Join us on November 19, 2020
Register for the Live Stream Here!
Bridge the Gap - SYNGAP Education and Research Foundation are excited to announce we will be hosting the first SYNGAP1: Externally Led Patient-Focused Drug Development Meeting in the United States.
Bridge the Gap is one of only 30+ organizations to hold an Externally Led - Externally Led PFDD meeting since the FDA program began in 2012.
Learn more about why this Externally Led - PFDD Meeting is a critical step in our strategy to help accelerate the research pathway toward new therapeutic treatments for those affected by SYNGAP1.
Check out what other patient advocacy organizations are sharing about their experiences and how they benefited from hosting an EL - PFDD Meeting - Here: Taking Stock of PFDD: A Vibrant Future for Patient-Focused Drug Development.
BTG's EL - PFDD Meeting will be held as a virtual, live-stream event, that is accessible to all SYNGAP1 Community Stakeholders. The meeting will have a guest moderator and include a participating panel of SYNGAP1 patients, caregivers and families, SYNGAP1 clinical and research experts. Virtual attendees will have an opportunity to ask questions and provide comments.
We will be providing updates as we move closer to the meeting date and can't wait to share more with you! Please contact us with any questions you may have.
Your input is CRITICAL!
Externally Led PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment.
Externally Led 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. As experts in what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.
The primary goal of externally led patient-focused drug development is to better incorporate the patient’s voice in drug development and evaluation, including but not limited to:
*Facilitating and advancing the use of systematic approaches to collecting and utilizing robust and meaningful patient and caregiver input to more consistently inform drug development and regulatory decision-making
*Encouraging identification and use of approaches and best practices to facilitate patient enrollment and minimizing the burden of patient participation in clinical trials
*Enhancing understanding and appropriate use of methods to capture information on patient preferences and the potential acceptability of tradeoffs between treatment benefit and risk outcomes Identifying the information that is most important to patients related to treatment benefits, risks, and burden, and how to best communicate the information to support their decision making.
For more information: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings
