Cincinnati, OH, August 10, 2016 (Newswire.com) - Camargo Pharmaceutical Services, the most experienced global strategist in the drug development industry specializing in the 505(b)(2) approval pathway, announces the additions of three Vice Presidents of Scientific and Regulatory Affairs in response to continued growth. Dr. Funmi Ajayi, Dr. Prem K. Narang, and Dr. James Medley have joined Camargo and bring significant industry and FDA experience to the team.
“2016 has brought opportunities to grow and expand our expertise at Camargo. The addition of three new vice presidents of scientific and regulatory affairs adds to our already deep experience in 505(b)(2) drug development,” said Ruth Stevens, Ph.D., MBA, Chief Scientific Officer and Executive Vice President at Camargo Pharmaceutical Services.
Dr. Funmi Ajayi joins Camargo after fourteen years with P&G Pharmaceutical and ten years with the Center for Drug Evaluation and Research (CDER) of the U.S. FDA. She received her Ph.D. in Pharmacology with emphasis in experimental therapeutics from the University of Ibadan, Nigeria. As Team Leader in the Office of Clinical Pharmacology & Biopharmaceutics, CDER, FDA, Dr. Ajayi led the review of several drug products for anti-infective, special pathogens and immunologic indications. Dr. Ajayi’s P&G career and responsibilities spanned an array of global assignments including leadership of the following organizations: Clinical Pharmacology & Pharmacokinetics, Experimental Medicine, Drug Safety & Surveillance, Clinical & Quantitative Sciences and, Clinical Sciences, Compliance & Governance."2016 has brought opportunities to grow and expand our expertise at Camargo. The addition of three new vice presidents of scientific and regulatory affairs adds to our already deep experience in 505(b)(2) drug development,"
Dr. Jim Medley brings over 30 years of pharmaceutical development, regulatory, and consulting experience with Valeant Pharmaceuticals, Biovail Therapeutics, Kos Life Sciences, J&J, Ikano Therapeutics, Vela Pharmaceuticals, Sanofi-Aventis, and Bristol-Myers Squibb. Dr. Medley has led multiple FDA meetings and authored and reviewed briefing documentation for FDA Advisory committees and EMA/CHMP Scientific Advice requests. He received his doctorate in Inorganic Chemistry from Louisiana State University, Baton Rouge. Prior to his industry career, he completed a post-doctoral fellowship at the University of South Carolina in Nuclear Magnetic Resonance spectroscopy.
Dr. Prem (P.K.) Narang joins Camargo with more than 25 years of leadership and management experience, with former executive roles at IPM, a NGO focused in HIV prevention, Dr. Reddy's Biologics, GE-Medical Diagnostics, Novartis-Oncology, and Pharmacia Oncology. He has also held roles at NIH and the U.S. FDA. Over his career, he has received numerous awards, edited two books, authored more than 60 peer-reviewed publications, and given more than 100 presentations at scientific fora. Dr. Narang received a M.S. from Panjab University, India, a M.S. in Pharmaceutics from West Virginia University, and a Ph.D. in Pharmacokinetics from University of Maryland.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure FDA buy-in every step of the way. Camargo routinely holds three to six pre-IND meetings a month, has over 200 FDA approvals and more than 70 drugs currently in development, and works with product developers across more than 25 countries. Connect with Camargo on LinkedIn, read Camargo’s 505(b)(2) blog, and visit camargopharma.com for more information.
Source: Camargo Pharmaceutical Services, LLC