7:30 am Registration & Coffee
8:20 am Chair’s Opening Remarks
Strategies to Support Long-Term Market Access Needs
8:30 am Are Reimbursement Systems Ready to Accommodate Outpatient- Administered CGTs?
Synopsis
- Understanding the drivers behind the increasing number of CGTs being administered in the outpatient setting, and whether current infrastructure is equipped to manage this growth
- Sharing strategies to work with states to overcome barriers to access
- Setting out a roadmap of improvements needed in reimbursement systems to support outpatient administration
9:00 am Talk Details to be Announced Shortly
Synopsis
Speaking Position Reserved for Uniphar
9:30 am Pivoting for Sustained Success: Maturing and Emerging Payment Models
Synopsis
- Implications of updated projections of CGT products, treated patients, and resultant product revenues through to 2032
- Lessons learned that are refining CGT payment models
- Emerging solutions to remaining challenges in providing patient access
10:00 am Morning Refreshments & Speed Networking
Synopsis
Our speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in the field and introduce yourself to the attendees that you would like to have more in-depth conversations with. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond
11:00 am Securing Adequate Out-of-State Coverage & Reimbursement
Synopsis
- Innovative strategies to overcome the challenge of Medicaid out-of-state coverage, with examples across a variety of states engaged
- Contracting with out-of-state providers to ensure adequate reimbursement
- Overcoming cross-border credentialing challenges
Evolving Health Systems to Expand Patient Access
11:30 am Strategies from Academia to Increase Access to Cell & Gene Therapies
Synopsis
- Outlining the Penn Medicine ‘Hub & Spoke’ model and how it is improving community access to CGTs
- Understanding the types of payment structures being used and important steps to ensure coverage by insurers
- Distinguishing between starting up a BMT program and CGT program
- Best practice advice for other community members looking to implement a similar mode
12:00 pm Pioneering Pathways: Expanding Reach of Cell and Gene Therapies
Synopsis
Speaking Position Reserved for Uniphar
12:30 pm Expanding Access to CAR-Ts Beyond Current Settings: How Can Health Systems Evolve to Meet Growing Cell Therapy Needs?
Synopsis
- Benchmarking the CAR-T expansion journey from its inception, and the current roadblocks to further expansion
- Discussing studies showing how expansion has improved patient access and outcomes
- Exploring solutions that have been proposed to improve access to CAR-Ts
- Outlining areas of research that are needed to address future challenges
1:00 pm Lunch & Networking
Preparing Early for Market Access & Health Technology Assessments
2:00 pm A Case Study of Effective Market Access Involvement in Early Clinical Phase Development
Synopsis
- Sharing an example of effective clinical trial design to meet future payer and HTA requirements
- Leveraging real-world evidence and robust evidence generation to supplement trial data
- Practical advice on payer engagement strategy through clinical development
2:30 pm The Critical Role of Market Access in Early Gene Therapy Development
Synopsis
- Engaging Market Access teams early to ensure pricing, reimbursement, and health system adoption challenges are addressed before costly late-stage hurdles arise
- Exploring how proactive Market Access strategies can shape clinical development, evidence generation, and payer engagement to maximize patient access and commercial success
3:00 pm Panel Discussion: Understanding Payer Concerns on CGT Durability, Risks & Benefits
Synopsis
- Pinpointing key reasons payers have around clinical uncertainty that hinders coverage
- Assessing the benefits and drawbacks of different strategies to minimise clinical uncertainty
- Payer perspectives on the current outlook and future direction for outcomes-based agreements
- Practical advice for manufacturers looking to propose payment contracts that mitigate this risk
3:40 pm Afternoon Refreshment Break & Scientific Poster Session
4:25 pm Outlining the Preparation and Engagement Work Required for an ICER Review
Synopsis
- The ICER value-assessment framework and the Importance within the international HTA context
- Evidence development and multistakeholder engagement in advance of an ICER review
- Preparation for participation in the ICER evaluation process
4:55 pm Panel Discussion: Designing a Clinical Development Program to Support Future Market Access
Synopsis
- What are the critical market access steps when entering the clinic?
- Bridging the gap between early-phase development and commercial: ensuring relevant payer and patient endpoints are a consideration in all phases of study design
- Practical advice when designing a clinical program for an intended first-in-class therapy
- Does engagement with Medicare look the same as commercial payers?