Session Abstract – PMWC 2019 Silicon Valley
Session Synopsis: Over the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies. As knowledge evolves and new targets emerge, clinical and translational research need to adapt to a rapidly changing environment to effectively translate novel concepts into sustainable and accessible therapeutic options for cancer patients. Clinical trial design in immuno-oncology, biomarker-oriented drug development paths, statistical design and endpoint selection, challenges in the design and conduct of personalized medicine clinical trials, risk-based monitoring, financing and reimbursement, as well as best operational practices are all crucial for success.
Session Chair Profile
M.D., Vice President of Early Phase Development and Immuno-oncology, Eli Lilly and Company
Kimberly Blackwell is the Vice President of Early Phase Development and Immuno-oncology at Lilly Oncology. A graduate of Mayo Clinic Medical School, Dr. Blackwell was Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical Center. She has played a major role in developing therapies that represent revolutionary non-chemotherapy based approaches for treating breast cancer. Her clinical and research interests include various topics in breast cancer including endocrine therapy, novel HER2 therapies, breast cancer vaccines, and other experimental therapeutics. She has studied and served as the principal investigator on studies that led to regulatory approval of four cancer agents, including the first biosimilar treatment for cancer in the United States. Due to her leadership, she has received numerous awards, including the Duke University Distinguished Alumni in 2015 and TIME Magazine’s 100 Most Influential People in the World in 2013. Additionally, Dr. Blackwell is a recipient of the Young Investigator Award in breast cancer from the National Cancer Institute Specialized Program of Research Excellence and the Joseph Greenfield Award for Mentorship of Clinical Research.
Ph.D., Vice President, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy
Theresa LaVallee has over 25 years of research and industry experience with a broad knowledge in the discovery and development of drug candidates. Theresa is Vice President, Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy and previously served as Senior Vice President, Celldex Therapeutics and Kolltan Pharmaceuticals. She also was Senior Director Translational Medicine at MedImmune and EntreMed. In these roles, she has advanced drugs in oncology, immunology and inflammatory diseases from discovery through late state development. Theresa has a depth of expertise in Translational Medicine enabling science driven development decisions and implementing effective use of biomarker assays in clinical studies. She is author or co-author of more than 50 publications and abstracts with a focus on Translational Medicine approaches in clinical development. She received her Ph.D. degree from University of California, Los Angeles and her B.A. degree from the University of California, Santa Barbara.
JR., M.D., Professor, Division Chief, Stanford University Medical Center
Dr. George W. Sledge, Jr., M.D. is Professor and Chief of Medical Oncology at Stanford University Medical Center. Dr. Sledge served as a Ballve-Lantero Professor of Oncology of Medicine and Pathology of Indiana University School of Medicine. He served as Co-Director of the breast cancer program at the Indiana University Cancer Center, where he was a Professor of Medicine and Pathology at the Indiana University Simon Cancer Center. Dr. Sledge specializes in the study and treatment of breast cancer and directed the first large, nationwide study on the use of paclitaxel to treat advanced breast cancer. His recent research focuses on novel biologic treatments for breast cancer. He served as a Professor of Indiana University Cancer Center Breast Cancer Program. He has also served as the chair of ASCO’s Education Committee, as a member of the Department of Defense Breast Cancer Research Program’s Integration Panel, as a member of the Food and Drug Administration’s Oncology Drug Advisory Committee (ODAC), and as a member of the External Advisory Committee for The Cancer Genome Atlas (TCGA) project. Dr. Sledge was awarded the Hope Funds for Cancer Research 2013 Award of ‘Excellence for Medicine’. He holds a B.A. from the University of Wisconsin and an M.D. from Tulane University.