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Monday, June 16
 

11:00am EDT

Advancing Innovation Through Essential Drug Delivery Outputs
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently an Assistant Director with the Regulation, Policy, and Guidance Staff in CDRH/OPEQ. In this capacity, James and his team collaborate across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.
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Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory Policy & Intelligence Director, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan Stevens is acting Division Director of FDA's Division of Drug Delivery, General Hospital and Human Factors. His division is responsible for regulation of drug delivery and general hospital device premarket submissions and postmarket safety and compliance. The division also provides... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum |   06: PersonalizedMed-ComboProd-Diagnostics, Forum

2:15pm EDT

Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
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 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

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Brendan O'Leary

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Mark Stewart, PhD

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Elaine Katrivanos

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Andrew Ciupek, PhD


Speakers
avatar for Andrew Ciupek

Andrew Ciupek

Associate Director, Clinical Research, GO2 for Lung Cancer, United States
Andrew Ciupek, PhD, is Associate Director of Clinical Research at GO2 for Lung Cancer. Originally a translational cancer researcher, Andrew transitioned to patient-advocacy to have increased impact on driving patient-centered research. At GO2, Andrew leads implementation of patient-centric... Read More →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
GM

Greg Morehouse

Senior Manager, RA Device, Combination Products, Abbvie, United States
Greg Morehouse has worked in regulatory affairs for precision medicine, both within in vitro diagnostics and pharmaceutical products, since 2018. Greg's experience with companion diagnostics across the pharmaceutical, medical device, and CRO industries affords him unique insights... Read More →
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Brendan O'Leary

Consultant, United States
Brendan O’Leary is Deputy Director of the Digital Health Center of Excellence (DHCoE) at FDA and led the DHCoE as its Acting Director throughout 2022. Over his nearly 14-year tenure with FDA, Mr. O’Leary has built an international reputation as an expert on digital health, medical... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

3:45pm EDT

Ethics in the Era of Precision Medicine and Advancing Technologies
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
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

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.

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


Speakers
avatar for Amanda Burkhardt

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session
 
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  • Keyword
    Advanced Analytics
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    Cell and Gene Therapy
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    Digital Technology
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    Non-CE
    Patient Experience
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TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming