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FACULTY MATERIALS

The following documents and materials are posted as background materials for the September 15, 2016 Webinar.

National Pharma Compliance Webinar: PhRMA/BIO Joint Principles on Responsible Sharing of Truthful and Non-Misleading Information about Medicines with Health Care Professionals and Payers

BACKGROUND MATERIALS

All Webinar materials will be posted prior to the event.

SPEAKER BIOS

Jeffrey Francer, MPP, JD
Vice President and Senior Counsel, PhRMA, Former Associate General Counsel and US Compliance Officer, Biogen Idec, Former Associate Chief Counsel, Food and Drug Administration, Washington, DC
Jeff Francer is Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) and serves as principal counsel to the association on issues relating to the research, development, and regulation of medicines in the US and globally.

Jeff coordinates legal advocacy before the FDA and other drug regulatory bodies on behalf of PhRMA. Mr. Francer also counsels and leads committees that draft PhRMA's Principles for Responsible Clinical Trial Data Sharing, Code on Interactions with Healthcare Professionals (the PhRMA Code), and its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.

Mr. Francer served as Associate Chief Counsel of the Food and Drug Administration from 2003-2005 where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation and emergency use of medical products, enforcement matters, legislative matters, and the agency's implementation of the Freedom of Information Act.

Immediately prior to joining PhRMA, Mr. Francer served as Associate General Counsel, U.S. 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.

Mr. Francer received his A.B. in Public Policy and Economics from Brown University, his M.P.P. from Harvard University, and his J.D. from the University of Virginia.


Thomas Hubbard, MPP
Vice President of Policy Research, The Network for Excellence in Health Innovation (NEHI), Former Executive Assistant for Economic Affairs, US Senator John Kerry, Cambridge, MA

Tom Hubbard works with NEHI's multi-sector membership of 90-plus organizations to find common ground on complex issues of innovation in health care. His responsibilities include projects on comparative effectiveness research, Real World Evidence, medication management and patient medication adherence.

Tom previously served as Vice President at the Massachusetts Technology Collaborative (MTC), as economic affairs aide to U.S. Senator John Kerry, and as Deputy Director of Development for Massachusetts Governor Michael Dukakis.

Tom is a graduate of Harvard College and the Harvard Kennedy School of Government.


Deborah M. Shelton, Esq.
Deputy General Counsel, Biotechnology Innovation Organization (BIO), Former Senior Counsel, Amgen, Former Partner, Sheppard, Mullin, Richter & Hampton LLP, Washington, DC

Deborah Shelton is Deputy General Counsel for Healthcare at the Biotechnology Innovation Organization, where she serves as lead counsel managing legal advice and services with respect to legal, policy, and regulatory healthcare matters affecting the biotechnology industry, with a focus on the regulatory activities of the FDA, in addition to CMS and NIH, and all related federal and state legislative activities.

Before joining BIO, she served as senior counsel to a leading biotech company's Global Biosimilars, Legislative and Regulatory Policy, and State Government Affairs Teams, providing wide-ranging FDA and related regulatory guidance on issues related to biopharmaceuticals. Before moving to her corporate roles, Ms. Shelton was a partner in an AmLaw 100 international law firm, where she was co-head of the Life Sciences Group.

For nearly two decades, Ms. Shelton has served clients regulated by the FDA, DEA, and other administrative agencies, providing support for products ranging from the investigational and approval stages through regulatory compliance and post-marketing requirements. She has published extensively and taught numerous continuing legal education courses on FDA-related matters.

Ms. Shelton serves as the advisory board for BNA's Pharmaceutical Law & Industry Report, and previously the editor of FDLI's Compilation of FDCA-Related Food and Drug Laws and the FDCA Statutory Supplement.


Allen Waxman, Esq.
Executive Vice President Market Access, Government Affairs & Corporate Advocacy, Eisai Inc., Chair of BIO's Board Standing Committee on Bioethics, Former General Counsel & Senior Vice President, Pfizer, New York, NY

Allen Waxman serves as Executive Vice President at Eisai Inc. In this position, he leads the Market Access team. The Market Access team manages the Company's interactions with payors and providers as well as group purchasing organizations and trade, including distributors and pharmacies. The team also manages pricing, contracting and reimbursement services and includes payor marketing. Mr. Waxman also is a member of the company's Executive Committee. In addition, Mr. Waxman chairs the Global Product Security Executive Board.

Mr. Waxman joined Eisai in April 2012 from Kaye Scholer, LLP, where he was a partner and chair of the firm's Life Sciences Group. There he focused on complex litigation, compliance and regulatory counseling, and government investigations. Prior to Kaye Scholer, Mr. Waxman held the position of General Counsel at Pfizer, where he had global responsibility for leading the Legal Division and served as a member of the company's Executive Leadership Team. Earlier in his career, Mr. Waxman was a partner at Williams & Connolly, LLP, based in Washington, D.C., where he tried civil and criminal cases and also served as national counsel in pharmaceutical litigation.


Kelly B. Freeman, PhD
Vice-President, GHC-Life Sciences, Pharmaceutical Compliance Forum (PCF) Administrator, Former Ethics and Compliance Officer, Eli Lilly and Company, Former PCF Co-Chair, Sun City Center, FL (Moderator)





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