Business Roundtable
Elusive Cancer Endpoints - How to Survive the Uncertainty
Monday, February 11, 2008
9:30 AM
Astor Salon
There has long been confusion over the ideal design of cancer drug trials and which endpoints are most appropriate to pursue, particularly for cancer vaccines. The issue of whether overall survival or progression-free survival is the better clinical endpoint was most recently highlighted by Dendreon's Provenge. This roundtable brings together a diverse panel of experts who will tackle the most important issues relevant to this tricky topic, provide recommendations on ideal trial design, and discuss how best to work with the FDA.
Moderators
- Greg Frykman, MD; Sr Vice President and Pharmaceutical Analyst, Stanford Group Company
Panelists
- Philip Lavin; Executive Chairman, Averion International Corp.
- David Urdal, Ph.D; Senior Vice President and Chief Scientific Officer, Dendreon
- Kenneth Anderson, MD; Director; Professor; and Chief of Division of Hematological Neoplasia, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute; Harvard Medical School; and Brigham and Women's Hospital
Who's Who
Dr. Frykman covers the pharmaceutical and biotechnology industry with a focus on scientific, medical and regulatory aspects of cancer therapies Formerly, Dr. Frykman worked as a medical reviewer in both the Division of Oncology Drug Products and the Center for Biologics at the Food and Drug Administration. He remains on the active medical staff at Montgomery General Hospital. He earned a bachelor?s degree in Physics and a Medical Doctorate, both from Loma Linda University; an Internal Medicine residency at the USC-Los Angeles County Medical Center; a Medical Oncology fellowship at the Johns Hopkins University; and additional training in Developmental Therapeutics at the National Cancer Institute. He is ABIM board certified in Internal Medicine, Hematology and Medical Oncology.
Philip T. Lavin, PhD has recently been appointed to the newly created position of Executive Chairman, as a result of Averion's acquisition of Hesperion. Dr. Lavin co-founded Boston Biostatistics, Inc. in 1983 while a Biostatistics Faculty member at the Harvard School of Public Health. Dr. Lavin has led the company from a group of Boston-based biostatistics consultants into a full-service contract research organization, which in 2001 changed its name to Averion Inc. and is the predessecor company of today's Averion International Corp. Dr. Lavin has participated in the design, analysis, presentation and publication of clinical studies since 1974. He authored or co-authored over 150 publications and is internationally recognized for his contributions to developing biomarkers (CA-125 and PSA), assessing prognostic factors for oncology studies, treating cardioplegia, designing Phase II cancer studies, measuring tumor response, optimizing liver and kidney transplants, characterizing infertility, defining composite endpoints, and identifying the value of limited weight loss. He has successfully supported many IDEs and INDs and has personally represented clients, leading to over 51 FDA product approvals, to date, more than any other biostatistician. Over the past twenty years, Dr. Lavin has served on three different FDA Advisory panels. He has also served as the Principal Investigator for Data Coordinating Centers for many government sponsored clinical studies. He is an active speaker at industry and professional society meetings. Dr. Lavin received his PhD in Applied Mathematics at Brown University in Providence, Rhode Island in 1972.
Dr. Urdal has served as Dendreon's Chief Scientific Officer since joining the Company in 1995. Prior to that time, Dr. Urdal held various positions with Immunex Corporation, including President of Immunex Manufacturing Corporation, Vice President and Director of Development, and head of the departments of biochemistry and membrane biochemistry. Dr. Urdal received an M.S. in Public Health and a Ph.D. in Biochemical Oncology from the University of Washington.
Dr. Anderson graduated from Johns Hopkins Medical School. He trained in internal medicine at Johns Hopkins Hospital and completed hematology, medical oncology, and tumor immunology training at the Dana-Farber Cancer Institute. Dr. Anderson is the Kraft Family Professor of Medicine at Harvard Medical School and serves as Chief of the Division of Hematologic Neoplasia, Director of the Jerome Lipper Multiple Myeloma Center, and Vice Chair of the Joint Program in Transfusion Medicine at the Dana-Farber Cancer Institute. He received the Waldenstrom's Award in 2003 for his translational research directed to the development of novel therapeutics targeting the myeloma cell in its microenvironment and is a Doris Duke Distinguished Clinical Research Scientist. In addition to serving on the Board of Directors of the MMRF, Dr. Anderson serves as Chairman of the MMRF's Scientific Advisory Committee, Chairman of the Multiple Myeloma Research Consortium, and Chairman of the National Comprehensive Cancer Network's Multiple Myeloma Clinical Practice Guidelines Committee.