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 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
9:30 am Fireside Chat + Round Table Discussion: 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
10:30 am Morning Networking Break
Enhancing Clarity Through IVDR to Accelerate Clinical Studies & Expedite Drug Development
12:00 pm Underpinning Successful Strategies & Challenges for Europe’s IVD Market
Synopsis
- Overcoming regulatory hurdles in bringing CDx to the Europe market
- Importance of multi-stakeholder engagement
- Alternative approaches that can lead to success
12:30 pm Crafting a Standardized Approach for CDx Development to Reduce the Burden of Numerable Applications & Fast-Track Approvals in Europe
Synopsis
Discuss the current challenges associated with numerous applications for companion diagnostic development, emphasising the burden on regulatory agencies and developers
How could we approach a standardised approach for CDx development, aiming to streamline processes, reduce redundancy, and accelerate approvals?
How can we improve the process of regulatory submissions in line with guidelines and standards set out by the authorities to achieve a quicker delivery?
1:00 pm Lunch & Networking Break
Forming Strategic Partnerships with CDx Developers to Align on Regulatory Expectations for Expedited Drug/Diagnostics Approvals
2:00 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
3:00 pm Piloting Change: The FDA’s Bold Strategies to Reduce the Burden in Clinical Trials
Synopsis
- Delving into the specifics of the FDA’s Oncology Diagnostic (Dx) Pilot Program and outlining the broader objectives of this initiative
- Comparing the new pilot to the current CDx regulations, while also discussing the potential challenges associated with industry participation and the practical aspects of implementing these policies
- Investigating the likely influence of this program on the U.S. regulatory landscape for CDx, particularly in the context of oncology drug development, and its connection to the anticipated down-classification of IVD