Hepatitis B Foundation Hosts
Patient-Focused Drug Development Meeting on HBV
June 9, 2020
The Hepatitis B Foundation (HBF) is pleased to have been approved by the U.S. Food and Drug Administration (FDA) to host a public meeting focused on chronic hepatitis B as part of the FDA’s externally led Patient-Focused Drug Development program. This one-day meeting is by invitation only (limited by room size) and will be held on Tuesday, June 9, 2020 in Rockville, MD. The meeting will be live-broadcast, so that people from around the world can listen-in and share their thoughts remotely.
Patients and family members will be invited to participate in professionally facilitated discussions on their lived experiences with chronic hepatitis B. Representatives from the FDA, HHS, NIH, CDC, industry, academia, and nonprofit and patient advocacy organizations will also be invited to attend and listen to the highly interactive discussions.
The primary purpose of this meeting is to hear directly from patients about their perspectives on living with chronic hepatitis B and their experiences with treatments to improve the development of new drugs for this serious liver disease.
With increased global attention on hepatitis B elimination and new drugs moving through the research pipeline, this meeting is an ideal opportunity to integrate the patient voice into the drug development process.
The patient perspective is critical in helping the FDA understand the context in which regulatory decisions are made for new drugs. By incorporating patient-focused outcomes into the process, the FDA will be better informed in their decisions and oversight during both drug development and its review of a commercial drug application.
The Hepatitis B Foundation is committed to increasing systematic patient engagement and documentation of patient experiences, wants, needs, and challenges to improve their health outcomes. The meeting we are hosting is an important public element of our commitment to improving the lives of those living with hepatitis B.
Our Chronic Hepatitis B Patient-Focused Drug Development Meeting will be live webcast on June 9, 2020 and a summary report will be prepared and published for public review. Stay tuned for more details in the coming months!
Inviting All People Living with Chronic Hepatitis B
If you’ve ever wanted to help guide the future of hepatitis B treatments, now is your chance! The Hepatitis B Foundation created a Patient Engagement Survey so we can hear your thoughts about living with hepatitis B. The survey only takes about 20-25 minutes and will be shared with the FDA as part of our Chronic Hepatitis B Patient-Focused Drug Development Meeting (see above). Both U.S. and international patients are invited to take the survey. All survey responses are anonymous.