Kamali Chance
Vice President
Quintiles, Inc.
USA
Biography
Dr. Chance has over 25+ years of work experience in the healthcare industry, including over 18 years in regulatory affairs at CRO, CMO, and pharmaceutical/biotechnology companies. She has spearheaded strategic global development for number of biosimilar products and has authored and/or co-authored number of articles on biosimilars. Dr. Chance has provided global regulatory strategy for number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Aranesp, Epogen, Recombinant Insulins, Forteo and Neupogen/Neulasta. Dr. Chance has authored/co-authored number of articles on biosimilars: • Investment Decisions Based on Biosimilar Programs, Part 1 • An Integrated Approach to Biosimilar Development & Commercialization • Elucidating Biosimilars Characterization • The Biosimilar Landscape: A Systematic Review of Its Current Status • Operational Challenges Associated with Biosimilar Drug Development • A Model for Expeditious Progress to a Phase 3 Trial • Biosimilars in rheumatology: understanding the rigor of their development… & many more…
Research Interest
Biosimilars, Biologics, Biosimilars Characterization, Drug Development