RX-360 Panel Discussions
Featured Panelist on "Risks to the Pharmaceutical Supply Chain; Can Rx-360 Help?"
Where: Informex 2012
Date: Wednesday, February 15th
Time: 7:30 a.m. - 8:45 a.m.
Room: Hall H, Room 261
Please join us for a hard-hitting panel discussion with experts from the FDA, Pew Health Group, Pfizer, SAFC, AMGEN and author Katherine Eban (Dangerous Doses).
Session Panelists:
Katherine Eban, Author, Dangerous Doses
Katherine Eban, an award-winning investigative reporter, is a contributor to Fortune Magazine. She also writes for Self, Vanity Fair and other national magazines. She has worked at Conde Nast Portfolio, the New York Times, New York, the New York Observer, and ABC News. Her work has been featured on national news programs including 60 Minutes, 20/20, Nightline and NPR. She was a 2006 Alicia Patterson fellow.
Dangerous Doses, her first book, was excerpted in Vanity Fair and was a Barnes & Noble “Discover Great New Writers” selection, a Borders Recommends pick and was named one of the Best Books of 2005 by Kirkus Reviews. It has won awards from the American Society of Journalists and Authors and the National Association of Health Care Journalists. While in progress, the book received grants from the Alfred P. Sloan Foundation and the Fund for Investigative Journalism.
Eban, a Rhodes Scholar, lives in Brooklyn with her husband and two daughters.
Michael Levy, FDA
Michael Levy is the Acting Director of the Office of Drug Security, Integrity, and Recalls in CDER's Office of Compliance at FDA. ODSIR handles issues related to supply chain security, including imports, recalls, and counterfeit drugs. From 2006 -2011, Mike was the Director of the Division of New Drugs and Labeling Compliance, which handled issues related to products that are marketed outside the FDA approval process. Before joining CDER in 2006, Mike worked since 2000 as an Associate Chief Counsel for Enforcement in the Office of Chief Counsel at FDA. Before coming to FDA, Mike was an Assistant District Attorney in the Philadelphia District Attorney’s Office. Mike graduated from Duke University School of Law, cum laude, and Amherst College, magna cum laude.
Gabrielle Cosel, Pew Health Group
Co-Author, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs
As Project Manager of the Pew Health Group’s drug safety project, Gabrielle works on federal initiatives to ensure the safety and oversight of the U.S. pharmaceutical supply chain. She was co author of Pew’s 2011 report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Prior to joining Pew, Gabrielle worked on issues of pharmaceutical safety and appropriate prescribing for national advocacy organization Community Catalyst, and in grassroots development and capacity-building with the Fund for Public Interest Research in Cambridge, Massachusetts.
Gabrielle holds a Master of Science in Human Rights from the London School of Economics and an undergraduate degree from Yale University.
Brian Johnson, Pfizer
Senior Director, Supply Chain Security
Brian Johnson is the Sr. Director Supply Chain Security at Pfizer. He is responsible for Pfizer’s corporate supply chain security program. This program was developed to combat growing supply chain threats related to product theft, product diversion, economic adulteration, and counterfeit goods.
Brian has been with Pfizer for 28 years and has held a number of leadership positions in manufacturing and quality assurance. He started in the Kalamazoo manufacturing plant and held various QA leadership positions supporting sterile manufacturing. In 2000 Brian was appointed Sr. Director Quality Assurance Global External Supply responsible for global contract manufacturing. Brian also relocated to Brussels Belgium in 2000 where he added QA responsibility for several manufacturing plants in Europe. Brian returned to New Jersey in 2003 to lead the America’s Contract Manufacturing QA organization until moving into his current role in 2010.
Brian has been actively involved in a number of external professional/trade organizations working on supply chain security initiatives including PhRMA, ISPE, PDA, and Rx360. Brian is currently on the Board of Directors for Rx360 and is co-leading the Rx360 Supply Chain Security Workgroup. He has a Bachelor of Science degree from Central Michigan University.
Tom Beil, SAFC
VP of Quality and Regulatory Affairs
Tom Beil is VP of Quality and Regulatory Affairs for Sigma-Aldrich/SAFC. Responsible for leading Sigma-Aldrich/SAFC corporate-wide quality assurance and regulatory programs, Tom re-joined Sigma-Aldrich from the Centocor division of Johnson & Johnson, where he was the Senior Director of Site Quality Assurance. Prior to working for Centocor, Tom worked as Associate Director of Quality Assurance for Wyeth. This is Tom’s second tenure with Sigma-Aldrich, having spent 13 years as Quality Systems Manager from 1986 to 1999, beginning as a Production Chemist and ending as Manager of Quality Assurance.
Tom’s wealth of knowledge and experience that is helping SAFC build upon its industry-leading regulatory compliance position. His current focus is on helping support risk mitigation, quality assurance and regulatory initiatives across SAFC’s product and service lines to enhance regulatory partnerships with customers to guide them through the challenges faced in procuring materials with the proper compliance profiles.
In addition to his in-depth knowledge of quality systems and the regulatory environment, Tom has experience in petrochemical chemistry, research biology, cell culture and purchasing, and received graduate and Masters degrees from Illinois State University, majoring in Biology with a minor in Chemistry.
Martin G. VanTrieste, AMGEN
Senior Vice President, Quality
Martin VanTrieste is the senior vice president of Quality at Amgen. He is responsible for all aspects of Quality Assurance, Quality Control, Compliance, Environment, Health and Safety along with Training at Amgen.
Prior to joining Amgen, VanTrieste was with Bayer HealthCare’s Biological Products Division as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division (now known as Hospira). While at Abbott, VanTrieste held various positions in Quality, Operations, and Research and Development. He started his career at Abbott in 1983 after
obtaining his Pharmacy degree from Temple University School of Pharmacy.
VanTrieste has been actively involved with various professional and trade organizations, including United States Pharmacopeia (USP), Pharmaceutical Quality Research Institute (PQRI), Pharmaceutical Research and Manufacturers of America (PhRMA), and AdvaMed, and he is a member of the Board of Directors of the Parenteral Drug Associations (PDA). He is the founder and first Chairman of Rx-360 and is currently on their Board of Directors. Rx-360 is a nonprofit international supply chain organization that will enhance patient safety by increasing the security and quality of all parts of the supply chain.
Moderator
Scott Watson, AMPAC Fine Chemicals
inExecutive Director, Sales and Marketing
Scott Watson has more than 25 years experience in operations, business development, sales and mergers and acquisitions. He is currently Executive Director, Sales and Marketing at AMPAC Fine Chemicals, Rancho Cordova, CA, a leading manufacturer of active pharmaceutical ingredients for the pharmaceutical and biotechnology industries.
Prior to AMPAC, Scott held sales and operational leadership positions with Southern BioSystems, Durect Corporation, DSM, and APTUIT. In addition, Scott spent 5 years working with a Private Equity firm doing leveraged transactions.
A 1983 graduate of the US Naval Academy, Scott developed his leadership skills serving as an officer aboard a US submarine. He earned his MBA from George Mason University, Fairfax, VA and is a Chartered Financial Analyst (CFA).
