DIA 2025 Global Annual Meeting

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-516-L04-P; CME 1.00; RN 1.00

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno

EMA Perspective
Andrew Thomson, PhD, MA, MS

Panelist
M. Khair ElZarrad, PhD, MPH

Panelist
Kevin Bugin, PhD, MS, RAC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-677-L04-P; CME 1.00; RN 1.00

In a world increasingly burdened by chronic diseases, the timely access to effective medications is a critical component of global health initiatives. This conference session aims to explore strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy. We will delve into the innovative regulatory approaches that can pave the way for faster development and registration and more equitable access of these vital medications.

Learning Objectives

Describe the strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy.

Chair

Carlos Garner, PhD

Speaker

Panelist
Francisco Nogueira, MBA

Panelist
Naoyuki Yasuda, MSc

Panelist
Anantha Shekhar

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-530-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-522-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory guidance and frameworks on data quality and feasibility assessments of RWD sources to support RWE study proposals for health authority and HTA engagements. It will include information about how to leverage diverse sources of targeted RWD to support and improve the evolution of new therapies and indications for product safety, outcomes, reduction in label use, and help HC professionals and industry to create a knowledge base for use of RWD.

Learning Objectives

Examine the challenges and value of real-world data (RWD) in regulatory decision-making; Discuss the guidance on data quality and feasibility of RWD for real-world evidence (RWE) studies in health authority interactions; Recognize strategies to integrate RWD into dossier data for regulatory alignment; Identify challenges in standardizing data collection and sharing across industry, regulators, and academia for global acceptance.

Chair

Mehmet Burcu, PhD, MS, FISPE

Speaker

Data Quality Framework and EMA Regulatory Perspectives
Patrice Verpillat, DrMed, MD, PhD, MPH

Oncology Quality, Characterization, and Assessment of Real-world Data: US Regulatory Perspectives
Donna Rivera, PharmD, MSc, FISPE

Building Transparency and Reproducibility into the Practice of Real World Evidence Research
Shirley Wang, PhD, MSc, FISPE

Facilitating robust evidence: integrating digital health data into multi-modal datasets
Laura Lasiter, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-544-L04-P; CME 1.00; RN 1.00

The FDA Accelerated Approval Program has been criticized for employing lower regulatory standards than traditional approval, undue delays in withdrawing therapies approved under Accelerated Approval for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence . Of specific focus for critics has been withdrawn treatments, which are being used as examples of the program’s ineffectiveness and basis for proposed changes. However, the purpose of the program is to allow acceptable risk in order to address patients with a large unmet need. The small percentage of drugs whose clinical benefit is ultimately not confirmed should not be viewed as a failure of the accelerated approval program. Rather, they represent an expected trade-off in expediting drug development that benefits patients with serious or life-threatening diseases. Withdrawals make up a small percentage of the total number of therapies approved under Accelerated Approval and do not reflect overall management of the program over its 30-year history, particularly improvements seen in the last decade in the time from accelerated approval to conversion. In addition, the reasons for the withdrawals are complex and need to be understood within the context of the overall impact on patient outcomes due to early access enabled by the program.

Learning Objectives

Examine the reasons for product withdrawals after Accelerated Approval and identify the different situations where a withdrawal may occur; Recognize clinical impact including life years gained and uptake after Accelerated Approval of oncology products that were later withdrawn; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of AAP and withdrawals.

Chair

Bridget Doherty, MPH, MS

Speaker

Industry Perspective
Kevin Bugin, PhD, MS, RAC

Non-Profit Perspective
Jeff Allen, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-546-L04-P; CME 1.00; RN 1.00

This session will focus on assessing the effectiveness of current regulatory collaboration efforts and identifying how those principles can be applied to chronic disease areas outside of oncology, such as metabolic disease and obesity.

Learning Objectives

Describe the impact of global regulatory collaboration on patient outcomes; Discuss risks associated with chronic disease and its impact on society as a whole; Identify innovative ways to address chronic disease through regulatory innovation and collaboration.

Chair

Brad Jordan, PhD

Speaker

Project ORBIS and ACCESS Experience
Melissa Hunt, MSc

Panelist
Magda Bujar, PhD, MSc

Applying Learnings from Project ORBIS
R. Angelo De Claro, MD

Industry Perspective
Laura Mccary-Bloss, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-547-L04-P; CME 1.00; RN 1.00

Explore WHO-led initiatives and global collaborations driving regulatory harmonization and innovation to ensure equitable access to medical products. This session highlights strategic efforts to address shared challenges and advance global health.

Learning Objectives

Discuss the progress and challenges in achieving regulatory convergence and harmonization; Recognize the role of regulatory reliance and collaboration in facilitating access to medical products; Discuss international partner’s perspective on navigating regulatory landscapes to enhance global health equity.

Chair

Hiiti Sillo, MSc, RPh

Speaker

CIP Network and its role in Advancing Global and Regional Regulatory Harmonization, Collaboration, and Work-Sharing
Jude Nwokike, MPH, MSc, RPh, RAC

Regulatory Harmonization: Advancing Global Health through Collaboration
Marion Laumonier, MSc

Shaping Global Health Research and Development through WHO Resources and Coordinated Scientific Advice
Mercedes Perez Gonzalez, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-538-L04-P; CME 1.00; RN 1.00

The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content

Learning Objectives

Recognize the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explain Customization and Multi-View Capabilities; Discuss how to evaluate the Impact on Decision-Making and Efficiency for Key Roles; Describe ways to examine Multi-Format Exchange of Protocol Information.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Digital Protocol Template: Industry Perspective
Vivian Combs, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-542-L04-P; CME 1.00; PDU 1.00 PMI 2166OVTGM7; RN 1.00

Explore strategies for high complexity projects, focusing on collaborations, regulatory submissions and asset integration. Gain insights on stakeholder management, risk mitigation, strategic planning to turn potential chaos into streamlined success.

Learning Objectives

Discuss challenging biopharmaceutical collaborations and efficient integration of assets; Identify effective strategies for managing complex regulatory submissions in the pharmaceutical industry; Recognize ways to assess risks and develop contingency plans for project timelines and budgets; State how to apply multiple stakeholder management techniques to ensure alignment and informed decision-making across governances.

Chair

Matthew Curin, PharmD

Speaker

Speaker
Andrea Jux

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-550-L04-P; CME 1.00; RN 1.00

We will discuss potential applications of AI in making diagnoses and treatment decisions, the appropriate ethical and regulatory boundaries, and how to progress forward balancing patient benefits against the potential risks.

Learning Objectives

Recognize the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions; Discuss ways to formulate plans to bring artificial intelligence solutions to market and shape regulations.

Chair

Eli Weinberg, PhD, MS

Speaker

Panelist
Isaac Kohane, MD, PhD

Panelist
Shweta Maniar

Panelist
Subha Madhavan, PhD, FACMI