Scott Harris, MD
Chief Medical Officer, Ocera Therapeutics, Inc.
Dr. Harris is an independent consultant with extensive clinical and regulatory experience in gastrointestinal and liver disease drug development. He served as the Chief Medical Officer and Vice President of Clinical Affairs at Napo Pharmaceuticals in South San Francisco, where he was the chief architect of the Phase 2-3 adaptive design employed in Napo’s ongoing pivotal trial in HIV-related diarrhea, currently partnered with Salix Pharmaceuticals. He also recently served as Chief Medical Officer of Ocera Therapeutics in San Diego, CA, where he directed pre- and post-IND drug development in irritable bowel syndrome, inflammatory bowel disease, and hepatic encephalopathy. Dr. Harris is a principal of Middleburg Consultants, Inc., a pharmaceutical and healthcare consulting firm, and has served as Professor of Clinical Medicine and Director of the Center for Inflammatory Bowel Disease, Georgetown University Hospital. Dr. Harris has held faculty positions at the Medical College of Wisconsin, where he conducted basic research in the mechanisms of diarrhea, and the University of Wisconsin in Milwaukee, where he served as Clinical Professor and Head of the Division of Gastroenterology. He has consulted in a variety of areas of gastrointestinal drug development, including upper GI motility disorders, gastroesophageal reflux disease, and inflammatory bowel disease. Dr. Harris is a magna cum laude graduate of Harvard College and Harvard Medical School. He undertook his post-graduate medical training at Johns Hopkins Hospital and Yale University School of Medicine and holds an M.S. in population health and administrative medicine from the University of Wisconsin Schools of Medicine. He is also a Fellow of the American College of Physicians and board certified in internal medicine and gastroenterology. Dr. Harris has served as a member of the International Advisory Panel of the International Foundation for Functional Gastrointestinal Disorders, the leading organization for irritable bowel syndrome advocacy, research and education, and President of the Crohn's & Colitis Foundation of America (CCFA) in Wisconsin. He is a recipient of the CCFA Premier Physician Award.

Hsiao Dee Lieu, M.D., F.A.C.C.
Vice President of Clinical Research, Nile Therapeutics, Inc.
Dr Lieu has over 13 years of experience in the biopharmaceutical/biotech industry including academic medicine (cardiology), molecular cardiology research, translational and clinical drug development including execution of large multinational Phase III clinical trials and responsibility for interactions with regulatory authorities and key opinion leaders in the U.S., Canada, and Europe. Dr. Lieu currently serves as Assistant Clinical Professor of Medicine, Cardiology Division at UCSF. Prior to joining Nile, Dr. Lieu served as the Director of Clinical Development for Portola Pharmaceuticals, Inc. In this role, Dr. Lieu was responsible for the overall clinical development plan and execution for early- to late-stage intravenous and oral molecules including a large ADP antagonist program in acute coronary syndrome. Before joining Portola, Dr. Lieu served as the Director of Clinical Research and Development at CVT. In this role, Dr. Lieu led the clinical development program for regadenoson, which included two successful large multinational Phase III trials and the drug is commercialized. Dr. Lieu also worked as a researcher at the J. David Gladstone Institute of Cardiovascular Disease at the University of California at San Francisco (UCSF) conducting molecular cardiology research in gene manipulation and induction of cardiomyopathy and atherosclerosis regression. Dr. Lieu completed his clinical cardiology fellowship at UCSF and his residency in internal medicine at Columbia University. He received his M.D. from the Albert Einstein College of Medicine with distinction in molecular biology research, and his B.A. from New York University.

Judith Quinlan
Vice President, Adaptive Trials, Cytel Inc.
Judith Quinlan began her career as a statistician in agriculture in Australia, before joining the UK-based pharmaceutical industry leader GlaxoSmithKline. While at GSK, Ms. Quinlan was director of Statistics for Neurology and GI in the UK, later moving to the US as Director of Statistics for Biopharmaceuticals. Throughout her GSK tenure, Ms. Quinlan actively promoted the use of adaptive designs, and other new statistical approaches, to improve clinical development. Following 10 years with GSK, Ms. Quinlan joined Cytel as Vice President, Adaptive Clinical Trials. Ms. Quinlan heads Cytel's adaptive study consultancy business, responding to the rapidly increasing demand for better clinical approaches from pharmaceutical, biotechnology and medical device companies. An active member of the PhRMA Adaptive Design Working Group (ADWG), Ms. Quinlan chairs the Adaptive Trial Case Study work stream. Ms. Quinlan is an often-invited speaker, well regarded for her innovative trial planning and implementation insights by statisticians, biopharmaceutical management and regulatory officials alike.

Todd Reul
Associate Director, Clinical Outsourcing ,Facet Biotech
Todd Reul has over seventeen years experience in the pharmaceutical industry including eleven in clinical research. He has successfully held positions in scientific research, clinical development, operations and management. This experience includes positions within sponsor and service provider companies resulting in a well-rounded perspective and understanding of the industry, the conduct of clinical trials and sponsor/service provider relationships. Mr. Reul is currently leading Clinical Outsourcing at Facet Biotech (previously PDL BioPharma), which is focused in Oncology. Originally from the East Coast, Mr. Reul went to the University of New Hampshire and graduated with a B.S. in Chemistry. After a few years as a Chemist for a large pharmaceutical company on the East Coast, he got a job at a small biotech company in the bay area and moved out west. As this small company grew, Mr. Reul transitioned from the lab to the clinical side of the business as a CRA/Monitor. After a few more years, he transitioned to the service provider side of the industry and held positions such as Project Manager, Group Leader and Associate Director. In these positions Mr. Reul was in part responsible for ensuring the sponsor companies’ (clients) needs were met and key relationships were maintained. Mr. Reul’s next opportunity brought him back to the sponsor side with Facet Biotech, where all his experience could be best utilized.

Trudy Vanhove, MD, PhD, MBA
Senior Director, Clinical Development, Neurogesx
Trudy Vanhove has 13 years of industry experience in clinical development ranging from small to large pharmaceutical companies. She is currently senior director of clinical development at NeurogesX. NeurogesX recently received FDA approval for Qutenza®, a high concentration capsaicin patch (8%) for the management of neuropathic pain associated with postherpetic neuralgia. Earlier last year (2009), NeurogesX received approval for Qutenza in the European Union. Before NeurogesX, Trudy was a medical director at XOMA where she directed pre- and post-IND drug development in cancer, rheumatoid arthritis, acne, cardiology and prevention of pneumonia/ARDS in trauma patients. Before joining XOMA she served as an associate director at Abbott Laboratories where she designed and implemented clinical trials with antiretrovirals and antibiotics. She holds an MD/PhD from Leuven, Belgium and completed a fellowship in clinical pharmacology at Stanford.