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Wednesday, June 17
 

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25

In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.

Learning Objectives

Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials; Identify key factors driving burden in clinical trials; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.

Chair

Abigail Dirks, MS

Speaker

Panelist
Stephanie Christopher, MA

Panelist
Katrina Mateo, PHD, MPH


Speakers
avatar for Stephanie Christopher

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States
Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →
avatar for Abigail Dirks

Abigail Dirks

Senior Data Scientist, Tufts Center for the Study of Drug Development, United States
Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →
avatar for Katrina Mateo

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States
Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

10:15am EDT

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objectives

Describe the core principles of Gen AI and explain their relevance to clinical operations; Identify practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

Chair

Ioannis Spyroglou, PHD

Speaker

Panelist
Roshan D'Souza

Bootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation Reporting
Frederik Collin, MS

Operational Impact, Scaling, and Limitations: From Algorithm to Practice
Karin Jonczak


Speakers
FC

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany
Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
avatar for Karin Jonczak

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States
IS

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States
Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#651: Regulatory CMC and Product Quality Hot Topics Discussion
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P; CME 1.00; RN 1.00

This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality.

Learning Objectives

Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging technologies in pharmaceutical quality systems; Examine how to analyze strategies for managing global regulatory complexity, supply chain resiliency, and international harmonization.

Chair

Celeste Frankenfeld Lamm

Speaker

Panelist
Peter Richardson

Panelist
Mahesh R. Ramanadham, PHARMD, MBA

Panelist
Kevin Fitzpatrick, RPH

Panelist
Yoshihiro Matsuda, DrMed


Speakers
avatar for Kevin Fitzpatrick

Kevin Fitzpatrick

Senior Vice President, Quality Assurance, AbbVie, United States
Kevin Fitzpatrick is Senior Vice President of Quality Assurance at AbbVie. Kevin was appointed to his current role in June 2025 after serving as Vice President, Quality Assurance, Biologics. Kevin has been with AbbVie/Abbot for 26 years, supporting CMC strategy and execution of AbbVie’s... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
Celeste Frankenfeld Lamm, Ph.D., is a Senior Director of Quality and Reg CMC Policy at Merck & Co., where she leads a team of policy professionals who work to capture and align subject matter expertise around manufacturing quality and regulatory science, and translate it into meaningful... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
avatar for Mahesh Ramanadham

Mahesh Ramanadham

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →
avatar for Peter Richardson

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands
Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Forum |   03: Data-Tech-AI, Forum
 
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DIA 2026 Global Annual Meeting
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Ballroom AB
Content Hub
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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