DAY TWO | WEDNESDAY, JULY 24
8:15 REGISTRATION & WELCOME COFFEE
8:45 CHAIRPERSON’S OPENING REMARKS
Alexander Zachos, Director, Advertising & Promotion Regulatory, TAKEDA
INTERPRETING & APPLYING THE GUIDANCE ON DRUG & DEVICE MANUFACTURER COMMUNICATIONS WITH PAYORS, FORMULARY COMMITTEES AND SIMILAR ENTITIES
In June of 2018, the FDA released the guidance document Drug & Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities, providing industry with a framework for communication surrounding drugs and devices approved for use, as well as surrounding unapproved products. The primary focus of this guidance surrounds the communication of health economic data and cost-effectiveness analysis to the payor community, which is of great importance to life science firms seeking access and coverage for new and existing therapies, and which influences reimbursement decisions greatly. Executives responsible for advertising and promotional regulatory affairs must consider how to best interpret and implement this important guidance, which broadens the scope of traditional communication, demonstrating value through savings and the use of real-world evidence and health economic data.
9:00 PART 1: INTERPRETATION OF THE COMMUNICATIONS WITH PAYORS GUIDANCE
- Foundation for the development of the document
- Collaboration & feedback from industry stakeholders
- General guidance surrounding interpretation
Alan Minsk, Partner & Leader, Food & Drug Practice Team, ARNALL GOLDEN GREGORY LLP
9:45 PART 2: INDUSTRY PERSPECTIVE ON INTEGRATION OF PAYOR COMMUNICATION IN AD/PROMO REGULATORY AFFAIRS
- Real-time example of framework implementation
- Positioning of real-world evidence & HEOR data
- Effective promotion of value through saving to payors
Paul Savidge, U.S. General Counsel, SPARK THERAPEUTICS
10:30 COFFEE & NETWORKING BREAK
11:00 ENSURING A BALANCED PRESENTATION OF RISK IN ALL ADVERTISING & PROMOTION ACTIVITIES
Within the ever-evolving life science marketplace, where many more products are available than ever before and consumers have more information which may influence behavior when speaking with healthcare professionals, advertising and promotion regulatory affairs professionals face the challenging task of ensuring that the audience is educated on the risks of the product along with the benefits which will drive product sales. Executives must therefore carefully weigh messaging in product ads and other materials against FDA regulations and guidances while also supporting the profitability of the company. This session features a practical look at methods for evaluating the presentation of risk in advertising, for the purpose of remaining compliant amid an increasingly competitive landscape.
- Considering depth of information to be presented
- Best practices for factoring in patient testimonials
- Exploring rationales behind presentations of risk
Kate Jurcik, Senior Director Regulatory Advertising & Promotion, VERASTEM ONCOLOGY
11:45 OPTIMIZING AD/PROMO REGULATORY AFFAIRS COMMUNICATIONS DURING THE INTERNAL REVIEW PROCESS
The complexities of the internal review committee process, which involves stakeholders across the organization from regulatory affairs, legal, advertising, marketing, and other areas of expertise, often lead to misalignment between committee members regarding ways in which to convey product information in advertising and promotional materials. While priorities, timelines, and other expectations vary across departments, a mutual understanding must be reached through effective communication. On the part of regulatory affairs professionals, clear description of the rationale behind decisions that may be viewed as unfavorable can be highly effective in ensuring that colleagues are able to efficiently develop content that is responsive to regulatory concerns, benefiting all involved by moving the review process forward in a timely manner.
- Breaking down regulatory complexities for other departments
- Considerations in the review of different types of materials
- Coaching for the promotion of a unified committee perspective
Stephanie Jameison, Director, Global Regulatory Affairs, Promotion Compliance
OTSUKA PHARMACEUTICAL COMPANIES
12:30 LUNCHEON FOR ALL PARTICIPANTS LEVERAGING ONLINE MESSAGING FOR MAXIMUM IMPACT WHILE REMAINING COMPLIANT WITH FDA GUIDANCES
In the constantly changing realm online platforms, where capabilities for sharing information are rapidly expanding, marketing teams seek approval for product messaging that may push the boundaries for FDAcompliant advertising and promotional activities. Despite development of FDA guidances on the role of social media in pharmaceutical and biotech product advertising and promotion, ad/promo regulatory affairs executives remain cautious regarding the use of social media and other digital platforms, resulting in missed opportunities for customer engagement. Forward-thinking executives seek insight into the strategies being put in place by others in the industry to allow for interaction with customers online while remaining compliant with FDA standards.
1:30 PART 1 – CASE STUDIES: AD/PROMO REGULATORY REVIEW OF DIGITAL & ONLINE MESSAGING
Mary Kuskin, Director of Regulatory Affairs, Advertising & Promotion, SAGE THERAPEUTICS
1:45 PART 2 – EXCHANGE GROUPS: COMPARING PERSPECTIVES ON THE REVIEW OF PRODUCT INFORMATION SHARED VIA SOCIAL MEDIA
- Sharing rationales for different social media strategies
- Comparing techniques for working around limitations
- Rapidly adapting to changes in social media platforms
GROUP 1: Moderate-Substantial Social Media Presence
Stephanie Jameison, OTSUKA PHARMACEUTICAL COMPANIES
GROUP 2: Limited Social Media Presence
Danielle Carreon, CELGENE
2:30 MAINTAINING PROMOTIONAL REGULATORY ALIGNMENT IN BRANDED PATIENT ADVOCACY OUTREACH
Patient advocacy initiatives throughout the life science industry provide an opportunity for corporations to engage with patient and caregiver stakeholders, providing support and a platform for communities of patients with a wide range of health conditions. While the intent of interactions is not traditionally of a promotional nature, advertising and promotional regulatory affairs executives must consider branded initiatives to determine whether programs are crossing into promotional activities which would require review and regulatory submission. Of particular concern are increasingly common co-pay assistance programs and other financial programs designed to aid patients, which can be interpreted as potential inducements to prescribe, drawing concern and regulatory scrutiny.
- Boundaries of ad/promo in patient advocacy efforts
- Branded campaigns vs. neutral disease awareness
- Inducements to prescribe & kickback concerns
Christopher Mapes, Associate Director, Regulatory Affairs – Commercialization, DERMIRA, INC.
3:15 COFFEE & NETWORKING BREAK
3:30 EXAMINING THE IMPACT OF GLOBALIZATION ON THE ADVERTISING & PROMOTION REGULATORY AFFAIRS ROLE
As many life science corporations pursue an increasingly international presence, industry experts view the role of the advertising and promotion regulatory affairs professional as expanding to include more practical knowledge of the global regulatory environment. This requires a much wider breadth of knowledge due to the significant disparities between regulations from one country to the next, where even the most traditional methods of communication in the US such as television advertisements are not permitted in other geographic areas. It is therefore critical for ad/promo leaders within forward-focused companies to seek knowledge of the changing regulatory landscape at the global level.
- Adapting to settings with direct-to-consumer bans
- International regulations with similarities to CFL
Amy Kendall, Director, International Regulatory Affairs, ABBVIE
Daisy Chhatwal, Senior Director, Regulatory Strategy, BLUEBIRD BIO
4:15 OPTIMIZING THE POSITION OF AD/PROMO REGULATORY AFFAIRS IN PRE-LAUNCH ACTIVITIES
Of critical importance to the success of a new product, launch sequencing and launch activities are a considerable challenge to pharmaceutical and biotechnology corporations as numerous aspects including FDA clearance timelines are at times unpredictable and uncertain. For advertising and promotional regulatory affairs executives, a level of collaboration and integration with launch teams is essential in ensuring promotional materials meet regulatory guidelines, provide a balanced approach to risks, as well as assist in the adoption of new products. Analysis of a recent launch case study and the roadmap utilized by ad/promo regulatory affairs teams in conjunction with launch teams will provide participants with an insight into effective alignment of resources and priorities to ensure a positive launch.
- Timeline of ad/promo review in launch sequencing
- Practical steps taken to align with launch teams
- Balancing time for pre-launch & established products
John Paul Marcus, Director, Regulatory Affairs, Advertising & Promotion, HORIZON THERAPEUTICS
4:45 CLOSING REMARKS & CONFERENCE CONCLUSION