DIA 2025 Global Annual Meeting

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-613-L04-P; CME 1.00; RN 1.00

Come learn about the exciting world of digital protocol and how industry innovators are taking the steps to transition from a document-centric protocol to a data-centric protocol, how digital protocol use cases can be enabled by AI and listen to how you and your company can prepare for the change required to adopt digital protocol. We will start with an update on current initiatives including the TransCelerate Digital Data Flow (DDF), CDISC Unified Study Definition Model (USDM), and ICH M11 Harmonized Protocol. Then we will explore the opportunities industry has to leverage structured digital protocol information to enable AI supporting innovation such as intelligent study design, automation of data transformation and analysis, and dynamic regulatory review. Finally, we will share our thoughts on how you and your company can get started on the digital protocol journey.

Learning Objectives

Recognize how various digital protocol collaborations are working together including ICH M11, TransCelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Discuss possible AI use cases that can leverage standard digital protocol information; Describe ways to prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Preparing for ICH M11 and Digital Protocols: Am I Ready?
William Illis, MPH

Industry Initiative Updates: How TransCelerate DDF, CDISC, USDM, and ICH M11 are Transforming Industry
Chris Decker, MS

Opportunities for Digital Protocol Standards Can Enable AI
Robert DiCicco, PharmD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-625-L04-P; CME 1.00; RN 1.00

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Panelist
Alex Bliu, PhD

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Anja Schiel, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-640-L04-P; CME 1.00; RN 1.00

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Judy Shin, PhD

Speaker

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-641-L04-P; CME 1.00; RN 1.00

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speaker

From Data to Action: Driving Inclusive Clinical Trials
Del Smith, PhD, MS

Placing Patients First in the Era of Advanced Tech and AI
Patrick Gee, SR, PhD, MS

Responsible AI and Diversity in Clinical Trials
Nicole Ward, MBA, MS, PMP

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-639-L04-P; CME 1.00; RN 1.00

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speaker

Industry Perspective
David Sidney Ross, MBA, MSc, PMP, RAC

EMA Perspective
Hilmar Hamann, PhD

Health Canada Perspective
Marcin Boruk, MBA, MSc

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-650-L04-P; CME 1.00; RN 1.00

In the rapidly evolving landscape of medical product development, the utilization of synthetic data and digital twins has gained increasing interest as a transformative approach to accelerate the development and approval of medical products. This session aims to explore the potential and innovative applications of these technologies in the realm of drug development, featuring speakers from health authorities, academia and industry. Dr. Khaled El Emam, Professor at the University of Ottawa, will present his latest research on generating synthetic data to augment clinical trials. Additionally, he will explore practical applications of synthetic data generation using real-world data. Dr. Arman Sabbaghi, Associate Professor at Purdue University, with prior experience at Unlearn, will present AI-Generated Digital Twins to deliver more efficient clinical trials. He will discuss the innovative statistical methodologies and novel trial designs that combine historical data, artificial intelligence (AI), and randomization to deliver smaller, faster, and more powerful RCTs that are built with regulatory guidance in mind. Dr. Ye Li, Mathematical Statistician, CDER, FDA will present statistical challenges leveraging machine learning in clinical trials. Several key factors that may influence the application of ML and AI algorithms in analyzing efficacy data will be discussed, including estimand and type I error rate control, as well as the importance of interpretability and reproducibility of ML/AI models to ensure robust and reliable results. Furthermore, she will address corresponding considerations related to these factors when using Digital Twins.

Learning Objectives

Describe what synthetic data and digital twins are; Discuss ways to apply AI to generate synthetic data and digital twin; Illustrate the potential of synthetic data and digital twins in medical product development.

Chair

Di Zhang, PhD

Speaker

Applications of Synthetic Data in Clinical Trials and Real-World Studies
Khaled El Emam, PhD

Statistical Methods for Unleashing AI-Generated Digital Twins to Deliver More Efficient Randomized Controlled Trials
Arman Sabbaghi, PhD, MA

Leveraging Machine Learning in Clinical Trials: Statistical Challenges
Ye Li, PhD

Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation; Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals; Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-654-L04-P; CME 1.00; RN 1.00

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Identify privacy-preserving approaches for accessing and sharing real-world data (RWD); Discuss use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine policy and regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

Global Privacy and Regulatory Considerations for Synthetic Data
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Real-World Applications of Distributed Data Analytic Solutions in Real-World Data Networks
Darren Toh, DrSc, FISPE

Privacy-Preserving Solutions for RWD Access and Collaboration: A Life Science Industry Perspective on Challenges & Opportunities
Mehmet Burcu, PhD, MS, FISPE

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao