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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
 
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
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  • Trust and Responsible Innovation