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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)
• 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


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!