Agenda for Day 2 - Tuesday October 6, 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)
Analysis of recent legislative actions, regulatory guidance, and enforcement trends affecting pharmaceutical pricing and government program participation.
- Alice Valder Curran - Partner, Hogan Lovells Cadwalader
- Jesse Mendelsohn - Senior Vice President, Professional Services, Model N
- Meghal Patel - Chief Product Officer for Truzo, Model N
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 - Healthcare Partner, Sidley Austin LLP
- Jeffrey Handwerker - Partner, Arnold & Porter LLP
- Chris Schott - Partner, Latham & Watkins
- Kristie Gurley - Partner, Covington & Burling
- Kathleen Dynan Black - Director Government Strategy & Operations, Pfizer
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 - Chief Strategy Officer, Second Sight Solutions
Join Kernel Solutions for a Solution Summit!
This session explores how automation transforms Medicaid operations, eliminating repetitive, manual tasks and replacing them with timely, actionable financial insight. Across the full financial lifecycle, invoice processing flows directly into Gross‑To‑Net, leveraging dynamic dashboards combined with AI‑driven anomaly detection to deliver real‑time visibility into operational throughput and financial performance, surfacing discrepancies before they escalate into material risk.
Space is limited - make sure to RSVP to secure your seat at this insightful session!
- Marcus Bourget - Medicaid Solutions Lead / Customer Success Officer (CSO), Kernel
- Josh Gingerich - Chief Customer Success Officer, Kernel
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
- Melody Hamel - Senior Operations Counsel, Viatris Inc
This session provides practical guidance on preparing for, negotiating, and implementing your FSS contract with the VA, including insights on how contracting officers are interpreting the FAR overhaul implementation, the shift to 20-year contract options under mass modifications for 651b, and what's changing in FSS contracting practices
- Ted Karnezis - Principal Owner, Karnezis Consulting
- Sharon Chang - Director of Federal Supply Schedule Service, US Department of Veterans Affairs
- Diana Lawal - Chief - Contracting Brand - Pharmacy & Dental Division Team B, US Department of Veterans Affairs
Streamline workflows across Government Pricing, Finance, and Treasury to manage the dual complexities of Maximum Fair Price (MFP) implementation and the first invoicing cycles for Part B and Part D inflation rebates
Develop robust, audit-ready protocols to verify CMS inflation rebate calculations, address system integration challenges, and manage compressed appeals timelines to mitigate overpayment risks
Redesign lifecycle pricing models to balance domestic price increases against inflation-penalty thresholds while safeguarding ASP, Medicaid Best Price, and commercial discounting strategies in an MFP-capped market
Implement technical safeguards across 340B, Medicaid, and MFP, ensuring compliance with 2026 regulatory guidance and accurate financial reporting
- John Glover - Partner, Pearl Management
- Farruq Jafery - Former Vice President of Pricing, Contract Operations & Reimbursement, Novo Nordisk
Government Pricing audits continue to uncover many of the same compliance gaps across manufacturers of every size. The difference today is that organizations no longer need to rely solely on manual reviews, spreadsheets, and resource-intensive assessments. AI and intelligent automation are fundamentally changing how compliance teams identify risk, validate data, and prepare for audits. With more than 20 years of Government Pricing audit and assessment experience, we have seen the common types of gaps and issues across all sizes and type of manufactures, as well as where we can apply innovative technology, such as automating Class of Trade Review instead of time intensive and inefficient manual reviews. Not only is this more efficient and accurate, it provides greater transparency, traceability, and audit-ready documentation.
Creating an AI-enabled GP Documentation Library to organize and align policies, procedures, reasonable assumptions, methodologies, and supporting evidence into a searchable, continuously maintained knowledge base
Using AI to evaluate methodology integrity, including validation of domain table mappings, smoothing algorithms, and calculation logic to identify inconsistencies and misalignment to Policy and Procedure documentation before they become audit findings
Automating Customer Master and Class of Trade analysis Evaluating COT assignment in the Customer Master data, identifying assignment exceptions, and improving the accuracy of 340B eligibility validation
Building an intelligent Contract Master Reconciling contract data with Government Pricing systems and Accounts Payable while documenting Bona Fide Service Fee determinations and supporting rationale
Applying AI to data collection, reconciliation, and validation across disparate source systems to improve data quality, reduce manual effort, and accelerate monthly and quarterly reporting cycles
Leveraging AI for parallel pricing calculations and predictive testing to validate results, identify anomalies, evaluate smoothing methodologies, and strengthen audit readiness before submissions are made
- Chris Cobourn - Managing Director, Helio GP Advisory Services
- Shrutej Patel - Director, Gov’t Pricing & Contracts, Ipsen
- Kuba Mijakowsk - Manager, Helio
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
- Pari Mody - Partner, Arnold & Porter
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
Understand how proposed PBM reforms, FTC transparency initiatives, and evolving market dynamics may reshape manufacturer access, contracting, commercialization, and operational investments
Understand how PBM reform is disrupting the traditional rebate-driven access model
Assess why and how PBM incentives may change and our perspective on future influence
Anticipate the shift from financial controls to clinical and patient access controls
Prepare for expanding transparency, reporting, and audit requirements
Discuss considerations manufacturer strategies and operational capabilities needed in the new rebate/fee environment
- Judd Caulfield - Associate General Counsel, US Rx Business Unit, Galderma
- Andrew Cosgrove - Senior Director, Healthcare Policy and Research, BIO
- Shiraz Hasan - General Manager, Market Access Technology & Solutions, IQVIA
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 - Data Strategy & Innovation Associate Director, Gilead
- Jean Pathil - Director of Government Pricing, Sumitomo Pharma America
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
- Jeff Park - Senior Director, Pricing and Policy Strategy, Nuvation Bio Inc.
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
