Jessica is a senior regulatory professional and consultant with 10 years of experience in the global biopharmaceutical industry. She provides strategic product development and approval strategies to pharmaceutical and biotechnology companies with a focus on investigational therapies for the treatment of rare, serious and life-threatening conditions.

Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his medical degree from NYU School of Medicine, received post-graduate training in Internal Medicine at Vanderbilt University Hospitals, and completed specialty training in hematology at the University of North Carolina.

Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical industry for the past 20 years in similar roles at Wyeth, Janssen, Shire and Pfizer. Linda has developed and/or validated COAs across multiple therapeutic categories. Linda is trained as a statistician.

Ronald Bartek, MS, serves as President of the Friedreich’s Ataxia Research Alliance, on the Board of Directors for the National Organization for Rare Disorders, and as a Board Director for the Alliance for a Stronger FDA. Ron previously served for twenty years in the federal government executive and legislative branches, including in the Policy Staff of the House Armed Services Committee and the US State Department, in defense, foreign policy, and intelligence. He is also a member of the US National Institutes of Health (NIH) NCATS Advisory Council/Cures Acceleration Network Review Board, and of the NIH/NINDS National Advisory Council. Ron earned his Master’s Degree in Russian Area Studies from Georgetown University.

David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of experience in biotechnology regulatory, rare disease drug development, quality, process development, and research and development and has chaired several Oligo-based Therapeutics Conferences co-sponsored by DIA and FDA.