AI Strategy and Business Value in Clinical Development
Driving AI ROI, Impact, and Value
5/18/2026 - May 19, 2026 ALL TIMES EDT
CHI’s inaugural conference on “AI Strategy and Business Value in Clinical Development” explores the strategic, operational, and financial dimensions of AI adoption in clinical development. It will address the key questions leadership teams face regarding AI in clinical research. Senior leaders and cross-functional experts will discuss strategic issues such as change management, implementation and adoption challenges, responsible AI use, outsourcing versus insourcing approaches, regulatory expectations, cost considerations, and the importance of selecting fit-for-purpose applications, technology investments, and how to demonstrate and measure ROI. By bridging technical innovation with business priorities, the sessions will highlight practical strategies for integrating AI into clinical workflows, enabling the long-awaited transformation of clinical research.

Monday, May 18

Registration and Morning Coffee

Organizer's Welcome Remarks

SCALING AI INNOVATION

AI-Enabled Patient Voice Integration in Digital Protocol Design

Photo of Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine , Executive Director and Professor, Tufts Center for the Study of Drug Development. , Tufts University School of Medicine
Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine , Executive Director and Professor, Tufts Center for the Study of Drug Development. , Tufts University School of Medicine
Photo of Henry Wei, MD, Executive Director, Development Innovation, Regeneron , Executive Director , Development Innovation , Regeneron Pharmaceuticals Inc
Henry Wei, MD, Executive Director, Development Innovation, Regeneron , Executive Director , Development Innovation , Regeneron Pharmaceuticals Inc

Patient perspectives have long informed clinical trial design, but AI now makes this process scalable. This session explores how AI-driven tools capture and analyze patient insights across larger populations, informing endpoint selection, digital protocols, and trial workflows. Panelists will share strategies for leveraging AI to enhance trial relevance, engagement, and outcomes while maintaining scientific rigor and regulatory compliance.

AI Brings Change to Clinical Data Operations

Photo of Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck , Senior Director & Global Head Clinical Database Services , Clinical Database Svcs , Merck
Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck , Senior Director & Global Head Clinical Database Services , Clinical Database Svcs , Merck

AI is reshaping clinical data departments, driving new workflows, faster insights, and greater efficiency. This session explores the change management challenges that come with AI adoption, including workflow redesign, staff adaptation, and maintaining data quality and compliance. Panelists will share practical strategies for navigating these transformations and successfully integrating AI into everyday operations.

Best Practices for AI Implementation

Photo of Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo, Inc. , Business Systems Transformation , Global Development Information Management , Daiichi Sankyo Inc
Janie Hansen, Business Systems Transformation, Global Development Information Management, Daiichi Sankyo, Inc. , Business Systems Transformation , Global Development Information Management , Daiichi Sankyo Inc

AI is transforming clinical trials, but successful implementation requires careful planning and execution. This session explores best practices, strategies, and approaches for integrating AI into trial design, operations, and data management. Panelists will discuss practical lessons on workflow adaptation, team training, regulatory considerations, and measuring impact to ensure AI adoption drives efficiency, data quality, and meaningful clinical outcomes.

Grand Opening Coffee Break in the Exhibit Hall

AI TO TRANSFORM ONCOLOGY TRIALS

Chairperson's Remarks 

Mitchell Denker, Head, Data Strategy and Products, R&D Data Science and Digital Health, Janssen Pharmaceuticals , Head, Data Strategy and Products , R&D Data Science and Digital Health , Janssen Pharmaceuticals

AI-Augmented mRNA Oncology Development: Personalization at Scale

Photo of Kyle Holen, Senior Vice President, Head, Oncology Development, Moderna , Senior Vice President, Head , Oncology Development , Moderna
Kyle Holen, Senior Vice President, Head, Oncology Development, Moderna , Senior Vice President, Head , Oncology Development , Moderna

AI is enabling a new era of personalized mRNA oncology therapies, making patient-specific approaches scalable. This session explores how AI-driven tools inform target selection, optimize trial design, and accelerate development timelines. Panelists will discuss strategies for integrating AI into mRNA programs, balancing personalization with efficiency, and delivering precise, data-driven oncology treatments at scale while maintaining safety and regulatory compliance.

Transforming End-to-End Clinical Development through AI

Photo of Jorge Reis-Filho, PhD, Chief of AI for Science Innovation, Enterprise AI Unit, AstraZeneca , Chief of AI for Science Innovation, Enterprise AI Unit , AstraZeneca
Jorge Reis-Filho, PhD, Chief of AI for Science Innovation, Enterprise AI Unit, AstraZeneca , Chief of AI for Science Innovation, Enterprise AI Unit , AstraZeneca

AI is rapidly transforming clinical development, and we are approaching a future where frontier AI models will outperform humans in complex reasoning tasks. To have the maximum impact on improving patient outcomes, AstraZeneca is applying AI across oncology R&D to help deliver on its bold ambition of one day eliminating cancer as a cause of death.

Operationalizing AI in Clinical Trials: From Strategy to Scalable Impact

Photo of Bill Arneson, Director, Business Operational Transformation, Moffitt Cancer Center , Director Business Operational Transformation , Business Operational Transformation , Moffitt Cancer Center
Bill Arneson, Director, Business Operational Transformation, Moffitt Cancer Center , Director Business Operational Transformation , Business Operational Transformation , Moffitt Cancer Center
Photo of Milijana Ugrenovic-Petrovic, MPM Senior Director, Clinical Research Operations, Moffitt Cancer Center , Senior Director Clinical Research Operations , Clinical Trials Office , H Lee Moffitt Cancer Ctr & Research Institute
Milijana Ugrenovic-Petrovic, MPM Senior Director, Clinical Research Operations, Moffitt Cancer Center , Senior Director Clinical Research Operations , Clinical Trials Office , H Lee Moffitt Cancer Ctr & Research Institute

This presentation will share Moffitt Cancer Center’s journey in embedding AI into clinical trials operations, highlighting real-world use cases, implementation strategies, and measurable outcomes. Drawing from initiatives such as EHR-to-EDC integration, AI-enabled prescreening, and CPOE deployment, it will offer a practical roadmap for scalable AI adoption aligned with institutional goals.

Refreshment Break in the Exhibit Hall

PLENARY SESSION

Keynote Opening Remarks

Photo of Marina Filshtinsky, MD, Executive Director, Conferences and Portfolio, Cambridge Healthtech Institute , Executive Director, Conferences , Cambridge Healthtech Institute
Marina Filshtinsky, MD, Executive Director, Conferences and Portfolio, Cambridge Healthtech Institute , Executive Director, Conferences , Cambridge Healthtech Institute

KEYNOTE PRESENTATION:
Validating Generative AI for Clinical Development

Photo of Pratik Shah, PhD, Professor, Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering, University of California , Professor , Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering , University of California
Pratik Shah, PhD, Professor, Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering, University of California , Professor , Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering , University of California

The development of robust AI for clinical development is limited by scarcity of large-scale annotated datasets and clear frameworks for real-world translation. This talk will present examples of clinically validated generative AI that enhances clinical-trial efficiency, evidence generation, and patient outcomes. The discussion will conclude with a regulatory-science perspective on emerging challenges and necessary standards for validating and approving complex, AI-enabled medical devices for safe and effective patient care.

KEYNOTE FIRESIDE CHAT:
Investing in the AI-Driven Future of Clinical Development

Photo of Sandeep Burugupalli, Head, Data Science & Biopharmaceuticals R&D, AstraZeneca , Head, Data Science & Biopharmaceuticals R&D , AstraZeneca
Sandeep Burugupalli, Head, Data Science & Biopharmaceuticals R&D, AstraZeneca , Head, Data Science & Biopharmaceuticals R&D , AstraZeneca
Photo of Cris De Luca, Partner, Sanofi Ventures , Partner , Digital Investments , Sanofi Ventures
Cris De Luca, Partner, Sanofi Ventures , Partner , Digital Investments , Sanofi Ventures
Photo of Carrie Williams, Vice President & Partner, McKesson Ventures , VP & Partner , McKesson Ventures
Carrie Williams, Vice President & Partner, McKesson Ventures , VP & Partner , McKesson Ventures

AI is transforming every stage of clinical development, generating unprecedented investment activity across venture capital and pharmaceutical corporate venture arms. This plenary panel brings together a cross-section of investors to discuss where capital is flowing, what technologies show the strongest near-term value, and which business models are most likely to endure. Attendees will gain a clear view of how investors are prioritizing innovation in clinical development and what signals they are watching to guide future deployments of capital.

Interactive Breakout Discussions

INTERACTIVE DISCUSSIONS

Interactive Breakout Discussions

Interactive Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each breakout will be led by a facilitator/s who keeps the discussion on track and the group engaged. Please visit the Interactive Breakout Discussions page on the conference website for a complete listing of topics and descriptions. Interactive Breakout Discussions are offered in-person only.

Presentation to be Announced

Networking Reception in the Exhibit Hall

Dinner Short Course Registration

*Separate registration required. See short course page for details.

DINNER SHORT COURSE: AI Implementation in Practice: A Hands-on Short Course (Bring Your Laptop)

INSTRUCTORS:

Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany

Prasanna Rao, Chief Products and Innovation Officer, Saama 

This interactive workshop will provide a practical overview of key considerations for implementing AI in clinical operations and beyond. Topics will include ethical implications and regulatory updates such as the EU AI Act, a clear explanation of AI APIs and how they function, and best practices for effective prompt engineering. Attendees will gain valuable insights into common pitfalls to avoid strategies to successfully integrate AI tools in a regulated environment.​

Tuesday, May 19

"Bytes and Bites" in the Exhibit Hall

Join your colleagues for coffee and a quick bite before diving into another day of sessions.

AI-PROMPTED CHANGE MANAGEMENT

Chairperson’s Remarks

Transforming Clinical Trials with AI: Managing Change and Measuring ROI

Photo of Hassan Kadhim, Senior Director, DTE Business Engagement for Clinical Operations and Medical Writing, Vertex Pharmaceuticals , Senior Director , DTE Business Engagement for Clinical Operations and Medical Writing , Vertex Pharmaceuticals
Hassan Kadhim, Senior Director, DTE Business Engagement for Clinical Operations and Medical Writing, Vertex Pharmaceuticals , Senior Director , DTE Business Engagement for Clinical Operations and Medical Writing , Vertex Pharmaceuticals

AI is reshaping clinical trials, driving operational change and new efficiencies—but how do organizations manage this transformation and measure its value? This session explores strategies for implementing AI, tracking performance, and assessing ROI.

AI in Clinical Trials: Building Skilled Teams

Photo of Angela Radcliffe, DTRA Member & Founder, How Mighty We Ventures , Founder , Enterprise Digital Innovation , How Mighty We Ventures
Angela Radcliffe, DTRA Member & Founder, How Mighty We Ventures , Founder , Enterprise Digital Innovation , How Mighty We Ventures

AI is transforming clinical trials, but its success depends on skilled, prepared teams. This session explores strategies for training clinical operations, data, and trial management teams to effectively use AI tools. Panelists will discuss best practices for upskilling staff, integrating AI into workflows, and ensuring data quality, compliance, and trial efficiency while fostering collaboration and adoption across teams.

Panel Moderator:

PANEL DISCUSSION:
Responsible Use of AI in Clinical Development 

Photo of Carolyn J. Pfeiffer, Senior Director, Program Management & AI Ethics, Data Strategy & Platforms/ Data Science & Digital Health, Johnson & Johnson , Senior Director, Program Management & AI Ethics , Data Strategy & Platforms/ Data Science & Digital Health , Johnson & Johnson
Carolyn J. Pfeiffer, Senior Director, Program Management & AI Ethics, Data Strategy & Platforms/ Data Science & Digital Health, Johnson & Johnson , Senior Director, Program Management & AI Ethics , Data Strategy & Platforms/ Data Science & Digital Health , Johnson & Johnson

Panelists:

Photo of Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI) , Professor , Computer Science , Northwestern University
Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI) , Professor , Computer Science , Northwestern University

Coffee Break in the Exhibit Hall

FIT-FOR-PURPOSE AI IN CLINICAL DEVELOPMENT: A NECESSITY, NOT A CHOICE

Chairperson’s Remarks

Data Framework for AI Implementation in Clinical Research 

Photo of Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany , Head, Operational Design Center , Merck KGaA, Darmstadt, Germany
Jonathan Crowther, PhD, Head, Operational Design Center, Merck KGaA, Darmstadt, Germany , Head, Operational Design Center , Merck KGaA, Darmstadt, Germany
Photo of Hrvoje Mohoric, Head of Clinical & Digital Innovation & Applications, Merck , Head, Clinical & Digital Innovation & Applications , Merck
Hrvoje Mohoric, Head of Clinical & Digital Innovation & Applications, Merck , Head, Clinical & Digital Innovation & Applications , Merck

A robust data framework is essential for effective AI implementation in clinical research. It ensures high-quality, interoperable, and secure data across diverse sources, enabling reliable model development and regulatory-grade insights. By integrating standardized data structures, governance, and validation processes, such a framework accelerates evidence generation, supports ethical AI use, and enhances the efficiency and impact of clinical research.

Panel Moderator:

PANEL DISCUSSION:
Fit-for-Purpose AI in Clinical Trials

Photo of Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc. , CEO , Endpoint Clinical, Inc.
Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc. , CEO , Endpoint Clinical, Inc.

Panelists:

Photo of Vinod Das, Pharma R&D, Drug Innovation and AI Enablement, Bayer Pharmaceuticals , Pharma R&D, Drug Innovation and AI Enablement , Bayer Corporation
Vinod Das, Pharma R&D, Drug Innovation and AI Enablement, Bayer Pharmaceuticals , Pharma R&D, Drug Innovation and AI Enablement , Bayer Corporation
Photo of Subha Madhavan, PhD, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Pfizer Inc. , Vice President and Head, AI/ML, Quantitative and Digtal Sciences , Pfizer
Subha Madhavan, PhD, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Pfizer Inc. , Vice President and Head, AI/ML, Quantitative and Digtal Sciences , Pfizer
Photo of Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc. , Director & Head, Clinical Systems & Digital Operations , Data Sciences , AbbVie Inc
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc. , Director & Head, Clinical Systems & Digital Operations , Data Sciences , AbbVie Inc

Transition to Lunch

PLENARY SESSION

Keynote Opening Remarks

Photo of Iris Goldman, Conference Producer, Cambridge Innovation Institute , Production , Cambridge Innovation Institute
Iris Goldman, Conference Producer, Cambridge Innovation Institute , Production , Cambridge Innovation Institute

KEYNOTE PRESENTATION:
The Next Leap: What AI Means for How We Work and What We Build

Photo of Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI) , Professor , Computer Science , Northwestern University
Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI) , Professor , Computer Science , Northwestern University

Artificial intelligence is transforming every industry it touches, and clinical research is no exception. Generative AI tools like ChatGPT are rapidly becoming powerful partners in the work of designing, running, and accelerating clinical trials. In this talk, we’ll cut through the hype and look directly at how these systems can help us today—streamlining protocol development, speeding recruitment, reducing documentation overload, strengthening safety monitoring, and unlocking faster insights from the data you already collect. We’ll also take a quick look at what’s coming. As AI systems become more capable and more adaptive, they will reshape how trials are planned, executed, and evaluated. The question is no longer if this shift is coming, but how we prepare for it. And because clinical trials carry real stakes for patients and science, we’ll focus on what must be done to integrate AI responsibly, ensuring transparency, data integrity, regulatory alignment, and trust. This is about empowering trial teams with tools that make research faster, clearer, and more effective—while keeping humanity at the center of every decision.

Panel Moderator:

KEYNOTE PANEL DISCUSSION:
Navigating the AI Era: Strategic Reflections from FDA Former Regulators and Technologists

Photo of Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen
Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen

Panelists:

Photo of M. Khair ElZarrad, PhD, MPH, Vice President, Regulatory Policy, BridgeBio; Former Deputy Director Office of Medical Policy, Center for Drug Evaluation & Research, FDA CDER , Vice President , Regulatory Policy , BridgeBio
M. Khair ElZarrad, PhD, MPH, Vice President, Regulatory Policy, BridgeBio; Former Deputy Director Office of Medical Policy, Center for Drug Evaluation & Research, FDA CDER , Vice President , Regulatory Policy , BridgeBio
Photo of Kushboo Sharma, CEO, Accumulus Synergy , CEO , Accumulus Synergy
Kushboo Sharma, CEO, Accumulus Synergy , CEO , Accumulus Synergy
Photo of Vid Desai, Desai Tech Consulting , Desai Tech Consulting
Vid Desai, Desai Tech Consulting , Desai Tech Consulting

Panel Moderator:

KEYNOTE PANEL DISCUSSION:
Realizing Business Value from AI Implementation in Clinical Development

Photo of Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen , Head of Statistical Programming, Digital and Data Sciences , Biogen
Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen , Head of Statistical Programming, Digital and Data Sciences , Biogen

Panelists:

Photo of Kyle Holen, Senior Vice President, Head, Oncology Development, Moderna , Senior Vice President, Head , Oncology Development , Moderna
Kyle Holen, Senior Vice President, Head, Oncology Development, Moderna , Senior Vice President, Head , Oncology Development , Moderna
Photo of Subha Madhavan, PhD, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Pfizer Inc. , Vice President and Head, AI/ML, Quantitative and Digtal Sciences , Pfizer
Subha Madhavan, PhD, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Pfizer Inc. , Vice President and Head, AI/ML, Quantitative and Digtal Sciences , Pfizer
Photo of Jason Raines, Vice President, Clinical Data and Insights, AstraZeneca , Vice President , Clinical Data and Insights , AstraZeneca
Jason Raines, Vice President, Clinical Data and Insights, AstraZeneca , Vice President , Clinical Data and Insights , AstraZeneca

Close of Conference


For more details on the conference, please contact:

 

Marina Filshtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781-972-5496

Email: mfilshtinsky@healthtech.com

 

Iris Goldman

Conference Producer

Cambridge Healthtech Institute

Email: igoldman@healthtech.com

 

For sponsorship information, please contact:

 

Companies A – E

Ilana Quigley

Director, Sales

Cambridge Healthtech Institute

Phone: (+1) 857-636-2334

Email: iquigley@healthtech.com

 

Companies F – N

Katelin Fitzgerald

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-247-1824

Email: kfitzgerald@cambridgeinnovationinstitute.com

 

Companies O – V

Jon Stroup

Lead Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5483

Email: jstroup@healthtech.com

 

Companies W – Z

Patty Rose

Vice President, Sales

Cambridge Healthtech Institute

Phone: (+1) 781-972-1349

Email: prose@healthtech.com

 

For media and association partnerships, please contact:

Andrew Hall

Marketing Manager

Cambridge Healthtech Institute

Email: ahall@healthtech.com


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