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Meet the FDA. Focus: Genomic Medicine

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Room 2103, Mission Hall

550 16th Street

UCSF Mission Bay

San Francisco, CA 94158

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Space is limited. Please only register if you are sure you can attend!

We're pleased to welcome four representatives of the FDA's Center for Devices & Radiological Health, specialists in genomics, for an open roundtable discussion. These FDA scientists work on investigational biomarker tests, molecular testing for genetic diseases, oncology molecular tests, companion diagnostics, and next generation technologies. This is an opportunity for entrepreneurs to interact with officials responsible for regulating commercial technologies, help them understand startups' perspective, and make the regulatory process smoother.

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ABOUT THE SPEAKERS


David Litwack

Dr. David Litwack received a B.S. in Chemistry from the University of Chicago, and a Ph.D. in Biology from MIT. After postdoctoral studies at the Salk Institute for Biological Studies, he joined the faculty of the University of Maryland School of Medicine as an Assistant Professor in the Department of Anatomy and Neurobiology and a member of the Program in Neuroscience. In that role, Dr. Litwack directed an NIH-funded lab that studied the role of transcription factors in neurogenesis in the mammalian brain and in human embryonic stem cells, and was a founding member of the School’s Center for Stem Cell Biology and Regenerative Medicine. In 2010, Dr. Litwack was awarded an AAAS Science and Technology Policy Fellowship in NCI’s Office of Biorepositories and Biospecimen Research. During this fellowship, he led several efforts to develop policy and programs to advance the use of biobanking for personalized medicine. In 2012, Dr. Litwack joined the Personalized Medicine Staff of the Office of In Vitro Diagnostics and Radiological Health at the FDA, where he develops policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies.

Hisani Madison

Dr. Hisani Madison is a Senior Scientific Reviewer in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration (FDA). Dr. Madison leads the review of submissions in the Molecular Pathology and Cytology Branch as part of the Division of Molecular Genetics and Pathology (DMGP). The Molecular Pathology and Cytology Branch is responsible for reviewing a wide range of devices including next generation sequencing technologies and hybridization-based molecular techniques to detect genetic alterations associated with cancer. Dr. Madison specializes in review of devices intended to aid in selection of therapy for patients with solid tumors.

Prior to her current position, Dr. Madison was a postdoctoral fellow in the Hormonal and Reproductive Epidemiology Branch of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute where she conducted molecular epidemiologic research focusing on breast cancer etiology and heterogeneity. Dr. Madison obtained her Ph.D. in Pathology from Duke University, where her doctoral research focused on identifying and characterizing genetic and epigenetic markers for the early detection, prognosis and prediction of breast and ovarian cancer. She also has an M.P.H. from Johns Hopkins Bloomberg School of Public Health where she trained in epidemiology and biostatistics and received a Certificate in Health Disparities and Health Inequality.

Reena Philip

Dr. Reena Philip currently holds the position of Director in the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostic Devices and Radiological Health, at Center for Devices and Radiologic Health at the FDA. At the FDA, she has been involved in many diverse activities including premarket clearance/approval, manufacturer assistance, post market regulatory compliance actions, and an ongoing participant in FDA multi-center reviews in companion diagnostics.

Brittany Shuck

Brittany Schuck, Ph.D. is a Senior Staff Fellow in the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA. In her current position, Dr. Schuck contributes to regulatory review of in vitro diagnostic devices to assure that patients have access to safe, effective, and high quality medical devices. Dr. Schuck is also involved in OIR’s efforts to foster innovation and advance regulatory science of in vitro diagnostic devices. Dr. Schuck’s regulatory review interests include genomics, proteomics, and microfluidic devices for use in specialized chemistry and cardio-renal diagnostic devices.

Prior to joining the FDA, Dr. Schuck completed her Ph.D. in Pharmaceutical Sciences at the University of North Carolina at Chapel Hill Eshelman School of Pharmacy and then completed a postdoctoral fellowship at the National Institutes of Health’s National Center for Advancing Translational Sciences.

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Room 2103, Mission Hall

550 16th Street

UCSF Mission Bay

San Francisco, CA 94158

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