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Tuesday, June 17
 

9:45am EDT

#212 IT: IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 1
Component Type: Session

In today's rapidly evolving regulatory landscape, AI/ML, NLP, & RPA are revolutionizing regulatory activities in the biopharma industry. Discover how these advanced technologies are transforming regulatory workflows, enhancing efficiency, and ensuring compliance. Attendees will learn about leveraging AI and ML for proactive regulatory intelligence, informed decision-making, dynamic task management, knowledge institutionalization, resource optimization, and real-time compliance monitoring.

Speaker

Speaker
Michelle Gyzen


Speakers
avatar for Michelle Gyzen

Michelle Gyzen

Senior Director, Regulatory Innovation & Technology, IQVIA, United States
Michelle has over 20 years of experience in pharmaceuticals, biotech, and medical devices. A senior director with expertise in designing large-scale regulatory outsourcing programs, offshore resource modeling, and regulatory tech integration and automation. In her current role, Michelle... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

#213 IT: Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 2
Component Type: Session

There is a critical balance to be struck, ensuring that study designs and digital endpoint solutions are not overburdensome to participants, but are still sufficiently robust to generate the quality data required to determine drug efficacy, safety, and impact to quality of life. In this engaging panel, we’ll review why maintaining patient focus is essential for success in today’s clinical studies, and how to do so successfully while maintaining the scientific rigor needed to achieve study goals.

Speaker

Speaker
Todd Rudo, MD

Speaker
Jay Ferro, MBA

Speaker
Kelly Dumais, PhD

Speaker
Stacy Hurt, MBA, MHA


Speakers
avatar for Kelly Dumais

Kelly Dumais

Director, eCOA Science and Consulting, Clario, United States
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient-reported outcomes (PROs) to support labeling... Read More →
avatar for Jay Ferro

Jay Ferro

EVP & Chief Information and Technology Officer, Clario, United States
Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years’ experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →
avatar for Todd Rudo

Todd Rudo

EVP, Chief Medical Officer, Clario, United States
Dr. Todd Rudo provides medical and scientific leadership across Clario. He has nearly 20 years of clinical cardiology & pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

#214 IT: Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 3
Component Type: Session

Global pharma companies are successfully implementing Gen AI across safety and regulatory workflows, driving efficiency and measurable ROI. Emmanuel “Manny” Belabe, Global Head of Operational Excellence at ArisGlobal, will discuss key strategies for implementation success, overcoming cultural challenges, and ensuring adoption.

Speaker

Speaker
Emmanuel Belabe


Speakers
avatar for Emmanuel Belabe

Emmanuel Belabe

Global Head, Operational Excellence • Global Customer Excellence, ArisGlobal, United States
Emmanuel Belabe, better known as “Manny”, has worked within ArisGlobal in a number of different roles over his 15 years with the company. During that time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products, while advocating... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

#232: Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 1
Component Type: Session

The global biosimilars market is growing rapidly. Today, there are over 50 biosimilars approved in the U.S. and over 120 biosimilars approved in Europe. However, only about 10% of the over 100 biologics expected to lose market exclusivity in the next decade have a biosimilar currently under development. This session will examine the different landscapes of biosimilar regulation and uptake in the global market today, focusing on a comparative analysis between the Europe and the United States.

Speaker

Speaker
Mariana Socal, MD, PhD, MS

Speaker
Gillian Woollett, PhD, MA


Speakers
avatar for Mariana Socal

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →
avatar for Gillian Woollett

Gillian Woollett

Vice President, Head Regulatory Strategy and Policy, Samsung Bioepis, United States
Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a U.S. presence for science-based regulatory strategy and policy in the leading global market for biologics. Previously, she was SVP and Principal Regulatory... Read More →
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

#233 IT: Yseop Innovation Theater: Scaling Regulatory Automation - The One-Click Vision
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 2
Component Type: Session

As automation evolves, regulatory teams are moving beyond isolated tools toward intelligent ecosystems that connect documents, data, and decisions. This session explores the path to One Click Dossier Generation, where multi-document submissions are generated seamlessly using a blend of AI, dynamic workflows, and connected systems. Learn what it takes to scale this vision, and how it’s already taking shape across the industry.

Speaker

Speaker
Jenni Pickett


Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

#233.1 IT: Microsoft Innovation Theater: Innovating Responsibly - AI in Regulated Environments
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 3
Component Type: Session

Join us for "Innovating Responsibly: AI in Regulated Environments," where we explore the practical impact of AI on the life sciences industry. Discover real-world examples of AI applications in regulated environments, highlighting how AI drives innovation and efficiency. Learn how Microsoft collaborates with regulatory bodies to support compliance and safer AI implementation. Gain insights into the technological safeguards that support responsible and secure AI use. This session will provide an overview of how these innovations are reshaping the future of work and discovery in our industry.

Learning Objectives

12:15 PM - 12:19 PM Welcome and Kickoff: Todd Mersch 12:19 PM - 12:27 PM AI Use Cases: Eunice Youhanna 12:27 PM - 12:35 PM MSFT Technology Working with Regulators: Vinita Grover 12:35 PM - 12:43 PM Technology Supporting Safeguards: John Burke 12:43 PM - 12:45 PM Closing Remarks: Akilah Daniels-Vincent

Speaker

Welcome and Kickoff
Todd Mersch

AI Use Cases
Eunice Youhanna

MSFT Technology Working with Regulators
Vinita Grover

Technology Supporting Safeguards
John Burke

Closing Remarks
Akilah Daniels-Vincent


Speakers
avatar for John Burke

John Burke

Cybersecurity Sales Director, Microsoft, United States
John Burke is a passionate technology advocate dedicated to helping customers unlock their full potential through the power of cloud services and digital transformation. In his role at Microsoft, he partners with organizations to deliver innovative solutions that drive efficiency... Read More →
avatar for Akilah Daniels-Vincent

Akilah Daniels-Vincent

Sr. Product Marketing Manager, Microsoft Cloud Marketing - Industry, United States
Akilah Daniels-Vincent is a visionary vanguard at Microsoft, where she leverages the power of data and AI to design cutting-edge marketing strategies that are reshaping the healthcare landscape. With a passion for innovation and impact, she is dedicated to empowering organizations... Read More →
avatar for Vinita Grover

Vinita Grover

Microsoft, United States
Vinita Grover is Senior Counsel at Microsoft, supporting the Health and Life Sciences business with legal and strategic guidance for Pharma and MedTech organizations. With over 15 years of experience in tech transactions, she advises on regulatory, compliance, and licensing matters... Read More →
avatar for Todd Mersch

Todd Mersch

US Life Sciences General Manager, Microsoft, United States
Todd leads Microsoft’s US Life Sciences and Medical Technology business. He brings over 20 years of executive experience in public and private sectors. Before Microsoft, he led a consulting business serving industries from defense to autonomous driving, following the successful... Read More →
avatar for Eunice Lin Youhanna

Eunice Lin Youhanna

Industry Advisor, Microsoft, Canada
Eunice Youhanna is a strategic leader and Industry Advisor with deep expertise in pharmaceutical innovation, particularly at the intersection of AI and commercial, medical, regulatory, and R&D functions. She partners with global life sciences organizations to drive transformation... Read More →
Tuesday June 17, 2025 11:45am - 12:15pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

#236.1 IT: Whatfix Innovation Theater: Closing the Digital Execution Gap in Life Science - A Practical Path to Compliance, Efficiency, and Speed
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 1
Component Type: Session

Despite investments in digital transformation, life sciences firms still face hurdles with tech adoption, compliance, and workforce efficiency. This session covers closing the “digital execution gap” using in-app guidance, automation, and behavioral analytics. Learn how teams across clinical, regulatory, and other functions use digital adoption platforms to: Ensure SOP adherence and GxP compliance; Reduce training time, support tickets, and operational errors; Drive consistent use of CTMS, QMS.

Speaker

Speaker
Parth Thesia


Speakers
avatar for Parth Thesia

Parth Thesia

Solutions Consulting - LifeSciences NA, Whatfix , United States
Parth Thesia is a seasoned Senior Solution Consultant with over 12 years of experience, specializing in Digital Transformation, Customer and Employee Experience, and Life Sciences. As the Solutions Consulting Leader for the Life Sciences GTM team at Whatfix, he leads strategic account... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

#237 IT: Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 3
Component Type: Session

Join Lilly for a hands-on presentation on the impact of digital health technologies (DHTs) in clinical trials. Discover how DHTs enhance patient experiences and increase access through an in-person demonstrations of the tools. During this presentation, Lilly will introduce DHT Templates, developed by BIO membership, designed to standardize the inclusion of DHT data within product submissions and provide a predictable approach to regulatory review.

Chair

Lauren Tobe, JD

Speaker

Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Ann Marie Hake, MD


Speakers
avatar for Ann Marie Hake

Ann Marie Hake

Executive Director, Medical – Digital Health, Eli Lilly and Company, United States
Ann Marie Hake is a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In her current role at Lilly, she is a clinical research physician in the Digital Health R&D group, as well as the Vice Chair of... Read More →
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

#237.1 IT: Salesforce Innovation Theater: Life Sciences Cloud - An Intelligent Clinical Engagement Platform
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

See how Salesforce is reimagining end-to-end clinical operations from study start up through close out. With Life Sciences Cloud and Agentforce, a comprehensive agentic AI platform, you can transform clinical systems of record to systems of insight and facilitate collaboration and automating study activities between sites, sponsors, vendors, and patients. The platform can automatically alert you to study risks and issues and manage outstanding tasks to ensure effective clinical trial management.

Speaker

Speaker
Lorie McClain

Speaker
Sharmin Nasrullah, MS


Speakers
avatar for Lorie McClain

Lorie McClain

Distinguished, Strategic Solution Engineer, Salesforce, United States
avatar for Sharmin Nasrullah

Sharmin Nasrullah

General Manager, Life Sciences, Clinical, Salesforce, United States
Sharmin Nasrullah brings over 20 years of experience across multiple disciplines across technology development, medical devices, digital health, clinical operations and clinical software. She is inspired by bringing cutting edge technology into the life sciences space to transform... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:05pm EDT

#239 IT: Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

2025 is the year to scale AI—but only a fraction of pilots make it to production. Discover why, where to invest now, and how to align emerging tech with real business needs. Hear real-world use cases in protocol optimization and clinical trial monitoring and discover how to align tech with true business needs. If you're ready to turn AI ambition into enterprise value, this session is a must-attend.

Speaker

Speaker
Ashley Bates

Speaker
Rachel Belani-Barker

Speaker
Dyke Simpson


Speakers
AB

Ashley Bates

Syneos Health, United States
avatar for Rachel Belani-Barker

Rachel Belani-Barker

Sr Account Development Mgr, Syneos Health, United States
avatar for Dyke Simpson

Dyke Simpson

Sr Account Development Mgr, Syneos Health, United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:05pm EDT

#239.1 IT: Faro Health, Inc Innovation Theater: Real World Applications of AI to Clinical Development
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 3
Component Type: Session

Clinical development is complex, with trials becoming increasingly costly and time-consuming. Generative AI holds promise to reduce time and cost through automation and data insights. In this talk, Patrick Leung (CTO, Faro Health Inc.) will explore how Faro applies its expertise in clinical science and AI to overcome challenges and develop next-generation tools that transform clinical development.

Speaker

Speaker
Patrick Leung


Speakers
PL

Patrick Leung

Chief Technology Officer, Faro Health Inc. , United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

#258 IT: Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 2
Component Type: Session

Generative AI adoption within the regulatory writing field has made tremendous progress over the last year. However, to maximize ROI, teams need to identify ways to expand automation beyond traditional benchmarks and clinical study report (CSR) applications. In this session Certara will share practical approaches for leveraging generative AI across the submission dossier from pre-clinical module 3 documents to PK study reports to PBRERs and more.

Speaker

Speaker
Nick Brown

Speaker
David Meats, II


Speakers
avatar for Nick Brown

Nick Brown

Director, Global Portfolio Leader, Certara.AI, Certara, United States
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing... Read More →
avatar for David Meats

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States
Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 2 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

#259 IT: Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 3
Component Type: Session

Current (pre-)screening methods are slow and expensive… but did you know that they also miss critical information? IntelliScript’s studies show that ineligible participants are randomizing into trials in shocking numbers. Irix® can fill the information gap and speed up enrollment by retrieving and interpreting health data on trial participants in a matter of seconds. Just collect a HIPAA authorization to access our proprietary, nationwide data and make better, faster eligibility decisions.

Speaker

Speaker
Alyssa Vincze


Speakers
avatar for Alyssa Vincze

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript , United States
Alyssa is an actuary serving as Principal and Director of R&D at Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She leads new product development and recently launched Irix®, a trial eligibility tool that leverages... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 3 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

#260 IT: Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 1
Component Type: Session

Clinical submissions demand extensive documentation, making manual processes slow and error-prone. AutoCT automates workflows for CSRs, protocols, and safety reports, reducing turnaround time, improving data quality, and enabling teams to focus on strategy. Learn about: AI-driven templates for rapid submission creation. Automated checks to reduce errors. Two-click data traceability. AI-assisted tools keep users in control. Join us for a live demo of AutoCT’s end-to-end workflow.

Speaker

Speaker
Brandon Rice


Speakers
avatar for Brandon Rice

Brandon Rice

CPO, Weave Bio, United States
Brandon leads Product at Weave, overseeing the development of AutoIND, an AI-powered platform streamlining IND preparation. His work focuses on building products that impact lives, deliver value, and enhance user experience. With a background in life science startups, he has worked... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
Innovation Theater 1 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session
 
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  • 00: Plenary
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