Securing the Future: Patient Safety and Supply Chain Integrity in Pharma
- Engage with leading experts discussing breakthrough innovations and challenges in pharmaceutical supply chain integrity.
- Hear about topics covering the latest in AI technology, regulatory updates, and global supply chain strategies.
- Network with industry leaders.
Thursday and Friday, September 11 – 12
Le Meridien, Washington, D.C.
TOPICS TO LOOK FORWARD TO
Day One: Thursday, September 11
| Time & Speaker | Topic |
|---|---|
| 9:00 a.m.
Jim Fries, CEO, Rx-360 |
Welcome Breakfast |
| 9:30 a.m.
Geoffrey Potter and Tim Waters, Partners, Patterson Belknap Webb & Tyler LLP |
Counterfeiting and Diversion of the Pharma Supply Chain |
| 10:30 a.m.
Leigh Verbois, Former Director, Office of Drug Security, Integrity, and Response, FDA |
DSCSA, National Security and Partnerships in Global Health |
| 12:30 p.m.
Ben Mills, Senior Director, Audit Operations & Quality, Rx-360 |
Panel Session on Pharmaceutical Quality and Patient Safety, featuring:
Rebecca Alcantara, Director, Global Supplier Quality and Compliance, Curia Kathleen E. Silva, Ph.D., Head of Quality Services, Life Science | Quality and Regulatory Management, MilliporeSigma, A business of Merck KGaA, Darmstadt, Germany Rob Welsh, Head of External Engagement, Avantor Biopharma Production |
| 1:30 p.m.
Ilisa Bernstein, President, Bernstein Rx Solutions |
The Link Between Pharma Quality and the Pharmacy |
| 2:30 p.m.
Ryan Kelly, Senior Director, Supply Chain Security & Brand Protection, Rx-360 |
APEC Toolkit |
| 3:15 p.m.
Steve Nicoll, Director, Business Excellence Coach, Lean Orange |
Efficiencies, Quality, & Supply Chain Integrity in Pharmaceutical Manufacturing |
| 6:00 p.m.
Scott Gottlieb, Physician, Former FDA Commissioner, New York Times |
Healthcare Innovation, Supply Chain Integrity, and the Worldwide Economy |
Day Two: Friday, September 12
| Time & Speaker | Topic |
|---|---|
| 9:00 a.m.
Arnon Lopes, Head of Customer Experience, Pharma & Healthcare, JAS Worldwide |
Pharma Distribution in Latin America |
| 9:30 a.m.
Karla Longo Gouveia, Associate Director, Supplier Quality Management, Merck Group |
SCARS – Supplier Correct Action Report Programs: A Practical Guide by Rx-360’s Latin America Working Group |
| 10:15 a.m.
Sufi Noor, Head of Marketing Operations, Rx-360 and Joe Schwendt, Founder & CEO, Runway Hero |
“Supplier Assessment Questionnaire”, a Resource Developed by the Rx-360 Supplier Quality Working Group |
| 11:00 a.m.
Jim Fries, CEO, Rx-360 |
Fireside Interview |
Stay tuned for additional speaker updates
Learn from Experts and Innovators
Scott Gottlieb
Physician; Former Commissioner, Food and Drug Administration (2017-2019); New York Times Best-Selling Author
Geoffrey Potter
Partner, Patterson Belknap Webb & Tyler LLP
Tim Waters
Partner, Patterson Belknap Webb & Tyler LLP
Ilisa Bernstein
President, Bernstein Rx Solutions
Leigh Verbois, Ph.D.
Former Director, Office of Drug Security, Integrity, and Response, FDA
Steve Nicoll
Director, Business Excellence Coach, The Lean Orange
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Arnon Lopes
Head of Customer Experience, Pharma & Healthcare, JAS Worldwide
Karla Longo Gouveia
Associate Director, Supplier Quality Management, Merck
This is a Can’t Miss Event
Deep Dive Keynotes: Engage with leading experts discussing breakthrough innovations and challenges in pharmaceutical supply chain integrity.
General Sessions and Keynote Speakers: Topics covering the latest in AI technology, regulatory updates, and global supply chain strategies.
Celebrate Innovation: Network with industry leaders during the Thursday Reception.
Spotlight on Excellence: Meet Our Keynote Speakers
Scott Gottlieb
Physician; Former Commissioner, Food and Drug Administration (2017-2019); New York Times Best-Selling Author
Scott Gottlieb, MD, is a physician and served as the 23rd Commissioner of the U.S. Food and Drug
Administration. He is currently a senior fellow at the American Enterprise Institute for Public Policy Research and a partner at the venture capital firm New Enterprise Associates.
Under his leadership, the FDA advanced new frameworks for the modern oversight of gene therapies, cell-based medicines, and digital health devices. The agency implemented new reforms to standardize drug reviews and made historic improvements in post-market data collection and the use of real-world evidence. He promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises. The agency’s prolific advances in new policy distinguished his tenure as FDA Commissioner, along with a record-setting number of approvals for novel drugs, medical devices, and generic medicines.
Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. He is the author of the New York Times bestselling book “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic” and is a regular contributor to CNBC and CBS News’ Face the Nation. Dr. Gottlieb serves on the board of directors of publicly traded companies Pfizer, Inc., Illumina, Inc., and TempusAI.
Dr. Gottlieb is an elected member of the National Academy of Medicine and completed medical school and a residency in internal medicine at the Mount Sinai School of Medicine, where he currently serves on the executive committee of the Mount Sinai Health System’s board of directors and co-chairs the board’s education committee. He graduated from Wesleyan University, where he majored in economics, and currently serves on the university’s board of directors. Dr. Gottlieb lives in Connecticut with his wife and three
daughters.
Geoffrey Potter
Partner, Patterson Belknap Webb & Tyler LLP
Geoffrey Potter is a Partner and Chair of Patterson Belknap’s Anti-Counterfeiting Practice and Brand Protection team. A highly-experienced trial lawyer, Mr. Potter litigates counterfeiting and product diversion cases on behalf of major corporations in multiple industries worldwide. These cases involve counterfeit products with the potential to cause serious injury or death, including counterfeit medical devices, pharmaceuticals, nutritional supplements, beverages and other consumer, industrial and electronic products.
In the anti-counterfeiting arena, he has successfully sued and executed seizure orders globally against hundreds of individuals and businesses that have manufactured and distributed counterfeits. Mr. Potter also counsels clients on risk reduction solutions and best practices for avoiding counterfeiting problems. He advises on proactive methods to secure products and packaging against counterfeiters. Outside of litigation, Mr. Potter counsels clients on integrated risk reduction solutions and best practices for avoiding counterfeiting problems. He advises on proactive methods to secure products and packaging against counterfeiters and on the development of programs to guard and monitor distribution channels.
Chambers USA named Mr. Potter a Leading Practitioner for Intellectual Property Litigation for his work in “high-stakes brand protection disputes.” The guide calls him a “noted authority on anti-counterfeiting issues” and clients described him as “one of the most brilliant, innovative, creative attorneys I have had the pleasure of working with” as well as “one of the smartest, most strategic thinking, aggressive lawyers… in IP.” Cited as an authority on anti-counterfeiting, his recent quotes have been published in The New York Times, Life Sciences Intellectual Property Review, IPWatchdog, The Wall Street Journal, and Fierce Pharma. Mr. Potter received his B.A. from Cornell University, and J.D. from New York University School of Law.