Kevin Whittlesey, Ph.D.


12+ years working in gene and cell therapy product development, overseeing the design and execution of pre(non)clinical IND-enabling programs for multiple AAV-based gene therapy products that are currently in clinical trials.

About Kevin

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.

Earlier in 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 Tissues and Advanced Therapies) in the Center for Biologics Evaluation and Research (CBER). He also led the development of the OCTGT Learn (now OTAT Learn) series of educational webinars for regenerative medicine product developers.

After leaving the FDA, 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.


  • D Kirn, D Schaffer D, K Whittlesey, M Kotterman, P Francis, P Szymanski “Codon optimized GLA gene and uses thereof.” Patent Pending.
  • LD Shea, LL Shea, KJ Whittlesey, Y Yang, C Rives, L DeLaporte, and J-H Jang. “Biodegradable scaffolds and uses thereof”. U.S. Patent 7,846,466 B2


  • Tsukamoto A, Abbot SE, Kadyk LC, DeWitt ND, Schaffer DV, Wertheim JA, Whittlesey KJ, Werner MJ. (2016). “Challenging Regeneration to Transform Medicine.” Stem Cells Trans. Med. 5(1): 1-7.
  • Frey-Vasconcells J, Whittlesey KJ, Baum E, Feigal EG. (2012). “Translation of stem cell research: points to consider in designing preclinical animal studies.” Stem Cells Trans. Med. 1(5): 353-8.
  • Feigal EG, Tsokas K, Zhang J, Cromer MV, Whittlesey KJ, Werner MJ. (2012). “Perspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?” Stem Cells Trans. Med. 1(11): 825-32.
  • Whittlesey KJ, Witten C. (2012). US FDA outreach to the regenerative medicine community: challenges and opportunities.” Regen. Med. 7(4):595-603.
  • Whittlesey KJ, MH Lee, JM Dang, M Colehour, J Arcidiacono, E Lazarus, DS Kaplan, D Fink, CN Durfor, A Batra, SL Hilbert, DL Grayeski, R McFarland, and C Witten. (2011). “Overview of the FDA Regulatory Process.” Principles of Regenerative Medicine, 2nd Edition. Ed. A Atala, R Lanza, J Thomson, R Nerem. Burlington: Academic Press.
  • Yang Y, De Laporte L, Zelivyanskaya ML, Whittlesey KJ, Anderson AJ, Cummings BJ and Shea LD (2009). “Multiple channel bridges for spinal cord injury: cellular characterization of host response.” Tissue Engineering Part A. 15(11): 3283-95.
  • Houchin-Ray T, Whittlesey KJ, and Shea LD (2007). “Spatially patterned gene delivery for localized neuron survival and neurite extension.” Molecular Therapy. 15(4): 705-12.
  • Whittlesey KJ and Shea LD (2006). “Nerve growth factor expression by PLG-mediated lipofection.” Biomaterials. 27(11):2477-86.
  • Whittlesey KJ and Shea LD (2004). “Delivery systems for small molecule drugs, proteins, and DNA: the neuroscience/biomaterial interface.” Experimental Neurology. 190(1):1-16.


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

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