.jpg "Lopa Bakrania, PhD, RAC photo")
Executive Director, Head of CMC-RA
Biohaven Pharmaceuticals
Dr. Lopa Bakrania has 19 years of pharmaceutical process chemistry and CMC regulatory affairs experience. She is the Executive Director and Head of CMC Regulatory Affairs at Biohaven. Prior to Biohaven, she spent 9 years as a CMC Regulatory Technical Documentation Strategist at Bristol Myers Squibb. She has led multiple early and late-stage global CMC submissions, one of them being Sotyktu (deucravacitinib), which she managed from early development to the marketing application.
Dr. Bakrania spent early part of her career as a process chemist at Bristol Myers Squibb. During her time there, she contributed toward the development of the manufacturing route and process for the drug substance of Nurtec® ODT, which was ultimately acquired by Biohaven. After moving to Biohaven, Dr. Bakrania was the CMC Regulatory lead in getting Nurtec filed globally.
Dr. Bakrania completed her Ph.D. in organic chemistry from University of Michigan-Ann Arbor. Dr. Bakrania is also an adjunct professor at Rowan University, where she teaches a course on Regulatory CMC and Process Development. Dr. Bakrania is an ACS Career Consultant and a program chair for the RAPS NJ/NYC Chapter.
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