Pre-Conference Payers & Regulatory Alignment Day
Monday, October 27

8:20 Check-In & Coffee

Workshop A

9:00 Strategies to Streamline Collaboration, Accelerate Decision Making & Improve Real-World Evidence Acceptance Across Pharma, Regulators & Payers

  • Patricia Dorling Senior Director - Value & Implementation Outcomes Research & Oncology, Merck & Co
  • Steve Gao Executive Director & Head, Real-World Evidence Inflammation, Gilead Sciences
  • Alexander Cole Executive Director & Head of Epidemiology & Real-World Science, Alexion Pharmaceuticals
  • Joseph Cappelleri Executive Director of Biostatistics & Head of Health Economics Outcomes Research Statistics, Pfizer

Synopsis

Navigating payer and regulatory requirements in RWE is a high-stakes challenge, one missed step can mean delays, denied coverage, or wasted data. Regulators demand rigor, payers prioritize cost-effectiveness, yet their definitions of “acceptable evidence” rarely align. With evolving guidelines and increasing scrutiny, how can pharma generate the right data to bridge this gap?

  • Unpack real-world case studies on where pharma, regulators, and payers are misaligned, and the subsequent impact
  • Discuss examples of RWE-driven approvals and reimbursements that have worked, and why
  • Develop practical steps to ensure RWE meets the needs of all stakeholders

12:00 Lunch & Networking Break

Workshop B

1:00 Case Studies on Payer & HTA Success in Reimbursement & Market Access to Understand Drivers for Payer Confidence in Real-World Evidence

  • Eugean Jiwanmall Senior Research Analyst for Medical Policy & Technology Evaluation, Independence Blue Cross
  • Javeria Khalid Teaching & Research Assistant, University of Houston

Synopsis

Due to differing priorities, payer and HTA success is a challenge. Payers focus on cost-effectiveness and real world impact, while HTAs prioritize scientific rigor and  long-term outcomes. Aligning RWE with these diverse expectations, while ensuring data quality and transparency, requires navigating complex regional requirements and evolving guidelines.

  • Delve into case studies of RWE strategies that secured market access, and those that didn’t, to identify key considerations for success
  • Address payer concerns on data credibility, transparency, and comparability
  • Identify how evolving methodologies are shaping reimbursement decisions

4:00 End of Workshop Day

VIEW FULL PROGRAM
CONFERENCE DAY ONE