7/27/2017
`
`FDA Organization > Meet Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
`
`Meet Peter Marks, M.D., Ph.D., Director,
`Center for Biologics Evaluation and
`Research
`
`is the director of the Center for Biologics Evaluation and
`Peter Marks, M.D., Ph.D.
`Research (CBER) at the Food and Drug Administration. The center is responsible
`for assuring the safety and effectiveness of biological products, including vaccines,
`allergenic products, blood and blood products, and cellular, tissue, and gene
`therapies.
`
`Dr. Marks and center staff are committed to facilitating the development of biological
`products and providing oversight throughout the product life cycle. Examples of
`these activities include:
`
`effectiveness data
`
`reviewing and providing advice during product development
`
`evaluating applications and making approval decisions based on safety and
`
`- conducting research that supports product development and characterization
`
`- monitoring the safety of biological products
`
`"The center regulates and does research on complex biologic products that touch people's lives on a daily basis," says
`Dr. Marks. "Many of the products that we regulate are vital for promoting and protecting the public health, including
`vaccines, blood products, and tissues for transplantation. I'm very proud to lead a team of highly committed individuals
`whose efforts help to ensure the timely development of safe and effective products to meet important medical needs."
`
`Dr. Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York
`University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship
`at Brigham and Women's Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist
`and eventually served as Clinical Director of Hematology.
`
`He then moved on to work for several years in the pharmaceutical industry on the clinical development of hematology
`and oncology products prior to returning to academic medicine at Yale University where he led the Adult Leukemia
`Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He joined the FDA in 2012 as Deputy Center
`Director for CBER and became Center Director in 2016. Dr. Marks is board certified in internal medicine, hematology
`and medical oncology, and is a Fellow of the American College of Physicians.
`
`Resources for You
`
`- FDA Leadershi Profiles IAboutFDAICentersOffices/ucm193757.htm
`
`- About the Center for Biologics Evaluation and Research (CBER)
`(lAboutFDAICentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm1
`
`https://www.fda.gov/AboutFDA/CentersOffices/ucm481936.htm
`
`Par Pharm., Inc.
`Exhibit 1 120
`Par Pharm., Inc. v. Novartis AG
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`Case lPR2016-01479
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`Ex. 1 120-0001
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`Ex. 1120-0001
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`7/27/2017
`
`FDA Organization > Meet Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
`
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