Development of small molecules and biologics as therapeutics has become increasingly complex as our understanding of basic biology and physiology has expanded. In particular, the design of human clinical research must incorporate scientific developments to assess the safety, efficacy and patient outcomes of potential new therapies to inform global regulatory authorities as well as the medical, scientific, and patient communities.
While trial design needs a sophisticated understanding of the pathophysiology of the disease under study, it is often practical operational design features that render the trial doable (or not), independent of the therapeutic area.
Peter Blaisdell will provide a primer on clinical trial design, including why it costs so much, the approach to different phases of clinical research, patient enrollment and retention, and matching the trial objectives with the research and regulatory goals. Working with a variety of functional area experts, within and outside the company, with very diverse perspectives on how to design a trial can be challenging. Incorporating these and other considerations, he will summarize selected practical and strategic considerations for conducting modern clinical research.
Peter Blaisdell, Ph.D., is an Executive Director, Global Study Management, at Amgen. He joined Amgen in 1998 supporting clinical research programs in infectious disease and nephrology. He has since led global teams in conducting pulmonary, cardiovascular and nephrology outcomes trials, successfully executing international phase 2 and 3 trials in support of filings as well as phase 4 trials providing post-marketing support for a variety of therapies.
Before joining Amgen, Dr. Blaisdell was a Senior Project Manager at Quintiles in the Mountain View office where he coordinated cross-functional teams in support of phase 2 - 4 trials for biotech and large pharma sponsors across a diverse range of therapeutic areas. He has contributed to cross-industry initiatives to expand the demographic diversity of trial enrollment and foster improved outreach to patient advocacy groups.
Dr Blaisdell has authored both basic research publications and business management articles focusing on the bio/pharma industry and has taught graduate business classes on research management in MBA programs. He holds a Ph.D. in Biochemistry from the University of Minnesota where he also conducted post-doctoral research in microbiology.