September 15-17, 2025
Delivered as a Hybrid EventFairmont Chicago Millennium Park, Chicago, ILkeyboard_arrow_right
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Day Three - CT (Central Time)
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Day Three - CT (Central Time)
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Showing 1 of 1 Streams
Registration
7:15am - 8:00am
Breakfast, Coffee and Registration
Showing 1 of 1 Streams
General Session
8:00am - 8:10amLive Stream
Co-Chair's Opening Remarks
- Josh O'Harra - Deputy General Counsel, Eli Lilly and Company
8:10am - 8:50amLive Stream
IRA Implementation at the Crossroads: Strategic Decision Framework for 2026 and Beyond
- Examine strategic inflection points as the IRA transitions from initial implementation to mature program operations, including essential recalibrations for commercial planning, forecasting, and portfolio optimization
- Analyze emerging patterns in market response across different stakeholder groups, illuminating how successful organizations are adapting their decision frameworks beyond basic compliance
- Explore the evolution of data-driven approaches for navigating negotiation preparation, financial modeling, and commercial contracting in response to early program experiences
- Develop forward-looking strategies that balance short-term tactical needs with long-term portfolio considerations as the program expands to include Part B drugs and additional therapeutic categories
- Jeff Baab - Partner, Advisory Services, IntegriChain
- Kristin Hicks - Partner, Arnold & Porter
8:50am - 9:40amLive Stream
Fireside Chat: External Counsel Roundtable Part II
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.
- Tom Evegan - Principal, Strategy & Management Consulting, RSM US LLP
- Alice Valder Curran - Partner, Global Regulatory, Hogan Lovells
- Margaux Hall - Partner, Ropes & Gray LLP
- Stephanie Trunk - Partner, ArentFox Schiff LLP
9:40am - 10:20am
Keynote State of the Industry Panel: CMS Updates and Regulatory Developments
Join CMS and other industry leaders as they share their vision for navigating today's complex landscape and important updates heading into 2026 and beyond.
- Josh O'Harra - Deputy General Counsel, Eli Lilly and Company
- Rujul Desai - Deputy General Counsel, Chief Legal Officer for CMS, U.S. Department of Health & Human Services
- Kristie Gurley - Partner, Washington, Covington & Burling LLP
Showing 1 of 1 Streams
Break
10:20am - 10:50am
Morning Networking Break
Showing 3 of 3 Streams
Track D: 340B Evolution Revolution: The Road Ahead
Track E: Policy Whiplash: The New Administration Edition
Track F: Closed Door Executive Strategy & Business Development
10:50am - 11:30amLive Stream
340B Topic TBA
11:35am - 12:15pmLive Stream
Operationalizing Fair Market Value (FMV): From Compliance Obligation to Business Enabler
- Overview of the regulatory backdrop and market dynamics driving FMV requirements
- Key process challenges including cross-functional ownership, data / documentation inconsistencies, and evolving engagement models
- Common approaches to FMV governance, internal rate-setting vs. external benchmarks, determination of approach (e.g., Cost vs. Market), and the role of technology in workflow and audit readiness
- Best practices for FMV processes to optimize contract authoring, enhance transparency and reduce risk
- Lessons from real-world implementations including strategies to centralize data / models to a single source of truth for all rate-related information and access to historical assessments
- Key takeaways for manufacturers to be operationally efficient and audit ready
- Ritu Pandey - Senior Manager, Marbls
- Justin White - Manager, Managed Markets Finance Governance, Novartis
10:50am - 11:30am
Administration Policy Shifts: Nine Months of Pharmaceutical Industry Impact
- Investigate the administration's Medicare drug price negotiation approach and IRA implementation, including enforcement changes, compliance requirements, and proposed legislative modifications since January 2025
- Review how new leadership at HHS, FDA, and CMS affects drug approval pathways and compliance expectations, with insights from industry leaders managing these transitions
- Assess international reference pricing and tariff policies impacting pharmaceutical imports and manufacturing, including effects on global supply chains and domestic production incentives
- Explore the administration's healthcare priorities in the 2026 budget proposal and regulatory agenda, with analysis of potential impacts on market access, pricing transparency, and innovation
- Lisa Clayton - Senior Director, Government Price Reporting, The Pricing Group, LLC
- Mallory O’Connor - Executive Director, Public Policy, Mallinckrodt Pharmaceuticals
11:35am - 12:15pm
International Reference Pricing: Return and Implications
- Examine the potential resurgence of international reference pricing policies under the new administration
- Compare previous attempts at implementation with current proposals and understand key differences
- Explore potential impacts on global pricing strategies, market access approaches, and launch sequencing
- Develop strategic frameworks for pharmaceutical pricing in an environment with potential cross-border referencing
- John Gould - Partner, Arnold & Porter
- Pari Mody - Partner, Arnold & Porter
10:50am - 12:10pm
Closed Door Executive Strategy & Business Development (10:50am – 12:55pm)
Join senior pharma executives for interactive discussions bridging policy with business strategy. Limited to 40 participants.*
Policy & Regulatory:
- 340B litigation impacts
- PBM reform implications
- IRA implementation challenges
- State regulatory trends
- Drug shortage mitigation
- FSS "Made in America" requirements
Enterprise Impact:
- Field sales adaptation
- Product lifecycle reassessment
- Treasury cash flow management
- Portfolio valuation shifts
- Cross-functional alignment
- M&A strategy evolution
Strategic Planning:
- Policy-informed product valuation
- R&D investment considerations
- Regulatory-to-business translation
- Technology integration
- Treasury/BD/Regulatory collaboration
- GTN optimization strategies
*Lunch will be provided to participants.
- Suzie Tam-Porter - VP, Channel & Contract Management, Genentech
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor Pharma
- Stephanie Kupski - Director US Pricing & Government Reporting, North American Commercial Operations, CSL Behring
Showing 2 of 2 Streams
Break
Track F: Closed Door Executive Strategy & Business Development
12:15pm - 1:00pm
Networking Luncheon
12:15pm - 1:00pm
Closed Door Executive Strategy & Business Development (10:50am – 12:55pm)
Join senior pharma executives for interactive discussions bridging policy with business strategy. Limited to 40 participants.*
Policy & Regulatory:
- 340B litigation impacts
- PBM reform implications
- IRA implementation challenges
- State regulatory trends
- Drug shortage mitigation
- FSS "Made in America" requirements
Enterprise Impact:
- Field sales adaptation
- Product lifecycle reassessment
- Treasury cash flow management
- Portfolio valuation shifts
- Cross-functional alignment
- M&A strategy evolution
Strategic Planning:
- Policy-informed product valuation
- R&D investment considerations
- Regulatory-to-business translation
- Technology integration
- Treasury/BD/Regulatory collaboration
- GTN optimization strategies
*Lunch will be provided to participants.
- Suzie Tam-Porter - VP, Channel & Contract Management, Genentech
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor Pharma
- Stephanie Kupski - Director US Pricing & Government Reporting, North American Commercial Operations, CSL Behring
Showing 1 of 1 Streams
General Session
1:40pm - 2:20pmLive Stream
Recent OIG Evaluations Involving Prescription Drug Pricing, Payment, and Coverage
Review of recent OIG investigations, audit findings, and enforcement actions related to government pricing programs, with focus on upcoming enforcement priorities.
- David Tawes - Regional Inspector General, Department of Health and Human Services, Office of Inspector General
- Sarah Vogel - Social Science Analyst and Team Leader, Office of Inspector General
2:20pm - 3:00pmLive Stream
ASP Reporting Challenges with Skin Substitutes and Beyond
- Understand the complex regulatory landscape for products paid like drugs but regulated as devices
- Address recent enforcement actions and compliance expectations for ASP reporting of skin substitutes and similar products
- Develop effective approaches for classifying products and ensuring accurate reporting
- Explore potential policy changes affecting ASP reporting requirements under the new administration
3:00pm - 3:05pm
Close of Conference - See You in 2026!
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