NOVEL CLINICAL TRIAL DESIGNS: MORE EFFICIENT AND EFFECTIVE TESTS OF REGENERATIVE MEDICINES DURING THE PANDEMIC AND BEYOND
Sponsored by IQVIA
This panel of industry, advocacy, and academic leaders will discuss challenges faced and innovative solutions explored, in addressing the unique requirements of clinical studies in cell and gene therapy. Participants will present their first-hand experience with various novel trial designs/elements including remote endpoints/telemedicine, virtual trials, hybrid/decentralized trials, platform trials, and external comparators. Cell and gene therapy trials already incur a unique set of challenges, and COVID-19 has dramatically transformed the clinical trial landscape, highlighting and accelerating the need for new ways of thinking that are more relevant now, but which will continue to be increasingly employed going forward.
David Cameron, Global Head of Novel Trial Design, IQVIA
Hearn Jay Cho, M.D., Ph.D., Chief Medical Officer, Multiple Myeloma Research Foundation
Shaji Kumar, M.D., Professor of Medicine, Division of Hematology, Mayo Clinic
Sabrina Paganoni, M.D., Ph.D., Assistant Professor, Harvard Medical School; Physician Scientist, Healey Center for ALS, Massachusetts General Hospital and Spaulding Rehabilitation Hospital
Aiman Shalabi, Pharm.D., VP R&D Cell and Gene Therapies, GSK