Consideration of patients' needs, experiences, and perspectives can contribute to medical product development processes, as well as inform regulatory and access decision-making. Patient perspectives and data are useful in validating and qualifying product development tools and resources, modifying product labeling, and aiding patient access to novel therapies. However, the need remains for greater guidance and stricter standards on how to share and apply patient information uniformly and consistently. Speakers intend to share a few case studies highlighting how patient-focused product development has contributed to and informed regulatory decision-making. They will examine opportunities for better integration of the patient's voice in product development and regulatory decisions, and how to align stakeholders in collaborating with the patient community to address unmet medical needs.

Moderator

Cartier Esham

Chief Scientific Officer and EVP of Emerging Companies, Biotechnology Innovation Organization (BIO)

Speakers

Robyn Bent

Director, CDER Patient Focused Drug Development Program, US Food and Drug Administration

Mary Elmer

Executive Director Patient Engagement Oncology, Merck

Sonya Eremenco

Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute

Andrew Fish

President and CEO, Medical Device Innovation Consortium

Ceciel Rooker

President and Executive Director, International Foundation for Gastrointestinal Disorders