Experience overseeing design/execution of nonclinical IND-enabling programs for gene and cell therapy products and regulatory strategy; former FDA
Product & Process Development
Analytical Development
Device Development
Regulatory Affairs
Nonclinical Development
Project & Program Management
Diligence & Business Strategy
Before joining Dark Horse in January of 2022, Kevin was most recently with 4D Molecular Therapeutics, an AAV-based gene therapy company where he held the positions of Senior Director of Program and Alliance Management and Vice President of Translational Medicine. During his time at 4DMT, Kevin served as the preclinical project leader for AAV based gene therapy products to treat Fabry disease and cystic fibrosis. In that capacity, he oversaw the design and execution of preclinical studies in support of those two successful IND filings. The range of other activities he participated in at the growing company included serving as a scientific subject matter expert on the cross-functional team leading the $90 million Series B fundraising round.
With DHC clients, Kevin has particularly enjoyed working with early stage companies in developing a roadmap to IND filing, including preclinical study design and regulatory strategy.
At the start of his career, Kevin was a Senior Consultant with Booz Allen Hamilton, where he leveraged his stem cell expertise in support of the company’s growing life sciences practice. Kevin subsequently spent several years working at the interface of science and public policy. He served as a science advisor to two members of the U.S. House of Representatives, working on issues that included biomedical research policy such as research funding, biosimilars and FDA regulation.
Kevin also served as a Commissioner’s Fellow at the FDA. During that time, he served as a product reviewer in the Office of Cell, Tissue, and Gene Therapies (now the Office of Therapeutic Products) in the Center for Biologics Evaluation and Research (CBER). He also led the development of the OCTGT Learn (now OTP Learn) series of educational webinars for regenerative medicine product developers.
After leaving the FDA and before coming to Dark Horse, Kevin joined the California Institute for Regenerative Medicine (CIRM) as a Science Officer and was later promoted to Senior Science Officer. In those roles, he managed a portfolio of up to $60 million of regenerative medicine products at various stages of development from preclinical and IND-enabling work up through Phase 2 clinical trials. His work spanned a wide range of disease areas, including neurologic disease, retinal disease, diabetes, and orthopedics.
4D Molecular Therapeutics
Vice President, Translational Medicine
Senior Director, Program and Alliance Management
Director, Program and Alliance Management
California Institute for Regenerative Medicine
Senior Science Officer
Science Officer
Food and Drug Administration
FDA Commissioner’s Fellow
U.S. House of Representatives
Science and Technology Policy Fellow
National Academy of Sciences
Christine Mirzayan Science and Technology Policy Graduate Fellow
Booz Allen Hamilton
Senior Consultant
Northwestern University
Ph.D. in Biological Sciences
Occidental College
B.A. with Distinction in Biochemistry