Cure SMA is pleased to announce a new webinar on interactions between the FDA and the SMA community. The webinar will be held on March 8, 2017, at 1:00pm EST (10:00am PST/ 11:00am MST/ 12:00pm CST).
The goal is to provide both a broad overview of how our community can continue to productively engage with the FDA, as well as specific information and details on the Patient Focused Drug Development (PFDD) Meeting, scheduled for April 18.
We will be joined by two panelists from the FDA, and one from the patient advocacy sphere with experience in hosting a successful PFDD meeting.
Panelists include:
- Devanand Jillapalli, MD, Medical Officer, Office of Orphan Products Development, Office of the Commissioner, FDA
- Salina V. Prasad, MS, MBA, Health Programs Coordinator, Office of Health and Constituent Affairs, Office of External Affairs, Office of Commissioner, FDA
- Molly White, Chief Executive Officer, Myotonic Dystrophy Foundation
With the first-ever approval of a treatment for SMA, and many additional therapies in development and in clinical trials, this is an important time to continue our work with the FDA. Factors that influence the treatment and management of SMA – such as benefit/risk, the design of future clinical trials, labeling, historical vs. placebo controls, and more – will continue to evolve as treatment evolves. It is critical that we maintain strong relationships with the FDA to communicate the growing and changing needs of our community.
Panelists will provide insight into how the FDA approaches these issues, and how and when our community can give timely, focused input on these and other topics. The webinar will conclude with a discussion of the Patient Focused Drug Development Meeting.
About the Panelists
Devanand Jillapalli, MD
Devanand Jillapalli is a Medical Officer in the Office of Orphan Products Development, Office of the Commisioner, FDA. He is a board-certified neurologist with specialization in neuromuscular diseases. Prior to the current position, he was a Medical Officer in the Center for Drug Evaluation and Research, FDA, involved in regulatory review of candidate therapeutics for neurological indications.
Salina V. Prasad, MS, MBA
Salina Prasad joined FDA’s Office of Health and Constituent Affairs, located within the agency’s Office of the Commissioner, as a Health Programs Coordinator in March 2013. Serving on OHCA’s Patient Liaison Team, Ms. Prasad is the Office’s team lead for neurology-related issues and medical products. She also helps to manage FDA’s Patient Representative Program, a critical program within the agency that ensures that patient perspectives are included in the medical product review process. Prior to FDA, Ms. Prasad was with the FDA’s sister agency, the Agency for Healthcare Research and Quality, for nearly 18 years where she worked on patient safety and medical error issues. Ms. Prasad received a B.S. in chemistry and biology from Columbia Union College, in addtion to a Master of Science and a Master of Business Administration in Biotechnology from Johns Hopkins University.
Molly White
Molly is Chief Executive Officer in charge of leadership, strategic direction and administrative oversight for the comprehensive programmatic and fundraising efforts of the Foundation and its staff. Molly has over 25 years of leadership-level experience building, implementing and running award-winning domestic and international community programs for organizations in both private and nonprofit sectors. She has created partnerships with a range of governmental, nonprofic and private sector stakeholders that include Gap, Inc., Nike, Inc., Visa, Inc., Sony, Williams Sonoma/Pottery Barn, AAA, The Estate Project for Artists with AIDS, Canyon Ranch Institute, the Ford Foundation and The Wilderness Society, to launch initiatives targeting key national issues such as childhood obesity prevention and components of healthcare reform.