On Monday, November 9, Cure SMA will be hosting a one-hour webinar on clinical trials and regulatory topics. The webinar will be held at 11:00am CST (9:00am PST/10:00am MST/12:00pm EST).
Jill Jarecki, Research Director at Cure SMA, will be joined by a panel of three drug development experts to discuss clinical trial design, expanded access, NDA processes, and more. The webinar will include a Q&A session.
This webinar is available to the entire SMA community free of charge. Pre-registration is required.
Meet the Panelists
Tim Franson, MD, is Chief Medical Officer at YourEncore. Prior to joining YourEncore, he was a principal in FaegreBD Consulting’s health and biosciences practice. While with FaegreBD, Franson provided comprehensive regulatory pre-approval and postmarketing regulatory advice, and bundled strategic consulting with the firm’s public policy, reimbursement, and communications services. During his time with FaegreBD, Franson leveraged his extensive clinical and regulatory experience in all pre- and post-approval phases of pharmaceutical development (small and large molecule) relating to interactions with the FDA for policy and product issues and manufacturing and supply chain initiatives.
Thomas Murray, PhD, is President Emeritus at The Hastings Center. He was formerly the Director of the Center for Biomedical Ethics in the School of Medicine at Case Western Reserve University, where he was also the Susan E. Watson Professor of Bioethics. He serves on many editorial boards and has testified before many Congressional committees. Among other current posts, he serves as Chair of the Ethical Issues Review Panel for the World Anti-Doping Agency, International Expert Advisor to Singapore’s Bioethics Advisory Committee, and Vice Chair of Charity Navigator. He has been president of the Society for Health and Human Values and of the American Society for Bioethics and Humanities. Murray is the author of more than 250 publications.
Tim Miller, MD, is VP & Head, Medical Affairs, North America Rare Diseases at Genzyme. Dr. Miller has worked in an incredible array of biotechnology / pharmaceutical programs, including cross functional and leadership roles in medical affairs, regulatory, and clinical research with direct synergies in all business unit operations. He has lead disease programming in the largest rare diseases registry program in existence. Prior to this, he Dr. Miller was Senior Director & Head of Medical Affairs at Cytokinetics, as well as a practicing clinical neurologist, medical director at a pediatric neuromuscular disorder clinic, and Assistant Professor of Neurology at the University of Arizona.
Additional Background Information
Download a copy of Learning about Clinical Trials
Learn about our “Voices of SMA” project
Read an update on Cure SMA’s FDA Engagement Initiative