DIA 2025 Global Annual Meeting: Full Schedule

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10:30am EDT

#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct

Tuesday June 17, 2025 10:30am - 11:30am EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-571-L04-P; CME 1.00; RN 1.00

Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.

Learning Objectives

Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight the importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.

Chair

Cheryl Grandinetti, PharmD

Speaker

Industry Perspectives
Michael Torok, PhD

Health Canada Perspective
Debbi Fox

MHRA Perspective
Jason Wakelin-Smith

Speakers

Debbi Fox

Compliance and Enforcement Specialist, Health Canada, Canada

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Keyword Clinical Trial Design, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

207A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-578-L04-P; CME 1.00; RN 1.00

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Speaker

Panelist
Joseph Dustin

Speakers

Joseph Dustin

Founder and Managing Partner, eClinical Consulting, United States

For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up 12 year run with Medidata. He has worked with top Pharmaceutical, Biotech and CRO... Read More →

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States

Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Forum

1:45pm EDT

#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-591-L04-P; CME 1.00; RN 1.00

In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.

Learning Objectives

Recognize the pros/cons and challenges in designing clinical trials with composite endpoints; Discuss advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.

Chair

Xiaoyu Cai, PhD

Speaker

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD

Application of Win Statistics in Non-Malignant Hematology
Wenquan Wang, PhD

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD

Speakers

Xiaoyu Cai

Insmed, Inc., United States

Xiaoyu Cai is an Associate Director, Biostatistics at Insmed, Inc. Prior to joining Insmed, she served for seven years as a Mathematical Statistician at the Center for Drug Evaluation and Research, Office of Biostatistics, within the U.S. Food and Drug Administration. She earned her... Read More →

Qian Tang

University of Iowa, United States

Qian Tang is a Ph.D. candidate in Statistics at the University of Iowa, specializing in machine learning, optimization, and statistical computation. Her research focuses on developing efficient algorithms for analyzing high-dimensional data, with applications in statistical learning... Read More →

Jialu Wang

Statistician, Vertex Pharmaceuticals, United States

Jialu is a senior biostatistician at Vertex Pharmaceuticals. She closely works with health economic and research and market access teams for reimbursements and HTA submissions of multiple therapies. She also works on late Phase 3b/4 studies. Her research interests include adaptive... Read More →

Wenquan Wang

Senior Director, Pfizer, United States

Wenquan got his PhD degree in Biostatistics from the University of Iowa. He was an assistant professor at University of Alabama at Birmingham before joining the pharmaceutical industry. He has over 20 years of experience in applying statistics in translational research and phase I-IV... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Session

4:00pm EDT

#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-602-L04-P; CME 1.00; RN 1.00

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?

Learning Objectives

Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance

Chair

Melissa Herman, MSc

Speaker

Industry Perspective
Maria Apostolaros, JD, PharmD, MS, RPh

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS

Speakers

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark

Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States

Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session | 09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
Tags Session

4:00pm EDT

#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-606-L04-P; CME 1.00; RN 1.00

Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.

Learning Objectives

Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Explain statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.

Chair

Xiang Zhang, PhD

Speaker

Externally Controlled Trials in Oncology: Regulatory Considerations and a Case Example
Arup Sinha, PhD

Panelist
Charles Lee, MBA, MS

An EU Regulatory Perspective on External Controls
Andrew Thomson, PhD, MA, MS

Uncovering the Challenges of Utilizing RWE in Regulatory Decision Making: Barriers, Mitigations and Future Directions
Ran Duan, PhD

Speakers

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →

Arup Sinha

Statistician, OTS, CDER, FDA, United States

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands

Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Session

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