Conference Day One
Conference Day One
Wednesday 26th June 2024
8:00 am Check-In & Coffee
8:50 am Chair’s Opening Remarks
Dissecting the Global Cell & Gene Landscape by Understanding the Current State & Address Critical Challenges to Improve Global Patient Access
9:00 am Discussing the Blueprint for a Successful Commercial Launch by Exploring Challenges & Uniting Industry, Government, & Payers to Address Challenges Together
Synopsis
- Discussing unique payer challenges for cell and gene therapy: how do you prepare for sustainable commercialization of these promising therapies?
- Key considerations for a successful commercial launch
- Knowing your customer (industry, government, payers and finding a way together)
9:30 am Fireside Chat: Reviewing Global Market Access & Challenges to Streamline Ongoing Strategies & Improve Patient Access
Synopsis
- What are the key challenges that are currently hindering effective pricing and reimbursement globally?
- What challenges have we overcome during the commercialization of currently approved cell and gene therapies?
- What challenges will be a priority to tackle in the next 5 years?
- What is the global state of cell and gene therapies?
10:00 am Morning Break & Speed Networking
Synopsis
As this community unites for the first time, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections
Evaluating Value-Based Pricing to Amortize the Financial Burden & Support Manufacturer’s Profitability
11:00 am The Health Plan Perspective on Financing Cell and Gene Therapies
Synopsis
- Incentivizing market-based solutions
- Learning from CMMI access model
- Provider engagement and responsibilities
11:30 am Accelerating Global Patient Access to CGTs: From Aspiration to Reality
Synopsis
- Do you aspire to provide global patient access?
- Leverage our experience gained over the last 5 years providing access to CGTs globally
- Maximise experience from early patient access to optimise your launch strategy
12:00 pm Panel Discussion: Discussing Outcome-Based Contracts to Prepare for Therapy Failures by Sharing Risk With Health Insurers
Synopsis
- How to provide an alternative to buy-and-bill?
- Exploring the variety of payers in the US landscape detailing the structures for government payers and commercial payers, and addressing the high variability of state government plans
- How to go into pricing agreements with each health plan to guarantee the best price
12:45 pm Lunch & Networking Break
Tackling Health Economics & Real-World Evidence to Establish a Robust Delivery Model for Expediting Approvals of Transformative Therapies
1:45 pm RWE to Optimize Access for Transformative Therapies
Synopsis
- Role of RWE in the US
- Why do we care?
- How is RWE leveraged across the lifecycle?
- Challenges and recommendations to optimize RWE for access
2:15 pm Panel Discussion: Analyzing the CMS Coverage with Evidence Development Model for Enhanced Access to Beneficiaries: A Real-World Evidence & Health Economics Perspective
Synopsis
- Assessing the scientific merit and clinical validity of interventions or therapies within Medicare/Medicaid-covered populations
- Exploring the reasonability and necessity of Medicare/Medicaid coverage for specific therapies
- Examining coverage contingent upon randomized control trials or real-world evidence studies to validate pre-market evidence in the applicable Medicare beneficiary population
- Aligning coverage with evidence development (CED) requirements and their relationship to outcomes expected in risksharing contracts
- Strategizing the integration of CED studies with existing risk-sharing contracts for optimal real-world evidence and health economics impact
3:15 pm Harnessing Tech for Effective Pharma-Payer Collaboration
Synopsis
- Learn how technology can expedite access and improve collaboration within pharma organizations and with payers
- Discuss strategies to elevate access conversations earlier in the planning and launch process
- Identify new ways to interact with payers and remove friction from payer engagement
3:30 pm Afternoon Break & Networking
Navigating the Complexities of Real-Wold Evidence by Addressing Patient Enrollment & Data Collection for Increased Access
4:00 pm Gaining In-Depth Insights into the US Market Landscape to Uncover Hidden Challenges & Anticipate Future Benefits for Strategic Decision-Making
Synopsis
- How to tackle patient enrolment hurdles such as co-pay concerns or fear to enhance treatment onboarding?
- Lessons learned about the barriers to utilization posing difficulties to broad access and utilization of cell and gene therapies as we prepare for more of these products to enter the market
- Assessing the potential value-based agreements, such as CMMI’s cell and gene therapy model in supporting increased access
4:30 pm Addressing the Evolving Role of Real-World Evidence & its Impact on the Sustainability of the Cell & Gene Space for Long-Term Viability
Synopsis
- How can real-world data support our understanding of durable benefits?
- How to address the uncertainty around the durability of treatment and true clinical value of these therapies?
- How to use the same data collection vehicle to also demonstrate benefit alongside safety?
- Understanding which data is representative of benefit and how to collect it