Monday, May 18
Registration and Morning Coffee
Organizer's Welcome Remarks
SCALING AI INNOVATION
Sponsored by: Chairperson's Remarks

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.
Clinical Trial Optimization in Practice: Leveraging Data and Technology to Drive Operational Impact

The clinical operations environment is becoming increasingly challenging in the execution of clinical studies. Industry-wide, the clinical trials landscape is becoming more saturated, leading to delays and growing execution risks across late-phase clinical study portfolios. This session will illustrate these challenges and demonstrate how Merck is mitigating risk through the use of data, technology, and process improvements to better serve patients.
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. This presentation will feature 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 by: Audit‑Ready Analytics in Clinical Development: What Changes When AI Enters the Workflow


As clinical analytics become more automated, regulatory agencies are increasingly focused on understanding how results were produced, not just what they show. This has elevated the importance of audit‑ready analytics and clear data lineage across the clinical development lifecycle. This session focuses on practical changes sponsors are making to support audit readiness, including the use of large language models to automate data transformation and the generation of tables, listings, and figures for regulatory submission. We will examine how embedding these capabilities into governed analytics workflows reduces manual effort, improves consistency, and supports smoother regulatory interactions across programs.
Grand Opening Coffee Break in the Exhibit Hall
AI TO TRANSFORM CLINICAL DEVELOPMENT
Chairperson's Remarks
Janie Hansen, formerly Business Systems Transformation, Global Development Information Management, Daiichi Sankyo, Inc. , Business Systems Transformation Associate , Global Development Information Management , Daiichi Sankyo Inc
Leveraging AI to Transform Site Engagement in Clinical Trials


In this session, we will be speaking about our foundational work to reduce tech burden for clinical trial sites, the use of AI to boost productivity and operational excellence for our internal teams, and our roadmap for further AI integration to a frictionless Site Engagement.
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.
Evaluating End-to-End Agentic AI Workflows for Clinical Trials

Clinical trials remain slow, fragmented, and operationally complex. Project Loom evaluates whether agentic AI workflows can execute trials end-to-end, from protocol generation through participant engagement and analysis. In a prospective simulation, multi-agent systems compressed timelines from months to days while maintaining high data fidelity under human oversight. We present performance, limitations, and a practical framework for where AI can (and cannot yet) reliably transform trial execution.
Sponsored by: From Start-Up to Scale: Lessons Learned from Widespread Deployment of AI-Driven Technology for Cancer Clinical Trial Operations


Scaled deployment and adoption of AI-enabled technology requires careful integration with clinical and operational workflows. Delivering value is multifactorial and includes deep understanding of site capabilities and specific trial context. We will share insights gained regarding factors affecting LLM performance, resourcing, change management, and impact measurement, and will review two case studies where approaches have produced measurable operational improvements. We conclude with practical lessons for clinical development leaders deploying AI technology at scale.
Sponsored by: Applied AI Today and Tomorrow in Global Patient Recruitment

Speaker to be Announced , Trialbee
Although AI is clearly in focus for clinical trial recruitment, most implementations are early, fragmented, or difficult to evaluate in terms of real-world impact.
In this session, Matt Walz, CEO of Trialbee, shares a practical perspective on applied A—approaches trained on real recruitment data, integrated into existing workflows, and evaluated based on operational outcomes. Using examples from active recruitment programs, the session will explore where AI is supporting global patient recruitment today and what is on the horizon for the next 12 months.
Attendees will:
Understand the difference between experimental (“sandboxâ€) AI and operational, applied AI in global patient recruitment today
Identify where AI is currently supporting recruitment across the patient funnel
Recognize how data quality, workflow integration, and governance influence outcomes
FEATURED SPEAKER:
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.
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: Revolutionize Clinical Trial 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
Marina Filshtinsky, MD, Executive Director, Conferences and Portfolio, Cambridge Healthtech Institute , Executive Director, Conferences , Cambridge Healthtech Institute
Sponsored by: Keynote Introduction

Claire Riches, Vice President, Clinical Solutions, Citeline , Vice President, Clinical Solutions , Citeline
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.
Sponsored by: Keynote Introduction

Pranava Goundan, Principal, AI, ZS Associates , Principal , AI , ZS Associates
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 (IN-PERSON ONLY)
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 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.
TABLE 1:
Translating Healthcare AI Success into Clinical
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
TABLE 2:
AI-Ready Clinical Data
Peter McMullan, Senior Solution Consultant, Confidencial , Senior Solution Consultant , Confidencial
TABLE 3:
Trust and Oversight of AI Agents
James Farrelly, Vice President, Head of Agent Product, Pfizer Inc. , Vice President, Head of Agent Product , Pfizer Inc
TABLE 4:
Regulatory Landscape for AI in Clinical Development
Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen , Head , Regulatory Policy and Intelligence , Amgen
TABLE 5:
Applying AI at the Site Level
Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS) , Chief Site Success Officer , Society for Clinical Research Sites (SCRS)
Laurent Spiess, PhD, Executive Director, Product Solutions, Cytel , Executive Director , Product Solutions , Cytel
TABLE 6:
AI-Powered Patient Recruitment and Retention
Kaushal Amin, Field CTO, KMS Technology , Field CTO , KMS Technology
Anastasia Christianson, PhD, Pharma Industry Data Science Leader , Pharma Industry Data Science Leader
Michelle Everill, formerly Vice President, Global Trial Optimization, Alnylam Pharmaceuticals , VP, Global Trial Optimization , Alnylam Pharmaceuticals
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:
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
Sponsored by: Chairperson's Remarks

Speaker to be Announced , Saama Technologies, Inc.
FEATURED SPEAKER:
From Tools to Transformation: Rebuilding the Clinical Trial Ecosystem with AI

AI adoption in Clinical Trials is stuck in low-impact pilots. The real opportunity is not better tools, but a fundamentally different ecosystem. This talk explores how next-gen technology can reshape protocols, site-selection, data flow, and decision-making across the ecosystem. Drawing from frontline experience, we will move beyond incremental pilots to what it actually takes to deliver faster, simpler, and more scalable clinical development.
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. This presentation 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.
AI Governance at the Site: Practical Frameworks Sites Need Now

As AI adoption accelerates in clinical research, sites face growing pressure to implement new tools while navigating unclear governance frameworks, limited training, and fragmented technologies. At the same time, sites are increasingly evaluated by opaque AI-driven algorithms for feasibility, selection, and performance. This presentation explores the site perspective on AI governance, operational integration, and trust—and why meaningful AI transformation in clinical trials depends on genuine partnership and successful implementation at the site level.
Sponsored by: The Trust Dividend: How Regulatory-Grade AI Compounds Value across the Trial Lifecycle


Every clinical development team will adopt AI. The harder question: which AI is trustworthy enough to drive key decisions? Drawing on lessons from Unlearn's journey to achieving regulatory qualification, this talk will show how trust earned once compounds across planning, monitoring and analyzing clinical trials. We’ll highlight design considerations for AI to accelerate human judgment and enable teams to run faster, more rigorous and interpretable clinical trials.
From Agentic TMF to Agentic Trial Execution: How Our First Deployment Shifted Mindsets Toward Running Clinical Trials Differently

This talk shares a real-world journey of deploying agentic AI teammates in clinical operations — from selecting the right use case (TMF management) to achieving fully autonomous, measurable results. The presentation covers key lessons learned and offers perspective on why the traditional vendor evaluation mindset fails for agentic AI, what mindset shift is the prerequisite for success, and how to distinguish solutions delivering true operational value from those adding complexity without impact.
Agentification of Life Sciences: Why Clinical Research Needs Agents—Not More Dashboards

As clinical research teams chase faster timelines and earlier submissions, dashboards alone are no longer enough. This session explores the agentification of life sciences—how agentic AI systems can actively orchestrate trial design, operations, and regulatory authoring to compress critical paths. We will examine where agents deliver real acceleration today, and the governance, oversight, and validation guardrails required to scale speed without compromising regulatory trust.
Sponsored by: Partnering with AI-Enabled Sites to Unlock Real-Time Data, Drive Enrollment, and Accelerate Trial Timelines



Clinical trials have long been a bottleneck in bringing breakthrough therapies to patients; AI is changing that by tackling some of the industry’s most persistent challenges. Sites are using AI to fundamentally change how they operate–improving efficiency, becoming fully data-driven, and eliminating guesswork in feasibility. Now, forward-thinking sponsors are partnering with AI-enabled sites at scale to optimize how they plan and run trials. In this session, Sanofi and Inato will discuss how they’re harnessing real-time site and patient data to confidently plan across Sanofi’s portfolio, accelerate trial timelines, and drive toward faster, higher, more predictable enrollment to bring medical breakthroughs to more patients globally.
Coffee Break in the Exhibit Hall
FIT-FOR-PURPOSE AI IN CLINICAL DEVELOPMENT: A NECESSITY, NOT A CHOICE
Chairperson's Remarks
Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc. , CEO , Endpoint Clinical, Inc.
FEATURED SPEAKER:
Clinical Trial Delivery in the Agentic Era: From Tools to Teammates

This presentation explores how agentic AI can reshape clinical trial delivery by moving beyond isolated automation toward a new human + agent operating model. Rather than positioning AI as a replacement for clinical, data, statistical, or operational expertise, the session focuses on how agents can amplify human judgment, surface risk earlier, and strengthen execution across the clinical lifecycle.
Using examples from study design, data collection, cleaning, standards conformance, analysis readiness, and reporting, we will examine how agent-ready workflows can improve quality, reduce rework, accelerate decision-making, and create more proactive trial delivery. The discussion will also address the critical guardrails required for adoption, including human accountability, audit-ready lineage, validation, transparency, and governance.
Attendees will leave with a practical perspective on how organizations can integrate AI agents into clinical trial execution in a way that is scalable, compliant, and scientifically grounded and why the future of clinical research will be led by teams that combine human expertise with agentic scale.
Panel Moderator:
PANEL DISCUSSION:
Fit-for-Purpose AI in Clinical Trials

Panelists:




Transition to Lunch
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: From Protocol to Execution: Powering Clinical Development with End-to-End, Verifiable AI


As clinical trials become more complex, fragmented point solutions and rigid, fixed designs are no longer sufficient to address the growing challenges in development. Improving success rates, reducing cost, and accelerating timelines requires a fundamentally different approach, one built on vertically integrated, verifiable, and validated AI systems.
In this session, PhaseV presents a cohesive, end-to-end platform perspective on clinical development, spanning study design, patient stratification, site selection, and protocol-to-submission workflows. Framed through the lens of the “three Vs†that define PhaseV’s approach, we will demonstrate why true impact comes from connecting these capabilities into a single, unified system rather than deploying them in isolation.
Practical, real-world examples will be shared demonstrating how PhaseV’s multimodal AI platform delivers measurable efficiencies and improved outcomes across diverse clinical development programs.
PLENARY SESSION
Keynote Opening Remarks
Iris Goldman, Conference Producer, Cambridge Innovation Institute , Production , Cambridge Innovation Institute
KEYNOTE INTRODUCTION:
Sponsored by: Less Burden, More Enrollment: Deploying Pre-Screening AI across Sites without Moving Data

Elke Nelson-Nichols, Vice President, Life Sciences, Rhino Federated Computing , VP, Life Sciences Strategy , Rhino Federated Computing
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:



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

















