Eric Gruff is the founder of E4 Consulting, which specializes in providing Regulatory Affairs, Quality Assurance, Pharmaceutical Development, and Project and Portfolio Management expertise to biotechnology and pharmaceutical clients. With over 25 years of experience in drug, biologic, and medical device development, Eric is able to provide both strategic and operational assistance to companies that are bringing new drug, biologic and device candidates into clinical trials and beyond. He has specific expertise in Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC), and Product Development. Eric specializes in establishing and managing programs for creation of regulatory strategy and submissions, GMP manufacturing of drug products, analytical development, stability programs, product formulation, Quality Assurance systems and audits, and process validation. Eric’s considerable experience in project and portfolio management enables him to provide clients with more effective and cost-saving means to progress drug projects while simultaneously maximizing the potential for success.
Eric’s career history includes 11 years with Pfizer’s La Jolla Laboratories (formerly Agouron Pharmaceuticals) in a variety of leadership roles in Pharmaceutical Development and Project Management. Prior to joining Pfizer, he held management positions at Molecular Biosystems, Inc., a San Diego biotechnology firm specializing in ultrasound, CT, and MRI contrast media. Since 2007, he has served as an independent regulatory consultant with responsibility for creating IND/IMPD/CTA, NDA/BLA/MAA, and IDE/510(k)/PMA submissions for several new drug and biologic candidates, and medical devices. Eric’s experience also includes veterinary drug programs for companion animals. Eric also currently serves as Project Leader for BCN Biosciences’ Yel002 radiation countermeasures drug candidate that is being developed under a BARDA Cooperative Agreement.
In addition to his position at E4 Consulting, Eric also serves as a consultant for Gerson Lehman Group’s Council of Advisors, and has been ranked in the Top 5% of all members (Leader designation). Eric serves on the Board of Directors for a public nonprofit agency, and is the Past Chair of the Board of Directors for the Escondido Humane Society. He is a member of RAPS, DIA and ACS.
Eric received a BS in Chemistry from Rensselaer Polytechnic Institute and subsequently obtained his PhD in Chemistry from SUNY Stony Brook. He then spent two years as a postdoctoral fellow at the Salk Institute for Biological Studies in La Jolla, CA working with Professor Leslie Orgel on the development of novel platinum-based DNA crosslinking agents as potential antisense therapeutics. Eric also holds an Executive MBA degree from San Diego State University.