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Tuesday, June 16
 

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A
Component Type: Session
Level: Intermediate

Many clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.

Learning Objectives

Design and execute a streamlined customer discovery process to validate unmet needs, buying triggers, and budget ownership before finalizing a go-to-market strategy; Translate insights into a sales learning roadmap that tests positioning, pricing, compliance, and objections to reduce commercial risk before raising capital; Align GTM and fundraising with validated demand to present a credible revenue story.

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA


Speakers
LH

Laura Hilty

Principal, HealthX Ventures, United States
JL

Jeff Lee

Board Director, Medstar Health Research Institute, United States
Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →
PS

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States
Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →
DS

Dan Sndyer

The Playbook, United States
DS

Dan Sndyer

The Playbook, United States
Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   18: Lift-Series, Session

10:15am EDT

#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies
Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-560-L04-P; CME 1.25; RN 1.25

Clinical trial start-up is often delayed by manual processes, fragmented systems, and inconsistent data. This workshop will explore how biopharmaceutical companies are using AI and interoperable data standards to enable patient centric study designs.

Learning Objectives

Explain how AI and USDM (the CDISC digital protocol data standard) work together to streamline study design and protocol development; Discuss ways to achieve patient-centric design and reduced patient burdens using AI in conjunction with clinical standards; Examine how data standards enable interoperability and multi-stakeholder collaboration including with sites and patients.

Chair

William Illis, MPH

Speaker

Panelist
Nicholas Brooke, MBA

Panelist
Prasanna Rao

Panelist
Vivian Dewoskin, MBA

Panelist
Sahishnu Patel, PHD


Speakers
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
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 →
avatar for William Illis

William Illis

Executive Director, Technology and Scientific Computing, Novartis , United States
Bill is Executive Director, Technology and Scientific Computing in the Advanced Quantitative Sciences line function at Novartis. He responsible for developing and implementing the analytics technology strategy focused on end-to-end clinical data flows, systems and processes. For the... Read More →
avatar for Sahishnu Patel

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States
Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →
avatar for Prasanna Rao

Prasanna Rao

Chief Products and Innovation Officer, Saama, United States
Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Workshop

10:15am EDT

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients
Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-564-L04-P; CME 1.25; RN 1.25

Examines how fragmented policies, trade barriers, pricing pressures, and other restrictions create innovation gridlock—blocking or stalling R&D, delaying clinical trials, disrupting supply, and threatening patient access to critical therapies.

Learning Objectives

Identify key policy and regulatory misalignments contributing to innovation gridlock in biopharma; Assess the global impact of these barriers on patient access to transformative therapies. and prioritize action based on criticality; Examine opportunities and actionable policy levers to realign systems and accelerate innovation for patients.

Chair

Alexis Reisin Miller, JD

Speaker

PMDA perspective
Daisuke Koga, MS, MSC

Industry perspective
Michelle Rohrer, PHD


Speakers
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
avatar for Michelle Rohrer

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech, A Member of the Roche Group, United States
Michelle Rohrer, PhD is Global Head of Product Development Regulatory at Genentech Roche. Michelle has worked at the company for 31 years, starting as a post-doctoral fellow. Michelle's awards include SF Business Times “The Most Influential Women in Bay Area Business” and PharmaVOICE... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   03: Data-Tech-AI, Forum

1:45pm EDT

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-572-L04-P; CME 1.25; RN 1.25

This session explores strategies to implement AI, cloud, and different data sources across the drug lifecycle and in regulatory activities to deliver patient benefits. Experts will discuss pilots, policies, and partnerships that can enable faster access to safe and effective medicines.

Learning Objectives

Explain how AI, cloud, and data can be utilized in regulatory processes to accelerate patient access to therapies; Assess implementation strategies that balance innovation with patient safety and trust; Identify collaborative models that embed patient-centric principles into digital regulatory ecosystems.

Chair

Rebecca Nebel, PHD

Speaker

Panelist
Kimberly Ann Beer, MA

Panelist
Andrew Robertson, JD, PHD

Panelist
Jonathan Walsh, PHD


Speakers
KB

Kimberly Beer

Senior Vice President, Policy & External Affairs, National Health Council, United States
Kimberly Beer is Senior Vice President of Policy and External Affairs at the National Health Council, where she leads policy and advocacy to improve access to affordable, high-quality care for people with chronic conditions and disabilities. She previously served as Senior Director... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
avatar for Rebecca Nebel

Rebecca Nebel

Director, Global Regulatory Policy and Intelligence, Amgen, United States
Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →
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 →
avatar for Jonathan Walsh

Jonathan Walsh

Chief Scientific Officer, Unlearn.AI, United States
Jon Walsh is the co-founder and Chief Scientific Officer of Unlearn.AI and a physicist by training. At Unlearn, Jon leads the integration of digital twins into drug development, with a particular focus on regulatory pathways and the intersection of statistics and machine learning... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

4:15pm EDT

#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-590-L04-P; CME 1.00; RN 1.00

Novel endpoints, biomarkers, and digital tools offer transformative potential but face regulatory acceptance challenges. Explore current landscape, successful case studies, and strategies for enhanced regulatory engagement through collaboration.

Learning Objectives

Discuss the current FDA regulatory framework for novel endpoints, biomarkers, and digital tools; Identify key challenges and gaps in regulatory acceptance and validation; Examine strategies for enhancing regulatory engagement and scientific alignment; Apply lessons from case studies and partnerships to future development programs.

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
M. Khair ElZarrad, PHD, MPH

Duke Margolis Perspective
Valerie J. Parker, MSC

Industry Perspective
Lauren Tobe, JD


Speakers
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Vice President, Regulatory Policy, BridgeBio, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Valerie Parker

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States
Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 13+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
 
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DIA 2026 Global Annual Meeting
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102AB
103A
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108A
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109AB
110A
111AB
112AB
114
115AB
115C
116
117
118AB
118C
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201AB
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203AB
204AB
Ballroom AB
Content Hub
Exchange
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
Spark Stage
TBD
Zone A
Zone B
  • 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
  • Intermediate
  • 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