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

  • Andrea Renninger Senior Director, Regulatory Affairs - Companion Diagnostic, Daiichi Sankyo
  • Claudia Dollins Vice President - Precision Medicines & Global Regulatory Affairs, GSK
  • Lori Roadcap Senior Director - Global Regulatory Sciences & Digital Health, Bristol Myers Squibb


  • 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?


  • 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


  • 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

  • Dun Liang Executive Director, Regulatory Affairs, CDx, Loxo@Lilly
  • Sarah McManus Director - Global Regulatory Affairs Diagnostic, Johnson & Johnson
  • Jai Pandey Head, Global Device Regulatory for IVD/CDx and Digital Health, Sanofi
  • Sid Mathur Executive Director - Regulatory Liaison, Merck


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

  • Jai Pandey Head, Global Device Regulatory for IVD/CDx and Digital Health, Sanofi


  • 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

3:15 pm Chairs Closing Remarks

3:20 pm End of World CDx Regulatory Affairs & Policy Summit 2024