CHI's Inaugural
AI and Data for Clinical Trial Optimization
Agentic GenAI Case Studies for Smarter Trials
May 18 - 19, 2026 ALL TIMES EDT
Monday, May 18
7:45 amRegistration and Morning Coffee
8:25 amOrganizer's Welcome Remarks
AGENTIC AI FRAMEWORK
Agentic AI in Clinical Development
Building Technical and Operational Foundations for Scalable AI in Clinical Trials
Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc.
This panel aims to expedite AI adoption for more efficient and effective treatment delivery by exploring the challenges and solutions associated with scaling and integrating AI throughout the clinical trial development lifecycle. Discussions will encompass technical scalability (infrastructure, data governance), operational integration (workflow, skill development), ethical and regulatory considerations (bias, privacy, validation), talent shortages, economic feasibility, and a variety of use cases, from early research to regulatory affairs.
Beyond AI Matching: Designing Patient-Centric Journeys for Trial Readiness
Dian Wessels, Director of Design, Product, myTomorrows
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.
AI + Data Ecosystems: Unlocking the Next Frontier in Clinical and Operational Excellence
Andrew Taylor, Senior Director, Clinical Data Management, Data Sciences Safety & Medical Writing, IQVIA
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.
10:35 amGrand Opening Coffee Break in the Exhibit Hall
AI-POWERED DECISION-MAKING
Agentic AI Framework to Assist with Decision-Making on Clinical Programs
Vladimir Ivanov, PhD, Research and Development, Pfizer Inc.
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.
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.
From Ambition to Operation: Implementing Agentic AI in Clinical Research
Andrew Mackinnon, Senior Vice President & Executive GM, Customer Value, Medable Inc.
• 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.
Transforming Clinical-Data Analytics with Agentic GenAI
Sina Djali, Managing Partner, Axcellion.ai
This panel explores how agentic generative AI (GenAI) is reshaping clinical-data analytics by enabling autonomous and adaptive systems that streamline data processing, uncover complex patterns, and generate actionable insights. The discussion will address the opportunities and risks of integrating agentic and applied GenAI into regulated clinical research environments, highlighting their potential to drive innovation while maintaining data integrity and patient safety.
LUNCHEON PRESENTATION: Expertise at the Decision Point: When AI Handles the Work, Humans Own the Decision
Abraham Gutman, Founder & CEO, AG Mednet, Inc.
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.
2:05 pmRefreshment Break in the Exhibit Hall
PLENARY SESSION
Validating Generative AI for Clinical Development
Pratik Shah, PhD, 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.
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 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 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.
4:40 pmNetworking Reception in the Exhibit Hall
5:40 pmDinner Short Course Registration
*Separate registration required. See short course page for details.
6:00 pmDINNER SHORT COURSE: AI Implementation in Practice: A Hands-on Short Course (Bring Your Laptop)
INSTRUCTORS:
Sachin 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
8:30 am"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
Data Strategy for Feasibility—Al and Machine-Learning Use Cases
Andrew Chen, Director, Analytics, Clinical Trial Feasibility & Analytics, Bayer AG
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: 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: 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.
10:00 amSponsored Presentation (Opportunity Available)
Enhancing Recruitment and Retention: How Can AI Help?
Anastasia Christianson, PhD, Pharma Industry Data Science Leader
This panel explores how artificial intelligence is transforming patient engagement across the clinical trial lifecycle. Industry experts will discuss AI-driven strategies for identifying eligible participants, accelerating recruitment, enhancing retention through personalized communication, and predicting potential dropouts. Learn how data analytics and machine learning are optimizing recruitment efficiency, improving patient engagement, and facilitating successful study outcomes.
AI in Clinical Trials: From Buzzword to Breakthrough
Krishna Cheriath, Head, Digital & AI, Biopharma Services, Thermo Fisher Scientific, Inc.
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.
11:30 amCoffee Break in the Exhibit Hall
FIT-FOR-PURPOSE AI IN CLINICAL DEVELOPMENT: A NECESSITY, NOT A CHOICE
Clinical Trial Delivery in the Agentic Era: From Tools to Teammates
Samar Noor, Vice President, Head Clinical Data Insights and Analytics, Data and Quantitative Sciences, Bristol Myers Squibb Co.
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.
Fit-for-Purpose AI in Clinical Trials
Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc.
This panel brings together leaders from Pfizer, Bayer, BMS, and AbbVie. The discussion will focus on real-world use cases that demonstrate measurable business value. Panelists will share strategies for defining value, overcoming adoption barriers, and driving change management to embed AI into core processes. Attendees will gain insights into practical approaches for scaling AI initiatives, aligning stakeholders, and ensuring sustainable impact across the clinical-development lifecycle.
LUNCHEON PRESENTATION: From Protocol to Execution: Powering Clinical Development with End-to-End, Verifiable AI
Hamza Sheikh, Head of Business Development, PhaseV Trials, Inc.
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
The Next Leap: What AI Means for How We Work and What We Build
Kristian Hammond, PhD, Professor, Computer Science, Northwestern University; Director, The Center for Advancing Safety of Machine Intelligence (CASMI)
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.
Navigating the AI Era: Strategic Reflections from FDA Former Regulators and Technologists
Kevin Bugin, PhD, Associate Vice President, Head, Global Regulatory Policy and Intelligence, Amgen
This executive-level session convenes past and present FDA leaders shaping AI policy to examine how regulatory expectations are adapting to new AI capabilities in clinical development. Panelists will discuss strategic priorities, policy evolution, and lessons learned from inside the Agency. The dialogue will equip industry innovators to engage regulators effectively and advance responsible AI adoption.
3:10 pmClose of Conference
Programs
