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Monday, June 16
 

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 →
BO

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
 
Tuesday, June 17
 

10:30am EDT

Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
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; 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


Speakers
avatar for Hillary Andrews

Hillary Andrews

Director, Regulatory and Research Partnerships, Friends of Cancer Research, United States
Hillary Andrews serves as the Director, Regulatory and Research Partnerships at Friends of Cancer Research (Friends) where she supports the development and implementation of the organization’s research and policy agenda. She uses her scientific and advocacy background to develop... Read More →
avatar for Chris Bray

Chris Bray

Head of Global Regulatory Affairs Precision Medicine & Companion Diagnostics, Merck Serono Ltd., United Kingdom
Chris has worked within the biotechnology and pharma industry for over 25 years, including over 20 years in the IVD and personalized healthcare space. He has a successful track record in CDx and drug (co-) development, collaborating with global teams to deliver on precision medicine... Read More →
avatar for Chris Karlovich

Chris Karlovich

Director, Molecular Characterization Laboratory, Leidos Biomedical Research, United States
Chris Karlovich Ph.D. is Director of the Molecular Characterization (MoCha) Laboratory at the Frederick National Laboratory (FNL). Since joining FNL in 2017, he has made key contributions to several important NCI precision medicine initiatives. Among these was NCI-MATCH, the largest... Read More →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
DL

Dun Liang

Director, Global Regulatory Affairs, Diagnostics, Eli Lilly & Co., United States
Dun is a diagnostics and regulatory expert with unique experience across pharma, diagnostics, and government. At Eli Lilly, He provides critical strategic and tactical guidance, interpretation, and assessments on diagnostic regulations globally. He coordinates, plans, and executes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am 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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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