DIA 2025 Global Annual Meeting

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-569-L04-P; CME 1.00; RN 1.00

This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test

Learning Objectives

Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Recognize approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Speaker

Establishing a National Clinical Laboratory Network of Validated Assays
Chris Karlovich, PhD

Regulatory Considerations and Strategies for Rare Biomarker Validation
Dun Liang, PhD

Discuss challenges and best practices for CDx validation
Elaine Katrivanos

Provide global regulatory expectations, challenges, and approaches
Chris Bray

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-584-L04-P; CME 1.00; RN 1.00

As of April 2, 2025, President Trump signed 103 Executive Orders in 2025 (EO 14147 to EO 14249) and sweeping government actions have led to widespread change in the health and biomedical research industries. Impacts on precision the effects of many of the Orders are largely unknown and tied up in legislative process. This has created considerable uncertainty for biomedical research and subsequent development of precision medicines and diagnostics. In this session we will review the 2025 Executive Orders, the court decision striking down the LDT Final Rule, and certain organizational changes at FDA that impact precision medicine and research and will delve deeper into the global impacts that are expected as a result.

Learning Objectives

List 2025 Executive Orders affecting personalized medicine and innovation in product and diagnostics development; Summarize impacts of 2025 Executive Orders on health innovation, research, regulations including the LDT final rule and patients; Discuss potential implications of current changes in the environment on global R&D.

Chair

Courtney Granville, PhD, MPH

Speaker

Panelist
Megan Doyle, JD, MPH

Panelist
Lia Ridout

Panelist
Carly McWilliams, MBA

Panelist
Nathan Brown, JD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum