DIA 2025 Global Annual Meeting

Component Type: Session
Level: Basic

Through this session, we will explore the advantages of incorporating AI and digital pathology for drug and biomarker discovery as part of a long-term CDx partnership. We will also explore potential regulatory challenges in this ever-evolving space.

Learning Objectives

Discuss the importance of a complete development lifecycle of drug and companion diagnostic; Describe a complete development lifecycle of a drug and companion diagnostic; Describe potential regulatory challenges facing AI, Digital Pathology, and CDx development.

Chair

Fatima Khaiser, MA

Component Type: Session
Level: Intermediate

Precision medicine integrates advanced technology and healthcare to tailor treatments to individuals, aiming to enhance outcomes. However, the rise of artificial intelligence (AI) and advanced technologies in this field introduces new ethical complexities. Privacy, informed consent, and social justice remain central concerns, but evolving technologies brings additional challenges, such as biases in algorithmic predictions and the transparency of decision-making processes. AI-driven models used to predict treatment outcomes or develop personalized care plans can reflect societal biases if trained on unrepresentative or flawed data. This raises concerns about fairness, as patients could be unjustly stratified based on genetic, racial, or socioeconomic factors. Precision medicine, which stratifies patients by genetic profiles, risks perpetuating discrimination or exacerbating health disparities.

Learning Objectives

Understanding of bioethical impact within the next generation of medcine; Ackowledge the importance of the inclusion of diverse, representative populations and handling of incidental findings—unanticipated results that arise during genetic screening—must be ethically integrated into research protocol.

Chair

James Wabby, MHS

Speaker

Ethics in the Era of Precision Medicine and Advancing Technologies
James Wabby, MHS

Ethics in the Era of Precision Medicine and Advancing Technologies
Amanda Burkhardt, PhD

Component Type: Session
Level: Advanced

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; Explore approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Component Type: Session
Level: Intermediate

The FDA has published a final rule to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act. The publication of the rule has far-reaching implications for the quality and availability of diagnostic tests in the United States, as well as impacts on pharmaceutical product research. This session will discuss the final rule in a panel format, focusing on the impact to various stakeholders, as well as current compliance efforts and next steps for ensuring compliance. The session will also address the impact of the recent election, legislative and executive actions, and litigation, on the FDA’s regulation of laboratory developed tests.

Learning Objectives

List requirements of the LDT Final Rule and phased approach to regulation; Summarize implications of the FDA LDT Final Rule for patients, developers, health care systems, providers and regulatory decision making; Discuss approaches to implementing requirements of the final rule.

Chair

Courtney Granville, PhD, MPH

Component Type: Session
Level: Intermediate

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Analyze the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC