Stephen Revell, MD
Dr. Steve Revell is a senior physician who offers a unique breath of experience and insight into the pharmaceutical and biotech industries due to his eclectic background in clinical development, medical affairs and pharmacovigilance across several therapeutic areas over 20 years.
Steve has held senior global executive positions and/or consulting roles in pharmacovigilance, medical affairs, and clinical research with Hoffmann-La Roche (Switzerland), Alza, Biogen Idec, Acadia, Ipsen and Astellas Pharmaceuticals, working both in Europe and the US. This experience has provided him with insight into both large pharma and small biotech working environments.
Steve is no stranger to clinical trials having performed Phase 1 - 4 studies. This has included involvement in single site studies to multinational studies. He has created development plans for products, designed clinical trials and written protocols, in addition to discussing clinical trial design with the FDA. He has led clinical trial teams, and has been involved in site selection and site initiation visits. Steve has facilitated the smooth running of clinical trials, examples include performing site visits to stimulate flagging enrollment. He has presented at investigator meetings and clinical trial data at multiple scientific meetings .
Steve has been on the cutting edge of international drug safety and pharmacovigilance. He has extensive experience in clinical and post marketing drug safety and has been an invited speaker at numerous drug safety courses. Steve has had experience with both product withdrawal and product suspension and in this context has interacted with Regulatory Authorities in both the EU and US. He was an early adopter of the PSUR as a medium of providing safety information to the FDA. He has initiated and managed drug safety monitoring boards for multiple products in various therapeutic areas. In addition, his achievements include developing adverse event tracking systems, training courses, analysis of safety signals, review of individual safety report, and preparation of the safety sections for NDA submissions.
Steve received his medical degree from University of Rhodesia (currently University of Zimbabwe) and his MBA from the Open University (UK). He had post graduate training in both Anesthesiology and Pediatrics. Prior to joining the pharmaceutical industry he was a lecturer in the department of Pediatrics at the University of Cambridge. Steve maintains his medical license in the UK. He is a dual UK/US citizen. Steve resides on the West Coast of the US.