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.
DATE: February 27, 2018TIME: 8:00AM PST, 11:00AM EST The complexity of the manufacturing process of probiotic supplements, along with increased demand and strict criteria f...
GPCRs constitute the largest receptor family in the human genome. Over the years they have proven themselves to be druggable targets accounting for about 1/3 of all drugs on the market today....
There is an acute shortage of organs due to disease, trauma, congenital defects, and most importantly, age related maladies. The synthetic materials used in tissue engineering applications to...
Preterm birth (PTB) is the leading cause of infant mortality and morbidity worldwide. Both preterm labor and neonatal injuries have been linked to inflammation. Of all mediators of inflammati...
The path form biomarker discovery to conversion to a clinically useful companion diagnostic test presents many challenges. The talk will outline the regulatory requirements to developing a su...
Precision medicine allows for prediction of drug response and tailoring drug therapy based on genetic variability. This talk will provide examples of precision medicine initiatives at the Uni...
The distinction between "complementary" and "companion" diagnostics tests confuse many physicians and healthcare professionals. Panelists Professor Thomas Webster (Northea...
There are many tumor biomarkers but, they mostly reflect tumor mass or past growth, when what is more important is to obtain an indication of future growth and therapy response.Proliferat...
One-third of FDA-approved drugs target G protein-coupled receptors (GPCRs), transmembrane cell surface proteins that recognize small molecules and polypeptides with diverse chemical scaffolds...
DATE: January 30, 2018TIME: 9:00AM PST, 12:00PM ESTInfectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatica...
QuantiFERON TB (QFT) was the first interferon gamma release assay (IGRA) utilizing whole blood stimulation as a test for TB infection, gaining FDA approval in 2001. Subsequently there have be...
This webinar builds and expands on the recent labroots webinar by Dr. Gary Horowitz to emphasize how relatively in expensive assay standardization procedures can be incorporated into clinical...
The role of the microbiology laboratory in the processing of positive patient blood cultures has become more complicated with the increasing demand for rapid information to assist in the mana...
The integration of next-generation sequencing (NGS) tests into clinical laboratory practice across medical disciplines provides medically actionable data that in some cases are not otherwise...
Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than ever for curative effects. However, many technical challenges in T c...
DATE: October 19, 2017TIME: 08:00am PDT, 11:00am EDT Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than...
DATE: October 18, 2017TIME: 8:00 AM PST, 11:00 AM ESTOver the past decade, 25-OH vitamin D has become one of the most common assays requested by physicians.The increase in testing volum...
The detection of CTCs has been used as useful biomarkers in prognosis and monitoring therapeutic response of patients with metastatic cancer. However, during the course of cancer therapy, CTC...
The first small molecule inhibitor of the molecular chaperone Heat Shock Protein 90 (HSP90) was identified more than 20 years ago. Upon determination of the drug binding site and clarificatio...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: April 25, 2017TIME: 10:00am PT, 1:00pm ETImmunotherapy has emerged as one of the most promising options for the future treatment of a growing number of cancers and is to...
Genomics and metagenomics have become ubiquitous research efforts. Here we will show details of the development of physical, computational, and even space-based standards for metagenomi...
DATE: February 27, 2018TIME: 8:00AM PST, 11:00AM EST The complexity of the manufacturing process of probiotic supplements, along with increased demand and strict criteria f...
GPCRs constitute the largest receptor family in the human genome. Over the years they have proven themselves to be druggable targets accounting for about 1/3 of all drugs on the market today....
There is an acute shortage of organs due to disease, trauma, congenital defects, and most importantly, age related maladies. The synthetic materials used in tissue engineering applications to...
Preterm birth (PTB) is the leading cause of infant mortality and morbidity worldwide. Both preterm labor and neonatal injuries have been linked to inflammation. Of all mediators of inflammati...
The path form biomarker discovery to conversion to a clinically useful companion diagnostic test presents many challenges. The talk will outline the regulatory requirements to developing a su...
Precision medicine allows for prediction of drug response and tailoring drug therapy based on genetic variability. This talk will provide examples of precision medicine initiatives at the Uni...
The distinction between "complementary" and "companion" diagnostics tests confuse many physicians and healthcare professionals. Panelists Professor Thomas Webster (Northea...
There are many tumor biomarkers but, they mostly reflect tumor mass or past growth, when what is more important is to obtain an indication of future growth and therapy response.Proliferat...
One-third of FDA-approved drugs target G protein-coupled receptors (GPCRs), transmembrane cell surface proteins that recognize small molecules and polypeptides with diverse chemical scaffolds...
DATE: January 30, 2018TIME: 9:00AM PST, 12:00PM ESTInfectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatica...
QuantiFERON TB (QFT) was the first interferon gamma release assay (IGRA) utilizing whole blood stimulation as a test for TB infection, gaining FDA approval in 2001. Subsequently there have be...
This webinar builds and expands on the recent labroots webinar by Dr. Gary Horowitz to emphasize how relatively in expensive assay standardization procedures can be incorporated into clinical...
The role of the microbiology laboratory in the processing of positive patient blood cultures has become more complicated with the increasing demand for rapid information to assist in the mana...
The integration of next-generation sequencing (NGS) tests into clinical laboratory practice across medical disciplines provides medically actionable data that in some cases are not otherwise...
Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than ever for curative effects. However, many technical challenges in T c...
DATE: October 19, 2017TIME: 08:00am PDT, 11:00am EDT Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than...
DATE: October 18, 2017TIME: 8:00 AM PST, 11:00 AM ESTOver the past decade, 25-OH vitamin D has become one of the most common assays requested by physicians.The increase in testing volum...
The detection of CTCs has been used as useful biomarkers in prognosis and monitoring therapeutic response of patients with metastatic cancer. However, during the course of cancer therapy, CTC...
The first small molecule inhibitor of the molecular chaperone Heat Shock Protein 90 (HSP90) was identified more than 20 years ago. Upon determination of the drug binding site and clarificatio...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: April 25, 2017TIME: 10:00am PT, 1:00pm ETImmunotherapy has emerged as one of the most promising options for the future treatment of a growing number of cancers and is to...
Genomics and metagenomics have become ubiquitous research efforts. Here we will show details of the development of physical, computational, and even space-based standards for metagenomi...
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