Director, Merck & Co., Inc., United States
Celeste Frankenfeld Lamm, Ph.D., is currently a Director of Global Regulatory Affairs – CMC at Merck & Co, Inc. with 14 years of industry experience. In this capacity she is responsible for regulatory strategy, engagement with regulatory authorities, and preparation of clinical...
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European Editor, IPQ Publications
Janine was a pharmaceutical assessor in the Medicines Licensing Division of MHRA from 1997 until June 2016; the latter 10 years with focus on device-drug combination (DDC) products, carrying out consultations for several EU Notified Bodies. She advised on drug-device combination product...
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Scientific Director, Dossier Development & Operations, Small Molecule Pharma Dev, Janssen Research & Development, LLC
Deborah Schachter has more than 20 years of combination product experience. In her current role, Dr. Schachter is responsible for the strategy development and execution of the combination product dossier content and standards for both small molecule and biologic drug product CTA and...
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Chief, Branch I, DPMA1, OLDP, OPQ, CDER, FDA
Ph.D - Temple University, Philadelphia, PA Currently a Chemist at FDA/CDER, has been with FDA since 2003.