Life Science Advertising and Promotion Regulatory Affairs Conference

July 23-24, 2019 | Alexandria, VA

Hilton Alexandria Old Town

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DAY ONE | TUESDAY, JULY 23

7:45 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Alexander Zachos, Director, Advertising & Promotion Regulatory, TAKEDA

8:45 OPENING ICE BREAKER: TOOLS & TECHNIQUES FOR MONITORING AD/PROMO REGULATORY ENFORCEMENT TRENDS

9:00 KEYNOTE PANEL: IMPACT OF EVOLVING HEALTHCARE DYNAMIC ON ADVERTISING & PROMOTION REGULATORY AFFAIRS
As healthcare priorities across the United States evolve, and a greater focus is placed on cost effective, high quality outcomes, with healthcare providers and payors continuing to embrace the transition from volume-based to value-based care, the methods in which products are promoted and the information shared with patients and physicians is rapidly changing. For executives responsible for advertising and promotion regulatory affairs, this has resulted in new types of data to consider, such as real world evidence, sensitive pricing information as well as a much greater emphasis on outcomes. Health policy and government initiatives such as the 21st Century Cures Act are also rapidly escalating the use and prominence of patient perspectives, which requires a risk-based approach when used in promotional activities.

John Paul Marcus, HORIZON THERAPEUTICS

Alexander Zachos, TAKEDA

Glenn Byrd, formerly of ASTRAZENECA

 

DECIPHERING & IMPLEMENTING THE GUIDANCE ON MEDICAL PRODUCT COMMUNICATIONS THAT ARE CONSISTENT WITH THE FDA-REQUIRED LABELING

9:45 PART 1 – INTERPRETATION OF THE CFL GUIDANCE

  • Brief history and overview of the CFL Guidance
  • Practical considerations for implementing the CFL Guidance
  • Best practices in applying the three CFL factors

Abraham Gitterman, Associate, ARNOLD & PORTER

 

10:30 COFFEE & NETWORKING BREAK

 

11:00 PART 2 – NAVIGATING THE CFL GUIDANCE FOR ENHANCED SHARING OF PRODUCT INFORMATION

  • Practical application of FDA’s CFL Guidance
  • Interpretation of FDA’s three factors
    • Comparable product communication
    • Potential for increased product risks
    • Aligning directions for safe utilization
  • Integration of the three factors into decision making

Cheryl Troilo, Director, Office of Promotion & Advertising Review, MERCK & CO., INC.

 

11:45 PART 3 – PANEL: ANALYSIS OF NEW OPPORTUNITIES PROVIDED TO INDUSTRY BY CFL GUIDANCE

  • Creative dive into the range of opportunities for expansion of educational/promotional content
  • Examining ways in which this changes the game for industry
  • Considering which parties should potentially be involved in content development
  • Strategically applying the guidance to future initiatives

Glenn Byrd, formerly of ASTRAZENECA

Kate Jurcik, VERASTEM ONCOLOGY

Nick Senior, NOVARTIS, Formerly of FDA

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 PART 4 – WORKSHOP: PRACTICAL APPLICATION OF CFL’S THREE FACTORS IN THE AD/PROMO REGULATORY REVIEW PROCESS
The OPDP’s guidance on Medical Product Communications That Are Consistent With the FDA-Required Labeling has given industry new capacity to communicate with the public regarding product information, and provides three factors by which advertising and promotional materials must be measured for the purpose of remaining compliant. However, with limited examples available to represent the wide variety of potential materials for review through various avenues, ad/promo executives face the challenging task of evaluating communications against these new standards while also mitigating risk of noncompliance. Delegates will workshop the regulatory review of three specific advertising and promotional communications, driving deeper understanding of best practices.

James Vigil, Director, US Regulatory Affairs Advertising & Promotion, ABBVIE

 

2:45 UPDATE ON RECENT ENFORCEMENT OF REGULATIONS & GUIDANCES RELATED TO ADVERTISING & PROMOTION
In order to accurately review advertising and promotional activities, it is crucial that professionals in the life sciences remain up to date on ad/promo regulatory enforcement trends throughout the industry. Audience members will benefit from information regarding recent FDA enforcement actions that are pertinent to ad/promo regulatory affairs in pharmaceutical and biotech companies. With a focus on relevant trends and items receiving attention from the OPDP, this session will equip ad/ promo leaders to better understand the basis for enforcement actions, ultimately empowering optimal decision making.

Heather Bañuelos, Former Associate Chief Counsel, FDA & Counsel, FDA & Life Sciences
KING & SPALDING LLP

Gillian Russell, Counsel, FDA & Life Sciences, KING & SPALDING LLP

 

3:30 COFFEE & NETWORKING BREAK

 

3:45 EXCHANGE GROUPS: ENHANCING THE REVIEW OF MATERIALS FOR EXHIBIT BOOTHS AT TRADE SHOWS & CONVENTIONS
Pharmaceutical and biotech companies regularly utilize conventions, medical conferences, and other events to increase awareness of product information, presenting advertising and promotion regulatory affairs professionals with unique challenges in ensuring that the communications put forth at such events remain compliant with regulations and guidances. Among these concerns is the need to keep scientific conversations with the medical community clearly differentiated from promotional activities, while ensuring that product risks are presented in a manner that is reasonably similar to the presentation of benefits in all printed messaging. This session enables delegates to share and evaluate techniques for displaying drug information at exhibit booths in the most advantageous ways possible while remaining within the boundaries of FDA regulations.

  • Pros and cons of using a separate booth for scientific speech
  • Managing differences in booth materials between localities
  • Exploring successful techniques for displaying information

Richard Lem, BAYER HEALTHCARE

Ilze Antons, LUNDBECK

Danielle Carreon, CELGENE

 

4:45 ANALYZING THE FDA’S DIFFERENTIATION BETWEEN DISEASE AWARENESS & PROMOTIONAL COMMUNICATIONS
While disease awareness communications are beyond the scope of the FDA, ambiguity persists with regard to where the FDA draws the line of distinction between this type of communication and promotional information. It is imperative for life science companies to gain nuanced understanding of potentially unexpected attributes that may cause a communication to be considered promotional in order to avoid improper inclusion of such messaging in materials intended for disease awareness communication. This session features one organization’s experience with navigating this grey area in order to disseminate meaningful disease information while staying within the intended scope.

Alexander Zachos, Director, Advertising & Promotion Regulatory, TAKEDA

 

5:15 CLOSING REMARKS & DAY 1 CONCLUSION

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