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.

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated the majority of those, and is also working on novel methodologies for capturing patient experience data. Mr Valentine has also authored an analysis cataloguing FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.

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.

Katy Benjamin, PhD is a Principal of Patient Reported Outcomes at ICON. She has extensive experience in rare diseases and outcomes research, including the qualitative and quantitative development of patient reported outcomes measures. Currently, she is the Chair of the ISPOR Task Force on COAs for Rare Disease Research in Clinical Trials. Prior to joining ICON, Dr. Benjamin held positions at several other companies and also had a successful consulting practice for 15 years. She received her PhD from the Johns Hopkins Bloomberg School of Public Health, a MS in Health Policy and Management from the Harvard School of Public Health and a MSW in Clinical Social Work from the Univ. of Michigan.