Agenda for Day 2 - Tuesday October 6th, 2026
- Kathleen Dynan Black - Director Government Strategy & Operations, Pfizer
This session will provide stakeholders with key policy, programmatic and compliance updates on the federal 340B Drug Pricing Program.
Review recent policy developments shaping the pharmaceutical and life sciences landscape
Explore regulatory trends impacting Medicare, PBM reform, and drug pricing strategies
Discuss the broader implications of evolving policies on market access and innovation
- Sabrina Aery - Founder and Principal, Aery Policy & Access Partners, LLC
- Karyn Schwartz - Senior Vice President, Policy and Research Department, PhRMA
- Jack Geisser - Vice President, Healthcare Policy, BIO
- Nicolas Ferreyros - Managing Director, Policy, Advocacy, and Communications, Community Oncology Alliance (COA)
- Rujul Desai - Senior Counselor to the Administrator, Centers for Medicare & Medicaid Services
Analysis of recent legislative actions, regulatory guidance, and enforcement trends affecting pharmaceutical pricing and government program participation.
- Alice Valder Curran - Partner, Global Regulatory, Hogan Lovells
- Angie Franks - Chief Executive Officer, Kalderos
Hear from an expert panel of attorneys as they each moderate a topic and interactive discussion among attendees, and themselves, on the most pressing issues facing MDRP and Government Pricing.
- Meena Datta - Partner, Sidley Austin LLP
- Jeffrey Handwerker - Partner, Arnold & Porter LLP
- Kristie Gurley - Partner, Covington & Burling (former HHS Office of General Counsel, CMS Division)
- Chris Schott - Partner, Latham & Watkins
Evaluate operational realities of the MFP process, including system integrations, workflow adaptations, and stakeholder coordination opportunities & challenges
Analyze early performance metrics and identify key success factors, including 340B deduplication learnings
Review good faith resolution processes and claim validation procedures that have emerged during the first MFP effectuation, with lessons learned for optimization
- Katheryne Richardson, PharmD - Managing Director, Berkeley Research Group, LLC
Outline essential MFP requirements and implementation status, including practical approaches for meeting program guidelines
Discuss deadlines and implementation preparation
Learnings from experience in engagements to date with CMS and other stakeholders
Covering documentation requirements, operational readiness assessments, and compliance verification processes
- Jennifer Lospinoso - Managing Director & Consulting Lead, Riparian
2026 has seen more ASP rule changes than the past twenty-years put together. This session will explore these changes and consider what may be coming next from CMS, including regarding:
Bona Fide Service Fee Certifications
Reasonable Assumption Submissions
Bundled Sales Arrangements
- John Gould - Partner, Arnold & Porter
Prepare for 2026 state price caps like PDAB UPLs while protecting trade secrets, including R&D and manufacturing costs
Use confidentiality protocols, such as "confidentiality tagging," to shield proprietary pricing and rebate data from FOIA requests
Align teams to meet NASHP Model reporting standards with consistent net price calculations across states
Create standardized narratives to justify pricing while limiting disclosure of sensitive strategies
Implement early warning systems for audits, using case law to define disclosure boundaries
- Elizabeth Lindquist - Partner, Arnold & Porter
Adjust specialty distribution models as "Any Willing Provider" laws in 17+ states force PBMs to include independent pharmacies in exclusive networks
Prepare for 2026 bans in Arkansas and Arizona that prohibit PBMs from owning or licensing mail-order and specialty pharmacies, disrupting preferred channels
Ensure compliance with Indiana’s July 1, 2026, mandate restricting compounding of GLP-1s and biologics to protect brand integrity from medical spa alternatives
Implement Massachusetts’ 2026 Shield Law 2.0 to meet privacy-focused pharmacy labeling requirements for sensitive therapies
Adapt to California’s January 1, 2026, ban on PBM spread pricing by transitioning to pass-through models and increasing fee transparency
Benchmark pricing and GTN performance against 2025-2026 industry standards using actionable data insights
Analyze pre/post deal variance across channels, scenario modeling frequency, and common data challenges to assess organizational positioning
Evaluate accrual accuracy for the new Part D Manufacturer Discount Program and the effectiveness of automated 340B duplicate discount scrubbing in the redesigned environment
Identify operational strengths and opportunities by comparing practices to industry benchmarks
Discover strategies to manage pricing complexity, improve cross-functional collaboration, and implement sustainable processes that drive compliance and commercial success
- Kate Neely - Vice President Trade Relations & Customer Contracting, Alvogen
Assess the 2026 impact of uncapped inflation rebates, identifying legacy SKUs with rebate obligations exceeding 100% of AMP
Leverage WAC reductions to mitigate inflationary rebates and stabilize gross-to-net (GTN) for at-risk mature portfolios
Examine MDRP withdrawals and product discontinuations for negative-margin assets, evaluating legal implications for remaining commercial availability
Consider the GENEROUS model to align Medicaid net prices with international benchmarks, replacing uncapped rebates with negotiated agreements
Implement cross-functional protocols to manage Medicaid price resets' impact on 340B ceiling prices and commercial rebate guarantees, avoiding revenue erosion
- Jay Sinha - Pricing & Reimbursement Manager, Amgen
Dive into the operational complexities of Round 3 Medicare negotiations, focusing on ASP reporting, inflation-based rebates, and compliance hurdles specific to physician-administered drugs
Assess the real-world impact of MFPs on provider acquisition costs, administration fees, and health system operations, with actionable strategies for mitigating financial strain
Develop tailored communication strategies for providers and health systems, addressing concerns about reimbursement uncertainty and operational disruptions
Explore the evolving role of biosimilars and cell and gene therapies in reshaping provider workflows and investment priorities in the Part B space
Assess revenue impacts of GLOBE (Part B) and GUARD (Part D), focusing on how international price caps influence domestic ASP and interact with 340B ceiling prices
Optimize global data reporting, ensuring accurate second-lowest price submissions for GENEROUS while aligning with U.S. financial disclosures and SEC requirements
Enhance rebate and contract governance, updating templates and strategies to prevent double-discounting and address MFN-based rebate liabilities
Develop compliant patient support programs, aligning BALANCE initiatives with U.S. Anti-Kickback Statute (AKS) and Fair Market Value standards
Prepare for 2026 reporting deadlines, standardizing Reasonable Assumptions documentation and ensuring alignment on unit definitions and GDP adjusters for international price submissions
- David Dai - Senior Director, CG Oncology
- Victoria Corke - Of Counsel, Covington & Burling
Navigate competitive dynamics between originators, biosimilars, and generics with a focus on pricing, PBM pressures, and channel optimization
Address profitability challenges, including 340B duplicate discount scrubs for biosimilars across retail (Part D) and clinic (Part B) channels
Prepare for state price caps and align reporting for high-cost generics with transparency mandates
Strategize for biosimilar substitution rules and zero-dollar co-pay mandates for chronic condition generics
Manage price erosion, renegotiate contracts, and optimize portfolios as markets mature
Use live polling to uncover how and why peers are adopting AI for pricing, contracting, and compliance
Benchmark trends on GTN accuracy, 340B disputes, and WAC reset modeling for 2027
See AI in action with a live demo on prompt engineering for PBM contracts, PDAB summaries, and IRA negotiations
Share success stories and challenges in AI adoption through interactive discussions
Explore the future of pricing teams, focusing on AI-augmented strategy and essential skills for compliance
- Srini Sripada, PhD - Senior Manager, Government Contracts & Pricing, Gilead Sciences
Realign distributor fee-for-service contracts to address revenue challenges from WAC reductions and MFN-based caps, ensuring sustainable service fees
Prepare for the October 2026 Inventory Floor Stock Crisis by managing Inventory Compensation Credit (ICC) payouts for on-hand stock impacted by IRA Maximum Fair Prices or GLOBE/GUARD benchmarks
Streamline chargeback reconciliation by tightening the "look-back" period to prevent margin leakage during transitions to lower federal price points
Leverage predictive analytics to manage distributor speculative buying ahead of price resets, optimizing inventory levels and minimizing rebate and floor-stock liabilities
Ensure compliance with Bona Fide Service Fee requirements by keeping distributor payments below Fair Market Value thresholds to avoid Medicaid Best Price triggers
Expand CAR-T therapies into autoimmune conditions by addressing access challenges in community and specialty settings
Highlight CGT’s curative value with outcome data, cost comparisons, and hospitalization avoidance metrics
Tackle hospital margin pressures and DRG-based reimbursement gaps in Medicare Part A, while navigating the 2026 legal landscape of 340B eligibility for specialized biologics
Operationalize Outcomes-Based Agreements (OBAs) and 'subscription' models aligned with the CMS Cell and Gene Therapy Access Model launching in late 2026
Optimize manufacturing with automation, scale economies, and logistics tailored to patient-specific products
Ensure quality and efficiency through robust supply chain and inventory management frameworks
- Zaki Mahmood - Senior Director Distribution Pricing & Operations, Autolus