Jan 26th 2017 |
Time: 2:30 PM - 3:30 PM EST

About Our Speakers


  • Outcome line Wayne L. Pines

    Wayne L. Pines

    President, Healthcare – APCO Worldwide

    Wayne L. Pines serves as President of Healthcare and Regulatory Services at APCO Worldwide in Washington, D.C., and also is a member of APCO’s International Advisory Council. Mr. Pines provides strategic communications counsel to pharmaceutical, medical device and other companies facing crises or media, legislative, regulatory or marketing challenges. He has helped companies and organizations handle many high visibility health-related issues. He also conducts training for senior management on media, medical advertising and crisis communications. Mr. Pines served 10 years in senior positions at the Food and Drug Administration (FDA). He was FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief media spokesman for the FDA for seven years and also was the founding editor of the award-winning FDA Consumer magazine. While at FDA he won multiple awards, and in 2004, he was named the FDA’s Alumnus of the Year. Mr. Pines also has served as Executive Vice President of an international public relations firm; as a reporter and city editor of a daily newspaper; and as chairman of a market research firm. Mr. Pines has published 13 books on crisis management, the FDA and public affairs/media relations, including A Practical Guide to FDA’s Food and Drug Law and Regulation, now entering its sixth edition, and A Century of Consumer Protection, which commemorated FDA’s first century. He is a director and former chairman of the board of the MedStar Health Research Institute, which oversees research at ten hospitals in the Washington-Baltimore area, and was founding president of the Alliance for a Stronger FDA, a coalition of 200 organizations seeking more appropriated funding for FDA. He was a founding director of the FDA Alumni Association and is now its communications chair. He has served on the boards of a number of biopharmaceutical companies and non-profit organizations, including the regional board of the Anti-Defamation League.
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  • Outcome line Kellie B. Combs

    Kellie B. Combs

    PARTNER at Ropes & Gray

    Kellie Combs provides legal and strategic advice to pharmaceutical, biotechnology, and medical device manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Recognized as a “Rising Star” in Food and Drug Law by Super Lawyers, Kellie has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advises clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, Kellie has performed regulatory due diligence in connection with transactions involving life sciences clients and has advised on a number of government investigations of FDA-regulated companies.
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  • Outcome line Courtney Piron

    Courtney Piron

    Executive Director and Global Health Care Practice Lead – APCO Worldwide

    Courtney Piron, executive director, is APCO Worldwide's global health care practice lead based in Washington, D.C. She specializes in advising clients on health policy issues. Ms. Piron has more than 15 years experience in health policy, government relations and crisis communication. Ms. Piron has extensive background in policy development and strategic communication for the health care sector. Prior to joining APCO, Ms. Piron served as a director in the economic & policy research group, a division of corporate affairs at Pfizer Inc. At Pfizer, Ms. Piron’s primary areas of responsibility included health system reform, policy communication, the industry’s economic contribution to states and U.S. regulatory policy issues. Ms. Piron has extensive knowledge about pharmaceutical and biotech policy issues, health care reform, Medicare coverage and reimbursement, disease management, and Food and Drug Administration regulatory policy. She was a frequent speaker on public policy issues facing the pharmaceutical industry and served as a source to the media on issues related to the field. Before joining Pfizer in 2001, Ms. Piron was director of health policy for Wyeth. During her five-year tenure she was responsible for analyzing federal health policy related to the pharmaceutical business and developing policy positions. Ms. Piron previously worked as a communication consultant with Burson-Marsteller in its lobbying and crisis management departments in both Washington, D.C., and New York. Ms. Piron also worked on Capitol Hill and in the U.S. Food and Drug Administration’s Office of the Commissioner. Ms. Piron holds a Bachelor of Arts in Political Science from Dickinson College and a Master of Public Administration in Public Policy from the University of Pittsburgh.
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  • Outcome line John F. Kamp, JD, PhD

    John F. Kamp

    Executive Director, Coalition for Healthcare Communication

    Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a drug marketing group with offices in New York City and Washington, DC. He is also of counsel with the law firm Wiley Rein LLP, and is a well-known advocate for First Amendment rights of individuals and corporations. His professional experience includes 10 years with the Washington office of the American Association of Advertising Agencies and nearly a decade in public policy positions at the Federal Communications Commission. Before moving to Washington, Dr. Kamp taught journalism at the University of Iowa and at Tulsa University. Dr. Kamp is a frequent speaker at industry meetings on ethical, legal, and political issues surrounding drug marketing, and is recognized as an authority on these issues by the print and broadcast press. He serves on the public advisory committee of the American Academy of Family Physicians and education advisory boards of Wyeth and Genentech. He is on the editorial boards of the Rx Compliance Report, Medical Marketing and Media, and the FDA Advertising and Promotion Manual. Dr. Kamp is co-author (with Wayne Pines) of 3 books on compliance with FDA policy published by FDA News, including DTC Advertising and Promotion: The Changing Environment, published in January 2006. He is also a public member of the National Advertising Review Board, the self-regulation body of the advertising industry run by the National Better Business Bureau. Dr. Kamp earned his bachelors degree at the University of Notre Dame, his doctorate from the University of Iowa and his juris doctorate at the University of Tulsa. Disclosure: John Kamp is Executive Director of the Coalition for Healthcare Communication, a policy group with membership from health marketing trade associations and companies. Kamp has provided regulatory and strategic consulting and/or regulatory training for several marketing companies and drug and device companies. Kamp owns stock in companies in the drug and device industries, including Johnson & Johnson, Pfizer, Wyeth and Amylin, and in related communication and media companies, including McGraw-Hill, Omnicom and WPP Group. Kamp also serves as “of counsel” at Wiley, Rein, LLP, in Washington, DC. Mr. Kamp is not an expert in the practice of medicine and does not make therapeutic recommendations for any specific drug, device or procedure. Thus, any discussion of medical practice, including "off label” use, will be only in the context of public policy, industry practice, and/or government regulation.

About this Webinar

The Trump Administration has promised major changes to how healthcare is financed and regulated. The Food and Drug administration is responsible for regulating medical products and manufacturer communication, and will have new leadership along with a general pledge by the incoming Administration to cut regulation. FDA is not directly involved in the price of pharmaceuticals. But ironically one of the key issues that both Donald Trump and Hillary Clinton agreed on during the campaign was the need to control drug pricing. This webinar will examine how FDA will fare under the Trump Administration; what changes to expect; and how drug pricing and off label communication by manufacturers will be handled in the Trump Administration.

Agenda

2:30-2:35: Indegene Introduction

2:35-2:40: Wayne Pines- Introduction & Overview of Pharmaceutical Issues in Transitioning to Trump's Presidency

2:40-2:55: John Kamp- FDA in the Trump Administration – Issues and Impact on Companies

2.55-3.05: Courtney Piron- Critical Issues in Drug Pricing

3.05-3.15: Kellie Combs: Critical Issues in Off Label Communication

3.15-3.30: Panel Discussion and Audience Questions

Any Queries?

Kushal Byregowda

kushal.byregowda@Indegene.com
www.indegene.com

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