Executive Profile

Kathryn Stein Ph.D. Senior Vice President of Product Development & Regulatory Affairs, MacroGenics, Inc.

Age	Total Calculated Compensation	This person is connected to 1 Board Members in 1 different organizations across 1 different industries. See Board Relationships
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Background

Dr. Kathryn E. Stein Ph.D. serves as Senior Vice President, Product Development & Regulatory Affairs of Macrogenics, Inc. Dr. Stein has over 22 years of experience at the FDA, working on all regulatory aspects of therapeutic proteins and monoclonal antibodies and was a leader in policy development at FDA for these products. Dr. Stein was Vice President, Product Development and Regulatory Affairs at MacroGenics from 2002 to 2005. With the acquisition of a GMP manufacturing ... facility by MacroGenics in January 2005, Dr. Stein assumed the additional responsibility for Quality Assurance and Manufacturing. Dr. Stein has a wealth of regulatory and practical drug development expertise in therapeutic proteins. She serves as a Member of Development Advisory Board of Biolex Incorporated. Dr. Stein currently serves as Vice President for Product Development and Regulatory Affairs at MacroGenics, Inc. From 1980 to 2002, Dr. Stein was a Member of the Center for Biologics Evaluation and Research (CBER) of the FDA, and Director of the Division of Monoclonal Antibodies since inception in 1992. She was also the key framer of the FDA Guidance document on therapeutic proteins made from transgenic plant systems. Dr. Stein held post-doctoral positions at Harvard Medical School and the National Institute of Allergy and Infectious Diseases. The breadth and depth of Dr. Steins experience at the FDA are critical as MacroGenics pipeline candidates advance to the clinic and her familiarity with all aspects of monoclonal antibody and vaccine approval will ensure rapid and compliant submissions to the FDA for MacroGenics products. Dr. Stein is the author of over 60 research publications. Dr. Stein received her B.A. in Chemistry from Bard College in Annandale-on-Hudson, New York and her Ph.D. in Microbiology and Immunology from the Albert Einstein College of Medicine of Yeshiva University in the Bronx, New York.

Corporate Headquarters 9640 Medical Center Drive Rockville, Maryland 20850 United States Phone: 301-251-5172 Fax: 301-251-5321 Board Members Memberships There is no Board Members Memberships data available. Education PhD Albert Einstein College of Medicine BA Bard College Other Affiliations Biolex Therapeutics, Inc. Bard College Albert Einstein College of Medicine Harvard Medical School

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