DAY TWO - Thursday June 20, 2024
8:30 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Pioneering Novel Strategies to Approach Rare Diseases at the Intersection of Drug & Device Regulation to Meet Unmet Patient Needs
9:00 am Executive Workshop: A Global Perspective on the Interface Between Drug & Device Regulation in Clinical Studies
Synopsis
- Significance of global clinical design in device regulatory affairs
- Discussing strategies for incorporating digital technologies into clinical studies and patient care
- Addressing challenges in patient selection, monitoring, and data collection when integrating devices into clinical trials
- Exploring strategies for addressing unmet patient needs through innovative drug-device combinations
- Expectations from CDx partnerships, with respect to diagnostic testing, to maintain good practice
- An exploration of the LDT Final Rule
10:30 am Morning Networking Break
Forming Strategic Partnerships with CDx Developers to Align on Regulatory Expectations for Expedited Drug/Diagnostics Approvals
11:30 am AI/ML Is Taking Over the World. Is it Taking Over CDx too?
Synopsis
- Use cases for AI/ML in and alongside CDx
- Regulatory and practical challenges for AI/ML in CDx trials
- Where are we now and where are we going? Policy shifts for CDx and AI/ML and what it means for future development
12:00 pm Panel Discussion: Strategically Planning CDx Partnerships to Ensure Effective Relationships to Expedite Regulatory Approvals
Synopsis
- Early regulatory involvement in CDx partnerships
- Setting out clear expectations and requirements to establish effective relationships for quick development and regulatory approval of CDx
- Strategies to ensure seamless communication and collaboration between pharma, diagnostic developers and regulatory authorities
1:00 pm Lunch & Networking Break
2:00 pm Ask the Experts: Navigating the Paradigm Shift: The Role and Regulation of Companion Diagnostics (CDx) in Precision Medicine
Synopsis
Join us for an open-to-the-floor Q&A session on the evolving landscape of CDx. This session will feature industry experts discussing the paradigm shift in precision oncology drug development and clinical practice, evolving regulatory landscape, and the future direction of CDx. We’ll explore the challenges, new regulations, and practical considerations for CDx in clinical practice and drug trials. The Q&As are designed to spark a broad and insightful discussion.
2:45 pm Assessing Challenges in Existing Regulatory Frameworks for Rare Diseases to Facilitate CDx Approval Across Diverse Therapeutic Domains & Navigating the Complex Landscape of Diagnostics in Gene Therapies
Synopsis
- What are the critical challenges associated with obtaining patient samples for rare diseases to meet the validation requirements for regulatory approval?
- Navigating innovative approaches in overcoming evidentiary hurdles specific to rare diseases within the CDx regulatory framework- a shift from oncology, evolving global regulatory landscape, decision on centralized versus point of care testing
- Analysing the complex nature of companion diagnostics in rare diseases, for e.g., gene therapy space to support accelerated approvals, increased need for patient testing in certain indications
- Reimbursement challenges for CDx in rare disease setting