.jpg "Gary M. Dull, PhD photo")
Master Scientist
RAI Services Company
Gary M. Dull, Ph.D. holds the title of Master Scientist at RAI Services Company (Winston-Salem, NC). He is an organic chemist with extensive experience in the pharmaceutical tobacco and industries (78 US Patents). Over 16 years of experience in the supervision and mentoring of scientists in medicinal chemistry, analytical chemistry, chemical process development and vapor product development groups. Extensive experience in pharmaceutical development (28 years) including drug discovery, API candidate selection, route selection, process development, salt selection, stability studies, scale-up synthesis in the laboratory, pilot plant and manufacturing plant, service as “man in the plant” to facilitate technology transfer, preparation and filing of patent applications and regulatory documents (INDs, IMPDs), FDA interactions on Chemistry and Manufacturing Controls (CMC) issues, project management of preclinical and clinical drug candidates for project teams, vendor selection, outsourcing and contract management for API manufacture under cGMPs, oversight of the formulation development and cGMP manufacture of clinical trial materials (drug products), scientific and cGMP quality systems audits. Over 16 years of service on an Institutional Review Board (IRB) at Wake Forest University Baptist Medical Center since January 2005 reviewing clinical trial documentation (protocols, consent forms, amendments and continuing reviews). Over 10 years of experience in developing new tobacco materials, aroma-releasing agents, nicotine salts, and Electronic Nicotine Delivery Systems (ENDS) (14 tobacco related patents). Recent industrial experience (3 years) in assisting and monitoring clinical science studies in a team-oriented environment, including study design, protocol development, clinical data review and documentation.