Agenda for Day 2 - Tuesday December 8, 2026 - US/Pacific
Hear from leading attorneys as they discuss the legal, regulatory, and compliance developments creating the greatest uncertainty across government pricing and contracting functions.
Discussion Topics
MFN implementation
CMS international reference pricing initiatives (GENEROUS/GUARD/GLOBE)
MFP developments
340B litigation
PBM reform
State transparency requirements
Executive Orders and regulatory uncertainty
- Renee Watson - Senior Associate General Counsel, US Pricing & Access Legal Business Partner, Gilead Sciences
Pricing decisions often create unintended downstream consequences. This session explores the growing relationship between gross-to-net dynamics, PBM economics, government pricing obligations, and long-term profitability.
Discussion Topics
Rebate inflation trends
WAC strategy considerations
Price protection mechanisms
Contracting implications
Understanding the “GTN bubble”
- Erika George - Exec. Director, Head of Pricing & Contracting, BridgeBio
- Dan Stefureak - Senior Director, Pricing & Contracting, Corecept Therapeutics
- Nick Ianconi - Associate Director, Government Pricing, Avyxa
Artificial intelligence is beginning to move beyond experimentation and into practical use cases across pricing and contracting organizations. Hear how manufacturers are leveraging AI tools to improve efficiency, reduce manual effort, and support compliance activities.
Discussion Topics
Contract analytics
Rebate validation
State transparency monitoring
Compliance review
Reporting workflow optimization
- Kathy Burke - Vice President - Market Access, Osteal Therapeutics
As policymakers scrutinize PBM practices and manufacturers face increasing rebate pressure, understanding the future of formulary management and PBM economics has become essential for pricing leaders.
Discussion Topics
Rebate economics
Formulary pressure
Current administration priorities
Pass-through models
Bona fide service fees
- Jeff Shouse - Corporate Account Director, US Market Access, BeOne Medicines
- Jennifer Gunn - Senior Director Pricing & Contracting, Mineralys Therapeutics
This session brings together state and former state leaders to provide a perspective manufacturers rarely hear directly: the operational realities, constraints, and priorities shaping Medicaid program decision-making.
Discussion Topics
State rebate administration challenges
Why states make certain operational decisions
Medicaid disputes and resolution approaches
System modernization efforts
PBM utilization and oversight
Cell and gene therapies continue to challenge traditional reimbursement, contracting, and government pricing frameworks. As manufacturers launch increasingly complex therapies with significant upfront costs, organizations must rethink how pricing, market access, government reporting, and payer engagement strategies work together.
Discussion Topics
Contracting and reimbursement challenges unique to cell and gene therapies
Government pricing implications and reporting considerations
Outcomes-based agreements and innovative contracting models
Payer affordability concerns
Lessons learned from recent launches
- Kathy Burke - Vice President - Market Access, Osteal Therapeutics
Gain insight into how state representatives and affordability review bodies are approaching prescription drug affordability reviews, and what manufacturers can do to engage effectively throughout the process.
Discussion Topics
- Factors states consider when evaluating drug value beyond cost
- Clinical impact, patient outcomes, affordability, and market dynamics
- Manufacturer notification, data submission, assessment, and decision-making
- Best practices for transparency and collaboration with state agencies
- Implications for pricing, contracting, access, and manufacturer engagement
A forward-looking discussion on the issues expected to shape government pricing, rebates, and contracting over the next 12 months.
Discussion Topics
- MFN
- MFP
- 340B
- PBM reform
- State transparency
- AI adoption
- Rujul Desai - Senior Counselor to the Administrator, Centers for Medicare & Medicaid Services
