Dirk Reitsma
Dirk brings extensive clinical development experience to Evidera after coming from MedImmune/AstraZeneca, where he served as vice president of clinical development leading the company’s active clinical oncology programs in biologicals, and overseeing the expansion of its oncology clinical development department. His experience at MedImmune/AstraZeneca included a Phase 1 program with blinatumomab and Phase 1 and 2 trials with several monoclonal antibodies. Dirk had an early interest in the development of biologics and biosimilars and was the invited chair of the two-day Advancing Biologics meeting in Brussels in January 2010, where he presented Navigating the Challenges of Developing Biosimilars. He founded PPD’s multidisciplinary biosimilar development services group in 2010 and spoke at the 2010 FDA Open Public Hearing titled Approval Pathway for Biosimilar and Interchangeable Biological Products where he discussed potential methods and study designs to demonstrate biosimilar interchangeability. He co-published an abstract at the 2011 ASCO annual meeting titled A Novel Approach to a Rituximab Biosimilar Development Plan, J Clin Oncol 29: 2011 (suppl; abstr e13064) and was senior author on Alternative Statistical Strategies for Biosimilar Drug Development, Generics and Biosimilars Initiative Journal; 3:3; 2014. He has supported clients developing biosimilars at meetings with the MHRA and the FDA. Dirk is interested in the use of Bayesian complex and innovative trial designs to enhance strategic decision making in drug development and has published on the topic (Reitsma DJ, Combest AJ. Challenges in the Development of an Autologous Heat Shock Protein Based Anti-Tumor Vaccine. Hum Vaccin Immunother. 2012 Aug;8(8):1152-5.).
Dirk’s experience includes serving as the head of clinical affairs and medical director at Antigenics Inc. and as associate director and later senior clinical research physician in oncology at Novartis Pharmaceuticals. Dirk received his medical degree from Erasmus University in Rotterdam, The Netherlands. His Phase I, II, and III oncology biologics clinical research experience includes solid tumors and haematological malignancies as well as four drug approvals for which he participated in three oncology drug advisory committee hearings.