Ron Wange, PhD

Ron Wange received a BS in Biochemistry from the University of California, Riverside and a PhD in Pharmacology from Vanderbilt University. Currently, he is a Principal Consultant for Aclairo. Prior to his position with Aclairo, he was an Associate Director for Pharmacology and Toxicology in the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). In this role, he was a member of the leadership team for the Pharm-Tox discipline in OND and provided expert scientific and regulatory policy support for all Pharm-Tox Divisions that support the OND Clinical Review Divisions as regards the pharmaceutical products under review in CDER. Ron also has over 7 years of experience as a member of the Executive Carcinogenicity Assessment Committee (ECAC), where he provided expert advice on dose selection for carcinogenicity Special Assessment Protocols (SPAs), interpretation of carcinogenicity study outcomes and the review of carcinogenicity study waiver requests for biologics and small molecules. He was a member of the Pharm-Tox subcommittees on Emerging Technology, Biologics, Immunotoxicology and Oligonucleotides (co-chairing several of these). He has played key roles in the development of multiple FDA guidances, including guidance on: (1) Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics, (2) Platform Technology Designation Program for Drug Development, (3) Rare Diseases: Considerations for the Development of Drugs and Biological Products,  (4) Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information, (5) Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals, (6) Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic, (7) ICH S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals, (8)  Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-threatening Disease.