Kamali Chance, PhD, Vice President, Regulatory Affairs

Kamali Chance headshot

Dr. Chance has more than 20 years of Regulatory experience in developing country specific and global regulatory strategies and clinical development plans to bring pharmaceutical and biotech products to US and EU markets. Dr. Chance has supported product development from early and late stages of development, from conceptual design to product launch at various companies during her tenure. In her role as VP of Regulatory Affairs, Dr. Chance is assists clients with gap analyses, preparing meeting requests and briefing packages to meet FDA requirements including INTERACT meetings, Pre-IND, EOP1, EOP2 and Pre-NDA/Pre-BLA meetings. She also supports clients as their US Agent and leads discussions with the FDA in written, by phone or in face to face meetings. Dr. Chance has authored and co-authored numerous articles on development of biosimilars as well as others on 505(b)(2) Drug Applications; “Key Challenges to US Topical Ocular Drug Development;” and “Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs.” Recently her book chapter on “Design and Implementation of Successful Regulatory Strategies in Biosimilar Development” was published in a book on biosimilars by Springer. Prior to Linical Americas, Dr. Chance was previously with BioSciencesCorp as Chief Regulatory Officer, QuintilesIms/Quintiles (IQVIA) as VP, Head, Global Biosimilars Regulatory Strategy and Synthon Pharmaceuticals as Dir of RA, Head, US Operations.  Dr. Chance received her PhD in Nutrition/Nutritional Biochemistry from the University of North Carolina in Greensboro and her MPH from the University of North Carolina in Chapel Hill. She has Regulatory Affairs Certification from Regulatory Affairs Professional Society.