Commissioner Gottlieb’s FDA
His First Year and a Look Ahead

Thursday, Aug. 16, 2018 · 1:30 p.m. - 3:00 p.m. EDT

What we know about the Gottlieb FDA: That lots is getting done.

What we need to know: What will he do next?

Who owns the crystal ball: Wayne Pines, long-time FDA spokesman and now a sought-after consultant, fronting a panel of FDA-watchers and gurus (TBA).

What you need to know: Where to sign up.

Mark your calendar for Thursday, Aug. 16, when Pines and a team of experts provide insights on the Gottlieb era. For 90 minutes, this team will lay out the key initiatives to date plus what to expect down the road. Here’s just a taste of what you’ll discover:

  • Drug pricing and marketing: What the Commissioner is trying to change, and how he’s going about making it happen
  • Drug and device approvals: How the process has changed, how it could change in the future
  • The opioid crisis: Comr. Gottlieb’s strategy to deal with it
  • Enforcement: Gottlieb priorities and how they’ll affect you
  • The Gottlieb agenda: Now – and down the road
  • And MUCH more!

In only his first year, Gottlieb and the FDA have taken actions intended to lower drug prices and alter the economics of healthcare delivery. Every drug and device maker, not to mention clinical trial operators and other FDA-regulated players, need to know what the Commissioner still has in store. Here’s how to find out … from folks who know.

Register now.

Who Will Benefit

Every FDA-regulated health sciences organization needs to attend this timely Webinar, particularly those with active drug/device development projects under way including:

  • C-Suite
  • Legal affairs
  • Regulatory/compliance
  • Quality control
  • Research/development
  • Marketing/sales
  • Strategic planning

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Meet Your Presenters

Wayne Pines

President of Health Care
APCO Worldwide

Wayne Pines was the FDA’s chief media spokesman for seven years. He has authored or edited a dozen books about crisis communication and the FDA and was named the FDA Alumnus of the Year in 2004. He is a director and current vice president of the Alliance for a Stronger FDA, a coalition of 200 organizations that seeks more appropriated funding for the agency. His books include the FDA Advertising and Promotion Manual; How to Work With the FDA; Making Your Case to the FDA: A Practical Guide to Food and Drug Law and Regulation; and Communicating in a Health Care Crisis. He now manages crisis communications for FDA-regulated clients as a senior director with Apco Worldwide.

John F. Kamp, JD, PhD

Washington Counsel
Coalition for Healthcare Communication

Dr. John F. Kamp has been involved with FDA policies for several decades. He deals with policies involving drug development and approvals, with an emphasis on the promotion and marketing of medical products. Dr. Kamp is Washington Counsel for the Coalition for Healthcare Communication, a drug marketing group with offices in New York City and Washington, DC. Kamp is well-known as an advocate for First Amendment rights of individuals and corporations, as well as for his understanding of communication and drug/device issues at the FDA.  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.

Kevin Madagan

Reed Smith

Kevin is a health care and FDA regulatory attorney and member of the Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about health care and FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. His clients include suppliers, manufacturers; repackagers; wholesale and private label distributors; pharmacies (503A, 503B, nuclear); and health care providers. Kevin specializes in providing legal and strategic advice regarding advertising and promotion, FDA enforcement, and supply chain security (e.g., global product sourcing and distribution, manufacturing and inspections, compounding, recalls, and import/export issues). He is a sought-after counselor for clients looking for long-term, multi-year support for their legal departments. Kevin also regularly advises strategic owners, private equity funds, underwriters and other public and privately-held businesses seeking specialized support in connection with health care financing and securities transactions, and domestic and international mergers and acquisitions. Clients greatly appreciate his added value to transactions from both a legal and business perspective.

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