An agenda built through deep collaboration with our community to ensure every session delivers substance over soundbites. You’ll hear from true subject matter leaders via candid case studies, collaborative roundtables, and varied panel discussions —providing clarity on what’s driving success across the clinical development landscape
• Capitalize on pipeline value by accelerating trial execution through the development of end-to-end drug development capabilities and an innovative development matrix, to better address complex patient needs at speed
• Enable faster, more comprehensive clinical development by forming strategic partnerships where speed, shared expertise, and patient impact are core drivers of success
Eric Hughes, EVP Global R&D and Chief Medical Officer, Teva
• Move beyond isolated AI pilots to scale intelligence across clinical development, enabling insights to flow across studies, teams, and functions
• Improve decision quality, accelerate evidence generation, and increase operational effectiveness through practical AI use strategies, while learning how leading organizations are building learning-driven clinical ecosystems that deliver faster innovation and better outcomes for patients
Stuart Pyle, Partner, Life Sciences R&D, IBM
• Strengthen portfolio resilience by leveraging AI-driven insights to optimize trial site selection and operating models to evolving regulation and patient access needs
• Scale agile, inclusive trial portfolios by embedding decentralized approaches and AI-enabled tools to reduce access barriers and support long-term clinical development priorities
Shobha Dhadda, SVP and Chief Clinical Science and Operations Officer, Clinical Development, Eisai
Cecilia Schott, VP, Head Precision Medicine Portfolio Planning, GSK
Grab a coffee and join our speakers from this mornings sessions to get the chance to ask your questions directly.
Table One: Eric Hughes, EVP Global R&D and Chief Medical Officer, Teva
Table Two: Stuart Pyle, Life Sciences R&D, IBM
Table Three: Shobha Dhadda, SVP and Chief Clinical Science and Operations Officer, Clinical Development, Eisai
Cecilia Schott, VP, Head Precision Medicine Portfolio Planning, GSK
- Secure access to the highest-performing sites by becoming sponsor of choice through stronger partnerships built on trust, transparency and consistent communication
- Elevate the quality of evidence delivered by reducing operational burden through targeted support and resources tailored to each site’s specific needs
Vanessa Gertsen, Head of Feasibility Delivery and Site Engagement, Late Development Oncology, AstraZeneca
Shannon Edwards, US Site Engagement Lead, AstraZeneca
Kathy Mickel, VP, Membership, Education & Programs, SCRS
Michael Oldfield, Director, Regulatory Affairs, Fox Chase Cancer Center
• How evaluating a research participants' research history to confirm eligibility closes a severe gap in the screening process
• How network participation and standardizing eligibility across studies, therapeutic areas, and sponsors enables a safer, faster, and more trusted research ecosystem
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Justin Goodarz, Chief Commercial Officer, Verified Clinical Trials
Quality by design, oversight by intent: building end-to-end frameworks that drive safer, smarter trial delivery
• Strengthen sponsor oversight by embedding quality by design principles and central monitoring at site level to trigger targeted interventions when risk thresholds are met
• Drive proactive improvement through a collaborative RBQM framework that connects sponsors, study teams and sites, creating ongoing feedback loops that surface risks early and support more informed, responsive decision-making
Laura Doyle, Senior Director, Clinical Operations, Alnylam Pharmaceuticals
Anne Marie Inglis, Senior Director, Clinical Operations Asset Lead, GSK
Safwan Kezbor, Executive Medical Director, Global Clinical Development, Shionogi
Justin Goodarz, Chief Commercial Officer, Verified Clinical Trials
Get hands-on in interactive sessions designed to translate ideas into practical, real-world solutions.
Session One: The New Rules of Clinical Trial Execution: Is Your Operating Model Ready?
The FDA’s Operation Trialblazer signals a new era for clinical operations, one that demands faster startup, stronger oversight, and more connected sponsor-site collaboration.
Join this interactive workshop to:
- Assess your organization's operational readiness using a live benchmark informed by Florence's industry research and sponsor-site insights
- Compare your results with peers and identify the gaps that most impact trial speed, oversight, and execution
- Leave with a practical framework for strengthening sponsor-site connectivity and preparing your organization for the next generation of clinical research
Andrea Bastek, VP Market Strategy, Florence Healthcare
Session Two: Federated AI for Faster Feasibility, Prescreening, and Cross-Border Evidence
- See federated AI in action: watch one eligibility question run across multiple sites simultaneously—harmonizing local data and identifying patients without moving a single patient-level record
- Pressure-test your own portfolio: leave with a practical framework showing which feasibility, prescreening, and cross-border evidence use cases can scale now, and what is still blocking them
Elke S. Nelson-Nichols, VP, Life Sciences Strategy, Rhino Federated Computing
• Improve trial feasibility and recruitment outcomes by creating structured feedback loops with patients that translate real-world insights on awareness, trust, and participation experience into more accessible and better-designed protocols.
• Strengthen patient retention via continuously capturing and acting on patient perspectives around data transparency, AI use, and communication preferences to shape personalized engagement strategies.
Annick de Bruin, Chief Research and Insights Officer, CISCRP
• Discover why recruitment built one study at a time misses how patients and communities actually move through their journey and what it takes to meet them at that breadth
• Hear a live conversation on what continuous, community-wide engagement looks like in practice, and what it means for sponsors managing a portfolio or a single trial
Brian Weiss, CEO, Carebox
Leah Szumita, Senior Director, Clinical Trial Support Center, Blood Cancer United
• Improve recruitment rates and strengthen retention by building meaningful, insight-led engagement with patient communities from the earliest stages of enrolment planning
• Create more diverse and accessible recruitment pathways by combining digital tools with direct community involvement to build trust, expand reach, and strengthen patient participation
Karen Correa, VP Clinical Development Operations, Boehringer Ingelheim
Amanda Decoker, Head of Patient Engagement, Experience and Recruitment, Takeda
Nicole Richie, VP Population Science, Genentech
Tonya Edison, AVP, Clinical Central Services & Innovation, Eli Lilly and Company
Stephen Andrews, Head of Biopharma Partnerships, Natera
Grab a coffee and join our speakers from this afternoon's sessions to get the chance to ask your questions directly.
Table One: Annick de Bruin, Chief Research and Insights Officer, CISCRP
Table Two: Brian Weiss, CEO, Carebox
Table Three: Karen Correa, VP Clinical Development Operations, Boehringer Ingelheim; Amanda Decoker, Head of Patient Engagement, Experience and Recruitment, Takeda; Nicole Richie, VP Population Science, Genentech; Tonya Edison, AVP, Clinical Central Service & Innovation, Eli Lilly and Company; Stephen Andrews, Head of Biopharma Partnerships, Natera
• Speed up evidence generation by challenging outdated practices and making better use of overlooked opportunities in clinical innovation, beyond the familiar focus on recruitment, decentralized trials and automation
• Embed innovation at scale by understanding what sets transforming organizations apart from experimenting ones, and building the leadership mindset needed to succeed in the next era of clinical development
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Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences
Moderator: Amy Turnquist, VP The Americas Operating Board, Healthcare Businesswomen's Association
The Missing Variable in Clinical Trial Performance
Eligibility tells us who can participate. Readiness helps us understand what patients need to make participation possible. Yet conventional recruitment still optimizes primarily for medical eligibility and speed through the funnel. This session explores how readiness can be measured early and continuously, and turned into an operating signal before preventable barriers become screen failure, dropout, enrollment volatility, or rescue.
Brittany Erana, CEO, Jumo Health
Get hands-on in interactive sessions designed to translate ideas into practical, real-world solutions.
Session One: Rethinking Site Selection: Innovate with Emerging Sites
• Expand trial capacity by identifying and activating emerging and under-utilised sites
• Foster cross-functional partnerships and stakeholder buy-in to support innovative site engagement models and build sustainable, trial-ready research networks
Kathy Mickel, VP, Membership, Education & Programs, SCRS
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Session Two: Where AI Earns its Place in Global Patient Recruitment
A working conversation among clinical operations leaders about the top opportunities for AI in global patient recruitment, what's real now and what's on the horizon, and how to add it without costing patients the choice and human contact that keep them engaged.
• Which parts of the recruitment path (e.g. identification, outreach, pre-screening, referral, enrollment) are producing measurable gains from AI today and what's coming next
• How sponsors add automation while protecting patient choice and trust: where human involvement stays non-negotiable, what sites need carried through a handoff, and what study teams are finding in their own recruitment data
Matt Walz, CEO, Trialbee
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Session Three: Lead portfolio-wide transformation by turning clinical innovation into lasting results - an interactive discussion
Following on from earlier onstage conversation with Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences, get hands-on in this interactive session designed to translate ideas into practical, real-world solutions.
Join Sammi to dive deeper into what keeps clinical innovation stuck at the pilot stage. Share your own experiences with peers and work together on practical ways to embed innovation across your portfolio.
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Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences
Women in leadership community networking breakfast in partnership with Healthcare Business Women's Association
Start the day with purpose – connecting, empowering, and elevating this generation of clinical leaders
What can women in pharma leadership teach us about reaching underrepresented patients and trial populations?
- Examine how lessons from advancing as an underrepresented leader can inform efforts to improve representation across clinical trial populations
- Share practical approaches for building trust with underserved communities, increasing enrollment diversity, and creating more accessible and patient-centric trials
- Identify cross-functional strategies that clinical development, operations, and patient engagement teams can implement to remove barriers to participation
- Leave with a concrete action plan and new peer connections to help drive more inclusive clinical research outcomes
Amy Turnquist, VP The Americas Operating Board, Healthcare Businesswomen's Association
• Learn why no single company, research site or community organization can make clinical research more representative on its own and how a coalition model can help turn ambition into measurable progress.
• Design effective partnerships through shared accountability and locally responsive solutions that can strengthen the broader healthcare ecosystem
Quita Beeler Highsmith, VP Population Health Centre of Excellence, Genentech
Alan Balch, Executive Chair, Patient Advocate Foundation
Structured codes tell you that a patient exists, but they rarely tell you who that patient is. This session makes the case that the richest signal about real-world patients’ lives in unstructured clinical notes, and transparency about the source is what earns trust.
Learn what the clinical narrative reveals that codes miss and how we’ve transformed complex data into Patient Intelligence, a connected, actionable solution that brings you closer to the patient. Hear how these insights can shape decisions across the clinical planning journey, from understanding patient populations and treatment patterns to trial design, site strategy, and recruitment.
Madeline Naylor, Chief Clinical Officer, Citeline
• Unlock speed in the data-to-decision phase by modernizing how clinical data is reviewed, analyzed, and reported, turning complex data into timely, decision-ready evidence
• Move beyond technology pilots to embed analytics, visualization, and AI into scalable ways of working, aligning technology with people, process, and culture to deliver sustainable value
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Eileen Ching, Senior Director, Head of Clinical & Statistical Programming Methodology, Johnson & Johnson
Moderator: Amy Turnquist, VP The Americas Operating Board, Healthcare Businesswomen's Association
Grab a coffee and head to a designated topic-based tables to continue the conversations and connect with like-minded peers.
Creating Smarter, Simpler and More Adaptive Organizations
- Turn trial data, operational experience, and AI-enabled insights into a continuous learning engine that improves study design, execution, and decision-making across the development lifecycle
- Simplify operating models, reduce trial complexity, and equip cross-functional teams with the skills, governance, and processes needed to scale innovation without compromising quality or oversight
Table One Discussion Focus: How can organizations use scientific, operational, and patient-generated insights to improve future development decisions?
Table Two Discussion Focus: How can organizations reduce complexity to improve experiences for both sites and participants?
Table Three Discussion Focus: What capabilities, governance structures, and cultural changes are required to scale AI innovation across clinical development?
Decentralizing cinical trials: better science through co-creation and multi-stakeholder collaboration
- Partner with communities from trial design through delivery to address the real-world barriers that impact participation, access, and engagement
- Create sustainable community research ecosystems that expand representation, accelerate learning across studies, and generate more relevant clinical evidence
Alan Balch, Executive Chair, Patient Advocate Foundation
• Expand access to diverse patient populations through community-based research networks
• Improve trial speed and data quality by with a site-centric approach
• Combine site performance intelligence, AI-enabled patient identification, and engaged site staff to drive stronger trial outcomes
Â
Dana Feuchtbaum, Chief Operating Officer, Iterative Health
• Reduce feasibility risk and strengthen the relevance of your evidence base by using patient registry, EHR, and claims data to validate inclusion/exclusion criteria against the realities of how patients present and progress in clinical practice
• Shorten recruitment timelines and produce more generalizable findings by mapping real world patient pathways to identify the right sites, patient populations, and engagement touchpoints before a trial launches
• Enhance trial predictability and performance by leveraging additional operational parameters to outline scenarios, strengthen forecast alignment, identify issues and assess impact of targeted interventions
Gayathri Sridhar, Director, Epidemiology and Real-World Evidence, ViiV
Vanessa Gertsen, Head of Feasibility Delivery and Site Engagement, Late Development Oncology, AstraZeneca
Denise Johnson Sura, AVP, Patient Engagement, Eli Lilly and Company
Joseph Kim, Chief Strategy Officer, Proof Pilot
• Capitalize on pipeline value by accelerating trial execution through the development of end-to-end drug development capabilities and an innovative development matrix, to better address complex patient needs at speed
• Enable faster, more comprehensive clinical development by forming strategic partnerships where speed, shared expertise, and patient impact are core drivers of success
Â
Eric Hughes, EVP Global R&D and Chief Medical Officer, Teva
• Move beyond isolated AI pilots to scale intelligence across clinical development, enabling insights to flow across studies, teams, and functions
• Improve decision quality, accelerate evidence generation, and increase operational effectiveness through practical AI use strategies, while learning how leading organizations are building learning-driven clinical ecosystems that deliver faster innovation and better outcomes for patients
Â
Stuart Pyle, Partner, Life Sciences R&D, IBM
• Strengthen portfolio resilience by leveraging AI-driven insights to optimize trial site selection and operating models to evolving regulation and patient access needs
• Scale agile, inclusive trial portfolios by embedding decentralized approaches and AI-enabled tools to reduce access barriers and support long-term clinical development priorities
Â
Shobha Dhadda, SVP and Chief Clinical Science and Operations Officer, Clinical Development, Eisai
Cecilia Schott, VP, Head Precision Medicine Portfolio Planning, GSK
- Secure access to the highest-performing sites by becoming sponsor of choice through stronger partnerships built on trust, transparency and consistent communication
- Elevate the quality of evidence delivered by reducing operational burden through targeted support and resources tailored to each site’s specific needs
Â
Vanessa Gertsen, Head of Feasibility Delivery and Site Engagement, Late Development Oncology, AstraZeneca
Shannon Edwards, US Site Engagement Lead, AstraZeneca
Kathy Mickel, VP, Membership, Education & Programs, SCRS
Michael Oldfield, Director, Regulatory Affairs, Fox Chase Cancer Center
• How evaluating a research participants' research history to confirm eligibility closes a severe gap in the screening process
• How network participation and standardizing eligibility across studies, therapeutic areas, and sponsors enables a safer, faster, and more trusted research ecosystem
Justin Goodarz, Chief Commercial Officer, Verified Clinical Trials
Quality by design, oversight by intent: building end-to-end frameworks that drive safer, smarter trial delivery
• Strengthen sponsor oversight by embedding quality by design principles and central monitoring at site level to trigger targeted interventions when risk thresholds are met
• Drive proactive improvement through a collaborative RBQM framework that connects sponsors, study teams and sites, creating ongoing feedback loops that surface risks early and support more informed, responsive decision-making
Laura Doyle, Senior Director, Clinical Operations, Alnylam Pharmaceuticals
Anne Marie Inglis, Senior Director, Clinical Operations Asset Lead, GSK
Safwan Kezbor, Executive Medical Director, Global Clinical Development, Shionogi
Justin Goodarz, Chief Commercial Officer, Verified Clinical Trials
• Improve trial feasibility and recruitment outcomes by creating structured feedback loops with patients that translate real-world insights on awareness, trust, and participation experience into more accessible and better-designed protocols.
• Strengthen patient retention via continuously capturing and acting on patient perspectives around data transparency, AI use, and communication preferences to shape personalized engagement strategies.
Annick de Bruin, Chief Research and Insights Officer, CISCRP
• Discover why recruitment built one study at a time misses how patients and communities actually move through their journey and what it takes to meet them at that breadth
• Hear a live conversation on what continuous, community-wide engagement looks like in practice, and what it means for sponsors managing a portfolio or a single trial
Â
Brian Weiss, CEO, Carebox
Leah Szumita, Senior Director, Clinical Trial Support Center, Blood Cancer United
• Improve recruitment rates and strengthen retention by building meaningful, insight-led engagement with patient communities from the earliest stages of enrolment planning
• Create more diverse and accessible recruitment pathways by combining digital tools with direct community involvement to build trust, expand reach, and strengthen patient participation
Â
Karen Correa, VP Clinical Development Operations, Boehringer Ingelheim
Amanda Decoker, Head of Patient Engagement, Experience and Recruitment, Takeda
Nicole Richie, VP Population Science, Genentech
Tonya Edison, AVP, Clinical Central Services & Innovation, Eli Lilly and Company
Stephen Andrews, Head of Biopharma Partnerships, Natera
• Speed up evidence generation by challenging outdated practices and making better use of overlooked opportunities in clinical innovation, beyond the familiar focus on recruitment, decentralized trials and automation
• Embed innovation at scale by understanding what sets transforming organizations apart from experimenting ones, and building the leadership mindset needed to succeed in the next era of clinical development
Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences
Moderator: Amy Turnquist, VP The Americas Operating Board, Healthcare Businesswomen's Association
The Missing Variable in Clinical Trial Performance
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Eligibility tells us who can participate. Readiness helps us understand what patients need to make participation possible. Yet conventional recruitment still optimizes primarily for medical eligibility and speed through the funnel. This session explores how readiness can be measured early and continuously, and turned into an operating signal before preventable barriers become screen failure, dropout, enrollment volatility, or rescue.
Â
Brittany Erana, CEO, Jumo Health
Get hands-on in interactive sessions designed to translate ideas into practical, real-world solutions.
Â
Session One: Rethinking Site Selection: Innovate with Emerging Sites
• Expand trial capacity by identifying and activating emerging and under-utilised sites
• Foster cross-functional partnerships and stakeholder buy-in to support innovative site engagement models and build sustainable, trial-ready research networks
Â
Kathy Mickel, VP, Membership, Education & Programs, SCRS
Â
Session Two: Where AI Earns its Place in Global Patient Recruitment
A working conversation among clinical operations leaders about the top opportunities for AI in global patient recruitment, what's real now and what's on the horizon, and how to add it without costing patients the choice and human contact that keep them engaged.
• Which parts of the recruitment path (e.g. identification, outreach, pre-screening, referral, enrollment) are producing measurable gains from AI today and what's coming next
• How sponsors add automation while protecting patient choice and trust: where human involvement stays non-negotiable, what sites need carried through a handoff, and what study teams are finding in their own recruitment data
Â
Matt Walz, CEO, Trialbee
Â
Session Three: Lead portfolio-wide transformation by turning clinical innovation into lasting results - an interactive discussion
Following on from earlier onstage conversation with Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences, get hands-on in this interactive session designed to translate ideas into practical, real-world solutions.
Join Sammi to dive deeper into what keeps clinical innovation stuck at the pilot stage. Share your own experiences with peers and work together on practical ways to embed innovation across your portfolio.
Â
Sammi Tang, SVP, Head of Quantitative Sciences and Evidence Generation, Astellas Life Sciences
• Learn why no single company, research site or community organization can make clinical research more representative on its own and how a coalition model can help turn ambition into measurable progress.
• Design effective partnerships through shared accountability and locally responsive solutions that can strengthen the broader healthcare ecosystem
Quita Beeler Highsmith, VP Population Health Centre of Excellence, Genentech
Alan Balch, Executive Chair, Patient Advocate Foundation
Structured codes tell you that a patient exists, but they rarely tell you who that patient is. This session makes the case that the richest signal about real-world patients’ lives in unstructured clinical notes, and transparency about the source is what earns trust.
Learn what the clinical narrative reveals that codes miss and how we’ve transformed complex data into Patient Intelligence, a connected, actionable solution that brings you closer to the patient. Hear how these insights can shape decisions across the clinical planning journey, from understanding patient populations and treatment patterns to trial design, site strategy, and recruitment.
Â
Madeline Naylor, Chief Clinical Officer, Citeline
• Unlock speed in the data-to-decision phase by modernizing how clinical data is reviewed, analyzed, and reported, turning complex data into timely, decision-ready evidence
• Move beyond technology pilots to embed analytics, visualization, and AI into scalable ways of working, aligning technology with people, process, and culture to deliver sustainable value
Eileen Ching, Senior Director, Head of Clinical & Statistical Programming Methodology, Johnson & Johnson
Moderator: Amy Turnquist, VP The Americas Operating Board, Healthcare Businesswomen's Association
Decentralizing cinical trials: better science through co-creation and multi-stakeholder collaboration
- Partner with communities from trial design through delivery to address the real-world barriers that impact participation, access, and engagement
- Create sustainable community research ecosystems that expand representation, accelerate learning across studies, and generate more relevant clinical evidence
Alan Balch, Executive Chair, Patient Advocate Foundation
• Expand access to diverse patient populations through community-based research networks
• Improve trial speed and data quality by with a site-centric approach
• Combine site performance intelligence, AI-enabled patient identification, and engaged site staff to drive stronger trial outcomes
Â
Dana Feuchtbaum, Chief Operating Officer, Iterative Health
• Reduce feasibility risk and strengthen the relevance of your evidence base by using patient registry, EHR, and claims data to validate inclusion/exclusion criteria against the realities of how patients present and progress in clinical practice
• Shorten recruitment timelines and produce more generalizable findings by mapping real world patient pathways to identify the right sites, patient populations, and engagement touchpoints before a trial launches
• Enhance trial predictability and performance by leveraging additional operational parameters to outline scenarios, strengthen forecast alignment, identify issues and assess impact of targeted interventions
Â
Gayathri Sridhar, Director, Epidemiology and Real-World Evidence, ViiV
Vanessa Gertsen, Head of Feasibility Delivery and Site Engagement, Late Development Oncology, AstraZeneca
Denise Johnson Sura, AVP, Patient Engagement, Eli Lilly and Company
Joseph Kim, Chief Strategy Officer, Proof Pilot