Dr. Rich Pfeifer is a Nonclinical Development strategist and board-certified toxicologist with >25 years’ experience in industry, including expertise in planning, conduct, and/or management of GLP-compliant safety testing of small-molecule and anti-sense-based therapeutics, biopharmaceuticals, enzyme and mRNA replacement therapies, vaccines, genetic therapies, and medical devices. He has broad industry experience with general, developmental and reproductive toxicology, neuro- and genetic toxicology, safety pharmacology, PK/ADME, carcinogenicity, combined PoC/BD/tumorigenicity studies, and niche expertise in investigative, immuno- and molecular toxicology. He has implemented IND/CTA- and NDA/BLA/MAA-enabling nonclinical development programs and regulatory submissions across a broad range of therapeutic categories: e.g., a significant contributor to >90 projects, >35 development-track decisions, >30 IND/CTA/CTNs, >5 NDA/BLA/MAAs, >25 diligences, and hundreds of supporting and integrated final reports. Dr. Pfeifer had been with AVROBIO ~7 years, most recently as Vice President, Toxicology, Research and Preclinical Development, and provided timely and resource-efficient execution of all pre/nonclinical activities needed to advance unique ex vivo LV-based gene therapies into Phase I/II/III testing (LSD/rare disease indications). Eighth (8th) employee hired, he led pre/nonclinical efforts through Series B and IPO financing, including CTA and IND approvals for the lead programs, and sale of the cystinosis GT asset to Novartis Cell & Gene Therapy. Before AVROBIO, Rich spent 7 years at Shire (now Takeda) as Head of Toxicology and, more recently, as Nonclinical Research Fellow, Global Nonclinical Development. In this capacity, he provided technical and strategic leadership in toxicology and drug safety assessment across R&D, initiated and partnered in alliances with other companies, ensured support of business development/due diligence efforts, and provided leadership and oversight of a nonclinical toxicology group. Prior to joining Shire, Rich functioned as Drug Safety expert on exploratory, discovery, and Global Development/Learn Teams across a broad range of therapeutic areas for Wyeth Research (now Pfizer). At Wyeth, he also headed an exploratory toxicology group, chaired the Immunotoxicology-Expert Working group, and served as a member of the ILSI HESI Immunotoxicology Technical Committee. Rich has directed and managed nonclinical safety assessment for new chemical/molecular entities in the contract services industry and served as Senior Toxicologist in Ciba-Geigy Corp.’s Plant Protection Division (now Syngenta). He was Assistant Professor of Toxicology in the Purdue University School of Pharmacy & Pharmacal Sciences and is peer-recognized in immunotoxicology, molecular carcinogenesis (tumor promotion), intrathecal enzyme replacement, and ex vivo gene therapy with more than 60 authored or co-authored papers, abstracts, and book chapters. Rich pursued postdoctoral fellowships in Immunotoxicology at the Chemical Industry Institute of Toxicology and the National Institute of Environmental Health Sciences. He received a BS in Biology from Bucknell University and a PhD in Pharmacology from the University of Rochester School of Medicine & Dentistry.