Dr. David Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. He has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over 100 INDs, over 12 IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents destined for regulatory authorities and as an advisor to integrated product development program teams and company boards. Dr. Shoemaker is currently the Principal at Integrated Product Development Consulting.
Since 2013, he has served as the Vice Chair of the Product Development Research Review Council and as a Product Development Review Committee Study Section Chair for the Cancer Prevention and Research Institute of Texas, and in that capacity has helped usher dozens of companies to the successful completion of their integrated product development plans. Dr. Shoemaker’s primary areas of interest focus on the development of clinical protocols and integrated product development plans for novel therapeutic products.Sessions: