Food, Drug & Cosmetic Law Section Meeting

Thursday, January 17, 2019
1:00 PM - 6:15 PM
Total MCLE Credits: 5.50 (Professional Practice 5.50)
Gibson Room


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)
• 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

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.

Mary Jo Carden
VP of Government and Pharmacy Affairs
Academy of Managed Care Pharmacy
Washington, D.C.

Timothy Ward
Hercules Pharmaceuticals, Inc. 
Port Washington, NY

Kelly A. Ryan
Senior Director
State Advocacy PhRMA
Albany, NY

2:25 p.m. – 2:30 p.m. Refreshment Break

2:30 p.m. – 3:45 p.m. Hot Topics in Devices: LDT and Digital Health (1.5 Credits in Areas of Professional Practice)

  • Insights on FDA’s 2018 “technical assistance” to Congress on the Diagnostic Accuracy and Innovation Act (DAIA) and the new Verifying Accurate Leading-edge IVCT Development (VALID) Act
  • How New York State leads in test oversight
  • FDA’s evolving approach to digital health technologies, including recent announcements about the Pre-Cert progr
  • Risks and opportunities of the FDA’s proposed regulatory model.

    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
    Washington, DC

    Howard Zucker, M.D., JD
    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

    Larissa Bergin, Esq.

    Jones Day
    Washington, DC

    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 
    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)

  • The question before the US Supreme Court in Helsinn v. Teva - did the America Invents Act change the law on secret sales?  
    • Issues for pharmaceutical companies to consider when structuring and publicizing agreements with third parties to avoid their invalidating patents.

    Janet B. Linn, Esq.

    Tarter Krinsky & Drogin LLP
    New York, NY

    Bruce S. Weintraub, Esq. 
    Pfizer Inc. 
    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)
    Thomas A. Cohn, Esq.

    Director and Senior Counsel
    New Avon LLC
    New York, NY

    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)
    Jennifer L. Orendi, Esq.

    Dalimonte Rueb LLP 
    Washington, DC

    Victoria J. Maniatis, Esq.
    Sanders Phillips Grossman, LLCGarden City, NY

6:00 p.m. – 6:15 p.m.           Food Drug & Cosmetic Law Section Annual Meeting, Business Meeting and Strategic Planning

6:30 p.m. – 7:30 p.m.           Off-Site Reception

                                                Arent Fox LLP (next door to the Hilton)
                                                1301 Avenue of the Americas, 42nd Floor
                                                 New York, NY 10019