Ron Wange

Provide expert advice regarding the nonclinical program for pharmaceutical development across all modalities (e.g., small molecule drugs, targeted protein degraders, oligonucleotides, and biologics).

• Provide leadership for the Pharm-Tox discipline as part of the Pharm-Tox Senior Leadership Team. • Provide high-level input at the Super Office and Center level on complex pharmacology and toxicology scientific issues for pharmaceutical products under Agency review. • Provide expert pharmacology and toxicology support for urgent and emerging public health needs associated with human pharmaceuticals and for addressing external queries to the Agency. • Provide expert scientific and regulatory policy support for all Clinical Review Divisions and Pharm-Tox Divisions regarding pharmaceutical products under Agency review. • Interact with industry and other stakeholders to understand current drug development issues and facilitate the resolution of such issues. This includes periodic meetings with BioSafe, DruSafe and technical committees of the Health and Environmental Sciences Institute (HESI), as well as other consortia. • Develop new CDER guidances and policies on nonclinical development of human pharmaceuticals as warranted in response to emerging needs.

Principal advisor to the review divisions within the Office of Drug Evaluation (ODE) 3 in scientific and regulatory matters related to pharmacology and toxicology. Involved in the formulation and implementation of new policies related to the nonclinical development of drugs and biotherapeutic agents. Nationally and internationally recognized expert in pharmacology and toxicology.

Provided leadership, training and mentorship to a team of pharmacology and toxicology professionals tasked with the review of Investigational New Drug (IND) applications and New Drug Applications (NDAs) submitted to the Division of Metabolism and Endocrinology Products (DMEP). Provided expert advice regarding nonclinical development programs in agency meetings with drug sponsors. Recognized CDER expert in immunotoxicology and in the review of protein therapeutic agents and oligonucleotide-based drugs.

Primary reviewer of Investigational New Drug (IND) applications and New Drug Applications (NDAs) for small molecule drugs, biotherapeutic proteins and oligonucleotide-based drugs in the Division of Metabolism and Endocrinology Products. Served as agency liaison to BioSafe on a whitepaper regarding immunogenicity assessment in nonclinical studies, served as Chair of the Nonclinical Biologics Subcommittee of the Pharmacology Toxicology Coordinating Committee, and was a member of several other PTCC subcommittees, including the Immunotoxicology, Oligonucleotide, and Information Technology subcommittees. Co-authored FDA guidance entitled “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment--Guidance for Industry.”

I established the T-Lymphocyte Signaling Unit in the Laboratory of Cellular and Molecular Biology at the National Institute on Aging. Over the 8 hears that I ran the laboratory, we made significant advances in our understanding of the molecular signaling events involved in T-cell activation following T-cell antigen receptor engagement. During this time I also served on the editorial board of The Journal of Biological Chemistry.

Designed, conducted and interpreted biochemical and molecular biologic research into T-cell antigen receptor signal transduction events in the laboratory of Dr. Larry Samelson at the National Institute of Child Health and Human Development at the NIH. Wrote or co-authored 18 manuscripts during my tenure in Dr. Samelson's laboratory.

Graduated with Highest Honors