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Type: 16: InnovationTheaters clear filter
Monday, June 15
 

10:15am EDT

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3
Component Type: Session

Biopharma organizations have spent decades generating clinical content. Trial master files, investigator documents, safety narratives, and regulatory submissions sit largely unclassified and functionally invisible across content repositories. Content was generated across every study, processed once, and never revisited — leaving every insight locked inside the document itself, blind to the AI systems now being built on top of it. Join us to hear from Industry leaders, in a candid conversation about transforming years of digital debt into an AI-ready content foundation. You will hear real-world perspectives on what metadata maturity looks like in practice and what becomes possible when intelligent content workflows finally reach regulated clinical data.

Chair

Box, Inc.

Speaker

Speaker
Manu Vohra

Speaker
Ali Shamoun

Speaker
Boris Braylyan, MBA


Speakers
avatar for Boris Braylyan

Boris Braylyan

Chief Digital & Data Officer, Parexel, United States
Boris Braylyan is a technology leader with over two decades of experience advancing digital innovation in regulated industries. His career spans large scale transformations in life sciences, including 20 years at Pfizer, where he modernized global clinical and regulatory systems and... Read More →
avatar for Box, Inc.

Box, Inc.

United States
avatar for Ali Shamoun

Ali Shamoun

Director, Global Development Systems, Regeneron, United States
avatar for Manu Vohra

Manu Vohra

Vice President and Managing Director, Life Sciences, Box, United States
Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After two decades deploying ECM solutions in a regulated industry, he's spending his efforts supporting Life Sciences companies to ride the Digital Transformation wave... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#401.2 IT: Deep Intelligent Pharma K.K. Innovation Theater: Accelerate Deep Tech Impact - Mentor Japanese MD/PhDs with Agentic AI from Startup Launch to Physician-Led Trials
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2
Component Type: Session

Japanese MDs and PhDs possess deep tacit knowledge and clinical insights that could transform patient care, yet turning these into successful deep tech startups and physician-led clinical trials remains extremely challenging due to fragmented support systems, regulatory complexity, and limited entrepreneurial resources. This session introduces a powerful new approach that combines structured mentoring with Agentic AI to guide Japanese physician-scientists from idea validation and company founding through to efficient, physician-led clinical development. Participants will discover practical frameworks and real-world examples of how Agentic AI accelerates critical steps—including protocol design, regulatory navigation, and evidence generation—while experienced mentors help bridge the gap between academic excellence and market impact. Attendees will leave with actionable strategies to unlock societal value from university and hospital tacit knowledge and build more successful, clinician-driven innovation pipelines in Japan and beyond.

Chair

DEEP INTELLIGENT PHARMA (SG) PRIVATE LIMITED

Speaker

Speaker
Shinya Yamamoto, PHD, MS


Speakers
DI
avatar for Shinya Yamamoto

Shinya Yamamoto

General Manager, Deep Intelligent Pharma ( Singapore) private limited, Japan
Shinya Yamamoto, PhD currently serves as GM of Deep Intelligent Pharma K.K., leading AI-driven innovation in drug development and clinical research. He is passionately committed to unlocking tacit knowledge from Japanese universities and medical institutions and transforming it into... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1
Component Type: Session



Chair

IQVIA

Speaker

Speaker
Raja Shankar, MS


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Raja Shankar

Raja Shankar

VP, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

This session explores practical, systematic approaches to AI-orchestrated authoring and quality control across the end-to-end R&D document lifecycle. We examine high-value use cases spanning clinical (Protocol, CSR, M2.5, M2.7), CMC, and nonclinical documentation to demonstrate how AI can drastically accelerate IND, NDA, and BLA filing timelines by shortening the draft-to-submission window. Attendees will see AI tool demonstrations showing how regulatory writing teams leverage AI within familiar environments, specifically a Microsoft Word add-in integrated with Veeva RIM. This approach ensures evidence-anchored content generation and orchestration across eCTD documents, utilizing content linkage for change intelligence. Finally, we introduce a document-network model that identifies propagation paths for automated updates across a tightly linked network of documents. This framework enables cross-document consistency and scalable QC for both initial submissions and subsequent amendments, empowering professionals to produce high-quality, compliant filings with greater efficiency and confidence.

Chair

AlphaLife Sciences

Speaker

Speaker
William Chen

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen founded AlphaLife Sciences to bring enterprise-grade AI to drug development—specifically to the complex, compliance-driven world of regulatory and clinical authoring. She brings over 30 years of software engineering leadership experience, including roles as Asia Pacific... Read More →
avatar for William Chen

William Chen

Principal Business Solution Architect, AlphaLife Sciences, United States
Will Chen is Head of Solutions at AlphaLife Sciences, where he leads the design and deployment of AI-driven solutions to transform clinical development and life sciences workflows. He specializes in translating complex scientific and regulatory challenges into scalable, commercially... Read More →
avatar for AlphaLife Sciences
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#420 IT: CGS Immersive Innovation Theater: From 12 Weeks to 6 - How AI Transformed Compliance Training
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3
Component Type: Session

The biggest barrier in regulated training isn’t delivery — it’s the painstaking process of development. In this live session, see how Cicero Learn, an AI engine built for compliance-driven organizations, automatically transforms SOPs, protocols, and SME interviews into fully structured, audit-ready training — no templates or instructional designers needed. You’ll also discover how a major blood services organization used this approach to cut new-hire certification time nearly in half while maintaining safety and compliance across thousands of learners. Walk away with a proven framework for piloting next-generation AI learning in your own regulated environment.

Chair

CGS Immersive

Speaker

Speaker
Micah White


Speakers
CI

CGS Immersive

United States
avatar for Micah White

Micah White

VP, Research & Development, CGS Immerive, United States
Micah White leads R&D at CGS Immersive, where he applies augmented reality, mixed reality, and generative AI to transform learning and performance in highly regulated environments. He directs the development of platforms such as TeamworkAR™ and Cicero — turning complex SOPs, protocols... Read More →
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

#424 IT: Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2
Component Type: Session

Quality improvement rarely starts with a blank slate — but what happens when it does? When CRISPR Therapeutics faced a contract deadline and an overly complex QMS, they chose disruption over incremental fixes, rebuilding their Quality processes from the ground up in just 52 days. In this session, CRISPR's Executive Director of Quality and Pharmacovigilance Operations, Kate Ellmer, and Kivo's VP of Services, Chris Xistris, share how stripping away the bells and whistles revealed a simpler, more effective path forward. Walk away with a practical framework for right-sizing your QMS, evaluating vendors under pressure, and turning operational constraints into a catalyst for real change.

Learning Objectives

How to think about Quality Management Systems from an entrepreneurial perspective; What “right-sizing” a Quality system means for smaller / scaling organizations; Concrete examples of simplified processes; What to look for when exploring a new system.

Chair

Kivo, Inc.

Speaker

Speaker
Kate Ellmer, MPH

Speaker
Chris Xistris


Speakers
avatar for Kate Ellmer

Kate Ellmer

Exec. Director, Quality and PV Operations, CRISPR Therapeutics, United States
Kate Ellmer is an Executive leader at CRISPR Therapeutics where she is responsible for Quality and Pharmacovigilance Operations. In her twenty-year industry career, she has explored her passion for implementing QMS and GxP systems that enable seamless business processes. Kate has... Read More →
KI

Kivo, Inc.

United States
avatar for Chris Xistris

Chris Xistris

Vice President of Services, Kivo, United States
Chris Xistris has 25+ years in Life Sciences, starting in Regulatory and Clinical Operations at small and mid-size biotechs. He then moved into consulting, building regulatory operations infrastructure for mid-size clients. Before joining Kivo, he spent over a decade at a Life Sciences... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

#425 IT: Parexel Innovation Theater: The Connected Submission - How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

Explore how AI enabled authoring is transforming regulatory content development, delivering measurable improvements in speed, consistency, and quality across submissions. Discuss how process standardization serves as the critical enabler for automation, supporting faster, more scalable submission execution. Understand how connecting authoring, standardization, and automation enables regulatory intelligence, unlocking insights from submission content to support proactive planning and decision making.

Learning Objectives

Explain how AI-enabled authoring, process standardization, and automation connect to create a modern regulatory submission ecosystem; Demonstrate practical steps and frameworks organizations can use to implement across the regulatory ecosystem; Discuss how integrated submission processes generate regulatory intelligence that supports proactive decision making.

Chair

Parexel

Speaker

Speaker
Katie Connelly


Speakers
avatar for Katie Connelly

Katie Connelly

SVP, Global Head of Regulatory Affairs, Parexel International, United States
Katie, a senior leader at Parexel, brings extensive experience in designing, implementing, and delivering regulatory programs, with deep expertise in product leadership and change management. She oversees global regulatory affairs and operations outsourcing, regulatory FSP, submissions... Read More →
avatar for Parexel

Parexel

United States
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

Google Cloud Innovation Theater: Accelerating Discovery: The Shift to Agentic Research Workflows with Google’s Co-Scientist
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3
Component Type: Session

In a secure Gemini Enterprise environment, Google’s Co-Scientist uses multi-agent systems to accelerate breakthroughs by bridging digital data and biological insights, enabling high-velocity "Design-Test-Refine" cycles.

Learning Objectives

In a secure Gemini Enterprise environment, Co-Scientist provides frictionless enablement of scientific processes via a "Scientist-in-the-Loop" architecture. This allows researchers to offload routine data orchestration, focusing expertise on high-level heuristic decision-making as "Mission Commanders" who retain final authority over all critical scientific breakthroughs.

Speaker

Speaker
David Henderson, PHD

Speaker
Volker Eyrich, PHD


Speakers
avatar for Volker Eyrich

Volker Eyrich

Customer Engineer, AI Infrastructure, Google Cloud, United States
Volker Eyrich, PhD, is a Customer Engineer at Google Cloud where he focuses on the areas of Scientific Research as well as Scientific Computing. He joined Google in 2018. Prior to Google he spent 18 years in Computational Drug Discovery focusing on algorithm and infrastructure development... Read More →
avatar for David Henderson

David Henderson

AI Customer Engineer, Life Sciences, Google Cloud, United States
David Henderson, PhD, is a Customer Engineer at Google Cloud within the Healthcare and Life Sciences industry team. He specializes in the application of advanced AI and high-performance computing to accelerate drug discovery and scientific research. David has played a key role in... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:45pm EDT

#428 IT: Evernorth Health Services Innovation Theater: Enabling Real World Patient Reported Outcomes Collection Through Specialty Pharmacy Engagement
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3
Component Type: Session

Patient-reported outcomes (PROs) are increasingly central to understanding real-world treatment experiences, yet recruiting patients into longitudinal PRO studies remains operationally challenging. Specialty pharmacies represent a high-frequency, trusted point of contact with patients receiving complex therapies, offering a scalable and underutilized opportunity for patient engagement. This presentation will discuss study design considerations, early engagement outcomes, and implications for scalable, patient-centered real-world evidence generation using existing healthcare touchpoints.

Learning Objectives

Describe the role of specialty pharmacy touchpoints in facilitating recruitment for real-world PRO studies; Evaluate early feasibility and engagement outcomes from a longitudinal PRO study leveraging pharmacy-based patient outreach; Identify design and operational considerations for integrating PRO data collection into real-world evidence generation.

Chair

Evernorth

Speaker

Speaker
Krystyna Amalfe, MPH


Speakers
avatar for Krystyna Amalfe

Krystyna Amalfe

Sr. Account Executive, Intelligence Solutions, Evernorth Health Services, United States
Krystyna Amalfe, MPH, is a public health professional with over 15 years of experience across clinical research, real world evidence, pharmaceutical lifecycle strategy, pharmacy benefit management, and payer markets. At Evernorth Health Services, she works at the intersection of data... Read More →
avatar for Evernorth

Evernorth

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:45pm EDT

#429 IT: Verily Health Inc Innovation Theater: Bridge the Evidence Gap - Integrating Consumer Wearables and Real-World Data for Continuous, Participant-Centric Insights
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1
Component Type: Session

Life sciences sponsors invest heavily in clinical trials, yet frequently lose visibility into patient outcomes the moment a study ends. While traditional real-world data attempts to bridge this gap, it relies on episodic snapshots that miss the continuous health signals that matter most: functional status and quality of life, reflected in sleep quality, daily physical activity, and autonomic function. This session presents a practical framework for integrating consumer wearable data with recontactable participant registries and curated electronic health records. By utilizing an open platform approach, sponsors can build a continuous evidence engine that generates actionable insights across the entire product lifecycle. Drawing from a decade of digital measures research across neurology, cardiovascular, and metabolic conditions, this presentation will share concrete strategies for designing wearable-enabled studies that balance data quality, participant experience, and scientific rigor.

Chair

Verily

Speaker

Speaker
Sooyoon Shin, PHD


Speakers
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Verily Health, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers and Science Innovation at Verily Health, where she leads research and evidence generation for digital health technologies. She oversees the development and implementation of AI/ML-enabled capabilities across clinical programs... Read More →
V

Verily

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session
 
Tuesday, June 16
 

9:15am EDT

#501 IT: Weave Bio Innovation Theater: Threading AI Throughout the Drug Development Lifecycle - An Enterprise Lens
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 3
Component Type: Session

Pressures to go faster and do more with less continually rise, and enterprise pharma organizations experience these pressures at scale. Quality cannot be compromised when rapidly constructing sophisticated, layered health authority narratives with evolving data. Questions from health authorities must be responded to with speed and precision. New technology offers relief, but choice of partner, workflow evolution, and organizational adoption are major hurdles to overcome. Drawing on real-world experience from our work with partners, we will explore how these challenges can be met in collaboration between technology builders and domain experts, and the benefits to be gained in doing so. We share a perspective on the benefits of a holistic approach, utilizing a single AI platform across workflows and throughout the lifecycle. We will also share our playbook: lessons learned and advice on how to approach selection, design, and implementation of AI systems for existing processes and systems. Pragmatic insights on where and how to lean into organizational change and where to work with existing systems and practices.

Chair

Weave Bio

Speaker

Speaker
Brandon Rice

Speaker
Andrew Robertson, JD, PHD


Speakers
avatar for Andrew Robertson

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#502 IT: IQVIA Innovation Theater: From Insight to Impact - Leveraging Patient Experience Data Through Technology and AI
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 1
Component Type: Session

This session examines persistent scientific and operational challenges in eCOA implementation, particularly in studies using high frequency patient reported data. The discussion focuses on how advanced monitoring technologies and AI driven analytics can be used to detect emerging risks such as disengagement, response drift, and early signal degradation while data collection is ongoing. Through real world examples, the session highlights how predictive analytics and pattern recognition can support earlier, more informed decisions, helping teams distinguish true clinical change from measurement artifacts and strengthen confidence in longitudinal outcome data.

Learning Objectives

Identify common scientific and operational risk patterns in high-frequency eCOA data; Understand how technology-enabled monitoring and AI-driven analytics can surface early indicators of data quality risk while data collection is ongoing; Recognize how predictive, proactive oversight supports earlier and more targeted intervention, strengthening confidence in endpoint integrity without replacing scientific judgment.

Chair

IQVIA

Speaker

Speaker
Lindsay Hughes, PHD, MS


Speakers
avatar for Lindsay Hughes

Lindsay Hughes

Principal, RDS, IQVIA, United States
Lindsay Hughes, PhD is a Principal in IQVIA’s Patient Centered Solutions practice, with nearly two decades of experience in behavioral and life sciences. Her work focuses on understanding how people interact with technology in clinical research settings and applying that insight... Read More →
avatar for IQVIA

IQVIA

United States
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#503 IT: Parexel Innovation Theater: Human-Centered AI - A Dual-Layer Model for Clinical Research Excellence
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 2
Component Type: Session

Learn about early wins from enterprise AI solutions: How these solutions have delivered measurable gains in speed, automation efficiency, and data quality without displacing human expertise. Explore Parexel use cases: the emergence of a second innovation layer driven by citizen developers (CRAs), who built targeted AI tools that automate labor intensive workflows and enhance operational consistency. Understand how a sustainable dual layer AI model that blends scalable enterprise automation with frontline innovation can accelerate trial execution, improve consistent quality and compliance, and empower clinical professionals as AI supported decision makers.

Learning Objectives

Participants will learn how to implement a dual-layer AI strategy that combines enterprise automation with citizen-developer innovation to reduce manual workload, accelerate clinical operations, and maintain regulatory compliance, while reinforcing rather than replacing human expertise.

Chair

Parexel

Speaker

Speaker
Boris Braylyan, MBA


Speakers
avatar for Boris Braylyan

Boris Braylyan

Chief Digital & Data Officer, Parexel, United States
Boris Braylyan is a technology leader with over two decades of experience advancing digital innovation in regulated industries. His career spans large scale transformations in life sciences, including 20 years at Pfizer, where he modernized global clinical and regulatory systems and... Read More →
avatar for Parexel

Parexel

United States
Tuesday June 16, 2026 9:15am - 9:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

11:45am EDT

#522 IT: Artos, Inc Innovation Theater: AI Isn't About Generating Documents, it's About Generating Data
Tuesday June 16, 2026 11:45am - 12:15pm EDT
Innovation Theater 2
Component Type: Session

The speakers will discuss how AI document generation is often a misunderstood problem. Sponsors focus on finding AI that can get words on a page, but they often lose sight of a broader, cross-functional, data strategy that this needs to fit within in order to achieve significant ROI. This discussion will provide a conversation around strategic adoption of AI and concrete case studies in support of that.

Learning Objectives

The evolving state of the regulatory landscape and the role data plays in it; Where AI can and can't solve problems; Successful implementations of AI in complex pharma contexts.

Chair

Artos AI

Speaker

Speaker
Sean McNiff

Speaker
Josh Kim


Speakers
AA

Artos AI

United States
avatar for Josh Kim

Josh Kim

CEO, Artos AI, United States
Josh is the CEO and co-founder of Artos, which provides the AI-native document creation and management suite for drug development document creation and management. Prior to Artos, Josh worked in regulatory, clinical, and commercial strategy roles at Ignyta and Erasca where he focused... Read More →
avatar for Sean McNiff

Sean McNiff

Director, Regulatory Operations, Vertex Pharmaceuticals, Inc, United States
Tuesday June 16, 2026 11:45am - 12:15pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

11:45am EDT

#523 IT: Syneos Health Innovation Theater: More Doesn't Guarantee Better - Why AI Success Depends on Organizational Agility, Not Just the Tech
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Innovation Theater 1
Component Type: Session

Across clinical development, a growing wave of AI tools is reshaping how work gets done, each designed to make processes faster, easier and more efficient. But in the rush to adopt AI, organizations can overlook the underlying sources of friction that limit performance. At the same time, reliance on monolithic platforms built for end-to-end standardization can limit flexibility, making it harder to evaluate, select and integrate the right innovations as the technology landscape continues to evolve. Drawing on our global experience supporting clinical programs across diverse sponsor models and levels of infrastructure maturity, this session outlines how to align people, processes, data and AI within adaptable operating environments to enable high-performance execution, sustained agility and the ability to continuously integrate new capabilities without disruption.

Chair

Syneos Health

Speaker

Speaker
Matt Harrington


Speakers
avatar for Matt Harrington

Matt Harrington

Global Head, Clinical Product, Syneos Technology Solutions, Syneos Health, United States
At Syneos Health, Matt is responsible for defining and delivering the clinical technology product strategy globally, including our AI enabled platforms that support study design, startup, execution and oversight. Matt joined Syneos Health in 2024. He has extensive clinical technology... Read More →
avatar for Syneos Health

Syneos Health

United States
Tuesday June 16, 2026 11:45am - 12:45pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#524 IT: Vivpro Corporation Innovation Theater: AI in Action - Scaling Regulatory Document Generation Across R&D
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

AI is no longer a future consideration—it is actively reshaping how regulatory work gets done. Organizations that delay risk falling behind, while those that move early can gain a meaningful competitive edge. This session offers a practical, experience-driven perspective on how to operationalize AI for regulatory document generation. We will demonstrate how REGAIN enables flexible document creation with dynamic sectioning and customizable prompts, empowering authors while maintaining quality and consistency. Attendees will also learn key lessons from a successful collaboration—highlighting the importance of governance, cross-functional alignment, and working as one integrated team to drive adoption and deliver measurable impact across R&D.

Learning Objectives

Scale AI-enabled document generation across R&D; Embed quality, compliance, and governance from the start; Leverage REGAIN to automatically generate documents with flexible sectioning, enabling authors to tailor content through custom prompts; Operate as one integrated team, Pfizer and Vivpro working in lockstep as the key to successful implementation

Chair

Vivpro Corporation

Speaker

Panelist
Joga Gobburu, PHD, MBA

Panelist
Angela Russell Winnier, PHD

Panelist
Tushar Nitave


Speakers
VC

Vivpro Corporation

United States
avatar for Joga Gobburu

Joga Gobburu

Co-Founder, Vivpro Corp, United States
Dr. Gobburu is a world-renowned scientific leader in the area of quantitative disease models and their applications to decisions. He is best known for transforming the field of pharmacometrics into a decision-supporting science. His experience as a senior biomedical research scientist... Read More →
avatar for Tushar Nitave

Tushar Nitave

Staff Software Engineer, Vivpro Corp, United States
Tushar Nitave brings over five years of data science and software engineering expertise to his role as a Staff Software Engineer at Vivpro Corp. He currently leads the engineering team for REGAIN, an AI-based solution for regulatory document creation, and holds a Master's in Computer... Read More →
avatar for Angela Winnier

Angela Winnier

Executive Director of Medical Writing, Pfizer, United States
Angela Winnier joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational... Read More →
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#525 IT: Yseop Innovation Theater: Design Regulatory Grade AI - Enable Scalable, Consistent Workflows Across Document Types
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 1
Component Type: Session

Content generation is easy. Delivering outputs that are accurate, traceable, and consistent enough for regulatory submission across diverse document types is not. As teams move beyond CSR into protocol, CMC, and pharmacovigilance workflows, many AI solutions fail to adapt, creating risk around compliance, scalability, and usability. This session explores what regulatory grade AI looks like in practice. Through real workflow examples, we will show how configurable, agentic systems embed compliance and validation behind the scenes while adapting to specific business needs, enabling scalable, submission ready outputs without compromising control.

Chair

Yseop

Speaker

Speaker
Camille Sauder

Speaker
Jenni Pickett, PHD


Speakers
avatar for Jenni Pickett

Jenni Pickett

Yseop, United States
Jenni Pickett, PhD, helps develop and deploy AI medical writing solutions for over a dozen large and small pharma companies as Head of Medical Writing for Yseop. She has 17 years of pharmaceutical industry experience, including 10 years of CMC experience and 7 years of regulatory... Read More →
avatar for Camille Sauder

Camille Sauder

Yseop, United States
With 10+ years in AI, Camille leads presales at Yseop, working directly with biopharma organizations on scoping and implementing AI solutions across complex workflows. Over 8 years at Yseop, she has held roles spanning AI technical consultant, project management, and customer success... Read More →
avatar for Yseop

Yseop

United States
Tuesday June 16, 2026 12:25pm - 12:55pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

#527 IT: Certara Innovation Theater: LLM-Driven Submissions: From Data Preparation to eCTD
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

When introducing efficiencies to your regulatory workflow, it’s not simply a question of writing faster. Teams need to look up and down stream to accelerate data delivery, automate consistent first drafts and enable faster eCTD preparation. This session presents a practical, framework for regulatory submissions that connects data pipelines and GenAI-assisted authoring with eCTD publishing and lifecycle execution using Certara CoAuthor™ and Certara GlobalSubmit™. Attendees will learn how to design governance and workflows that make LLMs usable in regulated environments: establishing standardized templates and structured sections for repeatability; applying “human-in-the-loop” review checkpoints; and leveraging publishing-time validation to surface issues earlier—before they become last-minute blockers. The session will also highlight where LLM support delivers the most value (data aggregation, first-draft acceleration, consistency across sections, and faster content iteration) and how submission operations can translate better-authored content into smoother assembly, review, and health authority–compliant deliverables.

Learning Objectives

A reference architecture for LLM-driven regulatory authoring through eCTD submission execution; Practical controls for compliant GenAI use: structured content, standardized templates, and expert oversight; Methods to reduce cycle time and technical risk through robust validation and streamlined eCTD review workflows.

Chair

Certara

Speaker

Speaker
Liam O'Leary


Speakers
avatar for Certara

Certara

United States
avatar for Liam O'Leary

Liam O'Leary

Client Solutions Architect, Certara, United States
Liam O’Leary is a Client Solutions Architect at Certara.AI, applying GenAI to bridge science and software for life-sciences teams. He has delivered over 50 CoAuthor demonstrations for pharmaceutical and biotech companies, developed training and workflows for regulatory writers... Read More →
Tuesday June 16, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

3:15pm EDT

#546 IT: Collate Innovation Theater: A Thousand Document Types - An AI Platform Approach to Document Authoring and Intelligence Adopted by Global Enterprises
Tuesday June 16, 2026 3:15pm - 3:45pm EDT
Innovation Theater 1
Component Type: Session



Chair

Collate

Speaker

Speaker
Surbhi Sarna


Speakers
C

Collate

United States
avatar for Surbhi Sarna

Surbhi Sarna

CEO, Collate, United States
Surbhi is the CEO and Founder of Collate. Previously, she was the CEO and Founder of nVision Medical, a medical device company that developed a novel method for the early detection of ovarian cancer, which was acquired by Boston Scientific for $275 million. She has served as a board... Read More →
Tuesday June 16, 2026 3:15pm - 3:45pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session
 
Wednesday, June 17
 

9:15am EDT

#601 IT: Faro Health Innovation Theater: Digital Protocols in Action - Enabling End-to-End Automation in Clinical Development
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 1
Component Type: Session

Clinical trials still rely heavily on static Word documents to define and communicate protocol intent, creating manual handoffs, data inconsistencies, and delays across every downstream system. This session explores how digital, structured protocols serve as the foundation for end-to-end automation in clinical development, eliminating the translation layer between study design and execution. Through a live demo of the Faro platform, attendees will see how a single structured protocol definition can simultaneously drive automation across multiple workflows — from EDC build to authoring and more. Attendees will leave with a concrete understanding of how a platform approach to protocol digitization can accelerate study startup, reduce amendment burden, and position their organization for AI-ready clinical development.

Learning Objectives

Learn how a structured, machine-readable protocol serves as a single source of truth that can drive multiple downstream systems; See firsthand how protocol digitization can support study design optimization, augment medical writing, and accelerate study startup through a live platform demo; Identify practical first steps for transitioning from document-based to digital protocol workflows within your organization.

Chair

Faro Health Inc.

Speaker

Speaker
Vivian Dewoskin, MBA


Speakers
avatar for Vivian Dewoskin

Vivian Dewoskin

Chief Commercial Officer, Faro Health Inc., United States
Vivian is the Chief Commercial Officer at Faro, where she leads sales, marketing, and commercial strategy. She works closely with Faro’s customers to understand their needs and goals, and translate them into Faro’s product development roadmap. Prior to Faro, Vivian held multiple... Read More →
FH

Faro Health Inc.

United States
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

9:15am EDT

#602 IT: PhaseV Trials Innovation Theater: From Protocol to Submission - The Real-World Impact of AI in Clinical Operations
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 2
Component Type: Session

As clinical trials grow increasingly complex, relying on historical correlations and rigid fixed designs is no longer viable. This session will discuss the practical application of AI across the clinical lifecycle, from identifying predictive early-derived endpoints to dynamically optimizing site selection and patient recruitment. We will share actionable success stories demonstrating how multimodal AI platforms are currently helping biopharma and CROs navigate regulatory demands for explainability while cutting trial durations by 40%.

Chair

PhaseV

Speaker

Speaker
Raviv Pryluk, PHD


Speakers
P

PhaseV

United States
avatar for Raviv Pryluk

Raviv Pryluk

CEO, PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technological company that developed a causal-ML-based platform for the design and execution of adaptive clinical trials. Raviv has over a decade of experience as a technological leader in the advanced technological defense industry, after... Read More →
Wednesday June 17, 2026 9:15am - 9:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session
 
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DIA 2026 Global Annual Meeting
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102AB
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111AB
112AB
114
115AB
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116
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118AB
118C
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Ballroom AB
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Innovation Theater 1
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Innovation Theater 3
Spark Stage
TBD
Zone A
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
  • 13: Community-Rounds
  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
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  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation