Kenneth V. Phelps

Kenneth V. Phelps

President and CEO

Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in 2003. As an expert in drug development and the industry authority on development via the 505(b)(2) regulatory approval pathway, Phelps leads the team that has guided hundreds of FDA approvals. Camargo now has the largest percentage of 505(b)(2) submissions of any team submitting to the U.S. Food and Drug Administration (FDA).

Before founding Camargo, Phelps’ diverse background in drug development had led to a number of executive-level assignments in the areas of quality control, project management and regulatory, clinical and medical affairs at Duramed Pharmaceuticals. Phelps also held a number of positions at Merrell-National Labs (which merged to become Merrell Dow and later evolved into Aventis), where he was responsible for global quality assurance, quality control and processing technology with an assignment based in Milan, Italy.

Today, as a thought leader in the shifting landscape of drug development and emergent pathways, Phelps addresses the financial challenges of pharmaceutical companies caused by the generics cliff and routinely presents on the topic at events worldwide. He hosts or co-hosts a yearly seminar in Israel geared toward global companies and how they can realize the opportunities of 505(b)(2) and expanded marketability. Phelps is also a founding member of the 505(b)(2) Forum, an assembly of product developers and service providers interested in improving best practices across the 505(b)(2) development process. He publishes articles frequently and is a featured interviewee in publications, videos and podcasts concerning new, repositioned and differentiated product development around the globe. You can access these resources by following the Camargo Blog where Phelps and his team elaborate on current market trends.

Ken’s Latest Video

Ken’s Latest Articles

Pre-IND Meetings: How to Achieve Success for 505(b)(2), 505(b)(2) Blog

India’s Drugmakers Step Up U.S. Involvement, as quoted in the Wall Street Journal, article by Suryatapa Bhattacharya

A Primer on the 505(b)(2) Pathway for Combination Drug / Device Products, at Pharmaceutical Online, February 16, 2016