Day 2 - Tuesday, May 19 2026 - ET (Eastern Time, GMT-05:00)
Gene and cell therapies continue to revolutionize medicine, offering transformative cures for conditions such as spinal muscular atrophy, hemophilia, blindness, and other previously untreatable diseases. Since 2023, the field has seen significant advancements in therapeutic development, regulatory frameworks, and pricing strategies. However, the high costs of these therapies remain a critical challenge for healthcare systems, insurers, and patients worldwide. In this updated session, Prof. Lo will revisit the challenges posed by the pricing and financing of gene and cell therapies, reflecting on the progress made since 2023. The discussion will explore the evolution of proposed funding models, including drug mortgages, subscription-based approaches (the "Netflix model"), and cost-plus pricing, while introducing new concepts such as outcome-based pricing, pooled risk-sharing agreements, and public-private partnerships.
Address persistent data quality issues that create compliance risks and operational inefficiencies for both manufacturers and covered entities
- Angie Franks - Chief Executive Officer, Kalderos
- Cigna's Transparency Revolution: How the industry's largest PBM is pioneering fee-based models and moving away from spread pricing - what's working, what's challenging, and real client adoption data
- PBM executives discuss how transparent pricing models change formulary decisions, manufacturer negotiations, and patient access strategies
- Industry perspectives on GLP-1 employer deals, Waltz Health partnerships, and whether direct manufacturer-employer relationships threaten or complement traditional PBM services
- Reform or Evolution? PBM leaders address federal policy pressures, state legislation impacts, and how the industry is proactively adapting to avoid regulatory disruption
- Where PBM executives see their industry heading - consolidation predictions, sustainable business models, and maintaining value in an increasingly transparent marketplace
- Examine recent CMS guidance reshaping ASP calculation requirements and industry compliance expectations
- Analyze the most significant bona fide service fee developments impacting manufacturers over the past two years
- Review real-world case studies demonstrating successful and problematic BFSF structures under current standards
- Explore documentation and cross-functional coordination requirements for ASP compliance
- Discuss emerging regulatory trends and proactive risk mitigation strategies for ASP calculations
- Meena Datta - Partner, Sidley Austin LLP
- Trevor Wear - Partner, Sidley Austin LLP
A review of the most pressing new models, policies and pressures affecting drug pricing including reaction to Medicare models, how IRA implementation is tracking, tariffs, PBM reform and a wide look at the administration’s MFN objectives.
- Kristie Gurley - Partner, Washington, Covington & Burling LLP
- Evaluate operational realities of the 340B rebate model transition, including system integrations, workflow adaptations, and stakeholder coordination challenges
- Analyze early performance metrics and identify key success factors versus implementation hurdles experienced by participating manufacturers and covered entities
- Review dispute resolution processes and claim validation procedures that have emerged during the pilot phase, with lessons learned for optimization
- Assess scalability considerations and infrastructure requirements for potential program expansion beyond the current pilot scope
- Katheryne Richardson, PharmD - Managing Director, Berkeley Research Group, LLC
- Strategic decision framework for evaluating Generous Model participation based on portfolio characteristics
- MFN negotiation insights from early adopter experiences and legal precedents
- Compliance roadmap with specific deadlines and operational requirements for implementation
- Meena Datta - Partner, Sidley Austin LLP
- Lisa Clayton - Senior Director, Government Price Reporting, The Pricing Group, LLC
- Establish systematic approaches to reconcile 340B pricing obligations with existing payor rebate structures
- Implement compliance frameworks that prevent duplicate discount scenarios across multiple program types
- Develop operational processes to validate 340B eligibility while maintaining payor rebate accuracy
- Create cross-functional workflows between 340B compliance teams and rebate operations departments
- Design monitoring systems to ensure ongoing program integrity across overlapping discount structures
- Bob Steller - Industry Principal of Life Sciences, Vistex
- Analysis of state enforcement actions and penalty structures following initial compliance cycles
- Operational translation of complex state requirements into decision-tree frameworks for pricing teams
- Trade secret protection challenges in examination of regulatory requests for supporting data and manufacturer response strategies
- State vs. Federal precedence: Legal landscape analysis where states are establishing independent transparency requirements beyond federal mandates
- Haile Dagne - Director, Policy & Reimbursement, GSK
What factors do PDABs consider when evaluating drug value beyond cost? Explore how states assess clinical impact, patient outcomes, and market dynamics
- Walk through the complete process when a drug comes under PDAB review - from notification through assessment to decision-making
- Best practices for transparency and collaboration between manufacturers, PDABs and state agencies
- Sharon Hunt - Associate Director State Reporting, Compliance, Sandoz
Interactive end to end walkthrough of 5 hypothetical products taking a price increase:
- Understand the intricacies of state-level pricing transparency laws and how they impact your pricing strategy
- Walk through real-world scenarios and challenges faced when increasing product prices, from the regulatory to the practical
- Learn best practices for managing relationships with partners who store, ship, and process financial transactions for your products
- Understand how to monitor and validate 3PL chargeback processing to prevent revenue leakage and operational errors
Develop strategies for delivering constructive feedback and maximizing value from your 3PL investment through structured communication and performance metrics
- Jennifer Marderstein - Senior Trade Analyst, Regeneron Pharmaceuticals
- Justin Austin - Supervisor, Chargebacks, Customer Operations, 3PL Specialty Solutions, CardinalHealth
- Understand how GPOs are shifting from traditional rebate models to alternative fee arrangements, including data fees, administrative charges, and performance-based components in response to pricing transparency pressures
- Implement proven frameworks for coordinating between pricing, contracting, finance, and legal teams to ensure seamless contract implementation, eligibility verification, and ongoing relationship management
- Explore alternatives to traditional GPO contracting including direct physician office relationships, specialty distributor partnerships, and hybrid models that balance market access with margin optimization
- Kevin Michols - Senior Director, Contract Development and Value, Alkermes
- Benchmark your pricing performance against industry standards
- Review 2025-2026 data on average pre/post deal variance across multiple channels, scenario modeling frequency, and common operational challenges to identify where your organization stands
- Understand how leading organizations are using quantitative analysis to navigate IRA negotiations, coverage gap redesign impacts, and cross-functional pricing decisions in the current regulatory environment
- Optimize operational frameworks through industry best practices
- Discover proven approaches for managing pricing complexity, improving cross-functional collaboration, and implementing sustainable processes that drive both compliance and commercial success
- Ryan Coelho - Director, Net Revenue Management, Zoetis
- Jeff Miller - VP Finance & Corporate Controller, Lannett Pharmaceuticals
- Analyze real-world implementation challenges and common pitfalls encountered during initial ASP reporting under the updated requirements
- Review practical examples of how to properly compile and organize required documentation for ASP calculations
- Establish standardized processes for gathering and validating data elements with step-by-step guidance and templates
- Implement quality control measures and sustainable workflows to ensure accuracy and compliance in future quarterly submissions
- Lynn Buhl - Managing Director, Riparian
- Justin Linder - Managing Director, Consulting, Riparian
- How hospitals qualify for the 340B program and collaborate with their communities to provide to low-income patients
- Identify current research on 340B hospitals’ provision of care to low-income and underserved patient populations
- Operational realities: A candid look at hospital data management, compliance, and manufacturer partnerships
- Real patient impact stories and access challenges from a hospital executive lens
- Bibi Wishart, PharmD, MBA, DPLA - Director of Pharmacy, 340B Program, Atrium Health
- Master evolving competitive dynamics between originators, biosimilars, and generics - examining real-world pricing strategies, PBM pressures, and channel optimization approaches across product types
- Balance profitability amid complex government program requirements, wholesaler fee structures, and membership validation challenges unique to biosimilar and generic business models
- Optimize operational execution across distribution channels while managing intricate chargeback processes and contract pharmacy relationships in an increasingly competitive landscape
- Analyze how IRA implementation, Medicare Part D redesign, and emerging PBM policies are reshaping market access opportunities and contracting approaches for non-brand manufacturers
- Future-proof your strategy by understanding shifting payor dynamics, regulatory requirements, and market entrant impacts on biosimilar and generic positioning
- Allan Thoen - Director & Associate General Counsel, Sandoz
- Price erosion management strategies
- Contract renegotiation tactics as market matures
- Portfolio optimization decisions (when to exit vs. invest)
- Payer relationship evolution from launch to maturity
- Ryan Coelho - Director, Net Revenue Management, Zoetis
- Cross-program pricing interconnections beyond FAMP calculations, including Medicaid supplemental rebates and commercial contract spillover effects
- Early warning indicators for margin erosion through automated monitoring of AMP fluctuations and downstream pricing impacts
- Commercial contracting vulnerabilities when government pricing changes trigger rebate escalations and volume-based adjustments
- Data analytics frameworks for identifying pricing interconnections across Medicare Part D, Medicaid, and 340B program interactions
- Case studies demonstrating how non-FAMP price changes created unexpected revenue leakage in commercial and government channels
- Cross-functional team coordination strategies for managing pricing decisions when multiple programs are interconnected
- Implement systematic approaches for tracking ownership changes, validating eligibility across complex networks, and maintaining contract compliance during M&A transitions and portfolio restructuring
- Create scalable processes for managing multiple GPO memberships, PBM relationships, and contract hierarchies while ensuring data accuracy and preventing revenue leakage across diverse technology platforms
- Establish comprehensive audit trail and exception handling procedures
- Build defensible documentation systems that support complex ownership validations, handle non-standard scenarios, and maintain compliance readiness for increasingly sophisticated payer and regulatory audits
