A host of issues have clouded patient recruitment for clinical trials, causing some severe issues for drug developers. Patient access to drug studies -- particularly in oncology -- has been a growing problem, along with key challenges in hiring site staff and the limitations involved with the structures now in place for managing trials. Endpoints News’ Kyle LaHucik has been digging deep into this, and offers a detailed look at the problems and potential solutions.
Dr. Luke is an Associate Professor of Medicine in the Division of Hematology/Oncology at the University of Pittsburgh and the Director of the Immunotherapy and Drug Development Center within the UPMC Hillman Cancer Center. Dr. Luke has a clinical research focus on the development of novel immunotherapies for advanced solid tumors and is an internationally recognized thought leader in melanoma oncology. Dr. Luke is the Principal Investigator of the UPMC Hillman enterprise genomic sequencing platform and leads an R01 funded translational research laboratory that leverages large scale multi-omic data to inform immunotherapy resistance, biomarker development and novel treatment strategies. Dr. Luke is an at large member of the Board of Directors for the Society for Immunotherapy of Cancer has held various leadership roles in other cancer research professional societies. He holds senior editorial positions at Clinical Cancer Research, Journal for Immunotherapy of Cancer and the American Cancer Society journal Cancer. He earned an M.D. from Rosalind Franklin University of Medicine and Science and trained in medical oncology at Memorial Sloan-Kettering Cancer Center.
Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhone-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa®), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.
Leisha A. Emens, M.D., Ph.D., is a Professor of Medicine at the UPMC Hillman Cancer Center. She received her MD/PhD in the Medical Scientist Training Program (MSTP) at Baylor College of Medicine, and completed postgraduate training at the National Cancer Institute, the University of Texas at Southwestern, and Johns Hopkins University. She joined the faculty at Johns Hopkins University in 2001, where she rose to the rank of Associate Professor of Oncology before joining the UPMC Hillman Cancer Center. She is a medical oncologist focused on breast cancer and is internationally recognized for her work in breast cancer immunotherapy. She developed and tested a vaccine for breast cancer patients, and more recently has played a key role in the development of the anti-PD-L1 agent atezolizumab for triple negative breast cancer and HER2+ breast cancer. Dr. Emens was a member of the FDA Advisory Committee on Cellular, Tissue, and Gene Therapies (CTGTC) 2012-2016. She is an active member of ASCO, AACR, and SITC, and is a member of the Cancer Immunology (CIMM) Steering Committee of the AACR. Dr. Emens serves as Vice President of the Society for Immunotherapy of Cancer (SITC), and will ascend to the role of SITC President in 2023. She also serves as section editor for Journal for the Immunotherapy of Cancer (JITC). Dr. Emens has received the President’s Award by the YWCA of Greater Baltimore, the Maryland Governor’s Citation, the Sy Holzer Immunotherapy Research Award, and the Stand Up to Cancer Laura Ziskin Prize in Breast Cancer Translational Research.
David is currently the Chief Medical Officer at Palleon Pharmaceuticals. Prior to joining Palleon, David was the Global Head of Hematology Development and Chair of the Precision Medicine Leadership Team at Novartis. Before this, he held numerous leadership positions at Bristol-Myers Squibb including Head of Oncology Early Clinical Development and Development Leader for Ipilimumab/Nivolumab Life Cycle Management. As the Nivolumab Clinical Head, David was responsible for the development of the first PD-1 inhibitor from proof of concept through initial registration in non-small cell lung cancer, melanoma, and renal cell carcinoma. David earned a BS in biology from MIT and an MD/PhD in Immunology from the University of Massachusetts Medical School. He completed internal medicine training at Dartmouth Hitchcock Medical Center and medical oncology training at the Memorial Sloan-Kettering Cancer Center.
Dr. Tanios Bekaii-Saab, MD, is a Professor of Medicine at the Mayo Clinic College of Medicine and Science, Leader of the Gastrointestinal Cancer Program at the Mayo Clinic Cancer Center, Chair for Medical Oncology in the Division of Hematology/Oncology at the Mayo Clinic in Phoenix, Arizona, USA. He is also the consortium chair for the ACCRU research Network. He is the co-leader of the Hepatobiliary Cancer Committee of the Alliance for Clinical Trials in Oncology cooperative group. He is also a member of the National Cancer Institute’s Hepatobiliary Task Force and Pancreatic Cancer Task Force.
Dr Bekaii-Saab has authored or co-authored more than 450 peer reviewed publications, abstracts, and book chapters, including papers in such journals as Lancet Oncology, Journal of Clinical Oncology, JAMA, Journal of the National Cancer Institute, Annals of Oncology, and Clinical Cancer Research.
Kyle LaHucik is an associate editor at Endpoints News, where he covers the people, partnerships, powder and pipelines behind the biopharma industry. His time on the beat began at Fierce Biotech, where he reported on financing, clinical trial results, management moves and the stories of LGBTQ+ leaders in life sciences. A graduate of the University of Missouri School of Journalism, Kyle has previously reported for Mergermarket, Bloomberg, the Columbia Missourian and other publications. He runs marathons, bikes along the Chicago lakefront and dabbles in bouldering outside of work hours.