Hepatitis B Foundation to host first-ever online Externally Led Patient-Focused Drug Development meeting
Doylestown, Pa., May 28, 2020 – In cooperation with the U.S. Food and Drug Administration, the Hepatitis B Foundation will host an online Externally Led Patient-Focused Drug Development (PFDD) meeting for those living with hepatitis B and other key stakeholders on June 9 from 12:30-4:30 p.m. EDT.
The Foundation was given approval by the FDA to host this meeting, which will be an online-only event due to COVID-19, making it the first in this format since the agency began holding PFDD meetings in 2012. The goal of the agency’s PFDD program is to “more systematically obtain the patient perspective on specific diseases and their treatments.” To date, there have been more than 25 PFDD sessions, each focused on a different disease.
“The Hepatitis B Foundation is eager to partner with the FDA to host this valuable meeting because we share the FDA’s commitment to eliciting input from people who are living with hepatitis B, their families and caregivers, and their health care providers,” Timothy M. Block, PhD, co-founder and president of the Foundation, said. “We are quite pleased that the FDA accepted our proposal and subsequently agreed to our reshaping the meeting into a virtual format.”
In the U.S., more than 2 million people are living with chronic hepatitis B and many more are at risk for becoming infected with the virus, which is a leading cause of liver cancer and deaths worldwide. Despite the tools available to prevent and eliminate hepatitis B, including safe and effective hepatitis B vaccines, only about 25% of adults in the U.S. have been vaccinated.
Chari Cohen, DrPH, MPH, the Hepatitis B Foundation’s senior vice president and organizer of the June 9 meeting, said that while the online format means considerable technical challenges, it presents a new opportunity.
“The online approach naturally offers far greater access to people living with hepatitis B across the United State and even overseas, without the burden of traveling to a specific location,” Cohen said. “We also were able to recruit expert speakers—and we have a very strong lineup—without the constraints of travel.”
The focus of the meeting will be two panel discussions led by 12 people living with hepatitis B. They will discuss the physical, psychosocial and professional impacts of living with chronic hepatitis B, as well as their perspectives on current and future approaches to treatment. The meeting also will have interactive components for attendees, including live polling questions, and the ability to submit real-time comments via email and phone. The Foundation team is encouraging advance submission of comments, especially for those who cannot join the live June 9 meeting.
The Foundation has posted a brief survey designed to capture the experiences of people living with hepatitis B, including symptoms, treatment and impact on their daily lives. More than 2,000 individuals have completed the survey so far. Respondents are from more than 30 countries, with about 700 in the U.S.
More than 400 people have registered to participate in the virtual meeting to date, though advance registration is optional. A recording and transcript of the meeting will be made available on the Foundation website. Additionally, the Foundation will prepare a report highlighting the important takeaways from the meeting, which will be available online and provided to federal and research partners to assist in planning of drug development and clinical trials for hepatitis B.