Thank you for your interest in the M-CERSI Conference on Patient-Focused Drug Development, a conference by the University of Maryland, with planning members from the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), Food and Drug Administration, academia, and industry.
About the Event:
The M-CERSI Conference on Patient-Focused Drug Development will be held on Monday, March 9, 2015 at the Hyatt Regency Hotel in Bethesda, MD. The conference will provide a forum for all patient-focused drug development (PFDD) stakeholders to gather for an open dialogue. Patients, caregivers, and patient advocacy groups, as well as regulators from the Food and Drug Administration (FDA); researchers from academia, industry, and other agencies; payers; and other stakeholders will come together to discuss the following topics:
- Definition of PFDD
- Essential components that need to be included in successful PFDD
- Current initiatives, such as those of the FDA, patient advocacy groups, and pharmaceutical companies
- Challenges to achieving PFDD and methods to overcome those challenges
- Recommendations on a plan of action that includes a description of stakeholders' roles to move PFDD forward
The goal of the conference is to foster discussions that address questions such as:
- What is the definition of PFDD?
- What is patient engagement in PFDD, and what are the best methods to accomplish meaningful patient engagement within PFDD?
- What are the roles for patients, payers, and industry in an ideal world with respect to PFDD?
- What information from patients best informs PFDD, and what are the best ways to gather that information?
- How can/will patient stakeholders, industry, regulators, and payers use information collected through PFDD?
- How can industry engage with patients, patient groups, and the FDA regarding conditions not included in FDA activities?
- How can patient advocacy groups best organize themselves to prepare for FDA meetings?
- How can industry use information generated through PFDD to develop new therapies?
- What measures might incentivize companies to adopt a patient-centered approach?
- How can companies engage patients in ways that the FDA will accept and find meaningful?
- What is the ideal common pathway for moving PFDD forward?
Conference deliverables will include a "Patient Engagement Rubric" for PFDD.