AI and Data for Clinical Trial Optimization
Agentic GenAI Case Studies for Smarter Trials
5/18/2026 - May 19, 2026 ALL TIMES EDT
Successful AI adoption in clinical research starts with having the right data and technology foundations in place. Building on the momentum of the AI theme at SCOPE Summit, CHI’s inaugural “AI and Data for Clinical Trial Optimization†conference will take a closer look at how to prepare, manage, and scale data for AI applications, from structuring datasets and ensuring interoperability to protecting privacy and security. The program will also highlight fit for purpose AI use cases that are already entering the mainstream and actively helping to optimize and accelerate clinical trials. Real world technical implementations and case studies of agentic and generative AI will offer practical lessons learned, helping attendees design systems that meet today’s needs while staying flexible, compliant, and ready for the rapid evolution of AI in clinical research.
Monday, May 18
Registration and Morning Coffee
Organizer's Welcome Remarks
AGENTIC AI FRAMEWORK
Sponsored by: Chairperson's Remarks
FEATURED SPEAKER:
Agentic AI in Clinical Development
This talk highlights practical ways agentic AI can reduce routine manual work across clinical development. Emphasis is placed on what is dependable today, how to implement it safely, and where human oversight remains essential.
Panel Moderator:
PANEL DISCUSSION:
Building Technical and Operational Foundations for Scalable AI in Clinical Trials
Panelists:
Sponsored by: Beyond AI Matching: Designing Patient-Centric Journeys for Trial Readiness
Clinical trial recruitment is often framed as a matching problem: finding the right patient for the right trial. But patient drop-off rarely happens because matching alone failed. Patients drop off when uncertainty, complexity, practical burden, and slow handoffs compound before they are ready to take the next step. In this talk, Dian Wessels, Director of Design at myTomorrows, introduces trial readiness as a more patient-centric lens for recruitment. He will show how readiness develops across the journey, from awareness and discovery to consideration, decision support, eligibility fit, practical preparation, and referral, demonstrating how each phase can reduce the risk of avoidable drop-off. Through examples from myTomorrows’ patient journeys, the talk explores where AI can accelerate search, intake, and pre-screening, and where human patient navigators are essential for building trust, clarity, and confidence. The result is not just more referrals, but more structured, trial-ready referrals that better support patients, BioPharma teams, and trial sites.
Sponsored by: AI + Data Ecosystems: Unlocking the Next Frontier in Clinical and Operational Excellence
This panel explores how AI and data ecosystems must operate in harmony to deliver transformative value. Success lies in pairing AI capabilities with robust data foundations to drive measurable improvements. Panelists will examine the dynamic relationship between AI and data, share real-world use cases, and highlight strategies that enhance study team performance and patient outcomes, while offering practical strategies for scaling AI in a regulated environment. Join us to discover how integrated approaches are reshaping clinical research and operational excellence.
Grand Opening Coffee Break in the Exhibit Hall
AI-POWERED DECISION-MAKING
Chairperson's Remarks
Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen , Head of Statistical Programming, Digital and Data Sciences , Biogen
Agentic AI Framework to Assist with Decision-Making on Clinical Programs
Recent breakthroughs have enabled LLMs to carry out multi-step scientific tasks through sophisticated tool use, reasoning, and orchestration. We develop an agentic AI framework to assist with decision making on clinical programs. This framework consists of multiple agents which integrate evidence from experimental data and scientific text to address complexity of the modern clinical programs. This framework demonstrated promising results while applied to several clinical programs.
Unifying Real-World, Operational, and Public Data to Transform Clinical-Trial Planning
We have designed and implemented a clinical-trial forecasting system powered by ML models and heterogeneous data using software, modeling, and systems best practices. Our flexible and scalable architecture allows us to rapidly iterate our models while maintaining a clear line of sight to source data and results. If Biogen can build this ourselves, other pharmaceutical companies can too.
Sponsored by: Turning Data into Decisions: Delivering Predictable Trial Outcomes with Clinical Intelligence
AI is now expected in clinical research, but outcomes matter most. Claire Riches, Vice President, Clinical Solutions at Citeline, and Ross Pettit, Chief Development Officer at Kestrel Therapeutics, share how trusted, connected data powered by AI is embedded into clinical workflows to drive more predictable decisions. From protocol design to patient identification and site selection, they show how teams move from insight to decision-ready intelligence—reducing uncertainty, accelerating timelines, and improving confidence.
Sponsored by: From Ambition to Operation: Implementing Agentic AI in Clinical Research
• Why clinical operations represent the defining bottleneck in drug development and how purpose-built agentic AI, grounded in regulatory frameworks including ICH E6 R3 and 21 CFR Part 11, can structurally expand capacity and reshape the productivity curve of clinical trials.
• What a real implementation journey looks like: from pilot activation to enterprise-scale deployment, including the sprint-based approaches that compress time-to-value and the governance considerations that make agentic systems viable in regulated environments.
• How clinical agents perform in practice with live examples drawn from CRA workflows demonstrating agents that function as expert collaborators embedded in operational processes, not standalone tools.
Panel Moderator:
PANEL DISCUSSION:
Transforming Clinical-Data Analytics with Agentic GenAI
Panelists:
LUNCHEON PRESENTATION:
Luncheon Presentation: Sponsored by: LUNCHEON PRESENTATION: Expertise at the Decision Point: When AI Handles the Work, Humans Own the Decision
AI is transforming what’s possible in clinical trials. But its full potential depends on something the field is only beginning to name: the operational architecture that transforms AI output into accountable, auditable decisions. When that infrastructure exists, human experts stop managing process and start owning decisions. That shift is not on the horizon. It is already in motion.
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
James Farrelly, Vice President, Head of Agent Product, PfizerSachin Karnik, Director, New Clinical Paradigm, Pfizer
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.
USE CASES
Chairperson's Remarks
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis , Senior Vice President , Business Development & Strategic Planning , Praxis
Data Strategy for Feasibility—Al and Machine-Learning Use Cases
We’ll share use cases of how we implemented an operating model with data-driven decision-making at its core. Leveraging the availability of more data than ever, we changed our ways of working to make the most out of it.
Lay Document Draft Generator Using AI
Purpose:Â To automate and expedite the creation of the Lay Protocol Synopsis (LPS) and Brief Summary (BS), which are time-sensitive regulatory documents needed for effective communication with ethics committees, patients, and the public. Method:Â Utilizes a library of prompts mapped to the CTP, along with a blend of rule-based template language, large-language models (LLMs), and retrieval augmented generation (RAG) to produce an initial draft of the LPS.
Sponsored by: AI and Data for Clinical-Trial Optimization, AI-Augmented Use Cases for Smarter Trials
Modern clinical trials face increasing complexity driven by fragmented data, manual processes, and rising regulatory expectations (R3). Traditional review models are no longer scalable, leading to delayed risk detection, limited traceability, and inefficient oversight. This presentation highlights how AI-augmented data review transforms clinical-trial operations by enabling real-time insights, automated custom listings, and improved collaboration across data, medical, and operational teams. By shifting from reactive to proactive oversight, organizations can accelerate decision-making, ensure traceability, and enhance data integrity—ultimately driving faster, more confident clinical outcomes
Panel Moderator:
PANEL DISCUSSION:
Enhancing Recruitment and Retention: How Can AI Help?
Panelists:
Sponsored by: AI in Clinical Trials: From Buzzword to Breakthrough
AI is rapidly moving from experimentation to real-world impact in clinical trials, reshaping how studies are designed, executed, monitored, and optimized. This talk will explore how AI agents and intelligent workflows can help reduce operational friction, improve decision-making, and augment the roles of clinical, regulatory, data, and operations teams. We will discuss why the real opportunity is not simply automating individual tasks, but reimagining end-to-end trial workflows, upskilling teams to work confidently with AI, and applying these technologies responsibly to accelerate research while maintaining quality, compliance, and trust.
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
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