Hepatitis B Foundation Plans Externally-Led Patient-Focused Drug Development Meeting for Chronic Hepatitis B in June 2020
DOYLESTOWN, PA (November 6, 2019) - The Hepatitis B Foundation is pleased to have been approved by the U.S. Food and Drug Administration (FDA) to host an externally-led Patient-Focused Drug Development (PFDD) meeting on June 9, 2020 that will focus on chronic hepatitis B infection (CHB). This will be a one-day meeting held in Rockville, MD, where patients and key stakeholders will be invited to gather for highly interactive discussions.
“The primary purpose of PFDD meetings is to hear directly from patients about their perspectives on living with a disease and their experiences with treatments, to improve the development of new drugs in the research pipeline,” stated Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation. The patient perspective is critical in helping FDA understand the context in which regulatory decisions are made for new drugs. This input can inform FDA’s decisions and oversight both during drug development and during its review of a marketing application.
The Hepatitis B Foundation’s PFDD meeting will help give FDA and other key stakeholders, including drug developers, healthcare providers and federal partners, an important opportunity to hear directly from patients, their families, and patient advocates about the symptoms that matter most to them, the impact the disease has on their daily lives, and their experiences with currently available treatments.
There is a tremendous need for a patient-focused meeting according to Timothy Block, PhD, Co-Founder and President of the Hepatitis B Foundation. “Currently, there are FDA-approved antiviral treatments that help to suppress hepatitis B virus replication and manage chronic infection, but there are many challenges with current treatment: it is not a cure, once people start treatment they need to take it for many years (often a lifetime), not everyone is eligible for treatment, and current treatment does not eliminate risk of progression to cirrhosis and liver cancer.“
“We have only a limited understanding of the broad impact of chronic hepatitis B on affected individuals,” adds Dr. Cohen. “Many aspects of the disease, including the experiences of living with and being treated for chronic hepatitis B infection, have not been formally captured in clinical trials or public health studies.”
With increased focus nationwide on hepatitis B elimination and many potential hepatitis B drugs moving through the research pipeline, this is an ideal opportunity to integrate the patient voice into the process. Systematic patient engagement and documentation of patient experiences, wants, needs, and challenges, can ensure that current and future strategies to improve health outcomes will best meet patients’ needs and have the greatest impact.
The Hepatitis B Foundation’s externally-led Patient Focused Drug Development meeting will help to ensure that by incorporating patient-focused outcomes, participation in future clinical trials will also increase, which is a critical step in seeing new hepatitis B therapies become FDA approved and in accelerating the Hepatitis B Foundation’s mission to make hepatitis B history.
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About the Hepatitis B Foundation: The Hepatitis B Foundation is the nation’s leading nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org, read our blog at hepb.org/blog, follow us on Twitter @HepBFoundation, find us on Facebook at facebook.com/hepbfoundation or call 215-489-4900.