Ruhi Ahmed PhD, RAC FLAG Therapeutics, Inc.
Dr. Ruhi Ahmed currently serves as Senior Vice President of Regulatory and Government Affairs at two companies: FLAG Therapeutics Inc., based in Raleigh, NC, and at Asceneuron SA, based in Lausanne, Switzerland. She has nearly 20 years of experience in the pharmaceutical and biotechnology industries doing global regulatory drug development, as well as program and portfolio management of assets from the preclinical to the commercial stage. Her expertise encompasses the successful filing/approval of investigational and marketing applications for multiple indications (e.g., neuromuscular, respiratory, cardiovascular, oncology and metabolic rare diseases) and for a wide variety of therapeutic modalities (e.g., prodrugs, biologics, protein therapeutics, gene therapy and small molecules).
Dr. Ahmed earned her BS in Biology and M.A. in Biochemistry from The University of Texas at Austin, and her MS in Regulatory Sciences and PhD in Molecular Pharmacology and Toxicology from the University of Southern California. She has been the lead of PDA’s Regulatory Affairs Interest Group since 2015 and has co-authored the PDA Technical Report on “Quality Risk Management of Biotechnology Manufactured APIs,” as well as other technical reports and book chapters related to risk management and biopharmaceutical manufacturing.
Dr. Ahmed earned her BS in Biology and M.A. in Biochemistry from The University of Texas at Austin, and her MS in Regulatory Sciences and PhD in Molecular Pharmacology and Toxicology from the University of Southern California. She has been the lead of PDA’s Regulatory Affairs Interest Group since 2015 and has co-authored the PDA Technical Report on “Quality Risk Management of Biotechnology Manufactured APIs,” as well as other technical reports and book chapters related to risk management and biopharmaceutical manufacturing.