Cure SMA to Host Webinar on the New Drug Application Process
On Tuesday, December 6, Cure SMA will be hosting a one-hour webinar on the New Drug Application (NDA) process. The webinar will be held at 12:00pm CST (10:00am PST/11:00am MST/1:00pm EST).
Jill Jarecki, chief scientific officer, and Kenneth Hobby, president, will be joined by a two clinical and regulatory experts to discuss the NDA process and how it may impact our community. The webinar will also include a 30-minute Q&A session.
This webinar is available to the entire SMA community free of charge. Pre-registration is required.
Submit Your Questions for Our Panelists
The registration form for this webinar also includes an opportunity to submit your questions in advance for the Q&A. While participants will also be able to submit questions during the webinar, we are encouraging everyone to submit their questions in advance, so that we can plan to answer as many of them as possible. Please restrict your questions to broader issues related to the NDA process. Our panelists are not equipped to discuss specific drug programs or specific NDA filings.
In addition to submitting your questions via our registration form, you can also submit questions by sending them to email@example.com and putting “NDA webinar” in the subject line.
Meet the Panelists
Since 2014, Jeanne Ireland has served as the Principal of Ireland Strategies, LLC, a regulatory and legislative strategic consulting firm focused on Food and Drug Administration matters. Ms. Ireland has over 20 years of experience in health policy and federal government relations, with a unique combination of service in Capitol Hill, federal agency, and patient advocacy leadership roles. Prior to launching her firm, she was Senior Advisor to the Commissioner (2012-2014) and Associate Commissioner for Legislation (2009-2012) at the Food and Drug Administration, where she led high priority policy and legislative initiatives, including negotiations on the Food and Drug Administration Safety and Innovation Act.
Before her tenure at FDA, Ms. Ireland held senior congressional staff positions as Chief Public Health Advisor to former Chairman John D. Dingell on the House Energy and Commerce Committee and Minority Staff Director for Senator Christopher J. Dodd on the Senate Health, Education, Labor and Pensions Committee's Subcommittee on Children and Families. Ms. Ireland also served from 2002-2008 as Director of Public Policy at the Elizabeth Glaser Pediatric AIDS Foundation, managing the Foundation's global and domestic HIV/AIDS advocacy efforts. In 2001, she was awarded a fellowship with the Robert Bosch Foundation in Berlin, Germany, where she spent a year working with government and nonprofit leaders on work/life policies. Ms. Ireland received a B.A. from the University of Virginia and A.M. from the University of Chicago.
Doug Kerr, MD, PhD, MBA, is the Global Development Team Lead and Vice President for Neurodegeneration at Shire. In this capacity, Doug is responsible for the lysosomal storage diseases and other neurology programs in adults and children. Doug joined Shire from Biogen, where he spent 7 years with most of his time in Neurology R&D. Doug is a neurologist and neuroscientist with over 120 publications in medical journals.
Doug completed his neurology residency training at The Johns Hopkins University School of Medicine and then served on the faculty there an Associate Professor of Neurology with joint appointments in the Department of Molecular Microbiology and Immunology and Cellular and Molecular Medicine. Doug received his MD degree from Jefferson Medical College in Philadelphia, his PhD in Biochemistry and Molecular biology also from Jefferson Medical College, and his MBA with a specialization in entrepreneurship and finance from Northeastern University. Doug is also a member of Cure SMA’s Board of Directors.