Session Abstract – PMWC 2020 Silicon Valley


New approaches are being adopted to overcome the challenges associated with matching and enrolling patients to the most appropriate clinical trial. Identifying opportunities for patients requires both an understanding of the patients’ molecular profile and other key clinical attributes to ensure enrollment data. In this session, we will learn about innovative and novel approaches and technologies that address clinical trial enrollment challenges.

 Session Chair Profile

M.D., Co-Founder, Chief Scientific Officer, Genomic Health

Biography
Under Steve's leadership Genomic Health used innovative molecular diagnostic methods and rigorous clinical studies to develop the Oncotype DX® breast cancer and colon cancer assays and has maintained an 80% product development success rate. Steve has been a leader in personalized medicine for more than two decades. Prior to co-founding Genomic Health in 2000, Steve served for 14 years in various roles in discovery research and medical affairs at Genentech, Inc., a biotechnology company dedicated to using human genetic information to discover, develop, manufacture and commercialize medicines to treat patients with serious or life-threatening medical conditions. Steve led the clinical team that gained approval for Herceptin®, a targeted biologic treatment for breast cancer. He also initiated the cancer clinical trials of the anti-angiogenesis agent, Avastin®. In addition, Steve discovered Pulmozyme®, a mucus-dissolving enzyme that is approved worldwide for the treatment of the genetic disease cystic fibrosis. Prior to joining Genentech, Steve was an Assistant Professor of Medicine and Pharmacology at New York University School of Medicine. In 2017, Steve was recognized for his contributions to precision medicine and named one of the Top 100 Innovators in the country by PharmaVOICE.


 Speaker Profile

M.D., Senior Vice President and Chief Medical Officer, American Society of Clinical Oncology

Biography
As Senior Vice President and Chief Medical Officer of the American Society of Clinical Oncology, Dr. Schilsky is involved in professional and patient education, quality improvement, policy and advocacy, communications, clinical research and development of CancerLinQ, ASCO’s rapid learning system for oncology. Prior to joining ASCO, Dr. Schilsky was a faculty member at the University of Chicago from 1984-2012. He served as Director of the University of Chicago Cancer Research Center (1991-99), as Associate Dean for Clinical Research (1999-2007) and as Chief of the Section of Hematology-Oncology (2009-2012). He presently serves as a member of the Board of Directors of the Reagan-Udall Foundation for the FDA, of Friends of Cancer Research and of the National Coalition for Cancer Research, and as a member of the National Cancer Policy Forum of the National Academy of Medicine. Dr. Schilsky has served as a member of the Board of Directors of ASCO and of the Conquer Cancer Foundation of ASCO and as ASCO President 2008-2009.


 Speaker Profile

M.D., Associate Professor of Medicine, Director Gastrointestinal Oncology, University of Chicago

Biography
Daniel Catenacci, MD, is an adult gastrointestinal medical oncologist and director of the Gastrointestinal Oncology Program at the University of Chicago. He serves as the assistant director of translational research in the Comprehensive Cancer Center. In addition to his clinical practice, Dr. Catenacci is an active basic and clinical researcher, focusing on the treatment of gastroesophageal (esophagus, gastroesophageal junction, and stomach) cancers. His bench-to-bedside translational research has an overarching goal to validate and improve personalized treatment, immunotherapy, and precision medicine for gastroesophageal cancer and other GI cancers. A major focus of his research is on the quantification of tumor genetic molecular heterogeneity both between individuals with gastroesophageal cancer, but importantly also within a given individual within one tumor site, and from one tumor site to another, and how this impacts personalized targeted therapeutic approaches. Additionally, Dr. Catenacci designs and executes novel clinical trials to implement treatment strategies based on these laboratory and clinical discoveries. Dr. Catenacci serves as associate editor for the Journal of American Medical Association Network Open (JAMA Netw Open) and is on the editorial board of the Journal of Clinical Oncology Precision Oncology (J Clin Oncol PO).


 Speaker Profile

M.D., Chair Solid Tumor Oncology and Investigational Therapeutics, Levine Cancer Institute, Atrium Health

Biography
In addition to his current role, Edward S. Kim is Medical Director of the Clinical Trials Office and the Donald S. Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute, Atrium Health in Charlotte, NC. Dr. Kim was previously at UT MD Anderson Cancer Center in Houston, Texas where he was a tenured Associate Professor of Medicine, Chief of the Section of Head and Neck Medical Oncology and Director of Clinical Research Operations in the Department of Thoracic/Head and Neck Medical Oncology. Dr Kim specializes in cancer biomarkers and novel targeted agents in the treatment and prevention settings and has expertise in lung, head and neck cancers. He chaired the Department of Defense Biomarker-based Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) personalized medicine program in lung cancer. He currently oversees the solid tumor faculty and research development at Levine Cancer Institute. Dr Kim is the author or coauthor of more than 100 published articles, book chapters, reviews in journals such as Lancet, Lancet Oncology, Journal of Clinical Oncology, Cancer Discovery, Clinical Cancer Research Cancer, and Cancer Prevention Research, involving cancer therapeutics and prevention with chemotherapy and novel targeted agents, with particular emphases on lung cancer and head and neck cancer.


 Speaker Profile

Senior Vice President, Acorn AI Labs, Medidata Solutions

Biography
Fareed Melhem is Senior Vice President in charge of Acorn AI Labs. Acorn AI Labs brings together data, technology, and expertise from Medidata and Partners to tackle the toughest problems in life sciences. A core focus of the Labs are the applications of data and advanced analytics to improve the design, planning, and execution of clinical trials. Prior to Medidata, he was an Associate Partner at McKinsey & Company where he led work with Biopharma, CROs, and Technology players in the R&D space. He co-led McKinsey’s Center for Analytics and Real World Evidence, advising clients on the application of advanced analytics across the product lifecycle. Fareed has written on the impact that data and analytics can have in driving in R&D and speaks regularly at conferences on the topic. Fareed holds an MBA from the Darden School of Business, University of Virginia and a BA in Economics and Math from Columbia University.