The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products. They are the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices.
Developing an in vitro diagnostic device is often a complex and demanding process. Doing so in the midst of a pandemic and the IVD global supply chain stretched like never before, with proje...
Over a year into the COVID-19 pandemic, key vulnerable populations in the United States and across the world lack access to effective vaccines. IDRI has developed technology that addresses s...
The past few decades have seen a substantial increase in the research based on nanocarrier based combinative drug therapies in various diseases such as cancer, tuberculosis, Alzheimer’...
Date: March 30, 2021 Time: 11:00am (PDT), 2:00pm (EDT) As the world continues to have a need for COVID-19 testing, BD offers a reliable rapid antigen COVID-19 testing solution through the BD...
The nuclear proliferation biomarker Ki-67 has multiple potential roles in breast and other cancers, both as a prognostic but also predictive marker. However, several studies have shown that...
Single-cell mass cytometry identifies mechanisms of resistance to immunotherapy in AML 6:30–7:00 am PDT Presented By: Shelley Herbrich, PhD Understanding CD19 negative relapse followin...
Seasonal and pandemic influenza virus infections can cause significant disease worldwide. Current vaccines only provide limited, short-lived protection, and antigenic drift/shift in the hema...
One of the most common pathologically relevant mutated variants of ALK-2 (activin receptor-like kinase-2) has a point mutation (R206H) in its Ser/Thr kinase domain that promotes uncontrolled...
DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
Background: The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well a...
Background and aim: Rapid and complex diagnosis of viral, bacterial and parasitic infections is highly desirable not only in clinical practice, but also in food safety or early warning syste...
The liver plays a critical role in the metabolism and clearance of more than 70% of marketed drugs. Furthermore, toxicity to the liver is a major reason for preclinical and clinical drug fai...
Learning Objectives: 1. Describe the exposure response relationships with vancomycin and acute kidney injury 2. Define biomarkers that may be useful to improve Precision Dosing...
Breast cancer is the most frequently occurring form of cancer in women. While 5-year survival rates for localized disease approach 99%, cases of advanced breast cancer have a much poorer pro...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and vaccine...
Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectiou...
DATE: October 17, 2019TIME: 10:00am PDTNext generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnost...
Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
DATE: August 14, 2019TIME: 8:00am PDT Infectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatically im...
DATE: May 15, 2019TIME: 7:00AM PDT, 10:00AM EDT, 3:00PM BST, 4:00PM CETLaboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific i...
DATE: April 11, 2019TIME: 10:00 AM PSTWith the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed i...
Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
Developing an in vitro diagnostic device is often a complex and demanding process. Doing so in the midst of a pandemic and the IVD global supply chain stretched like never before, with proje...
Over a year into the COVID-19 pandemic, key vulnerable populations in the United States and across the world lack access to effective vaccines. IDRI has developed technology that addresses s...
The past few decades have seen a substantial increase in the research based on nanocarrier based combinative drug therapies in various diseases such as cancer, tuberculosis, Alzheimer’...
Date: March 30, 2021 Time: 11:00am (PDT), 2:00pm (EDT) As the world continues to have a need for COVID-19 testing, BD offers a reliable rapid antigen COVID-19 testing solution through the BD...
The nuclear proliferation biomarker Ki-67 has multiple potential roles in breast and other cancers, both as a prognostic but also predictive marker. However, several studies have shown that...
Single-cell mass cytometry identifies mechanisms of resistance to immunotherapy in AML 6:30–7:00 am PDT Presented By: Shelley Herbrich, PhD Understanding CD19 negative relapse followin...
Seasonal and pandemic influenza virus infections can cause significant disease worldwide. Current vaccines only provide limited, short-lived protection, and antigenic drift/shift in the hema...
One of the most common pathologically relevant mutated variants of ALK-2 (activin receptor-like kinase-2) has a point mutation (R206H) in its Ser/Thr kinase domain that promotes uncontrolled...
DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
Background: The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well a...
Background and aim: Rapid and complex diagnosis of viral, bacterial and parasitic infections is highly desirable not only in clinical practice, but also in food safety or early warning syste...
The liver plays a critical role in the metabolism and clearance of more than 70% of marketed drugs. Furthermore, toxicity to the liver is a major reason for preclinical and clinical drug fai...
Learning Objectives: 1. Describe the exposure response relationships with vancomycin and acute kidney injury 2. Define biomarkers that may be useful to improve Precision Dosing...
Breast cancer is the most frequently occurring form of cancer in women. While 5-year survival rates for localized disease approach 99%, cases of advanced breast cancer have a much poorer pro...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and vaccine...
Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectiou...
DATE: October 17, 2019TIME: 10:00am PDTNext generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnost...
Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
DATE: August 14, 2019TIME: 8:00am PDT Infectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatically im...
DATE: May 15, 2019TIME: 7:00AM PDT, 10:00AM EDT, 3:00PM BST, 4:00PM CETLaboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific i...
DATE: April 11, 2019TIME: 10:00 AM PSTWith the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed i...
Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
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