Explore the Agenda
8:00 am Registration & Coffee
8:50 am Chair’s Opening Remarks
Reviewing the Current Cell & Gene Therapy Access Landscape to Inform Smarter Commercialization Decisions
9:00 am Fireside Chat: Shaping the Future of Cell & Gene Therapy Access
- Examining how evolving clinical data, payer expectations and policy shifts are redefining commercial success for advanced therapies
- Understanding how affordability pressures, evidence requirements and real-world delivery constraints are shaping near term and long-term market viability
- Exploring what manufacturers, payers and providers need to prioritize to sustain patient access as pipelines expand into larger and more common indications
10:00 am State Medicaid Coverage & Reimbursement Landscape for Cell & Gene Therapies
- Pharmacy vs. medical benefit impacts
- Various reimbursement models used
- Impacts of carveouts
10:30 am Morning Break & Speed Networking
Projecting Policy & Market Realities to Strengthen Future Cell & Gene Therapy Adoption
11:30 am Projecting Cell & Gene Therapy Trajectories to Refine Adoption, Coverage & Pricing Decisions
- Integrating cell and gene therapy development success rate and market projections to clarify future coverage, adoption and cost implications
- Mapping indication level differences to show why cell and gene therapies cannot be treated as a single market and where payer and patient dynamics diverge
- Highlighting how insurance and delivery system innovations could impact real-world cell and gene therapy uptake
12:00 pm Framing Short- & Long-Term Policy Pathways to Sustain Cell & Gene Therapy Adoption & System Level Affordability
- Drawing on early lessons from establishing DRG 18 to clarify how initial reimbursement structures have supported inpatient sustainability while exposing unresolved gaps for future cell and gene therapy volumes
- Mapping the core components of today’s reimbursement ecosystem to highlight why cell and gene therapies strain traditional frameworks and which stakeholder questions must be answered to ensure long term policy viability
- Integrating short term policy recommendations with forward looking considerations to outline what must be addressed now to sustain Medicare and Medicaid affordability as cell and gene therapy pipelines expand
12:30 pm Lunch Break & Networking
Optimizing Evidence Generation & Data Collection Processes to Accelerate Commercialization Success
1:30 pm Strengthening Evidence Generation to Support Pricing & Reimbursement
- Clarifying the data elements and evidence needed to assess durability, effectiveness, and long-term value to payers
- Evaluating how study design and population considerations influence evidence strength and reimbursement decisions
- Identifying approaches for generating credible clinical and economic evidence to support market access
2:00 pm Unlocking the Hidden Lever: Accelerating Global Access to Cell & Gene Therapies
- This talk will examine how expanded access can act as a critical but often underutilised lever to accelerate global uptake of cell and gene therapies
- Drawing on real-world delivery across more than 50 countries, it will explore how expanded access pathways and evolving regulatory approaches, including accelerated approvals, are helping unlock access where treatment is not yet available
- It will also examine how expanded access, pricing, and funding considerations intersect, and how these dynamics can support a smoother transition to long-term commercial sustainability
- Finally, the session will provide a practical perspective on what it takes to deliver global access across diverse geographies, navigating complex regulatory, logistical, and healthcare system environments
2:30 pm Afternoon Break & Networking
Advancing Site Readiness & Reimbursement Strategy to Broaden Adoption at the Community Oncology Level
3:30 pm Panel Discussion: Building Sustainable CAR-T Access Through Community Oncology Engagement
- Why community oncology is critical to scaling CAR-T and building infrastructure for long-term patient access
- Key operational and financial differences between academic and community sites that impact market entry
- How reimbursement timelines, coverage policies, and financial risk influence community adoption of high-cost cell therapies
4:30 pm Scaling Access for Acute Allogeneic Cell Therapies: Lessons from Launch & Market Expansion
- Navigating transplant center access barriers unique to allogeneic cell therapies including cost committees’ quality reviews and operational assumptions to accelerate adoption
- Educating payers and Medicaid programs on acute treatment timelines for allogeneic therapies where patients need access in days not weeks
- Expanding delivery beyond major academic centers by enabling smaller transplant programs to confidently administer allogeneic cell therapies through new access education and distribution approaches