Mohit Kashyap, PhD

Mohit Kashyap, PhD

Associate Director, Regulatory Affairs

Dr. Kashyap has 4+ years of experience in medical writing and regulatory consulting, specifically related to orphan drug development and nonclinical/clinical expertise. His regulatory experience includes providing a strategic course for developing drugs, participating in numerous FDA meetings and writing INDs, FDA meeting requests and briefing packages, orphan drug designations (US and EU), fast track designations, breakthrough therapy designations, and pediatric rare disease designations. Prior to joining DRA, Dr. Kashyap was an Associate Director of Regulatory Affairs at IQVIA and a Senior Regulatory Affairs Officer at Cote Orphan, LLC. Before moving to the field of regulatory affairs, he was an immuno-oncology scientist, first at Johnson & Johnson and then at MedImmune/Astrazeneca where he worked to develop anti-cancer drugs. He has a Ph.D. Degree in Microbiology and Immunology with a concentration in the immunology associated with inflammatory diseases from Virginia Commonwealth University and a BS in Biochemistry from University of Wisconsin-Madison.