Dimitri Bennett

About Dimitri Bennett

Responsible for the scientific activities to generate Real-World Evidence (RWE) and develop pharmacoepidemiologic, clinical, risk management strategies to support the areas of gastroenterology and cardiovascular/metabolic diseases. 20 years of Epidemiology/Drug Development experience to support Oncology/Haematology, CVD/Met, GI, Infectious Diseases and Neurology areas. Develop, design and implement global RWE/epidemiological studies based on evidence needs, including prospective or retrospective observational studies to support key stakeholders from Clinical, Safety, Medical Affairs, Health Outcomes, Market Access, and Regulatory teams.Strong expertise in the design, implementation, and conduct of PASS, PAES, and DUS studies including REMS, RMPs, Orphan Drug Applications, and PIPs. Deep understanding, interpretation and communication of benefit risk profile, & post-marketing drug safety epidemiology Ph IV studies. Expertise in data gathering, analysis, and management. Extensive experience in development of global Medical Affairs strategy to prioritize regional & Franchises’ needs.Expertise in establishing new collaborative relationships with external partners: KOLs, CROs, academia, investigators and working with national and international regulatory agencies.Fellow of the ISPE; Fellow at the American College of Epidemiology; Adjunct Scholar at the University of Pennsylvania Perelman School of Medicine, Center for Clinical Epidemiology and Biostatistics.

Experience

1. Senior Director Epidemiology Pharmacoepidemiology Gi, Global Evidence and Outcomes Group

   Takeda

   Mar 2022 — Present · Boston, MA, US

   Design observational RWE studies including Post-Authorization Safety Studies (PASS), Drug Utilization Studies (DUS) and others to fulfill post-marketing commitments using European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) methodological guidelines;Work closely with Product Safety Physicians to support safety signal evaluation in internal and external databases;Consult project teams and bring pharmacoepidemiological perspective, expertise and evidence-based recommendations in the design of post-marketing requirements and commitments;Design additional pharmacovigilance activities and risk minimization measures in RMP as needed;Provide review of relevant published literature, CSRs and other regulatory documents;Work collaboratively with cross-functional project teams including Clinical Development, Regulatory & Medical Affairs on the development of global marketing applications and life cycle activities;Support of various regulatory activities including NDAs, PSUR, DSUR, and others.

Education

• University of Alabama at Birmingham

  MPH, Epidemiology

  1997 — 1998

• Donetsk State Medical University 'M. Gorky'

  MD

  1985 — 1993