Secrets of Oncology Success– Lessons and Trends in Phase II Clinical Trial Outcomes
Monday, February 13th, 10:30am-11:25am
At last year’s BIO CEO conference, the BIO/BioMedTracker team presented data showing drugs in development for oncology indications were met with the lowest overall clinical trial success rate. This year we ask “Why?” Is there a trend or defining characteristic in trial design for those trials that did progress? Where is trial design headed and will this enable a reverse course? Is the industry ready to move beyond talk about innovative Phase II protocols and begin implementation?
Michael G. King, Jr., Managing Director, Rodman & Renshaw, LLC
Mohammad Azab, MD, M Sc, MBA, Chief Medical Officer, Astex Pharmaceuticals Inc.
Konstantin H. Dragnev, MD, Hematologist/Oncologist, Dartmouth-Hitchcock Medical Center
Michael Hay, Vice President/Product Manager, Sagient Research Systems
Michael M. Morrissey, PhD, President & Chief Executive Officer, Exelixis, Inc
Robert F. Ozols, MD, PhD, Senior Vice President, Fox Chase Cancer Center
Mohammad Azab, MD, M Sc, MBA
Chief Medical Officer, Astex Pharmaceuticals Inc.
Mohammad Azab joined as chief medical officer in July 2009. He possesses more than 20 years of experience in worldwide drug development, clinical research and medical affairs, resulting in eight approved drugs, including six in oncology. Previously, Dr. Azab served as president and CEO of Intradigm Corporation, a privately held Palo Alto, California, company developing siRNA cancer therapeutics. Prior to this, Dr. Azab served as executive vice president of Research and Development, and chief medical officer of Vancouver, British Columbia-based QLT Inc., where he led clinical development for now-approved drugs in oncology, gastrointestinal and ophthalmologic indications. He also served as Oncology Drug Team leader at UK-based Zeneca Pharmaceuticals, now AstraZeneca, where he held responsibilities in global clinical development and regulatory submissions. In this capacity, he managed the approval of drugs for prostate, breast, colorectal and lung cancer indications. Before Zeneca, Dr. Azab was an international medical manager in oncology at Sanofi Pharmaceuticals, now Sanofi-Aventis, in Gentilly, France. Dr. Azab received his medical degree in 1979 from Cairo University. He practiced as a medical oncologist and received post-graduate training and degrees in oncology research and statistics from the University of Paris-Sud and the University of Pierre and Marie Curie in France. He has published more than 100 medical papers and abstracts. He is an active member of the American Society of Clinical Oncology, the American Association of Cancer Research and the European Society of Medical Oncology. Dr. Azab received an MBA, with Distinction, from the Richard Ivey School of Business, University of Western Ontario.
Konstantin H. Dragnev, MD
Hematologist/Oncologist, Dartmouth-Hitchcock Medical Center
Dr. Dragnev received his MD in 1987 from the Higher Institute of Medicine in Sofia, Bulgaria. Following a residency in Internal Medicine at Baylor College of Medicine, Dr. Dragnev entered the H/O Fellowship Program at the Memorial Sloan Kettering in 1996; in 1998 he transferred to the Dartmouth Hitchcock Medical Center to complete his third year of fellowship. On July 1, 1999 he joined the staff of the Section of Hematology/Oncology at the DHMC as a lung cancer specialist. Dr. Dragnev is the Principal Investigator of several studies including a dose escalation trial of the combination of docetaxel, gemcitabine and filgrastim (NeupogenTM) for the treatment of patients with advanced solid tumors.
Vice President/Product Manager, Sagient Research Systems
Michael has been with Sagient for over seven years and has over 11 years of financial markets experience. He manages the BioMedTracker analyst team and serves as Vice President at Sagient. He is also responsible for product development, corporate planning and sales and marketing. Michael has consulted numerous top tier pharmaceutical companies on strategic decisions as well as worked closely with top healthcare investment firms providing insight on investment and trading decisions. Michael's financial markets career began at Thomson Financial in 2000. He reached the position of Manager, Capital Markets Intelligence and was directly responsible for corporate client relationships within the Technology sector. At Thomson he consulted senior management regarding shareholder composition, financial markets and competitive positioning. Michael received a Bachelor of Science degree in Finance from University of Colorado, Boulder.
Michael G. King, Jr.
Managing Director, Rodman & Renshaw, LLC
Michael G. King, Jr., is a Managing Director and Senior Biotechnology Analyst. Mr. King has over 17 years of experience as a leading biotechnology equity research analyst, consistently ranking at the top of Institutional Investor magazine's annual sell-side research survey in addition to being named that publication's "Home Run Hitter" in 2000. Most recently, Mr. King served as Senior Vice President of Corporate Development and Communication at ZIOPHARM Oncology (NASDAQ: ZIOP), a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics. Prior to joining ZIOPHARM, Mr. King was a Managing Director and Senior Biotechnology Analyst at Wedbush Securities.
Prior to that, Mr. King was a Managing Director and Senior Biotechnology Analyst at Merriman Curhan Ford with other prior positions at leading firms including Dillon Read, Vector Securities International, Robertson Stephens, Banc of America Securities and Rodman & Renshaw, where he was Director of Research. Mr. King began his career in finance in sales at Kidder Peabody.
Michael M. Morrissey, PhD
President & Chief Executive Officer, Exelixis, Inc
Michael M. Morrissey, PhD, has served as a director and as Exelixis' President and Chief Executive Officer since July 2010. From January 2007 through July 2010, he served as President of Research and Development. Previously, Dr. Morrissey served as the Company's Executive Vice President, Discovery (January 2006 -December 2006), Senior Vice President, Discovery (January 2003 - December 2005) and Vice President of Discovery Research (February 2000 - December 2002). From 1991 to 2000, Dr. Morrissey held several positions at Berlex Biosciences, last holding the position of Vice President, Discovery Research. From 1986 to 1991, Dr. Morrissey served as a Senior Scientist and Project Team Leader in Medicinal Chemistry at CIBA-Geigy Corporation, a pharmaceutical company. He is the author of numerous scientific publications in medicinal chemistry and drug discovery and an inventor on 70 issued U.S. patents and 25 additional published U.S. patent applications. Dr. Morrissey holds a B.S. (Honors) in Chemistry from the University of Wisconsin and a Ph.D. in Chemistry from Harvard University.
Robert F. Ozols, MD, PhD
Senior Vice President, Fox Chase Cancer Center
Dr. Ozols is senior vice president of Fox Chase Cancer Center in Philadelphia, where he oversees all of the Center's patient care, clinical research and medical science laboratory research. Internationally recognized for his expertise in ovarian cancer, Dr. Ozols' research focuses on how cancer cells develop resistance to anticancer drugs and on developing new chemotherapy regimens for ovarian cancer. He previously served on the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration. He is a former vice president of the International Gynecologic Cancer Society and served on the Board of Directors of the American Society of Clinical Oncology and the American Association of Cancer Institutes. He is past chair of ASCO's Cancer Research Committee and of the Cancer Communications Committee. He is the author of many scientific publications and has served on the editorial boards of the International Journal of Gynecologic Cancer, International Journal of Oncology, Cancer Research, Cancer Investigation, Journal of Experimental Therapeutics and Oncology and Clinical Cancer Research. He earned his bachelor's degree in chemistry, Ph.D. and M.D. from the University of Rochester. He completed his medical training at Dartmouth-Hitchcock Medical Center and a medical oncology fellowship at the National Cancer Institute.