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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
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

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
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
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

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
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

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
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 →
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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
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

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
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

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
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

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
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

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
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

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
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
 
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