Externally Led Patient-Focused Drug Development Meeting
Tuesday, October 1, 2024
We strongly encourage you to read further and learn more about how you and those closest to you are able to participate in the upcoming Externally Led Patient-Focused Drug Development (EL-PFDD) Meeting being held virtually on October 1, 2024.
What is Patient-Focused Drug Development?
Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.
FDA’s Role in Medical Product Development
One of the FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. FDA does not develop drugs nor conduct clinical trials. FDA does, however, play a constructive role in guiding, helping, or evaluating at some stages of the pre-clinical, translational, and clinical development at work.
History
- The PFDD initiative started in 2012 as part of FDA’s commitments under the Prescription Drug User Fee Act (PDUFA) V. After conducting FDA-led PFDD meetings, FDA recognized there are many more diseases/conditions that can be addressed beyond those that were planned and conducted by the FDA.
- To help expand the benefits of FDA’s PFDD initiative, in 2015, FDA announced the opportunity for externally-led (EL-PFDD) meetings. EL-PFDD meetings are planned and hosted by the patient organizations, with the input of FDA staff, and use the process established by FDA-led PFDD meetings as a model.
Audience
The key participants in PFDD meetings are patients, patient representatives, patient advocates, caregivers, loved ones, and anyone with a lived experience with the disease or condition. While patients and caregivers share their perspectives, key stakeholders are in listening mode as a part of the audience. This includes:
- The FDA and other regulatory/federal agencies
- Medical product developers
- Academic researchers
- Clinicians and healthcare professionals
It is important for all of these stakeholders to hear patient input as it may inform drug development. Aside from providing initial remarks from the FDA perspective, FDA staff participate as listeners in EL-PFDD meetings. The FA has been in support in the planning of this meeting.
Some host patient organizations choose to incorporate PFDD-style sessions as part of their annual conferences, scientific workshops, and other meetings. It is important to get patient input early in the drug development process.
PFDD Potential Outcomes
- EL-PFDD meetings are a great networking and community building opportunity for the patient community and EL-PFDD meetings can help to channel patient engagement and create momentum in the patient community. Several host patient organizations have hosted follow-up meetings to build on this momentum and have synergized their efforts with other patient organizations in the space.
- EL-PFDD meetings may also serve to identify opportunities for further discussions with patients about their condition and may also generate new research questions.
- EL-PFDD meetings offer an opportunity to foster relationships between patient organizations and industry/medical professionals.
CONTACT
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Union, NJ 07083
Phone: (908) 364-0272
Toll Free: (866) 227-3737
Fax: (908) 686-2019
contact@caresfoundation.org
