With the new Communications with Payors and Consistent with Labeling draft guidance documents, as well as the proliferation of big data, real world evidence has become increasingly prominent—relied upon by payors and potentially by health care professionals and other stakeholders. However, real world evidence is not classical randomized controlled clinical trial data. How should we evaluate real world evidence? What are the potential permitted uses of real world evidence? How strong should the data be before using it in a promotional context or as the basis for a value based contract? What guidelines should apply to manufacturer promotional communications of real world evidence? This webinar will explore the use of real world evidence and provide a framework through which to view the appropriate use of the evidence.
Joy J. Liu, VP, Commercial and Regulatory Legal, Vertex Pharmaceuticals, Inc., and Secretary and General Counsel, FDLI Board of Directors
Meredith Manning, Partner, Hogan Lovells US LLP
Kirke Weaver, Vice President, Office of General Counsel, Merck & Co., Inc.
Moderated by Michael Labson, Partner, Covington & Burling LLP
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Joy Liu leads the Commercial and Regulatory legal team at Vertex Pharmaceuticals. Prior to joining Vertex, Joy was a partner at Ropes & Gray and advised drug, biotech, and device companies on a broad range of FDA regulatory matters. Joy has significant experience working on advertising and promotion compliance matters, Hatch-Waxman exclusivity issues, and regulatory risk management. In private practice, she also worked on a number of government investigations involving allegations of off-label promotion, recalls, and safety reporting and led regulatory due diligence teams for licensing deals, mergers and acquisitions, and securities offerings.
Meredith Manning is a partner in the Washington, DC office of Hogan Lovells, and is a member of the firm’s Food, Drug, Devices & Agriculture Group. She focuses her practice on regulatory and policy issues affecting clients in the pharmaceutical and biotechnology industries, with an emphasis on Food and Drug Administration (FDA) enforcement matters. Ms. Manning has substantial experience in government enforcement of a variety of statutes, particularly the Federal Food, Drug and Cosmetic Act. Previously, she served as assistant United States attorney, Civil Division for the US Attorney’s Office in Washington, DC Prior to joining the US Attorney’s Office, Ms. Manning was Associate Chief Counsel in the Office of the General Counsel at FDA where she handled a variety of litigation and litigation-related counseling issues. Among cases assigned to Ms. Manning at the USAttorney’s Office and FDA were those related to approval of orphan drugs, biological products and generic drugs, as well as FDA’s policy on genetically modified food and the confidentiality of scientific data submitted to FDA. At FDA, she worked closely with agency officials in preparing enforcement cases for referral to the US Department of Justice, in creating administrative records to support the agency’s actions, and in advising policy makers on a variety of litigation-related issues. Ms. Manning received a Masters in Public Health from the UCLA School of Public Health and her JD from the University of Minnesota Law School.
Kirke Weaver, Vice President, Office of General Counsel, leads the US Regulatory Legal Group at Merck, which provides regulatory legal support to Merck’s research laboratories, the US marketing and sales organizations, and global commercial franchises. Kirke joined Merck in 2003, and has held numerous positions within the Office of General Counsel. He was part of the legal team with responsibility for the Vioxx litigation, has provided regulatory legal support for more than a dozen Merck products, and supported the US compliance department. Kirke has also worked in the commercial organization, heading Merck’s Customer Alliances & Innovation group to commercialize new tools and technologies to support medication adherence. Kirke is a graduate of the College of William & Mary and the Yale Law School.
Michael S. Labson is a partner in the Food, Drug and Device practice at Covington & Burling LLP. He provides strategic advice to pharmaceutical and biotechnology clients in dealing with FDA and other agencies. He has litigated life sciences cases, and works actively on transactional and legislative matters. Mike graduated magna cum laudefrom Harvard College, and magna cum laude from Harvard Law School, where he was an officer of the Harvard Law Review. He clerked for the Honorable David M. Ebel on the US Court of Appeals for the Tenth Circuit. Mike has been recognized in Chambers USA – America’s Leading Business Lawyers, Washington DC Super Lawyer, LMG Life Sciences, and PLC Life Sciences, Which Lawyer?, and Best Lawyers in America as a leading life sciences regulatory practitioner. He is a Fellow of the American Bar Association, and a member of Covington’s Management Committee.