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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

Register for the 2019 Annual Meeting Here or Download The Registration Form Here.

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

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.

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

Timothy Ward
President
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.

    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 
    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.

    Speaker:
    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)
    Moderator:
    Thomas A. Cohn, Esq.

    Director and Senior Counsel
    New Avon LLC
    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, 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

Food, Drug & Cosmetic Law Section Reception 

Thursday, January 17, 2019

6:30 p.m. - 7:30 p.m.

Arent Fox LLP
1301 Avenue of the Americas, 42nd Floor
New York, NY 10019

To Register: am2019fdcreception/

For further information, contact Lisa Bataille (lbataille@nysba.org)
(518) 487-5680


Welcome to the Food, Drug and Cosmetic Law Section 

More than 70 years ago, the Food, Drug and Cosmetic Law Section became one of the first sections to be formally organized by the New York State Bar Association. During the ensuing years, this group - the first organization in the country to be composed of in-house, law firm, government and trade association attorneys practicing food and drug law - has been a focal point for practitioners in this specialty. We welcome you to our expanded website! 


Why Join the NYSBA Food, Drug and Cosmetic Law Section?

Want to improve your professional skills and knowledge? It's easy when you join the Food, Drug and Cosmetic Law Section. Whether it's through meetings, good old-fashioned networking, participating in MCLE programs, professional resources, or legislation, Section activity is the key to keeping you informed on the latest developments in the food, drug and cosmetic law field. The Section also acts as a resource for business, civic and governmental groups.

View Section's Brochure for Membership Benefits

Join Online Now!

To join this Section by phone, call the Member Resource Center at (800) 582-2452 during business hours.

How much are Section dues? Very affordable with NYSBA membership. View the price list here (scroll down for Section dues). 

Are you interested in volunteering for a Section Committee?  Please email your staff liaison to indicate the committees you wish to join.  Thank you!