DAY ONE - Wednesday June 19, 2024

8:30 am Check-In & Light Breakfast

8:50 am Chair’s Opening Remarks

Unveiling Global Approaches to CDx Regulation to Unify Frameworks for Accelerated Approvals in International Markets

9:00 am Navigating the IVDR Maze to Overcome Regulatory Confusion & Bottlenecks to Expedite Approvals

  • Brian Baker Executive Director - Regulatory Affairs (In Vitro Diagnostics), Regeneron

Synopsis

  • How to overcome current regulatory challenges surrounding IVDR implementation?
  • Exploring the lack of specific guidance and the impact on processes and systems, and what can be done to add clarity to this

9:30 am Panel Discussion: Overcoming Challenges in a Shifting Regulatory Landscape to Gain CDx Approval Across Diverse Markets

  • Claudia Dollins Vice President, Global Regulatory Affairs, Precision Medicine & Digital Health, GSK
  • Jai Pandey Global Head of Device Regulatory for In Vitro Diagnostics & Companion Diagnostics, Digital Health, Sanofi
  • Debra Rasmussen World wide Executive Director Regulatory Affairs, Johnson & Johnson Services, Inc
  • Sid Mathur Executive Director, Regulatory Affairs & Companion Diagnostics, Merck

Synopsis

  • Discussing the dynamic nature of the regulatory landscape and strategies for adapting to changes, ensuring successful CDx approvals across different markets
  • How can we strive towards a unified regulatory framework – where could regulatory bodies collaborate to drive harmonious efforts in CDx regulation?
  • Exploring the advantages and disadvantages of different approaches to CDx regulation
  • Standardization goes beyond geopolitical realities – so what can be done?

10:30 am Morning Refreshments & Speed Networking

Synopsis

As the CDx Regulatory Affairs & Policy community unites for the first time, this valuable session will ensure that you can connect with your peers in the room to make new & lasting connections. All attendees will have the opportunity to meet & network with their industry equals.

Navigating LDT Regulation & Reimbursement to Expedite Policy Adaptations for Successful Scale Up

11:30 am Leveraging Tactical Considerations in Pharma to Balance LDT Regulation & CDx Development to Ease Regulatory Pressures

Synopsis

  • How could LDTs play a role in supporting global testing and scaling up CDx development?
  • Assessing the risk and benefits associated with relying on LDTs for testing purposes
  • Debating the business case for pharmaceutical companies to develop CDx in the context of regulatory changes and potential labelling requirements

12:00 pm Assessing Reimbursement Policies for LDTs Amid Evolving Regulatory Frameworks to Fast-Track Difficult Policy Adaptions

Synopsis

  • Exploring the context behind reimbursement strategies for LDT’s
  • How will reimbursement change as regulation increases?
  • How can pharma prepare to minimize commercial bottlenecks for reimbursement during shifting regulatory frameworks

12:30 pm Lunch & Networking Break

Curating Effective Policies to Navigate Complex Reimbursement Dynamics Globally for Swift Patient Access to Precision Drugs

1:30 pm Learning Opportunities from Reimbursement & CDx Regulatory Policies in APAC to Consider in Updated Policies

  • Debra Rasmussen World wide Executive Director Regulatory Affairs, Johnson & Johnson Services, Inc

Synopsis

  • Understand the current predicament of Japan regarding CDx reimbursement
  • What benefits of the Japanese approach should be considered moving forward
  • Understanding the different climates of APAC approaches of reimbursement for CDx
  • Working on solutions to ensure patients are still accessing optimal treatments

2:00 pm Fireside Chat: Navigating the Maze of Global Reimbursement Policies for CDx to Facilitate Patient Access to best-in-class Drugs

  • Eugean Jiwanmall Senior Scientist, Independence Blue Cross
  • Ralph Riley Director, Precision Medicine Access Strategy, Johnson & Johnson

Synopsis

  • Exploring the impact of pricing and reimbursement on patient access
  • Addressing frustrations in product availability for the majority of patients
  • Discussing the role of regulators and industry players in overcoming barriers
  • Highlighting the need for a shift towards value-based reimbursement

3:00 pm Afternoon & Networking Break

Harnessing AI & Novel Technologies to Establish Standardized & Objective Processes for Streamlining Clinical Trials

4:00 pm Perspectives on Regulatory Framework with Evidence-based Data from SOC to Bridge Gaps with Clinical Practice

  • Qing Li Director of Pathology - Clinical Development, Oncology, Moderna

Synopsis

  • Identify common elements in clinical practice from SOC that could be potentially used for patient stratification
  • Discuss gaps and strategies how to leverage diagnostic data by implementing AI/ML enable digital pathology platform to facilitate clinical development
  • Explore collaborative approaches across industry and regulatory agencies that can contribute to harmonized patient care
  • Maximize the utility of patient data from SOC in the context of use of ‘CDx’ or ‘LDT’

4:30 pm 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

5:00 pm Chair’s Closing Remarks & End of Conference Day One

DAY TWO
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