thermo Fisher Scientific Jeoffrey Schageman, Staff Scientist, Thermo Fisher Corp.
The Role of Lactate in the Risk Assessment of Morbidity and Mortality
05.30.2014 | 07:30:00 AM PT
Monet Sayegh, MD
Senior Medical/Clinical Consultant, Siemens Healthcare Diagnostics
How does the soluble mechanistic biomarker 14-3-3 eta assist in the management of Rheumatoid Arthritis?
05.30.2014 | 09:00:00 AM PT
Anthony Marotta, PhD
Chief Scientific Officer, Augurex Life Sciences Corp
Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using conventional and molecular tests. Dr's Bowman and Wang
05.30.2014 | 09:00:00 AM PT
Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD
Dr. Bowman is Medical Director, Enzo Clinical Laboratories Dr. Wang is Chief of Microbiology and Molecular Diagnostics Westchester Medical Center, New York Medical College
CME
Are we able to amplify single bacterial/viral/fungal genome equivalent?
05.30.2014 | 10:30:00 AM PT
Ivan Brukner, PhD
Head of Molecular Microbiology Unit- Molecular Biology, Jewish General Hospital - McGill University
Universal Definition of MI
05.30.2014 | 10:30:00 AM PT
Hans Loyda, PhD
Director, Scientific Affairs Cardiac, Roche Diagnostics Corporation
Keynote: Biochemical Markers of Bone Turnover in the Management of Postmenopausal Osteoporosis
05.30.2014 | 11:30:00 AM PT
Paul D Miller, MD
Distinguished Clinical Professor of Medicine, University of Colorado Health Sciences Center Medical Director Colorado Center for Bone Research
Opportunities to simplify clinical lipid assessment
05.30.2014 | 15:00:00 PM PT
David R Sullivan, MBBS, FRACP, FRCPA
Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital
PoCT Integrated into Clinical Care Contributing to Improved Cardiac Outcomes in Rural Areas
05.30.2014 | 15:00:00 PM PT
Rosy Tirimacco BSc
Network Operations &amp; Research Manager, iCCnet, Country Health SA Local Health Network Inc
CME

Clinical Diagnostics and Research

Speakers

Jeffrey N Weitzel, MD
Director, Clinical Cancer Genetics, Professor, Director, Cancer Screening & Prevention City of Hope

Dr. Jeffrey N. Weitzel is Chief of the Division of Clinical Cancer Genetics and the Cancer Screening & Prevention Program at the City of Hope Comprehensive Cancer Center. He received his medical degree from the University of Minnesota, is Board Certified in clinical genetics and medical oncology, and is a Professor of Oncology and Population Sciences at the City of Hope and a Clinical Professor of Preventive Medicine at the University of Southern California School of Medicine. At the vanguard of personalized medicine, Dr. Weitzels multidisciplinary clinical, research, and training programs emphasize translational research in genetic cancer risk assessment, chemoprevention, targeted therapy, clinical and psychosocial outcomes, genetic epidemiology and health services research in underserved minorities, and hereditary cancer in Latin America. He is a member of the American Society of Clinical Oncology and the National Comprehensive Cancer Network Genetics/Familial Risk Assessment practice guidelines committee. Dr. Weitzel is the principal investigator for the City of Hope Cancer Genetics Education Program and for the Clinical Cancer Genetics Community Research Network, which are funded by the National Cancer Institute.

Caroline M Apovian, MD, FACP, FACN
Professor of Medicine and Pediatrics, Boston University School of Medicine Director, Center for Nutrition and Weight Management, Boston Medical Center

Caroline Apovian is Professor of Medicine and Pediatrics, in the Section of Endocrinology, Diabetes, and Nutrition at Boston University School of Medicine, USA. She is also Director of the Center for Nutrition and Weight Management at Boston Medical Center, USA. Dr. Apovian is a nationally and internationally recognized authority on nutrition and has been in the field of obesity and nutrition since 1990. Her current research interests are in: weight loss and its effects on endothelial cell function, adipose cell metabolism and inflammation, research in the bariatric surgery population, and novel pharmacotherapeutic antiobesity agents. She is also an expert in the technique for subcutaneous adipose tissue biopsies, and has been performing these biopsies on research subjects for over 10 years. She was on the expert panel for updating the 2013 AHA/ACC/TOS Clinical Guidelines for the Management of Overweight and Obesity in Adults.Dr. Apovian was a recipient of the Physician Nutrition Specialist Award given by the American Society of Clinical Nutrition. This was for her work on developing and providing nutrition education, to medical students and physicians in training at Boston University School of Medicine. She has published over 200 articles, chapters, and reviews on the topics of: obesity, nutrition, and the relationship between adipose tissue and risk of developing cardiovascular disease. Dr. Apovian has recently published a new book entitled the The Overnight Diet and has also written a popular book for patients called The ALLI Diet Plan.Dr. Apovian has been a member of The Obesity Society since 1992, and has served on the Clinical Committee as well as Secretary/Treasurer and the Executive Committee from 2005 to 2008.  She has been a faculty speaker and has presented papers at several of the Society's Annual Scientific Meeting and until recently she served as Associate Editor for the Society's journal, Obesity.  

Fernando P Chaves, MD
Director of Global Scientific Affairs, Beckman Coulter, Inc.

Fernando Chaves, MD, is a board-certified anatomic and clinical pathologist and a board-certified hematopathologist. He is the director of global scientific affairs at Beckman Coulter, fostering the research of new clinical applications for data generated during a routine Complete Blood Count and differential and on the optimization of workflow in the hematology laboratory. While his area of major expertise is bacterial infection and sepsis, he has also researched myelodysplasia, myeloproliferative neoplasms, acute leukemias, vitamin B12 and folate deficiencies, dengue fever, and malaria, among other topics. 

Eric Vasbinder, BS
Chemistry Automation Supervisor Chemical Pathology Laboratory, University of Michigan Health System

Eric Vasbinder , Chemistry Automation Supervisor  at the University of Michigan Medical Center has 26 years experience in the clinical diagnostics industry.   Eric is responsible for the automation section of chemistry, which performs almost 9 million tests a year and operates in a 24X7 environment.  The laboratory provides testing services for all three hospitals on campus, with a total of 865 beds and 1,600 physicians. The laboratory also provides services to 30 health centers and 120 outpatient clinics within a 60-mile radius.  Erics extensive laboratory experience includes toxicology where he developed new assay procedures, improved existing methods, and chemistry automation.  Erics laboratory has been involved in numerous human studies and clinical trials all performed on the automation line.  The laboratory is currently supporting the Hepcidin and Anemia in trauma clinical trials, an ongoing study for the last 3 years.  In his role as Automation Manager, Eric has developed innovative new workflows and procedures which he successfully integrated into the labs routine clinical operations.  The resulting efficiency and productivity gains have helped the University of Michigan Medical Center laboratory to reduce errors by 73% and increase volume 97%, while holding headcount flat over the past 7 years. Eric has a B.S. in Medical Technology with a minor in Microbiology from Michigan Technological University

Belinda Yen-Lieberman, PhD
Director of Clinical Virology, Serology, and Cellular Immunology, Cleveland Clinic

Belinda Yen-Lieberman, PhD, is a Professor of Pathology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Cleveland, Ohio. Currently, she is the Medical Director of Clinical and Molecular Virology, Serology, and Cellular Immunology in the Department of Clinical Pathology, Pathology & Laboratory Medicine Institute at the Cleveland Clinic.Dr. Yen-Lieberman has authored more than 100 articles for numerous medical journals on a wide range of topics involving viruses and infectious disease, including studies involving HIV, Hepatitis B , Hepatitis C, Human Papilloma Viruses and Influenza A vaccine, tests for herpes simplex types 1 and 2, respiratory viruses and tuberculosis. Dr. Yen-Lieberman also serves on the Editorial boards of J. of Clinical Virology, J. of Clinical and Vaccine Immunology and J. of Clinical Microbiology.  She has served on the CLIA Subcommittee M53-A on Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection-Approved Guideline and CLIA MM06-A2 on Quantitative Molecular Methods for Infectious Diseases: Approved Guideline.  She is member of the Advisory Board on the AIDS Clinical Trial Group (ACTG/NIH) Virology Quality Assurance Program and a member of the AIDS Clinical Trial Group (Virology), the CDC HIV Rapid Testing Quality Assurance Workgroup, and the NIAID/NIH Special Emphasis Panel Study Section.Dr. Yen-Lieberman can be reached at yenb@ccf.org. 

Benjamin Abraham, MD
Anesthesiology/Chronic Pain Management, Cleveland Clinic

Dr. Abraham is a staff anesthesiologist at the Cleveland Clinic Foundation.  He specializes in the management of chronic pain, with a focus on multimodal treatment techniques.   This began with an interest in neuroscience, for which he received his Bachelors of Science at Johns Hopkins University.  His diverse interests in confocal microscopy, peptide processing, and nerve regeneration led to multiple awards and peer-reviewed publications.  After earning his medical degree from the State University of New York, he completed his training in General Anesthesiology and fellowship training in Interventional Pain Management at the Cleveland Clinic Foundation.    

Steven Wong, PhD, DABCC(TC), FACB
President, AACC 2014, Professor of Pathology, Director, Clinical Chemistry, Co-Director, Clinical and Translational Mass Spectrometry Center, Wake Forest University School of Medicine

Steven H. Wong, Ph.D., DABCC (TC), FACB, is Professor of Pathology with tenure, Director of Clinical Chemistry and Toxicology/Core Laboratory, Department of Pathology, Wake Forest School of Medicine. He is Co-Director of Clinical and Translational Mass Spectrometry Center. Dr. Wongs current scientific and clinical interests encompass clinical and translational applications of omics biomarkers for enabling personalized medicine and personalized justice: pharmacogenomics, proteomics, metabolomics, and mass spectrometry for clinical chemistry., TDM with emphasis on immunosuppressant and pain management therapy with adjunct pharmacogenomics and metabolomics., and oral fluid proteome and metabolome for clinical and forensic toxicology/workplace testing. In addition to over 121 publications and 146 abstracts, he edited/co-edited four books including Pharmacogenomics and Proteomics: Enabling the Practice of Personalized Medicine.Prior to joining Wake Forest, Dr. Wong was a Professor of Pathology, Director/Co-Director, Clinical Chemistry/Toxicology, TDM, Pharmacogenomics and Proteomics, Department of Pathology, Medical College of Wisconsin. He also served at the Milwaukee County Medical Examiners Office, the University of Connecticut School of Medicine., and Johns Hopkins University School of Medicine.An active AACC member since 1980, Dr. Wong is the current AACC President. He is a member of NACB, and chair of four divisions. Outside AACC, Dr. Wong is a member of the Drug Testing Advisory Board of Substance Abuse and Mental Health Services Administration/DHHS, and a member of the Antibody Committee of the National Cancer Institute/NIH. He is an editorial board member for Pharmacogenomics, Therapeutic Drug Monitoring, Annuals of Clinical & Laboratory Science, the Egyptian Journal of Hospital Medicine, and the Journal of Pediatric Biochemistry, and a past board member for Clinical Chemistry and Laboratory Medicine and Journal of Analytical Toxicology. 

Michael Holick, MD, PhD, Ravi I Thadhani, MD, MPH, Carol Wagner, MD
Dr. Holick, is Professor of Medicine, Physiology and Biophysics, Director of the General Clinical Research Center, Director of the Vitamin D, Skin and Bone Research Laboratory, Director, Biologic Effects of Light Research Center, Boston University Medical Center Dr. Thadhani is Chief, Division of Nephrology Massachusetts General Hospital, Harvard Medical School Dr. Carol Wagner is Professor of Pediatrics, Associate Director, Clinical & Translational Research Center, Medical University Sout
Paul D Miller, MD
Distinguished Clinical Professor of Medicine, University of Colorado Health Sciences Center Medical Director Colorado Center for Bone Research

  Dr. Paul D. Miller, FACP, is a world-renowned physician specializing in metabolic bone disease. He is widely considered a leading authority on bone biology, prevention and treatment of metabolic bone disorders, including osteoporosis. Dr. Miller is Medical Director at the Colorado Center for Bone Research in Lakewood, Colo., which is recognized as a top facility for diagnosis and treatment of metabolic bone disease. He is also a Distinguished Clinical Professor of Medicine at the University of Colorado, Health Sciences Center. Dr. Miller is Board Certified in both Internal Medicine and Nephrology (kidney diseases).Dr. Miller's research focuses on the treatment of osteoporosis in postmenopausal women, and he is the principal investigator in a number of clinical trials evaluating the safety and efficacy of current and potential therapies. He is the author and co-author of nearly 300 publications, including original articles, chapters and books. His insights and thought leadership have made him a media resource and sought-after speaker. He lectures extensively to physicians, drug companies and academics who find his comprehension unmatched.    

Anthony Marotta, PhD
Chief Scientific Officer, Augurex Life Sciences Corp

Dr. Anthony Marotta is a co-founder and the Chief Scientific Officer for Augurex Life Sciences, a company that is focused on the development of the 14-3-3 eta personalized medicine opportunity for the management of specific forms of arthritis including: rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). In 2013 through Dr. Marotta's leadership, Augurex received Health Canada approval and CE approval for their first diagnostic assay, the 14-3-3 eta ELISA that measures the level of the 14-3-3 eta protein in serum/plasma. Prior to co-founding Augurex, Dr. Marotta served as the Director of Business Development for Stressgen Bioreagents, a company that focused on providing research tools in the area of signal transduction and heat shock signaling.Dr. Marotta completed his PhD in Experimental Medicine at the University of British Columbia in Vancouver, Canada. His research interests include the identification of new therapeutic targets, investigating their mechanism of action, and the development of diagnostic and companion biomarker assays to personalise clinical disease management.  

Monet Sayegh, MD
Senior Medical/Clinical Consultant, Siemens Healthcare Diagnostics

Dr. Sayegh received his Bachelor of Science in Biology and Chemistry from the University of Mobile in Mobile, AL, Medical Technology from Anderson Memorial Hospital School of Medical Technology in Anderson, SC, Master of Science in Health Sciences with emphasis on Hematology/Oncology from the American University School of Graduate Studies in Coral Gables, FL and awarded Doctor of Medicine Degree from the American University School of Medicine in Coral Gables, FL. His Post- graduate training is in General Surgery with emphasis on Emergency Non-Trauma Minimally Invasive Laparoscopic Surgery from the University of Southern California in Los Angeles, CA.Dr. Sayegh has over 25 years of experience in the fields of Medicine, Research, Surgery and Clinical Laboratory Science. Background includes extensive Immunology/Allergy, Hematology/Oncology, Endocrinology, Special Chemistry, HLA Histocompatiblity and Maternal screen.  He held key consulting positions focused on multiple disciplines in Medicine , both hospital and reference laboratories. 

Hans Loyda, PhD
Director, Scientific Affairs Cardiac, Roche Diagnostics Corporation

Hans-Juergen Loyda, Ph.D., MBA, is Director of Clinical Development and Education of Medical and Scientific Affairs at Roche Diagnostics in Indianapolis. He holds a Bachelor of Science in Biology, a Doctorate in Zoology from the Rheinisch-Friedrichs-Wilhelms University in Bonn/Germany and a Master of Business Administration from the Indiana Wesleyan University. He has been with Roche Diagnostics for 28 years with extensive experience in sales and marketing. The last 8 years he has focused on developing relevant and compelling clinical evidence for cardiac biomarker in Medical & Scientific Affairs. For this area he is also scientific resource internally and externally.

David R Sullivan, MBBS, FRACP, FRCPA
Clinical Associate Professor, Dept of Biochemistry, Royal Prince Alfred Hospital

David Sullivan is a physician and chemical pathologist in the Department of Clinical Biochemistry at Royal Prince Alfred Hospital.  This includes conjoint appointment as Clinical Associate Professor, Central Clinical School, Faculty of Medicine and Charles Perkins Centre, University of Sydney. David has a long-term interest in lipid metabolism with particular emphasis on the gene environment interactions contributing to cardiovascular disease. He has been involved in the early use of many forms of lipid-lowering intervention. He remains a national leader of efforts to improve the detection and management of severe inherited dyslipidaemia, such as that seen in Familial Hypercholesterolaemia. David has experience in several international clinical posts, including World Health Organization (WHO) Fellowship at the MRC Lipoprotein Unit, Royal Postgraduate School of Medicine, Hammersmith Hospital, London and co-ordination of international clinical studies from the WHO reference lipid laboratory in Wageningen, Netherlands. In addition to his clinical activities in Australia, he has served on numerous clinical committees including the management committees of the LIPID and FIELD trials. Current research interests are focussed on biomarkers, post-prandial metabolism and novel therapies.

Kelli Bramlett and Jeoffrey Schageman
Kelli Bramlett, Senior Manager, R&D Thermo Fisher Scientific Jeoffrey Schageman, Staff Scientist, Thermo Fisher Corp.

Kelli Bramlett leads the RNA Sequencing Applications Team at Life Sciences Solutions, Thermo Fisher Scientific. She guides the Research and Development effort focused on creating innovation sequencing and data analysis solutions for the detailed analysis of RNA. Prior to joining Thermo Fisher Scientific, Ms. Bramlett was a drug development scientist at Ely Lilly and Company where she led a team of scientists specializing in gene regulation and nuclear receptor biology to identify novel drug targets. Ms. Bramlett built her background and experience in gene regulation through prior academic positions at Baylor College of Medicine and M.D. Anderson Cancer Center. Kelli holds an undergraduate degree in Chemistry from Rice University in Houston, TX and a Masters Degree in Pharmacology from Indiana University School of Medicine in Indianapolis, IN.

Jeoffrey Schageman is a staff scientist in the RNA Sequencing Applications Team at Life Sciences Solutions, Thermo Fisher Scientific. He specializes in the development and implementation analytical methods for NGS and gene expression analysis.   Jeoffrey typically leads the teams responsible for building analytical pipelines. The resulting pipelines provide analytical frameworks to enable other scientists to derive biological insight from seemingly insurmountable volumes of RNA sequence data.  Jeoffrey began his career in academia working on the Human Genome Project at UT Southwestern Medical Center in Dallas, then changed directions to focus on the bioinformatics of genome wide association studies in large cohorts to catalogue genetic variants related to cardiomyopathies. Mr. Schageman received his training in molecular biology and genetics from the University of North Texas.

Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD
Dr. Bowman is Medical Director, Enzo Clinical Laboratories Dr. Wang is Chief of Microbiology and Molecular Diagnostics Westchester Medical Center, New York Medical College

Dr. Cynthia Bowman has been a broad based general pathologist for over 30 years. She graduated with a BA in Chemistry from St. Olaf College, received her MD from Vanderbilt University Medical School, and trained for 6 years at the University of California, San Francisco as a surgery intern and then anatomic and clinical pathology resident. She worked as an emergency room physician during training and has always had a clinical perspective in her practices. She has worked in California, Maine, Massachusetts, New York and Australia as an anatomic and clinical pathologist and laboratory medical director in small, mid-sized, tertiary and academic  medical centers. She is currently Medical Director at Enzo Clinical Laboratories, a commercial reference laboratory and bioscience company in the NY metropolitan area, and in that capacity collaborates with the development and integration of molecular services into clinical testing.  She has been active in national laboratory organizations, especially the College of American Pathologists, where she was chair of the Point of Care Testing Resource Committee. In that capacity she guided the introduction and was the senior editor of a web-based POCT toolkit as a resource for laboratory director leadership in POCT.  She has also written and edited multiple educational pieces for the laboratory community as part of the CAP Excel Survey program and in 2012 she was awarded a Life Time Achievement Award by the CAP. She has spoken at AACC and CAP meetings and currently serves on several CLSI document development committees. She is currently chair of an International Federation of Clinical Chemistry POCT task force work group addressing the use of glucose  meters in critical care patients.  Her professional commitment has always been to integrate and translate pathology and laboratory medicine services into effective clinical care. She has dedicated her efforts in POCT as part of that vision to collaborate with all stakeholders and involve laboratory services as part of the continuum of care. She enjoys evaluating technology and integrating it into laboratory services.

Dr. Wang is the Chief of Laboratory Services for Microbiology, Virology and Molecular Diagnostics in the Department of Pathology at Westchester Medical Center. He is double board-certified in clinical microbiology and molecular diagnostics by the American Board of Medical Microbiology and American Board of Clinical Chemistry.Dr. Wang received his education and training in clinical medicine and epidemiology in China. He earned his Ph.D. degree in medical microbiology from University of Amsterdam, the Netherlands, and completed an accredited fellowship in clinical & public health microbiology at University of California, Los Angeles Medical Center. At Westchester Medical Center, Dr. Wang joins the Pathology Department and provides mainly clinical diagnostic services in microbiology and molecular diagnostics. He developed several home-brew molecular tests for in vitro diagnosis of infectious diseases. Apart from his clinical work, he has been serving as principal investigator of multiple research projects. The areas of his interest include laboratory diagnosis of infectious diseases, especially molecular detection and mechanism studies of emerging tick-borne diseases and antimicrobial resistance. He has published more than 50 peer-reviewed papers on these subjects. 

Ivan Brukner, PhD
Head of Molecular Microbiology Unit- Molecular Biology, Jewish General Hospital - McGill University

Dr Ivan Brukner entered into genomic era back in 1989 (ex-Yugoslavia), trying to describe and solve repeating sequence branching motif problem in building whole genome sequence.  Next 5-10 years, his research was targeting sequence-dependent DNA structural problems, where contradictory puzzle about origin of DNA curvature and bending (crystallographic versus soft biochemistry data) was resolved (Italy, Germany and Canada).  In 2000-2007, focus was directed   toward design of nucleic-acid-based ideal point of care diagnostic device. Robust, multiplex, hybridization-based diagnostic device (which operates at standard room temperatures - in spite of ~90% sequence cross-similarity) was constructed and functionally tested.  The universal protocol for selection of robust hybridization probes was result of this adventure.  After joining Jewish General Hospital in Montreal (~2009), his work was becoming more clinically applicable, focusing on high volume molecular assays with strong financial and/or diagnostic impact (MRSA, C.difficile, VRE). He realized the strong need for applicability of new molecular techniques in emergency, including NGS, and definition of technological bottlenecks is subject of his talk in this secession.

Steve Pelech, PhD
Professor, Department of Medicine, University of British Columbia, President & Chief Scientific Officer, Kinexus Bioinformatics Corporation

Dr. Steven Pelech has been the founder, president and chief scientific officer of Kinexus Bioinformatics Corporation for 15 years. He was previously the founder and president of Kinetek Pharmaceuticals, Inc. for 6 years. Prior to this, he spent 5 years in post-doctoral training with Sir Philip Cohen at the University of Dundee and Nobel laureate Dr. Edwin Krebs at the University of Washington in Seattle. Dr. Pelech was a founding scientist of the Biomedical Research Centre and of the Brain Research Centre located at the University of British Columbia (UBC). Since 1988, he has concurrently been on faculty at UBC and is presently a full professor in the Department of Medicine in the Division of Neurology. Dr. Pelech received his B.Sc. (1979; Honours) and Ph.D. (1982) degrees in Biochemistry from UBC. He has authored over 220 scientific peer- reviewed publications about signal transduction and is one of the discoverers of the MAP kinases. His recent focus has been on the development of a suite of open-access, on-line KiNET databases and SigNET knowledgebases, and on the creation of high content array platforms with antibodies and peptides to support systems proteomics research. He has served on grant review panels and as an ad-hoc reviewer for over 30 granting agencies and as an external reviewer for over 30 scientific journals.

Elizabeth Kenimer Leibach, EdD, MS, MLS(ASCP), SBB
Principal Officer, Healthcare Management and Education Services (HMES), Education Editor for Clinical Laboratory Science and Expert Consultant for the US Centers for Disease Control and Prevention

Dr. Elizabeth Kenimer Leibach is Principal Officer for Healthcare Management and Education Services (HMES), an interventional healthcare enterprise offering consultation in areas related to clinical laboratory services delivery, clinical and translational research, quality assessment, and education.  Activities include rural health clinic establishment, quality monitoring/evaluation, management of labs and lab networks, and application for grant monies to support the establishment of medical information system networks of health care organizations and providers.  Dr. Kenimer Leibach is actively involved in clinical research and publication in evidence-based laboratory medicine related to informatics and clinical decision support, individual and population-level health record data analysis, and quality metrics for evaluation of medical effectiveness and cost efficiency of laboratory services.  Other healthcare initiatives include development of evidence-based educational materials for consumers, healthcare providers, and health educators concerning major chronic diseases of the US population.  Applied quality theory integrates these efforts in the assessment of clinical laboratory performance measures and determination of the medical effectiveness of clinical laboratory information.Dr. Kenimer Leibach has a baccalaureate degree in Medical Technology (MLSCM), and a Master of Science degree in Cell and Molecular Biology from Georgia Regents University (formerly Medical College of Georgia), a Specialist in Blood Banking (SBBCM), certification through the University of Texas Health Sciences Center in Dallas (Parkland Memorial Hospital) School of Blood Banking Technology, and a Doctor of Education in Adult Education from The University of Georgia.  Dr. Kenimer Leibach also serves as Education Editor for Clinical Laboratory Science and Expert Consultant for the US Centers for Disease Control and Prevention. 

Emma Bowden, PhD
Director, Translational Medicine, Thermo-Fisher Scientific

With Thermo Fisher Scientific, Dr. Bowden leads Pharma Client Services to provide custom bioinformatics solutions for oncology drug development and research. This group develops complete solutions from target discovery and validation, predictive biomarkers of response and drug combination synergies, to clinical testing hypotheses   Dr. Bowden has more than 18 years of research and leadership experience in cancer biology and drug development in both academic and industry settings. She has served as an Assistant Professor at Georgetown University. While in industry, Dr. Bowden led multiple preclinical projects and strategy area teams supporting the development of various types of biologic including antibodies, multispecifics and antibody-drug conjugates. She holds a PhD in Biochemistry from University of Bristol. 

Barbara Van Der Pol, PhD, MPH
Associate Professor of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine

Dr. Van Der Pol has been involved in laboratory-based epidemiologic and behavioral research in the field of sexually transmitted infections (STI) and HIV for more than 30 years.  She has extensive experience with development and evaluation of molecular diagnostic assays and is internationally recognized as an expert in this field. She participated in writing the CDC STD Diagnostic Laboratory Guidelines and the WHO STD/HIV Laboratory Diagnostics Manual. Dr. Van Der Pol has also evaluated novel methods for STI detection and developed molecular diagnostic assay for the identification of organisms for which no FDA-approved assays exists.  Her laboratory developed and evaluated a molecular assay for the detection of Trichomonas vaginalis DNA 12 years before such an assay would become commercially available. She also assessed the feasibility of using self-obtained vaginal swabs collected in non-clinical settings for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.  This is now the CDC recommended optimal sample type for diagnosis of these infections.  More recently she demonstrated the feasibility of patient collected rectal samples, again in a non-clinical setting, for use with chlamydia and gonorrhea testing.  In addition to her work in the US, Dr. Van Der Pol has spent 2 decades working in sub-Saharan Africa providing technology transfer, capacity building and quality improvement training.  She is currently serving as a consultant to the CDC for laboratory strengthening efforts in the Caribbean region.

Vijay Nambi, MD
Assistant Professor of Medicine, Baylor College of Medicine
Peter M Kazon, JD
Attorney, Alston & Bird, LLP

Peter Kazon has over 25 years of experience assisting companies and individuals in negotiating the complex legal and regulatory issues that health care providers routinely face. He counsels providers on matters involving Medicare coverage, reimbursement, billing, fraud and abuse and Stark self-referral issues. Among his specialties are advising clinical laboratories and diagnostic companies on regulatory and compliance matters, and assisting companies with emerging medical technologies with coverage, coding and reimbursement issues. In addition, Peter assists companies on compliance with the Food, Drug and Cosmetic Act and its recent amendments, with particular attention to FDA actions affecting in vitro diagnostic products.Mr. Kazon is a frequent speaker and writer on health care issues and sits on the editorial advisory board of BNAs Plan and Provider Report. His recent speeches have addressed a variety of topics, including Medicare medical necessity requirements, regulatory requirements applicable to genetic tests, new federal requirements applicable to the provision of electronic medical record technology and Medicare reimbursement issues.After receiving a B.A., magna cum laude, from Tufts University in 1975, Mr. Kazon earned his J.D. from Temple University in 1978. After law school, Mr. Kazon worked for five years at the Federal Trade Commissions Bureau of Competition, where he specialized in health care antitrust matters. 

Julia Engstrom-Melnyk, PhD
Scientific Affairs Manager, Medical and Scientific Affairs, Roche Diagnostics

Dr. Julia Engstrom-Melnyk is a Scientific Affairs Manager within Medical and Scientific Affairs for Roche Diagnostics Corporation, supporting two geographic territories and serving as the scientific and clinical HPV subject matter expert for the U.S.  In these roles, she has collaborated with both North American and global colleagues on several high-profile projects and studies and has served as an invited speaker at both domestic and international conferences.Dr. Engstrom-Melnyk received her Ph.D. in Molecular Biology and Genetics from the University of Delaware, discovering and developing gene therapy approaches to treat genetically-inherited disorders.  As a Postdoctoral Fellow at Harvard Medical School/Beth Israel Deaconess Medical Center, her research explored signaling pathways following DNA damage and the biological processes of DNA repair.Dr. Julia Engstrom-Melnyk is a Scientific Affairs Manager within Medical and Scientific Affairs for Roche Diagnostics Corporation, supporting two geographic territories and serving as the scientific and clinical HPV subject matter expert for the U.S.In these roles, she has collaborated with both North American and global colleagues on several high-profile projects and studies and has served as an invited speaker at both domestic and international conferences. Dr. Engstrom-Melnyk received her Ph.D. in Molecular Biology and Genetics from the University of Delaware, discovering and developing gene therapy approaches to treat genetically-inherited disorders.As a Postdoctoral Fellow at Harvard Medical School/Beth Israel Deaconess Medical Center, her research explored signaling pathways following DNA damage and the biological processes of DNA repair.

Mathias Streitz, MS, Certified Biologist
Head of the Flow-Cytometry Facility, Institute of Medical Immunology, Charite - Universittsmedizin Berlin
Richard O'Hara, PhD
Senior Director of Scientific Affairs, Binding Site

      Richard M. O'Hara, Jr. grew up in Texas.  He received a baccalaureate degree in Biology from the University of Texas at Austin.  After working as a research associate for a few years he entered the Immunology Graduate Program at The University of Texas Southwestern Medical School in Dallas, Texas.  Dr. O'Hara spent the final two years of his graduate training at Dalhousie University in Halifax Nova Scotia working with the group that established the first Liver Transplant program in the region.     Following his graduate training he and his family moved to Boston where he entered a postdoctoral training program at Harvard Medical School, working on mechanisms of T cell mediated immune regulation.  He entered the pharmaceutical industry, joining Genetics Institute (later Wyeth Research) as a research scientist in 1988.  His work on cytokine biology led to the development of two new therapeutic drugs and several US patents in hematology and oncology.  Later work in the role of costimulation in graft rejection and autoimmunity led to the development of several other drug candidates.     In 2007, after more than twenty years of research in the fields of autoimmunity and transplantation, he joined The Binding Site as Sr. Director of Scientific Affairs.  In his role at Binding Site, Dr. O'Hara has presented extensively at major US academic medical centers on the characterization on monoclonal proteins in patients with Multiple Myeloma and other Plasma Cell Dyscrasias.    

Julie R Taylor, PhD, MS
Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC), Division of Laboratory Programs, Standards, and Services Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services Centers for Disease Control and Prevention

Julie received her B.S. degree in microbiology from the University of Alabama focusing on research in bacterial genetics then completed her M. S. and Ph.D. in microbiology at Auburn University where she studied immunity to bacteria and parasites. She gained experience in virology during a postdoctoral program at Emory University School of Medicine. Throughout her years of working in the private sector in laboratory and clinical research settings, Julie has identified, developed and completed programs addressing unmet needs in health care.    Her accomplishments include patents and FDA- or USDA- licensed medical devices, vaccines, and diagnostics.  She has developed both commercial and research diagnostics for detecting antigens, antibodies and cellular immunity.Julies research experience includes the areas of virology, immunology, parasitology, mycology, genetics and oncology.  She has worked nationally and internationally with professionals from hospitals, long term and home care institutions, academic institutions, medical device and pharmaceutical industries, State Public Health Departments, the World Health Organization, and the International Organization of Standards.  She has also served as a reviewer for health care journals.  These professional partnerships have resulted in journal publications, healthcare standards, and training programs.  Julie is currently the Project Lead for the Clinical Laboratory Integration into Health Care Collaboration (CLIHC)TM from the Division of Laboratory Programs, Standards, and Services at the Centers for Disease Control and Prevention (CDC).  She coordinates programs to improve laboratory quality by enhancing the capacity, infrastructure, and capabilities of laboratories worldwide.   

Charles D Hawker, PhD, MBA, FACB
Scientific Director, Automation & Special Projects, ARUP Laboratories, Professor (Adjunct) of Pathology, University of Utah

Dr. Charles Hawker is Scientific Director for Automation and Special Projects at ARUP, where he has been for 22 years. Dr. Hawker is also Professor (Adjunct) of Pathology in the University of Utah, School of Medicine. Previously, over a twenty year period, he held various positions in research and development and management at Laboratory Procedures, Inc. (Upjohn) and SmithKline Beecham Clinical Labs. At ARUP he has installed several major automation and robotic systems that have made ARUP one of the countrys most automated laboratories. He is a past president of the Association of Clinical Scientists, the National Academy of Clinical Biochemistry (NACB), and the Clinical Ligand Assay Society (CLAS). In July, 2014 he will received the AACCs highest award: Outstanding Lifetime Contributions to Clinical Chemistry and Laboratory Medicine, and AACCs MSPSD Division award for Outstanding Contributions to Management Sciences and Patient Safety. He has been honored by the Association of Clinical Scientists, Clinical and Laboratory Standards Institute (CLSI), NACB, and the Association for Laboratory Automation. He has chaired automation committees in CLSI and Health Level 7. He is the author of a chapter on clinical laboratory automation in the December, 2007 issue of Clinics in Laboratory Medicine and co-author of chapters in the Tietz Textbook of Clinical Chemistry and Molecular Diagnostics (4th and 5th Editions) and the Tietz Fundamentals of Clinical Chemistry (6th and 7th Editions). He is a frequent lecturer on laboratory automation to national and international audiences. He has three issued patents and has published 43 peer reviewed papers, 14 book chapters or invited reviews, 2 invited editorials, and 47 abstracts. His most recent research efforts have focused on the use of machine vision systems for automated quality inspection of clinical laboratory specimens, particularly the development of an automated camera system that uses optical character recognition (OCR) to identify mislabeled specimens.

Alice Weissfeld, PhD, D (ABMM), F(AAM)
President, CEO and Laboratory Director, Microbiology Specialists Incorporated

Alice Schauer Weissfeld, Ph.D., D(ABMM), F(AAM), is the President, CEO, and Laboratory Director of Microbiology Specialists Incorporated, a reference laboratory that she cofounded in 1984. She earned her doctoral degree in microbiology at Rutgers University, New Brunswick, NJ, and completed a postdoctoral fellowship in Public Health and Medical Laboratory Microbiology at Baylor College of Medicine, Houston, TX. She is a Diplomate of the American Board of Medical Microbiology of the American Academy of Microbiology and was elected to a fellowship in the American Academy of Microbiology in 1986.  Dr. Weissfeld is an author of the last three editions of Bailey and Scotts Diagnostic Microbiology, an editor of Clinical Microbiology Newsletter, and a member of the Professional Affairs Committee of ASM.  Dr. Weissfeld is currently a member of ASMs new Professional Practice Committee and Chair of its Subcommittee on Evidence-Based Medicine.  She has been the ASM delegate to the U.S. Pharmacopeia since 2005 and has worked with its Expert Panel to establish best microbiological practices for compounded sterile preparations.  Dr. Weissfeld has won three ASM national awards, the ABMM/ABMLI Professional Recognition Award (1999), the bioMrieux Sonnenwirth Award for Leadership in Clinical Microbiology (2004), and the ASM Founders Distinguished Service Award (2013).

Amadeo J Pesce, PhD, DABCC
Laboratory Director, Millennium Laboratories, Inc.

Amadeo J. Pesce received his BS in Biology from MIT, his Ph.D. from Brandeis University and was an NIH postdoctoral fellow in Biophysics at the University of Illinois at Urbana IL. He trained in Clinical Chemistry with Dr. Samuel Natelson at Michael Reese Hospital in Chicago. Starting in 1973, he served as a faculty member at the University of Cincinnati rising to the rank of Professor in the Department of Pathology and Laboratory Medicine and retiring as Professor Emeritus in 2006. He was Associate Director and then Director of the Toxicology Laboratory of University Hospital in Cincinnati from 1974 to 1997. He was acting Laboratory Director of Adams County Hospital and Drake Center from 1999 to 2006.  In 2007 he started with Millennium Laboratories of California as Laboratory Director. He was appointed as Adjunct Professor of Pathology and Laboratory Medicine at the UCSD School of Medicine in 2007. He became a Principal Investigator of the Millennium Research Institute in 2010.Dr. Pesce became NRCC qualified Clinical Chemist in 1971 and DABCC certified in 1972,. Dr. Pesce has served on the American Board of Clinical Chemistry, the certifying agency for Clinical ChemistsDr. Pesce is Co-Editor of Clinical Chemistry: Theory Analysis and Correlation now in its 5th Edition. He has written or co-edited 30 other books in clinical chemistry. He has written or co-authored more than 220 peer reviewed papers in the area of clinical chemistry.His awards include: Established Investigator, American Heart Association New York; Bernard J. Katchman Award from OVS-AACC; Alvin Dubin Award from National Academy of Clinical Biochemistry; Reggie Brockman Service Award Kidney Foundation of Greater CincinnatiDr. Pesce has served as the Laboratory Director of Millennium Laboratories since 2008. The laboratorys focus has been on providing drug and medication testing for physicians providing pain management and addiction treatments. 

James Freeman, BS
Director, Assay Development, Siemens Healthcare Diagnostics

Jim Freeman, Director of Assay Development for Siemens Healthcare Diagnostics in Tarrytown, NY,  is responsible for the development of infectious  disease, endocrinology, and bone metabolism assays on the ADVIA Centaur Systems. Jim graduated from San Jose State University with a B.S. in biochemistry and began his career in diagnostics in 1984 at Syntex Medical Diagnostics Division (SMDD), a subsidiary of Syva Co. At SMDD, he helped develop dipstick immunoassays for therapeutic drugs. During his tenure at Siemens, Jim created a finger-stick assay for cholesterol and HDL cholesterol as well as several immunoassays for the Technicon Immuno 1 Immunoassay analyzer, including carbamazepine, valproic acid, toxoplasma IgG, toxoplasma IgM, and H. pylori. As manager of the Monoclonal and Polyclonal Antibody Development Group, he developed several monoclonal and polyclonal antibodies used in several commercialized products. In January 2000, Jim joined the Assay Development Group to work on infectious-disease immunoassays for the ADVIA Centaur systems. He developed both the ADVIA Centaur EHIV and CHIV assays. Jim is also responsible for the development of the ADVIA Centaur procalcitonin, estradiol, and Toxo IgM II assays, as well as of several assays currently in development. The ADVIA Centaur Vitamin D Total Assay is the latest addition to his 25-year career in immunoassay development. Jim has authored several published articles and holds four patents, with four more pending approval.

David Ayoub, MD
Board Certified Diagnostic Radiologist, Clinical Radiologist, SC

Dr. David Ayoub is a board certified radiologist with over 20 years of experience in diagnostic radiology. He is a senior partner in Clinical Radiologists, SC, a large private practice multispecialty group practicing in over 35 hospitals and clinics in central and southern Illinois, in affiliation with Southern Illinois University School of Medicine radiology residency. His current interests have been early infantile rickets that mimics child abuse. He recently published a critique in the American Journal of Radiology that proposed rickets likely explained the classic metaphyseal lesion, once thought to be a pathognomonic sign of inflicted skeletal trauma in infants. He has reviewed over 400 cases of unexplained fractures in infants and presented preliminary findings at meetings of the American Society of Bone and Mineral Research and the Radiological Society of North America. His research involves a multidisciplinary approach in collaboration with experts from pediatrics, orthopedic surgery, genetics, endocrinology and child abuse. Current projects include detailing the radiographic findings of the skeletal changes of recovering rickets.

Howard Morris, PhD, FAACB, FFSc(RCPA)
Professor of Endocrine Bone Research Laboratory, Univ of South Australia

Professor Howard Morris is Professor of Medical Sciences at the University of South Australia and a Chief Medical Scientist in Chemical Pathology at SA Pathology, Adelaide, South Australia.He is currently Vice-President of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and Chair of the IFCC-International Osteoporosis Foundation Working Group on Standardization of Bone Marker Assays. He has over 30 years experience in Clinical Biochemistry largely managing the Endocrinology laboratory of a large public pathology service. Between 2003 and 2009 he was the Director of the Hanson Institute in Adelaide, the major medical research institute in South Australia. His research investigates the pathophysiology of osteoporosis and the effects of hormones including vitamin D and dietary calcium. He was the Louis Avioli Memorial Lecturer at the 2009 Annual Scientific Meeting of the American Society for Bone and Mineral Research. He is also Chair of the South Australian Department of Health Working Party on Osteoporosis and Fracture Prevention.

Patrick Joseph, MD and Richard Frank, MD
Patrick Joseph, MD, Medical Director, Siemens Clinical Laboratory (SCL), Siemens Healthcare Diagnostics Richard Frank, MD, Chief Medical Officer, Clinical Strategy and Policy, Siemens Healthcare

Dr. Richard Frank, MD 

Dr. Richard Frank is Chief Medical Officer, Clinical Strategy and Policy, for Siemens Healthcare. With over 30 years global experience in the design, regulatory labeling, public and private payment for, and clinical adoption of therapeutic and diagnostic drugs and devices, Dr. Frank offers a broad, real-world perspective on the evolving role of diagnostics in todays healthcare marketplace. Dr. Franks similarly global experience with government agencies and non-governmental organizations (NGOs), and within both academia and industry, gives him particular expertise in clinical evidentiary standards, government policy, and the product-, market-, and delivery system-specific inefficiencies and issues that burden payers and delay or skew patients access to the benefits of innovation. 

Dr. Patrick Joseph, MD

Dr. Patrick Joseph serves as Medical Director for the Siemens Clinical Laboratory (SCL) of Siemens Healthcare Diagnostics in Berkeley, California. A distinguished infectious-disease specialist and epidemiologist, Dr. Joseph is an appointed Fellow of the Infectious Disease Society of America and the Society of Healthcare Epidemiologists of America.Dr. Joseph completed his specialty training in internal medicine, infectious disease, and laboratory medicine at the University of California, San Francisco, where he is currently Associate Clinical Professor of Medicine. Since 1983, he has practiced clinical medicine and held laboratory director roles for commercial and research laboratories that employ both conventional and novel molecular diagnostic techniques. He currently holds medical staff appointments with Highland Alameda County Medical Center, San Ramon Regional Medical Center, and Alta-Bates Summit Medical Center in Berkeley, California. 

Robert Flatman, FAACB, MBA, B App Sc
Assistant Manager Biochemistry, Sullivan Nicolaides Pathology, Australia

Robert Flatman is the Assistant Manager in Biochemistry at Sullivan Nicolaides Pathology, a large private reference laboratory in Brisbane, Australia, and part of the Sonic Healthcare group.  A longstanding interest in Laboratory Information Systems (LIS) and IT has led in recent years to participation in  eHealth and Pathology Harmonisation initiatives, including the AACB Harmonisation committee, AACB Critical Results Working Party, RCPA PUTS project (Pathology, Units and Terminology Standardisation) and its successor the RCPA PITUS project (Pathology Information, Terminology and Units Standardisation).  These groups are working on recommendations for standardisation in pathology reporting, including reference intervals, critical results, terminology for requested and reporting, units and reporting formatting harmonisation.  Robert is currently chair of the IFCC/IUPAC joint committee for Nomenclatures, Properties and Units (NPU).He also has interests in Pathology education (AACB state education representative), and attained his Fellowship in the Australasian Association of Clinical Biochemists in 2010 (FAACB).    

Rosy Tirimacco BSc
Network Operations & Research Manager, iCCnet, Country Health SA Local Health Network Inc

Rosy Tirimacco is the Operations and Research Manager of the Integrated Cardiovascular Clinical Network Country Health South Australia.Rosy has extensive experience in implementing and running point-of-care testing (PoCT) in hospitals and General Practice. She is heavily involved in PoCT education of rural doctors and nurses across South Australia. She is particularly interested in the integration of PoCT into clinical care pathways.She is currently the chair of the Australasian Association of Clinical Biochemists Point of Care Testing Working Committee, chair of the IFCC PoCT Task Force, chair of the IFCC Glucose POCT working group and project manager of the Australian Point of Care Practitioners Network.Title: Troponin Point of Care Testing Integrated into Clinical Care Contributing to Improved Cardiac Outcomes in Rural and Remote Areas.

Clinical Diagnostics and Research

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At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives. We strive to address unmet medical needs through excellence in sciencefrom early detection and prevention of diseases to diagnosis, treatment and treatment monitoring.

As a brand of Thermo Fisher Scientific, Life Technologies believes in the power of science to transform lives. To support scientists worldwide, we offer high-quality, innovative life science solutionsfrom everyday essentials to instrumentsfor every lab, every application. All from the most cited product brands.

Siemens Healthcare Diagnostics is a global leader in in vitro diagnostics, providing healthcare professionals in hospital, reference, and physician office laboratories and point-of-care settings with the vital information required to accurately diagnose, treat, and monitor patients.

We offer systems and solutions across a broad spectrum of disciplinesimmunoassay, chemistry, automation, hemostasis and hematology, blood gas and electrolytes, diabetes, urinalysis, microbiology, and molecular. Our innovative portfolio of performance-driven solutions, unmatched test menu of more than 900 different tests, and personalized customer care streamlines workflow and enhances operational efficiency.

Working closely with laboratories, clinicians, and hospital administrators, we create forward-thinking products and solutions that are shaping and transforming diagnosticsimproving clinical outcomes and, ultimately, helping to improve patient care.

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We’re a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk.

Headquartered in Raritan, NJ, with manufacturing operations in Rochester NY, Pompano Beach, FL and Cardiff, Wales, Ortho Clinical Diagnostics has more than 2,500 employees worldwide. We are dedicated to investing significant resources to continuously improve our products and develop solutions to address unmet medical needs.

Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.

Binding Site is committed to improving patient lives worldwide through education, collaboration, and innovation. We do this by providing automated special protein instruments and a wide range of high quality assays, with over 20 new assays FDA cleared in 2013 and 2014.

Binding Sites SPAPLUS special protein analyzer is the newest, most efficient, cost-effective, and reliable instrument solution available for special protein testing. With a comprehensive menu of over 30 assays, the SPAPLUS is the perfect complement for todays lab.

The Freelite assays, developed and provided exclusively by Binding Site, are considered standard-of-care for the diagnosis of Myeloma and other monoclonal gammopathies.

Binding Sites Hevylite assays are now available in the U.S. Hevylite is a novel test for measurement of Myeloma serum proteins. Hevylite test results are used together with Freelite in the management of Myeloma patients.

Binding Site is also the market leader for IgG and IgA immunoglobulin subclass reagents.

In addition to our in vitro diagnostic portfolio, we provide a comprehensive product offering of antibodies, antigens, clinical specimens, collaborative immunoassay reagents, disease state sera, substrates, and contact manufacturing services for IVD manufacturers and suppliers.

The Freelite assays, developed and provided exclusively by Binding Site, are considered standard-of-care for the diagnosis of Myeloma and other monoclonal gammopathies and suppliers.

For over 40 years the company has been developing, producing and marketing reagent kits for in vitro diagnostics worldwide. With their most recent acquisition of the NorDiag Group, DiaSorin gains access to the nucleic acid isolation and cell separation markets. Its line of products used by diagnostic laboratories that are part of hospital facilities or operate independently (private diagnostic services laboratories) can meet the needs of the following clinical areas: infectious diseases, cardiac markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.

As the world leader in robotic workstation innovation we set the standards for reliability, performance, and fexibility.At Hamilton, we design liquid handling systems that allow you to automate your assays exactly the way you need.

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research).

At Randox Health we offer exclusive preventative and personalised medicine.We have invested £200 million over 30 years into the creation of our ground breaking health profiling, including revolutionary proteomic (protein) testing.

Randox Health’s award winning technology has been developed by our parent company; Randox Laboratories – a world leader in medical diagnostics.Randox Health has one of the largest portfolios of physical and biological assessments available on the globe; a unique fusion of medical expertise and scientific intelligence, providing a complete picture of your health today and real insight into how it might change in the future.

Randox Health’s in-house team of nurses, GPs and specialists can support you in taking steps to prevent illness – sometimes lifestyle changes are all that is needed – but we also provide the very best in early detection and rapid, targeted treatment.

DNASTAR, Inc. is a global software company headquartered in Madison, Wisconsin USA that has been meeting the needs of life scientists for more than 25 years. We were born out of the E. coli lab of Dr. Fred Blattner, Professor of Genetics at the University of Wisconsin, in 1984. Our early products reflected this background and association and we built a strong reputation during the Sanger sequencing years of providing outstanding desktop software for DNA and protein sequence assembly and analysis.

Scientists at Base Pair Biotechnologies have been studying aptamers and developing them on a research basis since 2004 and began recently offering these services commercially. With a patented multiplexed approach we can develop custom aptamers at unprecedented time and cost.

Base Pair Biotechnologies, Inc. is a spin-off of parent company, BioTex, Inc., the original developer of several molecular biology and diagnostic technologies currently being commercialized. Base Pair Bio is a privately held company located in the Med Center of Houston, Texas.

A not-for-profit membership organization, the Clinical and Laboratory Standards Institute (CLSI) brings together the global laboratory community for a common cause: fostering excellence in laboratory medicine. We do so by facilitating a unique process of developing clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals.

For over 40 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of clinical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve the publics health around the world.

Definiens was awarded Frost & Sullivan's 2013 Global Company of the Year for Tissue Diagnostics and Pathology Imaging Solutions.

Definiens is the leading provider of image analysis and data mining solutions for quantitative digital pathology in the life sciences, diagnostic biomarkers and healthcare industries. Definiens software provides detailed readouts from whole tissue slides, cell-based assays and full body scans and allows correlating this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and supports better decisions in research, diagnostics and therapy. Definiens vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients lives.

Definiens software frees clinicians and scientists from poring over images, enabling them to focus on the critical work of investigation and interpretation:

Clinicians can provide more accurate and informed patient care based on highly detailed and rich analysis of tissue slides or full body scans.

Scientists can run any size of study and correlate the image data with other types of information, such as experimental conditions or patient outcomes. This allows them to understand the mechanisms of disease, validate targets, identify relevant biomarkers and open new avenues of research.

As the amount of image data grows exponentially, automation of image and data analysis is the only way to reduce the information bottleneck. Definiens revolutionary technology provides unprecedented accuracy in identifying and quantifying biological attributes within images and turning them into knowledge.

Definiens is headquartered in Munich, Germany, and has a North American office in Carlsbad, California.

KRONUS is a leading provider of immunodiagnostic reagents and test kits to the research and clinical laboratory marketplace. Since its founding in 1986, the Company has sought to provide unique and innovative products coupled with the highest level of customer service and support.

Working in partnership with several of the world's leading research and developmental scientists, KRONUS continues to focus its efforts on providing products and service of the highest quality. To that end, the Company now offers more than a dozen immunoassay test kits and related laboratory reagents useful in the assessment of various autoimmune and endocrine/metabolic disorders.

Luminex Corporation (NASDAQ: LMNX) was incorporated in May 1995 and began commercial production of our first generation system in 1997. Luminexdevelops, manufactures and markets innovative biological testing technologies with applications throughout the diagnostic and life science industries. The companys open-architecture xMAP and xTAG Technologies enable large numbers of biological tests (bioassays) to be conducted and analyzed quickly, cost-effectively and accurately.Systems using xMAP technology perform discrete bioassays on the surface of color-coded beads known as microspheres, which are then read in a compact analyzer.

Next Advance, Inc. develops and sells innovative, high-value, user-friendly laboratory instruments for molecular biologists. Designed and tested by our multi-disciplined cross-trained staff, our products automate mundane tasks, freeing scientists from repetitive, time-consuming procedures.

System Biosciences (SBI) develops innovative research tools for MicroRNA research, Exosome research, and Genome Engineering tools, including the CRISPR-Cas9 SmartNuclease system and PrecisionX HR targeting vectors.SBIs ExoQuick Exosome precipitation reagent is the most highly published reagent for exosome isolation in the world, with dozens of product citations in top journals.SBI also specializes in biomarker discovery with our unique Exo-NGS service, offering an end-to-end solution starting with patient samples and delivering comprehensive data analytics on NGS sequencing of exosomal RNA libraries.

CRC Press, a premier global publisher of scientific, technical, and medical content, provides essential material for academics, professionals, and students. CRC Press products include world-class references, handbooks, and textbooks as well as the award-winning CRCnetBASE eBook collections. CRC Press is a member of Taylor & Francis Group, an informa business. Our mission is to serve the needs of scientists and the community at large by working with capable researchers and professionals from across the world to produce the most accurate and up to date scientific, technical, and medical resources.

LabRoots is the leading scientific social networking website and producer of educational virtual events and webinars. Contributing to the advancement of science through content sharing capabilities, LabRoots is a powerful advocate in amplifying global networks and communities.

Labcompare is designed for scientists and researchers working in Research and Development, Analytical Chemistry, Photonics, Laboratory Automation, Environmental Testing, Forensics, and Product Testing. Labcompare’s marketplace includes sections for scientific and analytical instruments, elemental analysis, stability chambers, optical equipment and lasers, thermal analysis instruments and many more. Labcompare combines easy search functionality, detailed and complete specifications, and the ability to compare products side-by-side across manufacturers to make it the ideal destination for scientists looking for new products to purchase.

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Clinical Diagnostics and Research

Program Committee

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Stephanie Willerth, PhD

Dr. Willerth currently holds a Canada Research Chair in Biomedical Engineering at the University of Victoria where she is dually appointed in the Department of Mechanical Engineering and Division of Medical Sciences. Her research group investigates how to engineer neural tissue by combining pluripotent stem cells, controlled drug delivery and biomaterial scaffolds . She has given invited talks at the Till and McCulloch Annual Meeting and at the 1st Annual British Columbia Stem Cell and Regeneration Medicine Initiative Meeting as well as presented at the 9th Annual World Biomaterials Congress in Chengdu, China. She belongs to both the Brain Research Centre (BRC) and the International Collaboration on Repair Discoveries (ICORD) - B.C. based organizations committed to treating brain diseases and disorders and finding long term treatments for the repair of spinal cord injuries respectively. Before accepting her faculty position, Dr. Willerth completed an NIH post doctoral fellowship  at the University of California-Berkeley and graduate studies at Washington University.

C Jimmy Lin, MD, PhD, MHS

Jimmy Lin, MD, PhD, MHS, is a 2012 TED Fellow and Founder & President of Rare Genomics Institute, the world's first platform to enable any community to leverage cutting-edge biotechnology to advance understanding of any rare disease. Partnering with 18 of the top medical institutions, such as Harvard, Yale, Johns Hopkins, and Stanford, RGI helps custom design personalized research projects for diseases so rare that no organization exists to help. Dr. Lin is also a medical school faculty member at the Washington University in St. Louis and led the computational analysis of the first ever exome sequenching studies for any human disease at Johns Hopkins. He has numerous publications in Science, Nature, Cell, Nature Genetics, and Nature Biotechnology, and has been featured in Forbes, Bloomberg, Wall Street Journal, Washington Post, and the Huffington Post.

Agnieszka Lichanzka Ph.D.

Agnieszka is currently a Staff Scientist and Laboratory Manager at TessArae, LLC in Sterling, VA, USA. She obtained her PhD at the University of Queensland in Australia in a field of biochemistry, and subsequently worked as a post-doctoral fellow at Queen's University of Belfast, University of Queensland and Institute for Molecular Biosciences. Since 2005 until 2008 she held a continuing appointment as a lecturer in a School of Dentistry at the University of Queensland and established her own laboratory in area of functional genomics and metabonomics. She has over 10 years of experience in molecular biology, genetics, genomics, biochemistry, microbiology and metabonomics. In addition she has experience as a science writer. Recently Agnieszka served on the Council of the Australian Society for Biochemistry and Molecular Biology and is still active in the society. Currently she is working on novel diagnostic assays for infectious diseases using microarray re-sequencing technology.

Martin Latterich, PhD

Dr. Latterich has nearly 20 years of academic and commercial and leadership experience and features an accomplished research career focused on the proteomics-based discovery of novel biomarkers in oncology, respiratory disease and neurodegenerative disorders.

Martin is currently CSO at BioScale, a Lexington, MA, based biotechnology corporation commercializing a novel acoustic biomarker quantification platform. Most recently Martin served as a Professor at the Proteogenomics Research Institute for Systems Medicine in San Diego, where his laboratory used proteomics and genomics to discover novel biomarkers of cancer and degenerative disease though a systems biology approach that includes proteomics. He is also the CSO, co-founder and a board member for the non-profit Nicholas Conor Institute for Pediatric Cancer Research. Martin's work at the institute included designing new technologies to enable the better treatment of children with cancer, using personalized medicine technology to match their unique genetic make-up and tumor physiology to available treatment options. He previously served on the faculty of the University of Montreal, McGill University and the Salk Institute. His grant-funded work has been recognized by the 2003 Tier I Canada Research Chair, the 1998 Pew Scholar Award and the 1997 Basil O'Connor Starter Scholar Award.

Dr. Latterich also held senior management positions at several biotechnology companies, including Diversa and Illumina, where he headed the proteomics initiatives. He has made significant contributions to the field of cell biology, clinical biomarker discovery, proteomics and genomics. Among his recent discoveries are biomarkers for cancer, respiratory disease and neurodegenerative disorders. Dr Latterich has edited one book on RNAi, is author on over 34 publications in leading scientific journals and is listed on numerous patent applications. Martin is Editor-in-Chief of the scientific journal Proteome Science. He has served on several national and international study sections. He was a postdoctoral fellow in molecular and cell biology in the laboratory of Dr. Randy Schekman at the HHMI and University of California, Berkeley. Dr. Latterich earned his Ph.D. in cell biology and a B.Sc. in biochemistry and molecular biology from Durham University, U.K.

Fred Russell Kramer, PhD

Fred Russell Kramer is Professor of Microbiology and Molecular Genetics at the New Jersey Medical School, and has been a Principal Investigator at the Public Health Research Institute for the past 25 years. He graduated from the University of Michigan in 1964 and received his doctorate from the Rockefeller University in 1969. He was on the faculty of the Department of Genetics and Development at Columbia University College of Physicians and Surgeons for 17 years and has been a Research Professor and Adjunct Professor in the Department of Microbiology at New York University School of Medicine for the past 24 years.

Daniel Irimia, MD, PhD

Dr. Irimia is an Assistant Professor in the Department of Surgery at the Massachusetts General Hospital, Shriners Hospitals for Children in Boston, and Harvard Medical School.  He is leading a research program that is focused on studying the roles of cellular migration in health and disease.  Dr. Irimia is interested in probing the role of cancer cell migration during cancer invasion and tumor metastasis.  He is also very interested in understanding how the ability of white blood cells to move and protect against microbes is being affected during the systemic inflammation responses after burn and trauma injuries.  For this research, he is employing the most advanced microscale technologies which enable us to design new tools and measure cell migration with better precision than ever before.

Ulrich Hengst, PhD

Dr. Ulrich Hengst studied biochemistry at the Ruhr University Bochum, Germany, and conducted his graduate research at the Friedrich Miescher Institute for Biomedical Research in Basel, Switzerland, in the group of Prof. Denis Monard. In 2003 he received his PhD from the University of Basel. For his postdoctoral training, Dr. Hengst joined the laboratory of Samie R. Jaffrey, MD, PhD at the Weill Cornell Medical College in New York, NY. In Dr. Jaffreys group, he investigated the role of axonally localized mRNAs for axonal development leading to the identification of the first examples of specific mRNAs that are translated in axons in response to extracellular signaling molecules and that mediate growth cone collapse and axon elongation, respectively.

In 2009, Dr. Hengst joined the Department of Pathology and Cell Biology and the Taub Institute for Research on Alzheimers Disease and the Aging Brain at Columbia University Medical Center in New York, NY, as an Assistant Professor. He has successfully established new research projects addressing the role of local protein synthesis in Alzheimers disease and neurodevelopment.

Timothy Harris, PhD

Since June 2011, Dr. Harris has served as the Senior Vice President of Translational Medicine at Biogen Idec. Dr. Harris has served as the Director of the Advanced Technology Program at SAIC Frederick since 2007 and Chief Technology Officer for SAIC Frederick since 2008. Prior to holding these positions, he served as the President and Chief Executive Officer of Novasite Pharmaceuticals Inc. from January 2005 to September 2006. Prior to that, he served as Chief Executive Officer for Structural GenomiX, Inc., a drug discovery and development company focused on innovative cancer therapeutics from 2003 to 2004 and as its President and Chief Executive Officer from 1999 to 2003. Dr. Harris started his career in biotechnology in 1981 as a group leader in Molecular Biology at Celltech Group and from 1989 to 1993 was Director of Biotechnology at Glaxo Group Research in the U.K. From 1993 until 1999, Dr. Harris was Chief Scientific Officer and Vice President of Research and Development at Sequana Therapeutics Inc. in San Diego, which became Axys Pharmaceuticals, Inc. in 1998 and was subsequently acquired by Celera Genomics. During the past five years, Dr. Harris has served on the board of directors of Dendreon Corporationration and he currently serves on the boards of directors of Origen Therapeutics, Inc. and Gyrasol Technologies and is Chairman of the Scientific Advisory Board of Bionomics Inc. in Australia.

Anthony Grace, PhD

Dr. Anthony A. Grace is a Distinguished Professor of Neuroscience and a

Professor of Psychiatry and Psychology at the University of Pittsburgh

in Pittsburgh, PA.  He received his Ph.D. from Yale University School of

Medicine with Dr. Benjamin S. Bunney and had postdoctoral training with

Dr. Rodolfo Llinas in the Department of Physiology and Biophysics at

New York University School of Medicine.  Dr. Grace has been involved in

translational research related to the dopamine system for over 30

years.   His early work pioneered the mode of action of antipsychotic

drugs, and the identification and characterization of

dopamine-containing neurons, and was the first to provide a means to

quantify their activity state and pattern in a way that is the standard

in the literature.  His current work involves novel treatments for

schizophrenia and its prevention, the role of dopamine in anhedonia and

affective disorders, and the mode of action of ketamine and novel

antidepressant drugs.  Dr. Grace has received several awards for his

research, including the Paul Janssen Schizophrenia Research Award and

the Lilly Basic Scientist Award from the International College of

Neuropsychopharmacology, the Efron Award from the American College of

Neuropsychopharmacology, as well as a NIMH MERIT award, a Distinguished

Investigator award from the National Alliance for Research in

Schizophrenia and Depression, the Judith Silver Memorial Investigator

Award from the National Alliance for the Mentally Ill, a Fellow of the

American Association for the Advancement of Science, and appointment as a

Distinguished Professor of Neuroscience at the University of

Pittsburgh.  He is also a past member of the governing council of the

American College of Neuropsychopharmacology and is on the editorial

board fornumerous leading journals in the field.

Pierre-Antoine Gourraud, PhD, MPH

Pierre-Antoine Gourraud is a former student of the Ecole Normale Suprieure de Lyon in France. After receiving an M.P.H. from University Paris XIII in 2002, he got his Ph.D. in Immunogenetic Epidemiology and Public Health from Toulouse University in 2005. He relocated to the United States to do his postdoctoral research in Neuroimmunogenetics of multiple sclerosis at UCSF in 2009 and joined the UCSF faculty in 2011. Dr Gourraud has established numerous research collaborations with investigators from all over the world: He develops bioinformatics resources at the National Center for Biotechnology Information (Immunogenetics markers: HLA, KIR, Microsatellites). At UCSF, he performs new generation of MS genetic association studies using massive sequencing technologies in various genetic ancestry backgrounds and continues developing software dedicated to translational digital medicine. His recent efforts have focused on the MS Bioscreen, a tablet-based navigation-system that integrates multiple dimensions of patient information including clinical evolution, therapeutic treatments, brain imaging, genomics and biomarker data.

Eric Gluck, MD, JD

Dr. Eric H. Gluck received his doctoral degree in medicine from New York Medical College in Valhalla, New York. He completed his residency at Beth Israel Medical Center in New York City and a pulmonary fellowship at the University of Utah School of Medicine in Salt Lake City, Utah. Dr. Gluck currently serves as the director of Critical Care Services at Swedish Covenant Hospital in Chicago, Illinois, and as a professor of medicine at Finch University of Health Sciences at the Chicago Medical School. Dr. Gluck is a fellow of the Society of Critical Care Medicine, American College of Chest Physicians, and the Chicago Institute of Medicine. He is a member of the American Thoracic Society, Society of Sigma Xi, Alpha Omega Alpha, and the American Society of Law, Medicine, and Ethics. He has delivered numerous lectures and co-authored many articles in the field of pulmonary critical care.

Ariel Louwrier Ph.D.

Dr. Louwrier has successfully brought strategic vision coupled with tactical operational success to positions he has been employed at throughout his career. He is an entrepreneur with a broad range of experience in a variety of scientific fields as well as excelling in executive management in the biotechnology industry. Growing up in Europe gained him the sound knowledge of multiple languages after which he moved to the UK for his undergraduate work at the University of Sussex, specializing in genetics and heat shock. This was followed by doing his PhD in Biochemistry and Biotransformations at the University of Kent at Canterbury, also in the UK. He worked in conjunction with SmithKline Beecham (now GSK) resulting in biosynthetic methods of amoxicillin production that have since been integrated into current manufacturing processes.  Ariel then went on to work at the Massachusetts Institute of Technology (MIT) in the field of non-aqueous enzymology and protein engineering in the Chemical Engineering Department. Later, returning to the UK he joined ABgene (now a Thermo Fisher portfolio company), in 1995. Shortly thereafter Ariel started StressMarq Biosciences Inc., a new reagent cellular-stress company, which continues to provide researchers worldwide with the highest quality heat shock and cellular stress reagents.

Tatjana Matejic, PhD, D(ABMLI)

Dr. Matejic is the founder of Biotech Expertise where she provides scientific and technical consulting services to biotech companies on development of functional assays reflective of mechanisms of drug action in the context of disease pathology, in vivo studies, and biomarkers.  She is an immunologist by training (Ph.D. in immunology, board certification in medical diagnostic immunology by the American Board of Medical Laboratory Immunology) with more than two decades of industrial experience working in research and development of Biotech/Pharma companies ranging from start-ups to multinational pharmaceutical corporations, Pfizer being the most recent one.  During her long career in industry she led and mentored diverse teams of scientists and contributed to all stages of project and product development from scientific idea to commercial product of diverse portfolio of biologics. She was recognized as a leader in development and implementation of strategies for evaluating biological function of therapeutic candidates. She contributed to efforts of interdisciplinary drug development teams to successfully advance numerous early and late stage clinical programs and a few commercial products across multiple therapeutic areas and disease targets. She also conducted technical diligence for transition of pipeline projects from discovery to development phase, as well as for technology assessment for in-licensing opportunities.

Kathryn Wellen, PhD

Dr. Kathryn Wellen received a PhD from Harvard University in 2006 and performed postdoctoral work at the University of Pennsylvania from 2006-2011.  In 2011 she joined the Department of Cancer Biology at the University of Pennsylvania as an Assistant Professor.  She is a 2012 Pew Scholar in the Biomedical Sciences and is a recipient of a 2012 Forbeck Scholar Award.  Her laboratorys research focuses on elucidating links between cellular metabolism and signaling, with a current emphasis on metabolic regulation of the epigenome.

Katerina Venderova, PharmD, PhD

Dr. Katerina Venderova obtained her master's and doctorate degrees in pharmacy, and her PhD in Toxicology from Charles University in the Czech Republic. She then received a fellowship from the Parkinson Society Canada and pursued her postdoctoral training at Toronto Western Research Institute (2 years), and subsequently at University of Ottawa in Canada (5 years), where she studied genetics of Parkinson's disease, mechanisms of neuronal death and cell signaling in the basal ganglia. Dr. Venderova joined Pacific in 2011.

Theral Timpson

Theral is the host of Mendelspod, where he interviews thought leaders from around the life science community.  He's a regular blogger at Mendelspod and frequent speaker and emcee at life science conferences and related events.  Theral is an active mentor in Silicon Valley for those seeking careers in science and or media.  He's the President and owner of Theral Timpson Productions where he offers consulting for life science marketing, strategic planning, and conflict resolution.   Mr. Timpson has over 15 years experience establishing and growing companies in the life science industry, including President and Co-Founder of Consumer Genetics and Vice President of Marketing at Medax International.     He received training from the E. Goldratt Institute in Theory of Constraints and holds a B.A. degree in English Literature from the University of Utah.

Deanne Taylor, MS, PhD

Dr. Taylors background is in biophysics, bioinformatics, computational biology and structural biology with emphasis on human genetics and translational medicine. She obtained her Ph.D. in Biophysics from  the University of Michigan, Ann Arbor, and completed a postdoctoral fellowship at Pfizer in Ann Arbor. She had worked in the pharmaceutical industry at EMD-Serono, transitioning into clinical and basic research by moving to Harvard School of Public Health and then to clinical research at RWJ/Rutgers.  She also served several years as the Program Director of the Graduate Program in Bioinformatics at Brandeis University, where she still occasionally teaches a course in Computational Systems Biology.

Her main areas of research are in the development of mathematical and computational methods to better understand biological variation and the genetic contribution to disease, coupling clinical information with high-dimensional biomedical data from next-gen sequencing, microarray, PCR, and proteomics experiments.  Some of her immediate research interests are in  development of methods to better classify effects of genetic variation within interacting systems through effects in gene function and contributions to disease, developing  mathematical genotype representations of variation in populations,  and using machine-learning techniques to build classifiers in  translational medicine research. Her  scientific contributions were acknowledged with the rest of the Divisions research team at the 2010 ASRM meeting when the REI division received the ASRM Prize Paper Award, where her contribution was in building databases, systems and validated methods for high-throughput genotype analyses .

Leigh Anne Swayne, PhD

Leigh Anne Swayne is a basic cell and molecular neurobiologist. After training in Canada and France, she started her independent research lab in January 2011 in the Division of Medical Sciences at the University of Victoria, in Victoria, BC Canada. Leigh Anne's work focuses on the role of ion channels in shaping postnatal neurogenesis. She combines biochemistry, proteomics, cell biology, electrophysiology, and microscopy to understand how ion channels direct this postnatal developmental process. Her lab's  ultimate goal is to find effective ways of boosting brain repair following injury or disease.

Ahmad Salehi, MD, PhD

Ahmad Salehi, M.D., Ph.D. is a Clinical Associate Professor at the Department of Psychiatry and Behavioral Sciences, Stanford Medical School and the Director of the Translational Laboratory at the VA Palo Alto Health Care System in California. He obtained his MD in Tehran, Iran and then moved to the Netherlands Institute for Brain Research, in Amsterdam to get his PhD. While he was there, he was selected as the best junior scientist in the field of Alzheimers disease in the Netherlands. After finishing his graduate studies and 3 years of postdoc in Amsterdam, he moved to Stanford Medical School. First as a postdoc, and then as a Senior Research Associate, he worked on mechanisms of failed axonal transport in mouse models of Down syndrome. For almost a decade, he was the Director of Stanford Brain Bank. Since 2009, Dr. Salehi has moved to the Department of Psychiatry and Behavioral Sciences at Stanford. In December 2010, he received the World Technology Award in the field of Biotechnology for his innovative work on the use of mouse models of Down syndrome. During his carrier, Ahmad has been involved in publication of a large number of papers from which several have appeared on the cover of Science, Cell: Stem Cell, Science Translational Medicine, Neuroscience and Bio-behavior Reviews, and Biological Psychiatry (twice).

John Quackenbush, PhD

John Quackenbush received his PhD in 1990 in theoretical physics from UCLA working on string theory models. Following two years as a postdoctoral fellow in physics, Dr. Quackenbush applied for and received a Special Emphasis Research Career Award from the National Center for Human Genome Research to work on the Human Genome Project. He spent two years at the Salk Institute and two years at Stanford University working at the interface of genomics and computational biology. In 1997 he joined the faculty of The Institute for Genomic Research (TIGR) where his focus began to shift to understanding what was encoded within the human genome. Since joining the faculties of the Dana-Farber Cancer Institute and the Harvard School of Public Health in 2005, his work has focused on the use of genomic data to reconstruct the networks of genes that drive the development of diseases such as cancer and emphysema.

Judd Moul, MD, FACS

Dr Judd W. Moul is James H. Semans, MD Professor of Surgery, Division of Urologic Surgery, and Director of the Duke Prostate Center, Duke Cancer Institute at Duke University Medical Center.  Prior to joining Duke, he was Professor of Surgery at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland and an attending Urologic Oncologist at the Walter Reed Army Medical Center (WRAMC) in Washington, DC.  In addition, he was Director of the Center for Prostate Disease Research (CPDR); a Congress-mandated research program of the Department of Defense based at USUHS and WRAMC.  In 2004, he completed a 26-year U.S. Army career, retiring as a full Colonel in the Medical Corps, and became Chief of the Division of Urologic Surgery at Duke.  Serving as Chief from 2004 to 2011, he brought innovation and growth to the program.  Most notably, he started the Duke Prostate Center, expanded the urology residency training program through a novel collaboration with the Department of Defense and was able to maintain Duke Urology as a top 10 program in the nation throughout his tenure.

Dr Moul completed his Urologic Oncology Fellowship at Duke University and graduated Summa Cum Laude from Pennsylvania State University.  He earned his medical degree from Jefferson Medical College, where he was elected to Phi Beta Kappa and Alpha Omega Alpha.

Dr Moul currently serves on the editorial boards of Prostate Cancer, Prostate Cancer and Prostatic Diseases, BJU International, American Journal of Mens Health, Brazilian Journal of Urology, World Journal of Urology, and Oncology REALTIME.  He has published over 500 medical and scientific manuscripts and book chapters and has lectured at national and international meetings.  He has appeared on ABC, NBC, CNN, PBS, and other media as a prostate cancer authority.  Honors and awards received have included the American Medical Associations Young Physicians Section Community Service Award for his national involvement in prostate cancer patient support groups, the Sir Henry Welcome Research Medal and Prize from the Association of Military Surgeons of the United States, the prestigious Gold Cystoscope Award by the American Urological Association, the Baron Dominique Jean Larrey Military Surgeon Award for Excellence, the Order of Military Medical Merit from the Surgeon General at the US Army, and the Castle Connolly National Physician of the Year award.

Vincent Mauro, Ph.D.

Dr. Mauro is an Associate Professor in the Department of Neurobiology at the Scripps Research Institute in La Jolla, California. He is also a co-founder and lead scientist of Promosome, a biotechnology company focused on bioproduction enablement and DNA vaccines. In addition, Dr. Mauro is a Senior Fellow in Experimental Neurobiology at the Neurosciences Institute in San Diego, California.

Prior to moving to The Scripps Research Institute, Dr. Mauro received his Ph.D. at McGill University in Montreal, Quebec, and continued his studies as a postdoctoral fellow at The Rockefeller University in New York City. 

Dr. Mauro studies both fundamental and applied aspects of translational control mechanisms. His basic research is focused on understanding how eukaryotic mRNAs recruit ribosomes, how ribosomes subsequently locate initiation codons, and how ribosomes regulate the translation of specific subsets of mRNAs. Dr. Mauro's applied studies build on his basic research. These applied studies have led to the identification of Translational Enhancer Elements (TEEs) and the generation of synthetic translational enhancers.

Paul Mathews, PhD

Dr. Paul J. Mathews received his bachelors degree from the University of Oregon where he studied invertebrate behavioral plasticity in the lab of Dr. Nathan Tublitz. He received his Ph.D. in neuroscience from the University of Texas at Austin under the mentorship of Dr. Nace Golding. Dr. Mathews work focused on understanding how the biophysical properties of specific voltage-gated ion channels in an auditory brainstem nuclei contribute to their capacity to make sub-millisecond computations necessary for low frequency sound localization. For the past several years Dr. Mathews has been working at UCLA under the mentorship of Dr. Tom Otis where he is currently working to uncover the cerebellar circuit mechanisms that underlie motor learning and memory. To do this Dr. Mathews is utilizing a multifaceted approach that includes both in vitro and in vivo electrophysiology, optogenetics, advanced optics, histology, and behavioral manipulations to make links between cerebellar circuit activity and motor output in rodent models. He is currently on the job market looking for a tenured track assistant professor position.

Wieslaw Furmaga, MD

Director, Clinical Chemistry Laboratory University Hospital

Director, General Laboratory Cancer Treatment Research Center

Director, Proteomics Laboratory UTHSC at San Antonio

Interim Director, Molecular Laboratory UTHSC at San Antonio

Associate Director, Mycology Laboratory UTHSC at San Antonio

I graduated from the Collegium Medicum at Jagiellonski University in

Poland, and subsequently completed residency program in anatomic,

clinical pathology and clinical chemistry. I have been practicing

pathology in the University of Texas Health Science Center at San

Antonio, Texas as a staff pathologist and medical director of clinical

chemistry and molecular laboratory.

I have been serving the Instrumental Resource Committee of the

College of American Pathologist (CAP) since 2008. Since 2009 I have

served for the Pharmacogenomics Committee, Educational subcommittee

working on Pharmacogenomics Educational Course. I was actively involved

in the CLSI on a project “Method Validation by using patient’s sample”.

The main scientific interest is in biomarkers for aggressive prostate

cancer as well as biomarkers for monitoring the trauma patients with

hemorrhagic shock.

David Carpentieri, MD

Dr. Carpentieri is a Medical Staff Member at Large, Pathology, Phoenix Children's Hospital and is Assistant Professor of Clinical Pathology and Pediatrics, University of Arizona and Assistant Professor of Pathology, Mayo Medical School.  His affiliations are with the American Association for Clinical Chemistry (AACC), the Childrens Oncology Group (COG), Society for Pediatric Pathology (SPP), and the International Society for Biological and Environmental Repositories (ISBER).

Howard Morris, PhD, FAACB, FFSc(RCPA)

Professor Howard Morris is Professor of Medical Sciences at the University of South Australia and a Chief Medical Scientist in Chemical Pathology at SA Pathology, Adelaide, South Australia.

He is currently Vice-President of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and Chair of the IFCC-International Osteoporosis Foundation Working Group on Standardization of Bone Marker Assays. He has over 30 years experience in Clinical Biochemistry largely managing the Endocrinology laboratory of a large public pathology service. Between 2003 and 2009 he was the Director of the Hanson Institute in Adelaide, the major medical research institute in South Australia. His research investigates the pathophysiology of osteoporosis and the effects of hormones including vitamin D and dietary calcium. He was the Louis Avioli Memorial Lecturer at the 2009 Annual Scientific Meeting of the American Society for Bone and Mineral Research. He is also Chair of the South Australian Department of Health Working Party on Osteoporosis and Fracture Prevention.

Ross J Molinaro, PhD, MT(ASCP), DABCC, FACB

Ross J. Molinaro, PhD, MT(ASCP), DABCC, FACB is an Assistant Professor

in the Department of Pathology and Laboratory Medicine at Emory

University. He received his PhD in Clinical Chemistry and Molecular

Medicine from Cleveland State University and completed the ComACC

training program at Emory as the first recipient of the AACC

Past-Presidents’ Scholarship. He currently serves as the Medical

Director of the Core Laboratory at Emory University Hospital Midtown and

co-Director of the Emory Clinical Translational Research Laboratory.

Ross also teaches various aspects of laboratory medicine to medical

students, pathology residents and fellows, clinical chemistry fellows,

and medical technology students.

Ross joined the AACC in 2005 and is a member of the Proteomics and

Clinical Translational Science Divisions. Ross is currently a committee

member of the Society for Young Clinical Laboratorians (SYCL). He is

also a member of the Professional Practice Review Course Curriculum

Organizing Committee and the Clinical Chemistry Trainee Council

Executive Committee as the Exam Questions Vault Coordinator. In

addition, Ross serves as an American Society for Clinical Pathology

(ASCP) Board Liaison to the Clinical Chemistry Examination Committee,

and a member of the Board of Governors as the ASCP/AACC Member

Representative. With over 40 publications and book chapters, his

interests reside in the practice and standardization of mass

spectrometry in the clinical laboratory and expanding the knowledge base

of clinical chemistry and laboratory medicine for medical students and

those practicing in different healthcare disciplines.

Mark Marzinke, PhD, BABCC

Mark Marzinke, PhD, DABCC earned a Ph.D. in Biochemistry from the University of Wisconsin-Madison and subsequently completed a clinical chemistry fellowship at The Johns Hopkins University in 2012. During his clinical fellowship, Dr. Marzinke focused on the development and validation of qualitative and quantitative mass spectrometric assays for the clinical monitoring and quantitation of pain management drugs and anti-neoplastic agents, respectively. Further, he performed large scale proteomics studies aimed at the temporal identification of biomarkers expressed during ovarian cancer progression. Dr. Marzinke is currently an Instructor in the Departments of Pathology and Medicine at the Johns Hopkins University School of Medicine (JHUSOM).  He serves as the Director of Preanalytics and General Chemistry in the Core Laboratory of the Johns Hopkins Hospital, where he focuses on workflow analysis and test utilization.  Additionally, he is the Associate Director of the Clinical Pharmacology Analytical Lab (CPAL) at the JHUSOM, where he focuses on the development and validation of quantitative mass spectrometric methods in rare matrices to support large clinical trials.   His research interests include the development, validation and implementation of assays focused on personalized medicine, including therapeutic drug monitoring and pharmacogenetic testing.  Dr. Marzinke is board certified by the American Board of Clinical Chemistry.

Alan Maisel, MD

Dr. Alan Maisel  attended University of Michigan Medical School and did his cardiology training at the University of California at San Diego.  He is currently Professor of Medicine at the University and director of the coronary care unit and the heart failure program at the affiliated Veterans Affairs Medical Center. He is considered one of the worlds experts on cardiac biomarkers, and is given credit for ushering in the use of BNP levels in clinical practice around the world. He has over 300 articles in print and a large clinical and basic science lab.  Dr. Maisel is also a fixture at the medical school, where he has won countless teaching awards from medical students as well as interns and residents. Dr Maisel s yearly San Diego Biomarker meeting is considered the most prestigious of its kind. Dr. Maisel is currently an Associate Editor of the Journal of American College of Cardiology.  He has published two medical novel and helps to raise five children,  He gave up on sleep five years ago.

Kamisha Johnson-Davis, PhD, DABCC, FACB

Dr. Johnson-Davis is a medical director of the Clinical Toxicology laboratory, Antifungal Testing and Immunosuppressants Testing at ARUP. Dr. Johnson-Davis received her PhD in pharmacology at the University of Utah and is board certified in clinical chemistry by the American Board of Clinical Chemistry. She completed her postdoctoral fellowship in clinical chemistry at the University of Utah, Department of Pathology, and was a postdoctoral research associate at the Center of Human Toxicology at the University of Utah. Dr. Johnson-Davis is a member of various professional societies, including the Academy of Clinical Laboratory Physicians and Scientists and the American Association for Clinical Chemistry.

Bruce Hollis, PhD

Bruce W. Hollis, Ph.D. received his B.Sc. and M.Sc. from the Ohio State University and subsequently his Ph.D. from the University of Guelph in 1979. Dr. Hollis then completed an Endocrine Fellowship at The Case Western Reserve University School of Medicine in 1982.  Dr. Hollis was then Appointed Assistant Professor of Nutrition at Case Western and remained there until 1986 when he moved to The Medical University of South Carolina where to he is Professor of Pediatrics, Biochemistry and Molecular Biology. He is also Director of Pediatric Nutritional Sciences. Dr. Hollis has studied vitamin D metabolism and nutrition for the past 35 years and has been an NIH grant recipient for the past 30 years. His current work focuses on the vitamin D requirements during pregnancy and lactation. Dr. Hollis has in excess of 200 peer reviewed articles in this area of investigation.

Michael Holick, MD, PhD

Michael F. Holick, Ph.D., M.D. is Professor of Medicine, Physiology and Biophysics; Director of the General Clinical Research Unit; and Director of the Bone Health Care Clinic and the Director of the Vitamin D, Skin and Bone Research Laboratory at Boston University Medical Center.

Dr. Holick has made numerous contributions to the field of the biochemistry, physiology, metabolism, and photobiology of vitamin D for human nutrition. Dr. Holick has established global recommendations advising sunlight exposure as an integral source of vitamin D.  He has helped increase awareness in the pediatric and medical communities regarding vitamin D deficiency pandemic, and its role in causing not only metabolic bone disease, and osteoporosis in adults, but increasing risk of children and adults developing common deadly cancers, schizophrenia, infectious diseases including TB and influenza, autoimmune diseases including type 1 diabetes and multiple sclerosis, type 2 diabetes, stroke and heart disease. He also observed the pregnant women who were vitamin D deficient were at increased risk for preeclampsia and requiring a C-section.  He has written more than 300 pier reviewed articles, edited or wrote 12 books including The Vitamin D Solution and is the recipient of numerous awards including the Linus Pauling Prize in Human Nutrition.

George Fritsma, MS, MT

George Fritsma is an associate professor in Laboratory Medicine of the Department of Pathology at the University of Alabama at Birmingham.

Prof. Fritsma manages www.fritsmafactor.com, “The Fritsma Factor, Your Interactive Hemostasis Resource,” a clinical coagulation educational resource and blog. The Fritsma Factor is sponsored by Precision BioLogic, Inc, Dartmouth, Nova Scotia, Canada.

Prof. Fritsma is the continuing education editor for the Clinical Laboratory Science Journal and a member of the American Association for Clinical Chemistry publications committee. He is co-editor of Hematology Clinical Principles and Applications, 4th edition, 2012, and he is and co-author of Quick Guide to Renal Disease Testing, 2011; Quick Guide to Venipuncture, 2010; Quick Guide to Coagulation 2nd Edition, 2009; and Quick Guide to Hematology Testing, 2007, all available from the ASCLS bookstore.

Prof. Fritsma is a 40-year member of the American Society for Clinical Laboratory Science and a member of the International Society for Thrombosis and Haemostasis. He holds a bachelor’s degree in biology and chemistry from Calvin College, Grand Rapids, Michigan, a Masters in Medical Technology from Wayne State University, Detroit, and advanced course work from the University of Illinois at Chicago.

Cynthia Bowman MD

Dr. Cynthia Bowman has been a broad based general pathologist for over 30 years. She graduated with a BA in Chemistry from St. Olaf College, received her MD from Vanderbilt University Medical School, and trained for 6 years at the University of California, San Francisco as a surgery intern and then anatomic and clinical pathology resident. She worked as an emergency room physician during training and has always had a clinical perspective in her practices. She has worked in California, Maine, Massachusetts, New York and Australia as an anatomic and clinical pathologist and laboratory medical director in small, mid-sized, tertiary and academic  medical centers. She is currently Medical Director at Enzo Clinical Laboratories, a commercial reference laboratory and bioscience company in the NY metropolitan area, and in that capacity collaborates with the development and integration of molecular services into clinical testing.  She has been active in national laboratory organizations, especially the College of American Pathologists, where she was chair of the Point of Care Testing Resource Committee. In that capacity she guided the introduction and was the senior editor of a web-based POCT toolkit as a resource for laboratory director leadership in POCT.  She has also written and edited multiple educational pieces for the laboratory community as part of the CAP Excel Survey program and in 2012 she was awarded a Life Time Achievement Award by the CAP. She has spoken at AACC and CAP meetings and currently serves on several CLSI document development committees. She is currently chair of an International Federation of Clinical Chemistry POCT task force work group addressing the use of glucose  meters in critical care patients.  Her professional commitment has always been to integrate and translate pathology and laboratory medicine services into effective clinical care. She has dedicated her efforts in POCT as part of that vision to collaborate with all stakeholders and involve laboratory services as part of the continuum of care. She enjoys evaluating technology and integrating it into laboratory services.

Christoph H. Borchers, Ph.D.

Dr. Borchers received his B.S., M.S. and Ph.D. from the University of Konstanz, Germany.  After his post-doctoral training and employment as a staff scientist at NIEHS/NIH/RTP, NC and he was the director of the Duke – UNC Proteomics Facility and held a faculty position at UNC Medical School in Chapel Hill, NC (2001-2006).  Since then Dr. Borchers is Associate Professor at University of Victoria (UVic), Canada and the Director of the UVic – Genome Proteomics Centre.  His research is centred around the improvement, development and application of proteomics technologies with major focus on techniques for quantitative targeted proteomics for clinical diagnostics.

Amy K Saenger, PhD, DABCC, FACB

Dr. Amy Saenger is an Assistant Professor of Laboratory Medicine and Pathology at the Mayo Clinic College of Medicine and Director of Cardiovascular Laboratory Medicine in the Department of Laboratory Medicine and Pathology at the Mayo Clinic in Rochester, Minn. She is the Director of the Clinical Chemistry Fellowship Program and is actively involved in training fellows, pathology residents, and allied laboratory health staff. She also serves as a Director on the Commission on Accreditation in Clinical Chemistry (ComACC) board and is an Associate Editor for the journal Clinical Chemistry. Dr. Saenger received her PhD in Analytical Chemistry from the University of Minnesota. She completed her clinical chemistry fellowship training at the University of Washington and is board certified in clinical chemistry (DABCC). 

Her research has focused on cardiac biomarkers such as troponin and natriuretic peptides, as well as novel biomarkers for the detection of oxidative and cardiovascular stress, damage, and heart failure. Dr. Saenger has been honored with the AACC Outstanding Scientific Achievements by a Young Investigator Award, the NACB George Grannis Award for Excellence in Research and Scientific Publication, the Paul E. Strandjord Young Investigator Award from the Academy of Clinical Physicians and Scientists, the Strandjord/Clayson Award for Meritorious Research from the University of Washington, and the AACC Outstanding Speaker Award. She serves on several AACC committees including the Clinical Laboratory News board of editors, the Society for Young Clinical Laboratorians executive committee, and is currently past-chair of the AACC Midwest Section.

Joely Straseski, PhD, MS, MT(ASCP), DABCC

Dr. Straseski is a medical director of endocrinology at ARUP Laboratories and an assistant professor of pathology at the University of Utah School of Medicine. She received her PhD in pathology and laboratory medicine and a Master’s degree in bacteriology from the University of Wisconsin-Madison, where she also served as a postdoctoral associate in the Department of Pathology. Dr. Straseski completed a postdoctoral fellowship in clinical chemistry at the Johns Hopkins Medical Institutions in Baltimore, Maryland. She has previously been awarded the Past-President Scholarship by the American Association for Clinical Chemistry, as well as a Distinguished Abstract Award from the National Academy of Clinical Biochemistry. Dr. Straseski is board certified in clinical chemistry by the American Board of Clinical Chemistry.

Charles Cantor, PhD

Dr. Charles Cantor is a founder, and Chief Scientific Officer at SEQUENOM, Inc., which is a genetics discovery company with tools, information and strategies for determining the medical impact of genes and genetic variations.

He is also the founder of SelectX Pharmaceuticals, a drug discovery company, Retrotope, an anti-aging company, and DiThera, a biotherapeutic company.

Dr. Cantor is professor emeritus of Biomedical Engineering and of Pharmacology and was the director of the Center for Advanced Biotechnology at Boston University.  He is currently adjunct professor of Bioengineering at UC San Diego, adjunct professor of Molecular Biology at the Scripps Institute for Research, and distinguished adjunct professor of Physiology and Biophysics at UC Irvine. Prior to this, Dr. Cantor held positions in Chemistry and then in Genetics and Development at Columbia University and in Molecular Biology at the University of California at Berkeley. Cantor was educated in chemistry at Columbia College (AB) and at the University of California Berkeley (PhD).

Dr. Cantor has been granted more than 60 US patents and, with Paul Schimmel, wrote a three-volume textbook on biophysical chemistry. He also co-authored the first textbook on Genomics titled 'The Science and Technology of the Human Genome Project'.  In addition, he sits on the advisory boards of numerous national and international biotechnology firms, has published more than 450 peer-reviewed articles, and is a member of the U.S. National Academy of Sciences.

Peter Blume-Jensen, MD, PhD

Dr. Peter Blume-Jensen has extensive expertise in basic and translational cancer research, oncogenic signaling, and targeted oncology therapeutics drug discovery prior to joining Metamark as CSO in 2010.  From 2001 to 2008 Peter was department head at first Serono, US and later at Merck Research Laboratories, Merck & Co, Inc. where he established novel, integrated oncology drug discovery departments and programs linking therapeutics to patient responder populations. Since 2008 he was Exec. Dir. and Vice President for External Scientific Affairs at Daiichi Sankyo Inc., served as the global 'Therapeutic Area Advisor' for Oncology, and was co-responsible for formulating a global oncology R&D strategy. He co-led the scientific M&A and due diligence resulting in the acquisition of Plexxikon (US$935M).  In 2010 he joined Metamark as CSO and 2nd employee.  Since June 2014, Peter has joined Xtuit Pharmaceuticals, a targeted therapeutics start-up, as CSO, and first employee.  Peter continues to serve as Chief Scientific Advisor and on the SAM for Metamark and also has joined the SAB of Veritas Gene, Inc, a NGS company.

Dr. Blume-Jensen has authored highly-cited original articles, reviews, and book chapters in Personalized Molecular Oncology. His review 'Oncogenic Kinase Signaling' in Nature is a citation classic in 'Clinical Medicine', and his work on genetically engineered cancer and male infertility mouse models has been widely portrayed on CNN and other news channels. His approaches for efficacy-predictive biomarkers have appeared on Nature Biotechnology's 'Hot patents' watch-list and in numerous Editorial highlights for Personalized Oncology. Dr. Blume-Jensen obtained his M.D. from Copenhagen, Denmark, his Ph.D. from Dr. Carl-Henrik Heldin's laboratory at the Ludwig Institute for Cancer Research, Uppsala, Sweden, and conducted his Post-Doctoral studies in Dr. Tony Hunter's laboratory at the Salk Institute, La Jolla, CA.

Josip Blonder, MD

Dr. Blonder is Head of the Clinical Proteomics Group, Laboratory of Proteomics & Analytical Technologies (LPAT), Cancer Research Technology Program, Leidos Biomedical Research, Inc. at NCIs, Frederick National Laboratory for Cancer Research (FNL). In 1978, Dr. Blonder received his M.D. at the Rijeka University School of Medicine, Croatia. He completed a residency in emergency medicine in 1984 and assumed the position of head of Emergency Medicine, Medical Center Mostar. In 1989, he completed a fellowship in cardiology at the German Heart Institute in Berlin. In 2000, through Associated Western Universities, Dr. Blonder was awarded a post-doc fellowship in proteomics at the Pacific Northwest National Laboratory (PNNL), Richland, WA (Advisor: Dr. Richard D. Smith). During the stay with Dr. Smith, his research focused on proteome-wide analysis of membrane proteins using high-accuracy and high-resolution mass spectrometry. In 2002 at the PNNL, he developed a shotgun proteomic method for profiling membrane proteins that resulted in an offer to join Leidos Biomedical Research, Inc. (formerly SAIC-Frederick Inc.), LPAT at NCI-Frederick. At the FNL, he extended the application of his method to global quantitative profiling of lipid raft and plasma membrane cell surface proteins resulting in significant discoveries subsequently confirmed in follow-up investigations using orthogonal molecular biology techniques [i.e., PLoS One. 2012;7(12):e51356; J Immunol. 2013 Jul 15;191(2):892-901.]. In 2006, Dr. Blonder was appointed as the head of Clinical Proteomics, extending his research to technology development that would allow in vivo molecular profiling of clinical tissue specimens and body fluids to facilitate a better understanding of cancer biology and cancer biomarker development. His group was the first to optimize the immunodepletion of tissue homogenates in the context of tissue directed proteomics for cancer biomarker discovery. This effort resulted in the publication [i.e., Anal Chem. 2010; 82(5):1584-8.] of a method that relies on concomitant analysis of tissue and blood specimens to unambiguously detect genuine tumor proteins in the blood of a patient diagnosed with non-metastatic cancer for biomarker discovery. Dr. Blonder brings a unique combination of his expertise in medicine, clinical proteomics, and bioinformatics to cancer research where he promotes the use of qualitative/quantitative shotgun proteomics and systems biology to better understand cancer biology. He leads active translational research focused on developing and applying advanced proteomics to directly profile cell surface proteins, solid tumors and body fluids in the context of molecular discovery/phenotyping using systems biology and pathway analysis. He is a lecturer at the Foundation for Advanced Education in the Sciences at NIH where he teaches a course on Clinical Proteomics and Biomarker Discovery. Since 2002, Dr. Blonder has authored over 50 scientific publications in areas of advanced mass spectrometry and clinical proteomics. He is an associate editor of BMC Cancer and a member of the American Association for Cancer Research and the American Society for Mass Spectrometry.

Joan W Bennett, PhD

Joan W. Bennett has been Professor II of Plant Biology and Pathology at Rutgers University since 2006. Prior to coming to Rutgers, she was on the faculty at Tulane University, New Orleans, Louisiana, for over thirty years. The Bennett laboratory studies the genetics and physiology of filamentous fungi. In addition to mycotoxins and secondary metabolites, the focus is on the volatile organic compounds emitted by fungi. These low molecular weight compounds are responsible for the familiar odors associated with the growth of molds and mushrooms. Some of them function as semiochemicals for insects while others serve as developmental signals for fungi. The Bennett lab has tested individual fungal VOCs in model systems, with the intent of providing a physiological basis for the hypothesis that volatile mold metabolites might be involved in “sick building syndrome.” For example, 1-octen-3-ol (“mushroom alcohol”) functions as a neurotoxin in Drosophila melanogaster and causes growth retardation in Arabidopsis thaliana. In other studies, we have demonstrated that living cultures of Trichoderma, a known biocontrol fungus, can enhance plant growth in the absence of physical contact between the plant and the fungus. In addition, we are investigating the potential use of fungi and their volatiles in bioenergy research. Dr. Bennett also has an active interest in fungal genomics and has been involved in genome projects for Aspergillus flavus, A. fumigatus and A. oryzae.

In addition to running a laboratory, Dr. Bennett is Associate Vice President for the Office for the Promotion of Women in Science, Engineering and Mathematics (“SciWomen”), charged with promoting the welfare of women in science, engineering, mathematics and the health professions across the three campuses of Rutgers University at Camden, New Brunswick and Newark.

Pinar Bayrak-Toydemir, MD, PhD

Dr. Bayrak-Toydemir is the medical director of the Molecular Genetics and Genomics Laboratories at ARUP and an associate professor of pathology at the University of Utah School of Medicine. Dr. Bayrak-Toydemir received her MD from the Ankara University School of Medicine in Ankara, Turkey, where she also received her PhD in human genetics. Subsequently, she completed her fellowship in clinical molecular genetics at the University of Utah. She is board certified in medical genetics.

Dr. Bayrak-Toydemir has focused her research efforts on understanding the molecular genetic characteristics of the Hereditary Hemorrhagic Telangiectasia (HHT) disease, an autosomal dominant vascular dysplasia. Her research aims to identify additional gene(s) that can cause HHT disease, to determine the roles of regulatory region mutations of known HHT genes, and to describe the genotype-phenotype correlation. In addition to HHT,  her research aims to identify gene(s) that cause various inherited vascular malformations.   She is also interested in application of next generation sequencing to molecular diagnostics.

Szczepan Baran, VMD, MS

Dr. Szczepan Baran is President and Chief Operating Officer of the Veterinary Bioscience Institute, which provides online surgical and biomethodology education to laboratory animal science and veterinary communities.  He also serves in the following capacities: Course Director at Drexel University College of Medicine for the online Masters of Laboratory Animal Science Program in Philadelphia; Adjunct Faculty in the Office of Research at Wake Forest University School of Medicine; and as a member of Clinical and Laboratory Standards Institute’s Document Development Committee.  Past experiences include: Chair and Co-chair on various laboratory animal science program committees; special volunteer position at the National Cancer Institute Laboratory of Genomic Diversity; and faculty at Delaware Valley College.

Dr. Baran earned a Master of Science degree from the University of Washington, a Veterinary Medical Doctorate from the University of Pennsylvania, and a Bachelor of Science degree in Animal Science from the University of Delaware. His research interests include embryonic stem cells, the development and validation of online surgical training programs, and the development and validation of rodent laparoscopic procedures. Dr. Baran has established a freezing protocol for Nonhuman Primate Embryonic Stem cells, which has increased their survival from 5% to over 90%. Additionally, he was a contributing team member in the development of one of the first canine embryonic stem cell lines. He has pioneered new territory by demonstrating the effectiveness of online surgical training in the laboratory animal medicine field.

Antonio Baines, Phd

Dr. Antonio T. Baines is an Associate Professor in the Department of Biology at North Carolina Central University (NCCU) and an adjunct professor in the Department of Pharmacology in the School of Medicine at the University of North Carolina (UNC) Chapel Hill. He earned a bachelors degree in biology from Norfolk State University and a doctorate in pharmacology and toxicology from the University of Arizona. Afterwards, Dr. Baines accepted a postdoctoral fellowship at UNC in pharmacology and radiation oncology under Drs. Channing Der and Adrienne Cox.  His research focused on understanding the role of the Ras oncogene as a molecular target in pancreatic cancer oncogenesis. In August 2006, Dr. Baines accepted a tenure-track faculty position at NCCU where he currently teaches and conducts research as a cancer biologist. Also, he mentors high school, undergraduate, and graduate students in his laboratory.

  

Pancreatic cancer is the 4th most common cause of cancer deaths in the United States with a high mortality rate and very limited treatment options. The overall focus of Dr. Baines research program is to identify and validate novel molecular targets in pancreatic cancer which can be targeted by potential cancer therapeutics.  Additionally, his lab aims to understand the role of these molecular targets in the development and progression of normal cells transforming into cancer cells of the pancreas. Currently, Dr Baines studies the functional significance of the oncogenic Pim kinase family in pancreatic cancer growth and development. He hypothesizes that inhibition of these enzymes will be an effective approach for antagonizing the aberrant growth of pancreatic carcinoma. In addition to working with colleagues in academia, he collaborates with various pharmaceutical companies that are developing Pim inhibitors. Results from his studies will allow for critical validation of these kinases as novel therapeutic targets for pancreatic cancer treatment. Dr. Baines research has been funded by NIH and other grant sources. He has presented his research at various national scientific meetings such as the Society of Toxicology and the American Association for Cancer Research. In addition, Dr. Baines has given invited research seminars at universities such as Duke University, UNC-Chapel Hill, North Carolina Agricultural and Technical (A&T) State University, Indiana University, North Carolina State University, University of Missouri-Kansas City and Massachusetts Institute of Technology (MIT).

R. Claudio Aguilar, Ph.D.
Ottavio Arancio MD, Ph.D

Dr. Ottavio Arancio received his Ph.D and M.D. from the University of Pisa (Italy).   From 1981 to 1986 he took residency training in Neurology at the University of Verona (Italy).  Dr. Arancio has held Faculty appointments at Columbia University, NYU School of Medicine and at SUNY HSCB.  In 2004 he became Faculty member of the Dept of Pathology & Cell biology and The Taub Institute for Research on Alzheimer’s Disease and the Aging Brain at Columbia University.  His honors include the “G. Moruzzi Fellowship” (Georgetown University), the “Anna Villa Rusconi Foundation Prize” (Italy), the “INSERM Poste vert Fellowship” (France), the AHAF centennial Award (2007), the Zenith Award (2007),  the Margaret Cahn Research Award (2008), and the Edward N. and Della L. Thome Memorial Foundation Award.

Dr Arancio is a cellular neurobiologist who has contributed to the characterization of the mechanisms of learning in both normal conditions and during neurodegenerative diseases.   During the last ten years he has pioneered the field of mechanisms of synaptic dysfunction in Alzheimer’s disease.  Dr. Arancio’s laboratory has focused primarily on events triggered by amyloid protein.  These studies, which have suggested new links between synaptic dysfunction and amyloid protein, are of a general relevance to the field of Alzheimer’s disease both for understanding the etiopathogenesis of the disease and for developing therapies aiming to improve the cognitive symptoms. 

Alan Wright, MD

Dr. Wright is the Chief Medical Officer at Roche Diagnostics Corporation in Indianapolis, Indiana.  Prior to joining Roche, Dr. Wright served as Senior Vice President of Health Improvement Strategies for Miraca Life Sciences.   He was the Vice President for Product Strategy and Business Development for Resolution Health, a privately held analytics and intervention company serving the managed care market place.  Until 2005, Dr. Wright was chairman and CEO of Star Pharmaceuticals, a generic pharmaceutical company he founded in 2002, serving the needs of the urological community.  Previously, he was Senior Vice President and Chief Science Officer of Caremark .  Dr. Wright also served as Senior Vice President and Chief Medical Officer for AdvancePCS. 

Dr. Wright graduated magna cum laude with a Bachelor of Science degree from Pennsylvania State University.  He received his medical doctorate from the University of Pennsylvania and completed his residency in internal medicine at Temple University in Philadelphia.  While at Temple he served as Chief Medical Resident from 1985 to 1986 and completed his Masters of Public Health degree at Johns Hopkins School of Hygiene and Public Health.  Dr. Wright is a member of several journal editorial boards.  He is a member of the American Medical Association and American College of Physicians.  He is also certified as a diplomat to the American Board of Internal Medicine and the National Board of Medical Examiners.

Sihe Wang, PhD DABCC FACB

Dr. Sihe Wang is Section Head and Medical Director of Clinical Biochemistry and Director of Clinical Biochemistry Fellowship Training Program, Cleveland Clinic, Cleveland, Ohio.  He also chairs the clinical chemistry integration effort for the Cleveland Clinic Health System which includes 1 Florida hospital, 8 community hospitals and 18 family health centers in Northeast Ohio. Additionally, he is Clinical Chemistry Professor, Cleveland State University.  Prior to his current position, Dr. Wang was Assistant Professor at Northwestern University; Director, Clinical Chemistry Laboratory and Referred Testing Laboratory, Children’s Memorial Hospital, Chicago, Illinois. Dr. Wang is a diplomate of the American Board of Clinical Chemistry (DABCC) and a fellow of the National Academy of Clinical Biochemistry (FACB).

Dr. Wang is a member of several professional organizations, including the American Society for Mass Spectrometry and the American Association for Clinical Chemistry (AACC). He served as chair of AACC Northeast Ohio Section in 2008 and 2009 and the president of North American Chinese Clinical Chemistry Association (NACCCA) 2008-2009. Currently he serves as the historian for NACCCA, the treasurer for the Pediatric and Maternal Fetal Division of AACC, the delegate for AACC Northeast Ohio section, commissioner for The Commission on Accreditation in Clinical Chemistry (ComACC), and a member of AACC's Strategies Online Editorial Advisory Board. The AACC presented him with the 2005, 2008, and 2010 Clinical Chemist Recognition Award. He is also the recipient of the 2006 Lemuel J. Bowie Young Investigator Award for the Chicago Section of the AACC. Dr. Wang has authored over 140 journal articles, book chapters, and abstracts. He also serves on several editorial boards of peer reviewed journals.

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Gavin Newman
Rudolf Gruber
Henry Meissner
Kuey Chen
Laura Smoker
Beth Hoover
Carl Oerke Jr
Karen Bijwaard
Lynette Lewis
Jie Li
ZHANZHONG SHI
Jane Tsai
Stephanie Bledsoe
Richard Wang
Barbara Stout
Albert Woods
Carolina Bekker
Sailaja Koduri
FELIPE GONZALEZ
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AGNES AWOMOYI
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