DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Basic

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Discuss improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy).

Chair

Allison Cuff Shimooka, MBA

Component Type: Session
Level: Basic

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 Digitial Protocol: Am I Prepared?
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

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
François Houyez

Panelist
Anja Schiel, PhD

Component Type: Forum
Level: Basic

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Speaker

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Catherine Gregor, MA, MBA

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Ken Wiley. Jr.

Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; List the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders?
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Inclusive Leadership Strategies to Effectively Manage Teams
Ruby Madison Ford, MPH

Component Type: Session
Level: Basic

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Discuss and assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Speaker

Industry Perspective
Khaudeja Bano, DrMed, MD, MS

WHO Perspective
Hiiti Sillo, MSc, RPh

Component Type: Forum
Level: Basic

The Indonesian regulation for clinical research has shown a significant transformation during the past year, after practically being at a very low level for the past decade. The Ministry of Health, together with the Indonesian Drug and Food Regulatory Body are prepared to welcome global pharmaceutical companies to conduct researches in various hospitals in the country.

Learning Objectives

Discuss the recent transformations in Indonesian clinical research regulations and their impact on the country's research environment; Recognize the opportunities and challenges for global pharmaceutical companies conducting clinical research in Indonesia under the new regulatory framework.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Indonesia’s Health Research Revolution: Fast-Tracking Innovation & Global Collaboration in Clinical Trials
Budi Gunadi Sadikin, PhD

Indonesia’s Regulatory Readiness in Embracing Clinical Trial Transformation
Taruna Ikrar, MD

INA-CRC: The Catalyst of Indonesia’s Clinical Trial Ecosystem Transformation
Indri Rooslamiati Supriadi, MS, RPh

Strengthening Indonesia’s Clinical Research Quality: The Critical Role of Clinical Research Unit
Yuli Felistia, MD

Panelist
Ria Siagian

Component Type: Session
Level: Basic

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.

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

Academic Perspective
Khaled El Emam, PhD

Industry Perspective
Arman Sabbaghi, PhD, MA

Statistical Challenges
Ye Li, PhD

Component Type: Forum
Level: Basic

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Discuss how mentorship fosters meaningful connections and knowledge sharing, impacting engagement, retention, and growth; Identify clear roles and responsibilities to ensure program success; Recognize mentorship’s role in collaboration and career development; Discuss ways to inspire organizations to adopt mentorship and individuals to seek or become mentors.

Chair

Carol Morales

Speaker

Insights as a Mentorship Program Organizer
Meghann Hartnett

The Executive Mentor Perspective
Leslie Sam

The Mentee Perspective
Sarah Tremethick