Session Synopsis: Successful translation of predictive biomarkers into the clinic is dependent on multiple aspects including a prospective outcomes analysis, a clear definition of the biomarker sensitivity and specificity requirements, and clinical trial design. Examples of impactful biomarkers in current clinical practice will be discussed.
Session Chair Profile
Ph.D., Vice President of Translational Medicine, Oncomed Pharmaceuticals
Ann Kapoun is Vice President of Translational Medicine at OncoMed Pharmaceuticals. Her expertise is in the clinical execution and implementation of biomarkers and patient stratification approaches. Dr. Kapoun served as Associate Director of Biomarker R&D in Clinical Pharmacology & Experimental Medicine at ALZA / Johnson & Johnson. Prior to that she was the Department Head of Biomarker R&D at Scios Inc., where she was responsible for their Biomarker and Pharmacogenomics programs in support of clinical trials. Dr. Kapoun received her Ph.D. from Indiana University, Bloomington, IN, and she has co-authored more than 30 scientific publications and patents.
Ph.D., Vice President, Molecular Diagnostics, Clovis Oncology
Dr. Raponi is responsible for designing and executing companion diagnostic strategies to support the development and commercialization of effective cancer therapeutics. Clovis Oncology currently has three compounds advancing in the clinic, each of which has a companion diagnostic also under development. These include CO-1686 (an EGFR mutant selective inhibitor) for the treatment of non-small cell lung cancer, rucaparib (an inhibitor of PARP) for the treatment of cancers with deficiencies in DNA repair, and lucitanib (an inhibitor of FGF and VEGF receptors) being developed in advanced breast and squamous cell lung cancer. He previously spent 15 years at Johnson & Johnson, building biomarker and companion diagnostic programs within the diagnostics (Veridex and Ortho-Clinical Diagnostics) and pharmaceutical (Janssen) franchises. Dr. Raponi received his Ph.D. in Molecular Genetics and Biochemistry from the University of New South Wales, Australia, and has published in the fields of gene therapy, cancer genomics and personalized medicine.
M.D., Ph.D., Medical Oncologist, Director of Cancer Immunology, Intermountain Healthcare
Terence Rhodes, MD/PhD, is the Director of Immuno-Oncology for Intermountain Healthcare. In this role he works to leverage the unique resources of Intermountain Healthcare and partner with academic institutions and industry to develop biomarkers for immunotherapies. In addition, he oversees the effort to increase access to immunotherapy clinic trials. Dr. Rhodes graduated from the medical scientist training program at WVU. He worked at the National Cancer Institute under the direction of virologist Dr. Wei-Shau Hu with his PhD dissertation focused on retroviral evolution and recombination. After residency, Dr. Rhodes was fortunate to complete a fellowship at Duke University in hematology and oncology. His research efforts at Duke University were focused on the tumor microenvironment in colorectal liver metastasis. Prior to his recent appointment at Intermountain Healthcare, he had a busy successful clinical oncology practice where he gained a greater appreciation of cancer patients’ many struggles, reinforcing the need for personalized therapy.
Current Immunotherapy Biomarkers and Future Directions
Although an active area of research, the lack of current clinical biomarkers for cancer immunotherapy comes at a significant delay in effective treatments and increased costs for the majority of patients who do not benefit from immunotherapy. Intermountain Healthcare’s unique resources will play a role in personalizing immuno-oncology.
M.D., Ph.D., Professor, School of Life Sciences, Arizona State University; Chief Medical Officer, National Biomarker Development Alliance; Professor Laboratory Medicine and Pathology, Mayo Clinic School of Medicine
Carolyn Compton, M.D., Ph.D., is an academic pathologist specializing in gastrointestinal disease and is board certified in both anatomic and clinical pathology. She is a Professor of Life Sciences at Arizona State University and a Professor of Laboratory Medicine and Pathology at the Mayo Clinic School of Medicine. She is an adjunct Professor of Pathology at the Johns Hopkins Medical School and the University of Arizona School of Medicine.She is the Chief Medical Officer of the National Biomarkers Development Alliance, a member of the BioDesign Institute. She is a former Professor of Pathology at Harvard Medical School, Chief of Gastrointestinal Pathology at Massachusetts General Hospital and Pathologist-in-Chief of the Boston Shriners Children’s Hospital. More recently she has served as the CEO and President of the Critical Path Institute (2012), the Director of the Office of Biorepositories and Biospecimen Research and the Director of the Innovative Molecular Analysis Technologies program at the National Cancer Institute (2005-2011), and the Strathcona Professor and Chair of the Department of Pathology at McGill University and Pathologist-in-Chief of the McGill University Health Center (2000-2005). She is a past Chair of the Cancer Committee of the College of American Pathologists and the immediate past Chair of the American Joint Committee on Cancer (AJCC). Currently, she is the Chair of the Precision Medicine Core of the AJCC and the Chair of the Specimen Standards for Precision Medicine Project of the College of American Pathologists. She serves on the United States Technical Advisory Group to the International Standards Organization and the Scientific and Ethical Advisory Board of the BBMRI of the European Research Infrastructure Consortium. She is a member of the Boar of Directors of HealthTell, Inc, and Chair of the Scientific Advisory Committee of Indivumed GmbH. Her research interests focus on colorectal cancer, medical prediction, biospecimen and biobanking science, and biomarker development. She has authored more than 500 scientific manuscripts, review articles, books, chapters and abstracts.
Developing Clinically Important (and Useful) Oncology Biomarkers: Challenges and Solutions
Biomarkers represent an intense area of scientific inquiry and the very foundation of precision (molecularly based) medicine which makes them an unparalleled value proposition in oncology. However, their development and use in the clinic faces a number of daunting challenges ranging from problems in discovery to validation in clinical trials. Although literally hundreds of thousands of biomarkers have been reported, very few have found use in the clinic. The mission of the NBDA, a biomarker think tank, is to bring solutions to the key challenges that face the biomarker field. The presentation will explore these key challenges and NBDA’s solution strategies.