FOOD, DRUG & COSMETIC LAW SECTION MEETING
Thursday, January 17, 2019
1:00 PM - 6:00 PM
Total MCLE Credits: 5.50 (Professional Practice 5.50)
Nassau West, 2nd Floor
#nysba19
HOT TOPICS IN FDA LAW
1:00 p.m. – 1:10 p.m. Welcoming Remarks
Brian J. Malkin, Esq., Section Chair
Arent Fox LLP
Washington, DC
1:10 p.m. – 2:25 p.m. Overview of Biologic Policy Initiatives (1.5 Credits in Areas of Professional Practice)
• What’s new with specialty medications? (an examination of the biologics/biosimilars industry)
• Update on gene therapy
• Approvals in Europe/UK
• Payment models in the US and access to therapy
• Obstacles for future development of novel gene therapy products, including scientific, regulatory, and financial
• Wholesaler’s perspective on their role with the supply chain including the payer community, as well as biological product supply chair evolution
Panelists:
Ronald W. Lanton, III, Esq. (Panel Chair)
Frier Levitt Government Affairs, LLC
Pine Brook, NJ
Sheila M. Arquette, R.PH.
Executive Director
National Association of Specialty Pharmacy
Washington, D.C.
JP Ahluwalia, M.D., M.PH.
FDA Center for Biologics Evaluation & Research
Silver Spring, MD
Kelly A. Ryan
Senior Director
State Advocacy PhRMA
Albany, NY
Timothy Ward
President
Hercules Pharmaceuticals, Inc.
Port Washington, NY
2:25 p.m. – 2:30 p.m. Refreshment Break
2:30 p.m. – 3:45 p.m. Medical Device Hot Topics: New Regulatory Models in Lab Developed Tests and Digital Health (1.5 Credits in Areas of Professional Practice)
• Insights on FDA’s 2018 “technical assistance” to Congress for LDT regulation
• New York State laboratory test oversight and FDA third party review framework
• FDA’s evolving regulatory approach to digital health technologies
• Intersecting issues in diagnostics and digital health
Panelists:
Bethany J. Hills, Esq. (Panel Chair)
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
New York, NY
Aaron Josephson, M.S.
ML Strategies, LLC
Washington, DC
Lesley Maloney
PharmD.Roche
Washington, DC
Howard Zucker,. M.D., JD
Commissioner
New York State Department of Health
Albany, NY
3:45 p.m. – 3:50 p.m. Refreshment Break
3:50 p.m. – 4:15 p.m. Blockchain in Healthcare (0.5 Credits in Areas of Professional Practice)
How blockchain can be used to comply with the Drug Supply Chain Security Act
Moderator:
Larissa Bergin, Esq.
Jones Day
Washington, DC
Panelists:
Combiz Richard Abdolrahimi, Esq.
Deloitte & Touche LLP
New York, NY
Colleen M. Heisey, Esq.
Jones Day
Washington, DC
4:15 p.m. – 4:40 p.m. GDPR Compliance: What You Need to Know (0.5 Credits in Areas of Professional Practice)
Amy B. Goldsmith (invited)
Tarter Krinsky & Drogin LLP, New York, NY
4:40 p.m. – 5:05 p.m. Helsinn v. Teva and Secret Prior Art (0.5 Credits in Areas of Professional Practice)
When are secret sales and offers for sale prior art? How confidential agreements with third parties may invalidate your patents
Speaker:
Janet B. Linn, Esq.
Tarter Krinsky & Drogin LLP
New York, NY
5:05 p.m. – 5:10 p.m. Refreshment Break
5:10 p.m. – 5:35 p.m. Animal Testing Legislation (0.5 Credits in Areas of Professional Practice)
Moderator:
Thomas A. Cohn, Esq.
Director and Senior Counsel
Avon USA
New York, NY
Speaker:
Sharon A. Blinkoff, Esq.
Lock Lorde LLP
New York, NY
5:35 p.m. – 6:00 p.m. Talcum Powder Products Litigation (0.5 Credits in Areas of Professional Practice)
Moderator:
Jennifer L. Orendi, Esq.
Dalimonte Rueb LLP
Washington, DC
Speaker:
Victoria J. Maniatis, Esq.
Sanders Phillips Grossman, LLC
Garden City, NY
