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
- Introduction - Scott LaGanga, Executive Director Partnership for Safe Medicines; Senior Vice President, Public Affairs - Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
- Welcome to the 2014 Interchange (Slideshare)
- Welcome to the 2014 Interchange (Youtube)
8:40 a.m. - 9:10 a.m. RESEARCH PRESENTATIONS
- New USP Guidelines for Drug Chain Distribution
Dr. Marv Shepherd, Director, Center for Pharmacoeconomic Studies
College of Pharmacy, University of Texas-Austin (PSM Board Member); Chairman of the Pharmacy Administration Division at the University of Texas at Austin’s College of Pharmacy - United States Pharmacopeia Good Distribution Practices Update (Slideshare)
- United States Pharmacopeia Good Distribution Practices Update(Youtube)
- After Counterfeit Avastin - What have we learned and what can be done?
Presented by Tim K. Mackey, MAS, PhD, Assistant Professor, UCSD School of Medicine
Associate Director, MAS Program in Health Policy and Law
Director, Global Health Policy Institute - After Avastin (Slideshare)
- After Avastin (Youtube)
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
- Bejon Misra, Partnership for Safe Medicines India
- Partnership for Safe Medicines India (Slideshare)
- Partnership for Safe Medicines India (Youtube)
- Madame LiHong Gu, Partnership for Safe Medicines China
- Partnership for Safe Medicines China (Slideshare)
- Partnership for Safe Medicines China (Youtube)
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:
- Libby Baney, Executive Director, Alliance for Safe Online Pharmacies
The Impacts of Fake Online Pharmacies on Patient Safety (Slideshare) - Todd Brown, Executive Director, Massachusetts Independent Pharmacists Association
Non-FDA Approved Foreign Drugs are being provided to vulnerable patients in Massachusetts (Slideshare) - Kenneth "Mac" McCall, III, President, Maine Pharmacy Association
State of Maine 2013 (Slideshare)
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
- Jim Hood, Attorney General, State of Mississippi
- Introduced by Thomas Kubic, Board Member, President & CEO Pharmaceutical Security Institute
- Mississippi Attorney General Jim Hood (Youtube)
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 Pharmacy4:17 p.m. - 5:15 p.m. NETWORKING RECEPTION