Prem K. Narang, PhD, FCP
Vice President, Scientific & Regulatory Affairs
Dr. Prem (P.K.) Narang is a seasoned executive with >25 years of leadership and management experience. By leveraging fit-for-purpose development and risk-management strategies, he strives to accelerate development & access with focus on business’s aspirations. He joined Camargo in 2016 as a Vice President of Scientific and Regulatory Affairs.
Most recently, Dr. Narang served as the EVP for Regulatory Affairs (RA) at IPM, a NGO focused in HIV prevention, where he was responsible for supporting all strategic & operational portfolio aspects. Prior to that Dr. Narang served as the VP of RA (+ CMC) & QA at Dr. Reddy’s Biologics business, where he contributed to R&D’s efforts and strategic planning to de-risk registration of products from India to highly regulated markets; initiating project to align quality systems to FDA /EMA standards. Previously, he held leadership roles as VP, Global Head of RA & Pharmacovigilance for GE-Medical Diagnostics; VP, Global Head of RA -Novartis-Oncology; and Sr. Director, Global RA –Pharmacia Oncology. Prior to roles in RA, P.K. was the US Head of Clinical Pharmacology/ Pharmacokinetics for Pharmacia and directed non-clinical (drug metabolism), clinical Phase I safety/tolerance, PK/PD, BA/BE, DDI programs to support development & submission planning. He contributed to the development of protocols, CSRs, PK/PD and clinical summaries for NDA/MAAs that led to several first-in-class NME approvals.
In these roles, he led global, culturally diverse teams and provided scientific, strategic and operational guidance to development & registration of pipeline & marketed products, leading to ~20 NME approvals and multiple label expansions in US, EU, and Japan. He has led planning and execution of interactions with FDA, EMA, EU national authorities, PMDA for various programs, including label negotiations to achieve desired business outcomes. He has presented strategy and technical information at such meetings, and contributed to clinical & commercial strategy Ad-Boards. His experience covers a broad array of regulated products (e.g., small molecules, biologics, diagnostics, and combinations), through various development and life-cycle phases (discovery, pre-IND, IND, NDA, launch, to post-approval changes/regulatory compliance) in Oncology, Anti-infective, Women’s Health, Anti-viral, CNS, Ophthalmology, Urology, and Cardiology therapeutic areas.
Dr. Narang received a M.S. from Panjab University, India, a M.S. in Pharmaceutics from West Virginia Univ., and a Ph.D. in Pharmacokinetics from Univ. of Maryland. He started his career at NIH, where he established a Clinical Pharmacokinetics Research Lab. that spearheaded the integration of PK/PD strategies in to clinical development programs at various institutes. When at NIH, P.K. spent ~2 years at the FDA (part-time) helping with the IND/NDA reviews.
Over his career, he has received numerous awards, edited two books, authored >60 peer-reviewed publications, and given >100 presentations at scientific fora.