Chief Regulatory Office, BioSciences Corporation
Accomplished executive with extensive experience in developing country specific and global regulatory strategies and clinical development plans to bring pharmaceutical and biotech products to US and EU markets. Kamali supports product development from conceptual design to product launch at various companies during her tenure.
She is continuing to lead the regulatory strategy, regulatory roadmaps, and clinical development plans for the development of number of innovative drug/device, biologic/device, cell therapy and gene therapy products including mRNA and CAR T cell immunotherapy products for oncology indications. Her tenure includes extensive experience in helping companies develop biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Epogen, Lucentis, Orencia, Aranesp, Recombinant Insulins (Glargine, Aspart, etc.), Forteo, Neupogen/Neulasta, Fabrazyme and Cerezyme. Biologic/device and drug/device have included development of regulatory strategy and clinical development plans for local delivery of these products in the GI Tract to the site of disease to improve safety and efficacy of existing products.
Kamali assists clients in 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 accompanies clients as their US Agent and leads the discussions at FDA face to face meetings. She spearheads INDs, NDAs and BLAs. Kamali 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. She 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.
Monday, September 14, 2020
12:00 PM – 1:30 PM EDT