DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-514-L04-P; CME 1.00; RN 1.00

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Recognize the technology landscape for more complex drug delivery combination products, specific patient considerations informing design and clinical risk, and the role of new regulatory tools like Essential Drug Delivery Outputs; Discuss current challenges facing combination products to deliver advanced therapies (Cell & Gene) or biologics including submission expectations (IND, NDA/BLAs), verification, validation, Control Strategy, and post-market changes.

Chair

Rumi Raquel Young, MS

Speaker

Overview of complex combination product technologies (implantable, on-body) and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development (EDDO Focus)
James Bertram, PhD, MS, RAC

Emerging Policies Driving Complex Combination Product Development (How other Policies Work with EDDO)
Chelsea O'Connell, MS, RAC

Patient Perspectives on Advanced Therapies and use of Complex Combination Products
Stephen Karpen, PharmD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-525-L04-P; CME 1.00; RN 1.00

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 companion diagnostic (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

Greg Morehouse, MS

Speaker

Panelist
Brendan O'Leary

Panelist
Mark Stewart, PhD

Panelist
Elaine Katrivanos

Panelist
Andrew Ciupek, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-541-L04-P; CME 1.00; RN 1.00

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

Discuss the bioethical impact within the next generation of medicine; Recognize the importance of the inclusion of diverse, representative populations and handling of incidental findings.; Discuss how pharmaceutical company possesses its own data that can be explored, which is specific to their organization and reflective of their trial designs; Describe methods that have potential to enhance patient safety in RCTs by leveraging these unique datasets.

Chair

James Wabby, MHS

Speaker

Panelist
Robert Danny Huntington, Esq, JD

Panelist
Scott Schell, MD, PhD, MBA, MPH

Panelist
Ann Marie Hake, MD

Panelist
Chris Schneiderman, MPH