Business Workshops
Clinical Trials that Seal the Deal - How to Design with Strategy in Mind
October 29, 2009
9:30 a.m. - 10:45 a.m.
Twin Peaks South
Clinical trial design is of critical importance for successful product development and marketing outcomes on the pathway to building new brands and lifesaving therapies. As clinical studies grow costlier and more complex from a regulatory perspective, biotech companies are faced with the challenge of designing studies that achieve solid clinical and long-term commercial objectives within a truncated spending model. Companies need to choose the right indication and consider the best route of drug development to yield the highest success rate and value. Some companies are electing to only perform development through Phase 2. Another area of current focus is adaptive clinical trial design, which allows for shorter and less expensive clinical studies, but has the potential to produce more complex statistics. This panel will explore how to undertake meaningful clinical trials design with a broader objective in mind – to attract big pharma or biotech as a future business development partner. Panelists will discuss traditional design vs. adaptive design issues, and how short-sighted and rational clinical trial practices can limit partnering opportunities or drive more appealing transactions.
Panelists:
- Keaven Anderson, Ph.D, Executive Director - Late Development Statistics, Merck Research Laboratories
- Timothy Herpin, Ph.D, Head of U.S. Search - Strategic Transactions Group, Bristol-Myers Squibb
- Roger Hill, Ph.D, MBA, Executive Director - Licensing & Business Development, Boehringer Ingelheim
- Joel Verter, Ph.D, Senior Vice President, Statistics Collaborative, Inc.
Who's Who
Keaven Anderson, Ph.D
Keaven Anderson has been the Executive Director of late-stage statistics for Merck Research Laboratories since December, 2003. Previously, Dr. Anderson had worked for Centocor for 13 years and the Framingham Heart Study for 6 years. He was a post-doctoral fellow at the Harvard School of Public Health following receipt of his Ph.D. in Mathematical Statistics from Stanford University and his Bachelor of Science in Statistics from Iowa State University. His interests have included oncology, cardiovascular disease epidemiology and clinical trials, survival analysis modeling and clinical trial design, including group sequential design and adaptive design.
Roger Hill, Ph.D, MBA
As Head, Global Licensing, Commercial Opportunities & Exec. Director, Global Licensing, CardioMetabolic Diseases, Dr. Hill's responsibilities include identifying and executing licensing & business development opportunities that enable Boehringer-Ingelheim's Women's Health, CardioMetabolic, and Urology franchises from idea through loss of exclusivity. Dr. Hill holds a B.Sc. and Ph.D. in Pharmacology from University College Dublin, Ireland; and an MBA in Hi-Tech Finance from Northeastern University. Following extensive Therapeutic Area R&D experiences at Sterling Winthrop Pharmaceuticals and Pfizer Global Research & Development, Dr. Hill transitioned to Business Development at Pfizer in 2007, and in August 2008 joined Boehringer Ingelheim based in Ridgefield, CT USA.
Joel Verter, Ph.D
Joel Verter, Ph.D., joined Statistics Collaborative, Inc. (SCI) in 2001. He is a member of the American Statistical Association, the International Biometric Society (Eastern North American Region), and the Society for Clinical Trials (Secretary and Executive Board Member 1995–2003).
From 1967 to 1991, Dr. Verter served as a Commissioned Officer in the United States Public Health Service. During that time, he was assigned to the Biometrics Research Branch of the National Heart, Lung, and Blood Institute (NHLBI), where he served two terms as the acting Branch Chief and contributed to the design, monitoring, and/or analysis of several trials, including the Framingham Heart Study, the Cooperative Study of Sickle Cell Disease (CSSCD), the Aspirin Myocardial Infarction Study (AMIS), the Multiple Risk Factor Intervention Trial (MRFIT), the Studies of Left Ventricular Dysfunction (SOLVD), the Digitalis Investigation Group trial (DIG), the Postmenopausal Estrogen/Progestin Interventions Trial (PEPI), the Bypass Angioplasty Revascularization Investigation (BARI), the Cardiac Arrhythmia Suppression Trial (CAST), the Granulocyte Transfusion trials, and the Penicillin Prophylaxis in Sickle Cell Disease trials (PROPS). During his tenure at the George Washington University Biostatistics Center (1992–2002), he also served as the Principal Investigator of two trials funded by NHLBI: Prevention of Events with Angiotensin-Converting Enzyme Inhibition (PEACE) and the Warfarin Antiplatelet Vascular Evaluation (WAVE).
He has served as a member of the Data Monitoring Committees (DMCs) for a number of multi-center clinical trials sponsored by the National Institutes of Health (NIH) and industry. He served a four-year term on the Blood Products Advisory Committee of the Food and Drug Administration (FDA) (1995–1999) and has been a member of several ad hoc FDA Advisory Panels.
His major areas of research are in the fields of clinical trial design, monitoring, and analysis.