DIA 2025 Global Annual Meeting

Component Type: Session
Level: Basic

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Component Type: Session
Level: Intermediate

Go beyond platitudes and qualitative advice on planning, deploying, and measuring the success of your recruitment campaign. Enjoy this Master Class in Recruitment Campaign Management from some of the industry's best minds

Learning Objectives

Build an evidence based forecast for centralized patient recruitment campaigns; Optimize channel mixes, vendor management, performance models, technology selection; Measure and optimize campaign performance and ROI.

Chair

Joseph Kim, MA, MBA

Component Type: Session
Level: Intermediate

In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.

Learning Objectives

Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.

Chair

Mehdi Najafzadeh, PhD, MA, MS

Component Type: Session
Level: Intermediate

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Understand the key benefits and challenges of applying AI technologies in RBQM; Gain insights into real-world examples of AI's impact on clinical trial risk management; Explore strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance. Learn how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Component Type: Session
Level: Intermediate

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Understand the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Review the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Component Type: Session
Level: Intermediate

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Lynda Mante

Component Type: Session
Level: Intermediate

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Examine PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Evaluate the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Component Type: Session
Level: Intermediate

This session will be based on a recent Tufts Center for the Study of Drug Development (CSDD) study that examined lung cancer studies to examine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from the Tufts CSDD tea

Learning Objectives

Identify areas within a study protocol where bias can manifest to adversely exclude marginalized patient populations; Discuss approaches, strategies, and lessons-learned to help de-bias protocol design.

Chair

Jennifer Kim, PhD

Speaker

Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS