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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

2:15pm EDT

Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Basic

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc


Speakers
avatar for Ankush Chandna

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States
KL

Kevin Lee

Data Scientist, Clinvia, United States
Kevin Lee is a Data Scientist and Biometrics Leader with 20 years of experience in Big Data, Cloud, Open-Source Programming, Data Sciences and Machine Learning in pharmaceuticals. His leadership and passion for innovation drive continuous advancement in Pharma. Recently focused on... 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
  12: ProfDevelopment, Session

2:15pm EDT

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Basic

Data science, AI and LLMs are redefining how we conduct clinical development to be faster, more efficient and more patient-centric. The National Insititute of Health, in partnership with the private sector, is leading the charge in driving change.

Learning Objectives

Describe examples of NIH innovation in tech-enabling clinical development through the application of data science, AI and LLMs; Identify potential opportunities for future public-private partnerships to accelerate tech enablement of clinical development.

Chair

Peter Ronco

Speaker

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Warren A Kibbe, PhD

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Arnaub Chatterjee, MHA, MPA

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Susan Gregurick


Speakers
avatar for Arnaub Chatterjee

Arnaub Chatterjee

President & GM - Life Sciences, Datavant, United States
Arnaub Chatterjee is Chief Product and Solutions Officer at TriNetX, a health technology platform focused on improving clinical research, evidence generation and safety. He also serves as Senior Advisor at the Carlyle Group where he evaluates investments in the life sciences and healthcare... Read More →
SG

Susan Gregurick

Associate Director, Data Science and Director, NIH ODSS, National Institute of Health, United States
WK

Warren Kibbe

Deputy Director, Data Science and Strategy, National Cancer Institute, United States
Dr. Kibbe is the Northwestern site PI for caBIG™ activities. Dr. Kibbe received his Ph.D. in Chemistry from Caltech, and was a visiting scientist at the Max Plank Institute for Biophysical Chemistry in Göttingen, Germany before joining the faculty at Northwestern.
avatar for Peter Ronco

Peter Ronco

CEO, Emmes, United States
Peter is an accomplished drug developer and innovative senior pharmaceutical executive who advises boards, private equity investors, and leaders across the pharmaceutical and biotech industry. He has extensive global experience across a broad range of therapeutic areas, including... 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
  13: Spotlight, Forum

3:45pm EDT

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Forum
Level: Basic

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch

J&J Experience
Joseph William Markmann

BMS experience
Sandra Krogulski, MA

Novartis Experience
David Yao


Speakers
avatar for Paul Bolot

Paul Bolot

Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot works in Regulatory Policy & Science at Bayer. Prior to joining Bayer, he worked as consultant in regulatory affairs at PharmaLex. He is a pharmacist (PharmD) by training and has a master's degree in international drug development and registration. He is based in Basel... Read More →
avatar for Sandra Krogulski

Sandra Krogulski

Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of... Read More →
JM

Joseph Markmann

Principal Data Science Lead, Global Regulatory Affairs, United States
BM

Ben Moscovitch

Public Policy, Amazon Web Services, United States
DY

David Yao

Associate Director, Regulatory Affairs CMC, Novartis, United States
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
  09: Regulatory, Forum

3:45pm EDT

AI in Patient Care: Aspirations and Considerations
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Advanced

We will discuss potential applications of AI in making diagnoses and treatment decisions, the appropriate ethical and regulatory boundaries, and how to progress forward balancing patient benefits against the potential risks.

Learning Objectives

Recognize the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions; Discuss ways to formulate plans to bring artificial intelligence solutions to market and shape regulations.

Chair

Eli Weinberg, PhD, MS

Speaker

Panelist
Isaac Kohane, MD, PhD

Panelist
Shweta Maniar

Panelist
Subha Madhavan, PhD, FACMI


Speakers
avatar for Isaac Kohane

Isaac Kohane

Chair, Department of Biomedical Informatics, Harvard Medical School, United States
Isaac Kohane, MD, PhD, is the chair of Harvard Medical School’s Department of Biomedical Informatics, whose mission is to develop methods and tools for a new generation of scientists and doctors to move biomedicine rapidly forward with the insight and precision offered by big data... Read More →
avatar for Subha Madhavan

Subha Madhavan

Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States
Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →
avatar for Shweta Maniar

Shweta Maniar

Director, Healthcare and Life Sciences Solutions, Google Cloud, United States
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
EW

Eli Weinberg

Partner, Bain & Co., United States
Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... 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
  13: Spotlight, Session |   09: Regulatory, Session
 
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    18: InnovationTheaters
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  • Level
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  • 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)
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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