AGenda

Conversations That Move Promotional Review Forward

January 19, 2027

Promotional Review in Motion: An MLR Leadership forum on Today’s Dynamic Regulatory Landscape

A collaborative roundtable for Medical, Regulatory, Legal and Commercial Leaders. This interactive forum will bring together experienced Medical, Regulatory, and Legal leaders for a candid, collaborative conversation about the most significant challenges facing promotional review today. This will be a participant led discussion by sharing perspectives, examining real-world challenges, and exploring how the industry is responding.

Separate purchase required. Participation information and additional details will be announced soon.

January 20–21, 2027

Advancing Promotional Review: MRL in Sync

The two-day program will bring together Medical, Regulatory, Legal and Commercial professionals for two days of expert-led sessions, panel discussions, real-world case studies, and collaborative conversations. Topics will explore the most relevant and pressing challenges pharmaceutical companies face today.

Attendees will gain practical insights, candid industry perspectives, and actionable solutions while exchanging experiences and building meaningful connections with colleagues,

The program also includes a networking event on the evening of January 20, providing an additional opportunity to connect with Medical, Regulatory, Legal and Commercial professionals.

The full agenda, session details, and speaker information will be announced soon.

Agenda topics, speakers, and timing are subject to change.

working Agenda

  • Speaker: Kit Aikin, Opus Regulatory

  • Speakers: Tara Barbanell, Amgen & Chris Spell, Opus Regulatory

    Step inside the review process as Medical and Regulatory experts evaluate a real-world SIUU scenario live—revealing how decisions are made, challenged, and aligned. 

    • Evaluating scientific appropriateness and data limitations in SIUU  

    • Interpreting regulatory intent, boundaries, and risk triggers  

    • Identifying where Medical and Regulatory perspectives align vs. diverge  

    • Translating decisions into practical, defensible communication approaches 

  • Speakers: Polly Patel, AbbVie & Mark Gaydos, Moderna

    Medical Affairs and Field Medical teams play a critical scientific, nonpromotional role while facing growing pressure to demonstrate measurable value. This session explores how to assess that value while preserving scientific integrity and navigating the boundaries between medical and commercial activities.

    • Examine practical challenges in reviewing materials, activities, and communications at the intersection of medical and commercial functions.

    • Gain tools to distinguish appropriate scientific exchange from promotional activity.

    • Explore frameworks to measure and communicate the impact of scientific exchange.

  • Speakers: Michelle Belliveau, Alexion & Julia Gardner, ERMA

  • Speakers: Denise Sanchez, Aesera & Marci Kiester, Opus Regulatory

  • More information coming soon

  • Speakers: Carla Brooks, Blueprint Medicines & Nada Glavan, Eisai

  • Speakers: Kristin Heinlein, Takeda & Alex Zachos, Boehringer Ingelheim

    • When Disease Education Becomes Product Promotion: Common MLR Pitfalls and How to Avoid Them 

    • The Net Impression: Lessons from FDA Actions on Disease Awareness Campaigns 

    • Recent FDA Enforcement Trends in Disease State Awareness Communications 

    • DSE: A Historical Perspective 

  • Speakers: Georgia Gayle, Alexion & Noah Goldstein, PBN Law