Mr. Robert Morgan serves as the Head of Scientific Regulatory Legal Affairs and Quality at ESTERN Medical CRO Life Sciences Group. A pivotal member of ESTERN Corporate Scientific Advisory Board since April 2009, Mr. Morgan boasts a multifaceted, hands-on, senior-level career in Clinical and Regulatory affairs spanning over 30 years. His expertise encompasses all facets of drug and device development across the United States, Canada, Europe, Latin America, India, and the Pacific Rim.
Possessing an MS in Biophysics with practical clinical and research experience, coupled with a JD specializing in contract analysis and negotiation, Mr. Morgan has authored numerous successful INDs, CTAs, 510(k)s, NDAs, MAAs, SPAs, Orphan Drug, and Pediatric submissions. His focus on innovative treatments, particularly in Oncology, has solidified his reputation as a distinguished professional in the field.
Mr. Morgan achieved a significant milestone by filing the first electronic IND application accepted by the FDA in the new international standard Common Technical Document format. His proactive approach and hands-on direction extend to designing early-phase clinical studies, drafting regulatory submissions, including US and European Orphan Drug applications, and composing abstracts and manuscripts for publication in professional journals. Additionally, he played a pivotal role in drafting proposed legislation on FDA Reform, providing background information to members of the US Congress.
Throughout his career, Mr. Morgan has held diverse senior executive positions with esteemed companies, including Samus Therapeutics, Medivector, ZIOPHARM Oncology, EPIX Pharmaceuticals, Inc., DuPont Pharmaceuticals Company, Genzyme Corp., Serono, PAREXEL International Corp., and Theseus Imaging Corp. Notably, he served as the Senior Vice President of Development Operations at Verastem Oncology and as the Head of Regulatory Affairs/Program Management for COVID-19 at Immunome, Inc.
In addition to his executive roles, Mr. Morgan contributes to academia as a professor in Regulatory, Quality, and Drug Development at Northeastern University in Boston, Massachusetts, and as a Faculty Member of the European Regulatory Professional Society, TOPRA. His educational background includes BS and MS Science degrees, complemented by a Law Degree, harmonizing his extensive expertise in legal contract analysis and negotiations.
A prolific author, Mr. Robert Morgan has an extensive publication track record and is an active member of various scientific organizations in the pharmaceutical industry. He is a distinguished member of the Massachusetts Bar Association, Food & Drug Law Institute, and DIA & Regulatory Affairs Professional Society.
