Medpace (MEDP) a scientifically-driven, global, full-service clinical contract research organization (CRO), announced the addition of Caitilin Hamill as Vice President of Regulatory Affairs. With extensive experience in the regulation of advanced therapies including cell and gene therapies, biologics, and combination products in broad therapeutic areas, Dr. Hamill strengthens Medpace’s ability to provide Sponsors guidance and support in all stages of product development programs, especially in some of the industry’s most complex scientific areas.
About Caitilin Hamill, PhD, MBA
Caitilin Hamill bring overs 13 years of regulatory affairs experience to Medpace’s leadership team. Her interdisciplinary scientific experience includes stem cell biology, bio-materials, growth factors, and transcription factors that control cell differentiation. Her specialties include scientific and regulatory strategy for the translation of biotechnology products and medical devices; US FDA laws, regulations, policies, and submissions (IND, IDE, 510(k), BLA and PMA).
Dr. Hamill spent several years at the FDA, where she initially reviewed applications for cell therapies in the CBER office that regulates cell and gene therapies. Later, Caitilin assumed a position in CBER’s Office of the Director where she oversaw systems for consistent review and dissemination of review policy, both within and outside of CBER/FDA. She represented FDA on three international committees and negotiated agreements that aligned to FDA and CBER goals resulting in the successful development of international standards that promote regulatory convergence, as well as contributed to 30 FDA guidance documents and regulations. Most recently, Caitlin led an interdisciplinary regulatory team at a CRO where she advised Sponsors on regulatory strategy and execution.
She earned her PhD in Neuroscience at Northwestern University and completed a Masters of Business Administration from the Wharton School of Business.
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.