
Monday, May 18
Registration and Morning Coffee
Organizer's Welcome Remarks
SCALING AI INNOVATION
Chairperson's Remarks (Sponsorship Opportunity Available)
AI-Enabled Patient Voice Integration in Digital Protocol Design


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

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

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.
Sponsored Presentation (Opportunity Available)
Grand Opening Coffee Break in the Exhibit Hall
AI TO TRANSFORM ONCOLOGY TRIALS
Chairperson's RemarksÂ
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

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

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.
Sponsored by: Talk Title to be Announced

Speaker to be Announced , Paradigm Health Inc
Sponsored by: Talk Title to be Announced

Speaker to be Announced , Trialbee
Operationalizing AI in Clinical Trials: From Strategy to Scalable Impact


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.
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: Revolutionize Clinical Trials Financial Management with Agentic AI


Join this session to explore how Agentic AI accelerates every step of your financial workflow—from protocol ingestion to budgeting, contracting, payments, and analytics. Learn how an AI-powered unified platform eliminates disparate silos, automates manual processes, and delivers measurable business value. Explore real-world AI use cases where your team's role shifts from doing to reviewing, enabling faster decisions and ensuring patient and site success.
Refreshment Break in the Exhibit Hall
PLENARY SESSION
Keynote Opening Remarks

Chairperson's Remarks (Sponsorship Opportunity Available)
KEYNOTE PRESENTATION:
Validating Generative AI for Clinical Development

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



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, SaamaÂ
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

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

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.
Sponsored by: From Static Plans to Living Scenarios: How AI Changes Behavior in Trial Planning


AI can transform trial planning by being designed to change decisions, not just predict outcomes. We will discuss AI's role in upstream planning, showing how planning-stage intelligence can highlight tradeoffs, clarify assumptions, and improve cross-functional decision-making without replacing human judgment. We'll share design lessons on embedding AI into planning loops, limiting its autonomy, and driving behavioral change in clinical development teams.
Panel Moderator:
PANEL DISCUSSION:
Responsible Use of AI in Clinical DevelopmentÂ

Panelists:

Sponsored by: Talk Title to be Announced

Speaker to be Announced , inato
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 ResearchÂ


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

Panelists:



Transition to Lunch
LUNCHEON PRESENTATION:
Luncheon Presentation: Sponsored by: Talk Title to be Announced

Speaker to be Announced , PhaseV Trials Ltd
PLENARY SESSION
Keynote Opening Remarks

Chairperson’s Remarks (Sponsorship Opportunity Available)
KEYNOTE PRESENTATION:
The Next Leap: What AI Means for How We Work and What We Build

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

Panelists:



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

Panelists:



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

















