Chief Science and Regulatory Officer

Dr. David Keller

Dr. David Keller is Step Change’s technology gatekeeper as well as regulatory navigator, taking the lead on all issues relating to science, safety, new technology or product approval. His background in clinical study design, his extensive experience working directly with the FDA and comprehensive understanding of chains of approval for foods, supplements and related products is integral to client success.

Another veteran of the highly successful Ganeden Probiotics leadership team, as Vice President of Scientific Operations, Dr. Keller was responsible for planning and executing all science-related activities: managing the labs and science teams, design/management of studies that led to 27 published papers, overseeing Quality Control, managing an IP portfolio of over 130 patents and spearheading all scientific regulatory matters, including successful FDA GRAS submissions and international regulatory approvals in Canada, China and India.

Given that regulatory guidelines for the various industries and market segments we serve are wildly different (dietary supplements vs. companion animal, for example), perhaps most beneficial to Step Change clients is Dr. Keller’s deep understanding of all those regulatory processes and hurdles. His focus on food ingredients, dietary supplements and the science behind them for over 15 years is another assurance of Step Change Innovation client satisfaction.

He holds a Master’s in Business Administration and a Doctorate in Podiatric Medicine. Dr. Keller is also a member of a number of prestigious professional organizations, among them United States Pharmacopeia (USP), and the International Probiotics Association (IPA), in which he serves on multiple working and advisory groups.