Why Attend

Preliminary Agenda

 

CLE

Wednesday, October 13

10:55 – 11:10 AM
Technology and Connection Support Session

11:15 – 11:30 AM
FDLI Welcome and Introduction  

11:30 AM – 12:15 PM
Keynote Address
Lauren K. Roth, Associate Commissioner for Policy, Office of the Commissioner, FDA (Invited)

12:30  – 1:15 PM
Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools
Thomas Miller, Sr. Counsel, Life Science Lead, Nixon GWILT Law

1:30 – 2:30 PM
Concurrent Breakouts

  • Best Practices for Globalizing Promotional Review
  • Drug and Device Uses of Digital Health Tools: Considerations for Advertising and Promotion
    Moderated by Eva Temkin, Partner, King & Spalding LLP

2:30 – 3:00 PM
Break

 

3:00 – 4:00 PM
Planning for Launch: Navigating the Office of Prescription Drug Promotion’s Core Launch Review Process
Bryant M. Godfrey
, Partner, Foley Hoag LLP

 

4:15 – 5:30 PM
Inter-Agency Enforcement Updates and Priorities
John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
Mark Carlisle Levy, Partner, Eckert Seamans Cherin & Mellott, LLC 

Thursday, October 14

11:00 – 11:15 AM
Technology and Connection Support Session

11:20 – 11:30 PM
FDLI Welcome and Introduction

11:30 AM – 12:00 PM
Keynote Address
RADM Denise Hinton, Chief Scientist, Office of the Commissioner, FDA (Invited)

12:15 –1:15 PM
Clinical Trial Recruitment and Preapproval Communications for Underrepresented Groups and Underserved Disease States

 

1:15 – 1:45 PM
Break

1:45 – 2:45 PM
Concurrent Breakout Sessions

  • Case Study: Best Practices in Drug Promotion
  • Case Study: Compliance Risks in Medical Device Advertising
    Gregory H. Levine, Partner, Ropes & Gray
  • Case Study: Dos and Don’ts in Veterinary Medicine Advertising and Promotion
    Elizabeth Butterworth Stutts, Principal, Elizabeth Butterworth Stutts, Esq, PLLC

3:00 – 3:45 PM
The Current State of Unbranded Promotion and Disease Awareness

 

4:00 – 5:15 PM
Navigating Social Media and Influencer Developments 
Madhavi Bellamkonda, Director, Regulatory Affairs AdPromo, Abbott Laboratories                                     
Jason W. Gordon, Partner, Reed Smith LLP
Gillian M. Russell, Counsel, King & Spalding LLP

 

Friday, October 15

11:40 – 11:55 AM
Technology and Connection Support Session

12:00 – 12:10 PM
FDLI Welcome

12:10 – 1:00 PM
Risk Reduction in a New Generation of TV Ads – Saving Time and Increasing Consumer Comprehension
Julie B. Chronis, Senior Counsel II, Gilead Sciences, Inc.

1:15 – 2:15 PM
Concurrent Breakout Sessions

  • Advertising and Promotion of Reference and Biosimilar Products — Where Are We Now?
  • Drug Cost Transparency: Government Mandates, Plans, and Impacts
  • Tailoring Marketing and Claims to the Post-Emergency Use Authorizations Era
    Bob Dean, Director, Advertising and Promotion, Merck & Co., Inc.
    Suzanne Levy Friedman, Senior Associate, Hogan Lovells US LLP

2:30 – 3:30 PM
The Impact of Telehealth on Advertising and Promotion

3:30 PM
Closing Remarks and Adjournment