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2014-keynote-speakers
FDA Deputy Commissioner Howard Sklamberg and
Mississippi Attorney General Jim Hood

Deputy Commissioner Sklamberg testifying before
Congress on counterfeit drugs.

PSM’s 5th annual conference was held on September 18, 2014 at the Knight Conference Center at The Newseum, 555 Pennsylvania Av., NW, Washington, D.C.

View Interchange 2014 Program (PDF)

The 2014 PSM Interchange brought together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting. Mississippi Attorney General Jim Hood shared with the sold out conference his reasons for pursuing Google about their relationships with fake online pharmacies. FDA Deputy Director Howard Sklamberg described what FDA is doing to implement the new FDA Safety and Information Act.

7:30 a.m. – 8:30 a.m. CONTINENTAL BREAKFAST AND SPONSOR TABLE BROWSING

8:30 a.m. – 8:40 a.m. WELCOME AND OPENING REMARKS

8:40 a.m. – 9:10 a.m. RESEARCH PRESENTATIONS

9:10 a.m. – 10:25 a.m. GENERAL SESSION (PANEL I)
Drug Counterfeiters Target Americans
Counterfeiters exploit weak global enforcement regimes to target unsuspecting Americans. To protect yourself and your family, learn what the global counterfeit drug situation is from policy and law enforcement experts.

  • Global Trends(Slideshare)
  • Global Trends(Youtube)
    • Moderator: Tom Kubic, President and CEO, Pharmaceutical Security Institute (PSM Board Member)

    Panelists:

    • Gillian Buckley, Program Officer, Institute of Medicine
    • Jim Dahl, Assistant Director of the FDA’s Office of Criminal Investigations (OCI) (retired) (PSM Board Member)
    • Samantha Gompel, IPM Communications Manager at the World Customs Organization
    • Philip Walsky, Acting Director, Office of Criminal Investigations, Food and Drug Administration

    10:25 a.m. – 10:40 a.m. REFRESHMENT BREAK AND SPONSOR TABLE BROWSING

    10:40 a.m. – 11.55 a.m. GENERAL SESSION (PANEL II)
    Patient Safety and Criminal Prosecutions in the U.S.
    Learn about recent cases involving counterfeit, misbranded, unapproved, and adulterated drugs and devices, the doctors who purchased them, and the sellers who market and distribute them. Federal prosecutors will discuss cases and explain the risks to American patients caused by these criminals.

  • Criminal Prosecutions: Patient Safety (Slideshare)
  • Criminal Prosecutions: Patient Safety (Youtube)
    • Moderator: Linda I. Marks, Senior Litigation Counsel, Consumer Protection Branch, U.S. Department of Justice

    Panelists:

    • Lindsay A. Kelly, Assistant U.S. Attorney Criminal Division, Cybercrime Unit, Eastern District of Virginia, U.S. Department of Justice
    • Jaime A. Peña, Assistant U.S. Attorney/Senior Litigation Chief, Criminal Division, Colorado District, U.S. Department of Justice

    11:55 a.m. – 12:55 p.m. NETWORKING LUNCHEON

    12:55 p.m. – 1:05 p.m. PRE-PANEL PRESENTATION

    1:05 p.m. – 2:20 p.m. GENERAL SESSION (PANEL III)
    The Impacts of Fake Online Pharmacies on Patient Safety
    Law enforcement, American pharmacists and patient safety advocates will discuss recently discovered threats to patient safety from online pharmacies.

  • The Impacts of Fake Online Pharmacies on Patient Safety (Slideshare)
  • The Impacts of Fake Online Pharmacies on Patient Safety (Youtube)
    • Moderator: Special Agent Daniel Burke, Senior Operations Manager in Charge of Cybercrime Investigations for the Office of Criminal Investigations, U.S. Food and Drug Administration

    Panelists:

    2:20 p.m. – 2:50 p.m. GENERAL SESSION (PANEL IV)
    How the Black Market Impacts Patients
    Public health experts discuss the impact on patients from counterfeit, non-FDA approved drugs in the U.S. and the world.

  • How the Black Market Impacts Patients (Slideshare)
  • How the Black Market Impacts Patients (Youtube)
    • Moderator: Jim Dahl, Board Member, Partnership for Safe Medicines; Assistant Director, Office of Criminal Investigations, U.S. Food and Drug Administration (retired)

    Panelists:

    • Kimberly New, National Association of Drug Diversion Investigators
    • Gaurvika Nayyar, Program Manager for Asia at United States Pharmacopeia’s Promoting the Quality of Medicines Program
    • Eric Sampson, Senior Science Advisor, CDC Foundation

    2:50 p.m. – 3:05 p.m. REFRESHMENT BREAK AND SPONSOR TABLE BROWSING

    3:05 p.m. – 3:35 p.m. GENERAL SESSION

    KEYNOTE SPEAKER

    3:35 p.m. – 4:15 p.m. GENERAL SESSION

    KEYNOTE SPEAKER

    • Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, Food and Drug Administration
    • Introduced by Scott LaGanga, Executive Director, Partnership for Safe Medicines; Vice President, Public Affairs – Advocacy, Pharmaceutical Research and Manufacturers of America
    • FDA Deputy Commissioner Howard Sklamberg (Youtube)

    4:15 p.m. – 4:17 p.m. CLOSING REMARKS
    Marv Shepherd, PhD, Director, The Center for Pharmacoeconomic Studies, College of Pharmacy, The University of Texas, Austin; Pharmacy Administration Division at the University of Texas at Austin’s College of Pharmacy

    Closing Remarks (Youtube)

    4:17 p.m. – 5:15 p.m. NETWORKING RECEPTION