The agreement effectuated by the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and the first reauthorization of the Biosimilars User Fee Act (BsUFA) substantially alter the fee structures of these programs and provide resources for FDA to carry out significant activities detailed in the letters of agreement between FDA and stakeholders. In this webinar, key stakeholders will describe the PDUFA and BsUFA agreements, highlight major changes, and identify implementation issues to watch. Following panelist presentations, there will be discussion of key issues among the panelists and an opportunity to ask questions.
Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization (BIO)
Lucy Vereshchagina, Vice President, Science & Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Allen, President and CEO, Friends of Cancer Research (Friends)
Jeffrey K. Francer, Senior Vice President & General Counsel, Association for Accessible Medicines (AAM)
Moderated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
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Kay Holcombe is Senior Vice President for Science Policy at the Biotechnology Innovation Organization (BIO). Ms. Holcombe works with the organization on all major policy initiatives, with a particular focus on regulatory policy. Prior to joining BIO, she was Vice President, FDA Alliances and Federal Agency Relations, at Sanofi, and Vice President for Government Relations at Genzyme Corporation. Kay works with government relations, policy, and legal staff as well as with principals of BIO member companies to develop and implement policies that advance the public health through biotechnology and to develop appropriate responses to government initiatives that affect the biopharmaceutical industry broadly. Before joining Genzyme in 2006, Kay spent 8 years as Executive Vice President of Policy Directions Inc., a government relations firm specializing in strategic planning and legislative and regulatory advocacy regarding health care and related issues. Kay received her BS in chemistry education from the University of Illinois and her MS in chemistry from the University of Virginia.
LUCY VERESHCHAGINA, Ph.D., is a Vice President, Science and Regulatory Advocacy at PhRMA. Lucy joined PhRMA in March 2012. In her role, Lucy leads the Regulatory Advocacy team with the focus on the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), as well as other regulatory policy and advocacy efforts such as pediatric drug development. Prior to joining PhRMA, Lucy spent over 12 years working for the FDA & Healthcare Practice at an international law firm, the Investigational Drug Branch at the National Cancer Institute, NIH, and the Walter Reed Army Institute of Research. Lucy earned her Ph.D. in chemistry from The Catholic University of America and completed her postdoctoral studies in molecular biology and immunology at the Walter Reed Army Institute of Research.
Jeff Allen is President and CEO of Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. During the past 20 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. For over 10 years, Jeff has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs, and research organization. As President and CEO, he leads the strategic development and implementation of Friends’ scientific, policy, research, and legislative initiatives, as well as overseeing Board governance and organizational operations. Prior to joining Friends, Jeff was an endocrinology researcher at the National Institutes of Health. His background in cancer research focused upon molecular changes associated with cancer formation as well as treatments to prevent cancer progression. Jeff received his PhD in cell and molecular biology from Georgetown University, and holds a Bachelor’s of Science in Biology from Bowling Green State University.
Elizabeth Jungman is the Director of Public Health Programs at The Pew Charitable Trusts, overseeing initiatives related to antibiotics, drug safety, and health care products. Before joining Pew, she served as a senior health policy adviser with the Senate Committee on Health, Education, Labor, and Pensions, where she played a key role in drafting and negotiating the Food and Drug Administration Safety and Innovation Act of 2012, the FDA provisions in the Pandemic All-Hazards Preparedness Reauthorization Act of 2013, and the Drug Quality and Security Act of 2013. Before moving to the Hill, Jungman was in private legal practice, where she counseled clients on a broad range of FDA regulatory matters and other health care issues related to the human pharmaceutical industry. She has an undergraduate biology degree from Harvard College, a law degree from Georgetown University, and a master’s degree in public health from Johns Hopkins University.
Jeff Francer is Senior Vice President and General Counsel of the Association for Accessible Medicines (AAM), where he leads the association’s legal and international trade advocacy. Mr. Francer served as Associate Chief Counsel of FDA from 2003-2005, where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation, manufacturing, promotion, enforcement, and legislative matters. After leaving FDA, Mr. Francer served as Associate General Counsel, US Compliance Officer, and Chief Privacy Officer of Biogen Idec, Inc. At Biogen Idec, Mr. Francer was the primary in-house counsel on FDA issues, fraud and abuse prevention, and patient privacy. Mr. Francer was also responsible for overseeing the U.S. corporate compliance program. Immediately prior to joining AAM, Mr. Francer served as Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) where he was the principal counsel to the association on issues relating to the research, development, and regulation of medicines in the US and globally. Mr. Francer received his AB in Public Policy and Economics from Brown University, his MPP from Harvard University, and his JD from the University of Virginia.