Conference Day Two
Wednesday 18th October 2023
8:00 am
Conference Registration & Welcome Coffee
8:50 am Chair’s Opening Remarks
Discussing the Logistical Considerations To Avoid Delays During the Running of an EAP
9:00 am Panel Discussion: Approaching Internal Collaboration & Capacity Building for EAPs
Synopsis
- Exploring opportunities for upskilling internal teams to enhance their understanding of EAPs and enable effective engagement with external stakeholders, including patients, regulators, and advocacy groups
- Identifying key strategies for finding the right person to communicate with regulatory agencies and other external stakeholders
- Utilising external partners to maximise the potential of biopharma EAP teams
9:45 am Fairly & Equitably Determining the Geographic Scope of EAPs
Synopsis
- Developing a fair and equitable process for determining which countries to include in an EAP
- Balancing the need to provide access to critical therapies with the need to manage financial risk and ensure sustainable programme operations
- Implications of topics 2 and 3 for mid versus larger size companies
10:15 am Securing Supply Chains throughout the Program Duration
Synopsis
- Recognizing the importance of securing stock for the duration of supplied access
- Examining sources of drug supply from clinical trial stock to marketed product to donations
- Understanding the regulatory implication of changing drug stock throughout the duration of supplied access
10:45 am
Morning Break & Networking
11:15 am Roundtable Discussion:
Synopsis
This interactive session gives you the opportunity to be part of the discussion, share ideas, and learn from your peers. Choose the table most relevant to you, and get ready to be part of this conversation:
- How can RWD Increase Your Patient Experience Understanding in an EAP?
- Ensuring Data Privacy are Followed
- Developing Effective Exit Strategies
12:15 pm Genomics England Supporting Pharmaceuticals & Biotechnology to Advance Genomic Healthcare and Move Towards Precision Medicine
Synopsis
- Exploring the collaborative efforts between Genomics England and pharmaceuticaL companies to drive genomic medicine
- Highlighting the potential for discovering new drug targets, identifying patient subgroups, and enhancing therapeutic approaches
- Showcasing real-world examples of how genomics-guided therapies are transforming patient outcomes and treatment efficacy
12:45 pm
Lunch Break & Networking
1:45 pm Streamlining Collaboration Between Sponsors & Clinicians to Improve Early Access: Experience With a Technology-Based Management Platform.
Synopsis
- Using workflows to speed EA requests and medical review and relieve the burden on clinicians and their staff
- Improving visibility and easing interaction between sponsors and clinical sites
- Capturing treatment information and experience reflective of Real World Data, leading to improved patient experience
Transitioning Out of An EAP While Supporting Patients
2:15 pm Interactive Group Discussion: Balancing Commercial Considerations with Long-Term Supply Chain Strategies in EAPs
Synopsis
- Addressing low volume concerns while ensuring timely and efficient distribution of critical therapies
- Devising a long-term supply chain strategy that forecasts an appropriate level of supply
- Printing clear and concise labelling to ensure compliance with regulatory requirements
2:45 pm Outlining the Changing Landscape of Post Trial Access
Synopsis
- Examining current trends in Early Access
- Understanding the regulatory aspects of Post Trial Access
- Addressing operational considerations in Post Trial Access
3:15 pm Afternoon Break
3:45 pm Integrating Approaches to Pre- and Post-Trial Access Programmes
Synopsis
- Leveraging the relationship between pre-approval access and post-trial access programmes and how one can impact the other
- Developing integrated end-to-end strategies that consider the entire product lifecycle and take a horizontal approach to pre- and post-trial access
- Addressing ethical considerations and develop exit strategies for situations where continued access to a product is necessary
4:15 pm Navigating Challenges and Lessons Learned: Transitioning Active Clinical Trial Patients to an Expanded Access Program During Study Closure
Synopsis
- Ensuring early communication with the CRO and investigators during study closure and the transition to Expanded Access
- Considering the Single Patient IND strategy for expanded access across multiple countries while recognising the need for additional support for participating investigators
- Including vendors for the smooth implementation of the transition process