David Shoemaker

Biography

David has over 25 years of experience in pharmaceutical product development. He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with ensuring products meet regulatory standards at all stages of the development process. He received his PhD in Physiology and Pharmacology from Duke University and offers extensive experience in many therapeutic areas. He has had primary responsibility for four BLAs and three NDAs and has managed or contributed to more than two dozen NDAs, BLAs, and MAAs. David has moderated dozens of regulatory authority meetings for all stages of development. His primary areas of expertise include clinical study design and regulatory strategy for development of novel drug and biological products. In his free time, David enjoys playing golf, as it allows him to apply many of the same skills that he uses for product development.

Research Interest

Healthcare