FasterCures announces Benefit Risk Advisory Council members
FasterCures today announced the members of its Benefit Risk Advisory Council[i], a diverse group of experts that will provide advice and recommendations aimed at expanding opportunities for patient perspectives to shape product development and influence regulatory decisions. Assessing benefits and risks is core to medical product development, regulation, and healthcare decision-making. A structured process for capturing this information for regulatory purposes is in the early stages of being implemented by the U.S. Food and Drug Administration, creating new opportunities for stakeholders in the R&D ecosystem.
“The tradeoffs between desired benefits and tolerable risks may look quite different whether you’re a patient, a physician, a regulator, or a drug/device developer. They also might change over time,” said Margaret Anderson, executive director of FasterCures. “This advisory council will help FasterCures foster better methods to elicit and understand dynamic patient perspectives in ways that will be useful to drug developers and regulators.”
The advisory council is comprised of 14 leaders representing varied interests – patient groups, academic institutions, industry associations, and pharmaceutical companies. They coalesce around the shared goal of ensuring that products patients value advance more rapidly from bench to bedside.
The FasterCures Benefit-Risk Advisory Council members are:
- Marc Boutin, JD, National Health Council
- John Bridges, PhD, Johns Hopkins Bloomberg School of Public Health
- Diane Dorman, National Organization for Rare Disorders (NORD)
- Andrew Emmett, MPH, Biotechnology Industry Organization (BIO)
- Patricia Furlong, Parent Project Muscular Dystrophy
- Sascha Haverfield, PhD, Pharmaceutical Research and Manufacturers for America (PhRMA)
- Paul Huckle, PhD, MPharm, RPh, GlaxoSmithKline
- Bennett Levitan, MD, PhD, Janssen R&D and Johnson & Johnson
- Robert Metcalf, PhD, Eli Lilly & Co.
- Robert J. Meyer, MD, University of Virginia, School of Medicine
- Amy Rick, JD, Parkinson’s Action Network
- Joseph S. Ross, MD, MHS, Yale University School of Medicine
- Joseph V. Selby, MD, MPH, Patient-Centered Outcomes Research Institute (PCORI)
- Anthony Yanni, MD, MBA, Sanofi-Genzyme Global R&D
The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 dramatically changed the landscape for benefit-risk assessment as it opened a new dialogue between patients, pharmaceutical and device developers/manufacturers, and regulatory gatekeepers about expected benefits and tolerable risks.
As Dr. Robert Meyer, director of the Virginia Center for Regulatory Sciences at the University of Virginia School of Medicine and member of this advisory council explains, “For FDA to do its job properly, it must have a robust understanding of how patients perceive the burden of their own diseases and how they would weigh alleviation of their disease’s impact versus the potential risks of any new treatment.”
The Advisory Council will guide FasterCures’ patient centered benefit-risk assessment program, designed to inform, instruct, and expand all stakeholders’ contributions about and to this growing area of engagement and science.
“For entrepreneurial biotechnology companies researching the next generation of modern medicines, the patient voice is crucial. A key element of the biomedical innovation ecosystem is a patient-centric and science-driven regulatory framework that carefully balances benefits and risks in the context of disease severity and unmet medical need,” states council member Andrew Emmett, MPH, managing director of science and regulatory affairs for the Biotechnology Industry Organization,
FasterCures, a center of the Milken Institute, is an action tank, determined to remove barriers to medical progress. We have only one goal: to save lives by speeding up and improving the medical research system (www.fastercures.org)