Conference Day Two
Thursday, July 31
8:00 am Check-In & Welcome Breakfast
8:45 am Chairperson’s Welcome Address
When Should an Expanded Access Program Start to Sunset: Re-Thinking Exit Strategies, Reimbursement Opportunities & Transitions to Commercial Products or Termination
9:00 am Fireside Chat: Developing Thoughtful & Transparent Exit Plans to Effectively Manage Expectations & Minimize Potential HCP Burden
Synopsis
- Developing a clear exit strategy through successful forward-planning that enables seamless transition of patients from expanded access, to commercial availability or other milestone-based activities
- Mitigating the impact of terminating expanded access through effective, transparent communication with external stakeholders
- Developing a closure process with internal stakeholders to ensure a compliant transition for expanded access patients in each participating country
10:00 am Roundtable Discussion: Breaking Down Siloes Through Effective, Proactive Collaboration for a Successful Commercial Launch
Synopsis
- Discussing how to effectively leverage the expertise of Market Access teams while preserving the core values of early access initiatives
- Understanding the value of gaining input from commercial teams to define the most appropriate strategy for your program
- Defining the value of leading early discussions with local health ministries and patient advocates prior to launching your expanded access program to highlight future commercial paths within different countries
11:00 am Morning Break
11:30 am Strategic Considerations for a Patient-Centric Approach in the Route to Commercialization
Synopsis
- Examining the ethical considerations on when and where is it appropriate to charge for access
- Balancing the pre-commercialization price with providing equitable access and the impact on future commercial pricing levels
- Unpacking the impacts of charging for unlicensed drug in regions without commercialization intention
Developing Proactive Strategies for Post Trial Access & Equitable Programs to Ensure “No Patient Left Behind”
12:00 pm Looking to the Future: Planning Ahead for Post-Trial Access to Create Equitable Solutions for All Stakeholders Involved
Synopsis
- Ethical considerations on the decisions to provide post-trial access to investigational medicine
- Defining an effective transition strategy with minimal disruption to patient care, regulatory compliance, and overall program efficiency through careful coordination and early engagement with clinical trial teams
- Understanding the different post-trial access regulations and policies from country-to-country and factors to consider when determining where to provide post-trial access
12:30 pm Expanding Patient Reach in EAPs: Overcoming Operational & Regulatory Challenges to Address Global Health Inequity related to Treatment Access
Synopsis
- Sustainability Challenge: Importance of sustainable medical access in low-to-medium income countries (LMICs) and emerging markets
- Stakeholders Engagement: The role of governments, NGOs, private sector, and international organizations
- Case Studies: Brief overview of successful models and key gaps that remain unaddressed
1:00 pm Lunch Break & Networking
Overcoming Supply & Labelling Hurdles to Drive Practical Supply Management in Expanded Access
2:00 pm Balancing Clinical Trial Requirements & EAPs Through Effective Inventory Management to Ensure Appropriate Resource Allocation
Synopsis
- Enabling appropriate forecasting of supply through effective technology integration to satisfy clinical trial needs alongside, post-trial access requirements, and anticipated expanded access demand of these drugs for patients in need
- Lessons learned from the delivery of a pre-approval programme alongside clinical pipeline progression
Leveraging Real-World Data from Expanded Access to Support Regulatory Approvals & Reimbursement Strategies for Better Patient Outcomes
2:30 pm Differentiated Approach to EAPs Using a Reimagined Model for Advancing Therapeutics
Synopsis
- Analyzing a novel funding model that is solely focused on delivering “hope for life” to patients
- Exploring lessons learned about gathering actionable clinical insights from the program
- Compliantly tracking longitudinal patient data to enable actionable insights, supplement clinical trial data, inform regulatory decision-making and advance cancer treatment decisions
3:00 pm Unpacking the Ethical Considerations for Informed Consent within Expanded Access to Effectively Manage Patient and Sponsor Expectations
Synopsis
- Exploring the ethical importance of informed consent and assent in Expanded Access to ensure patients understand the potential risks and benefits of these investigational drugs
- Highlighting the sponsor responsibility of creating a minimal programmatic standard for consent and ensuring that effective informed consent/assent has been successfully secured from the patient
- Considering the additional ethical obligations to patients in the context of collecting RWD including how it will be protected and used, both now and in the future