DIA 2025 Global Annual Meeting

Component Type: Session
Level: Advanced

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

Assess 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; Determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, DrMed, MBA

Speaker

Guidances at a Glance: Modernizing Oncology Clinical Trials through Decentralized and Pragmatic Approaches
Timil Patel, MD

Component Type: Forum
Level: Advanced

This session will delve into the historical and ethical context for distinguishing between clinical care and research and how the blurring poses a risk for engagement with patients. Experts in ethics and health literacy will discuss potential pitfall

Learning Objectives

Understand the ethical and historical context for distinguishing between clinical care and research; Describe the regulatory and ethical challenges that are exposed when sponsors and investigators push patients to clinical research; Understand how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Component Type: Session
Level: Advanced

Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.

Learning Objectives

Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.

Chair

Huong Huynh, PhD

Component Type: Session
Level: Advanced

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Illustrate how regulatory initiatives can facilitate innovation in CMC; Compare perspectives from senior leaders regarding regulatory initiatives and reguatory advancements.

Chair

Demetra Macheras, MBA

Component Type: Forum
Level: Advanced

Crossing 1.5 billion population in 2024, Africa's demographic boom is urging new models of development and innovation. In this fireside chat, four pioneers (from leading U.S. medical centers to Top 10 pharma to big-name philanthropies) will share their ground-breaking journey in advancing Africa healthcare and R&D capabilities, and ambitious plans ahead. The panelists will be joined by DIA's incoming and past Board Chairs to help unlock our community's collective energy and creativity on this worthy front and explore win-win collaborations.

Learning Objectives

Develop an understanding for the significant social progress and momentum in world's fastest growing continent, as well as implications for healthcare development, patient needs and opportunities, and life science innovations. Reflect upon the vision, achievements, lessons learned, and future goals shared by this cross-section of global and on-the-ground change makers. Seek common interest areas, find ways to work together, and spread the good word.

Chair

Rachel Zhang, MA, MBA

Speaker

Panelist
Huwaida Bulhan, MD

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca A. Vermeulen, RPh

Panelist
David Mukanga, PhD, MPH

Component Type: Session
Level: Advanced

This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.

Learning Objectives

Define prior knowledge (in the context of CMC submissions; Appraise what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Justify how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective
Miguelina Matthews

Industry Perspective
Andrew Chang, PhD

Component Type: Session
Level: Advanced

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

Understand the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions Formulate plans to bring artificial intelligence solutions to market and shape regulations

Chair

Eli Weinberg, PhD, MS

Component Type: Forum
Level: Advanced

This forum will provide information regarding new requirements for Diversity Action Plans. A panel of experts will describe details of these requirements, implementation challenges for rare genetic diseases, and strategies to address these challenges.

Learning Objectives

Describe how regulatory requirements for Diversity Action Plans might apply to orphan drug development; Plan regulatory strategy for inclusive and representative rare disease drug development; Identify challenges regarding compliance to Diversity Action Plan requirements in rare disease settings.

Chair

Mark Tobolowsky, JD

Component Type: Session
Level: Advanced

This session covers the importance of the trial risk assessment process, change control implementation and presents case studies from multiple regulators where effective RBQM could have helped prevent significant GCP non compliances for eSystems/DHTs

Learning Objectives

Discuss QbD and critical to quality factors for data reliability and participant safety in clinical trials including requirements in ICH E6 R3; Understand the importance of change control and risk assessment for data governance and eSystems/ DHTs; Learn from regulatory inspection and compliance case studies from multiple regulators; Identify routine GCP inspection requests.

Chair

Mandy Kaur Budwal-Jagait, MSc

Component Type: Session
Level: Advanced

This session will explore how Intelligent Automation (IA) and AI are transforming R&D and Regulatory Affairs by automating document-heavy processes and driving data-driven decisions. Through real-world use cases presented by industry sponsors, attendees will learn how IA and AI are being applied to improve efficiencies, reduce timelines, and optimize regulatory outcomes.

Learning Objectives

Understand AI applications in drug discovery, clinical trials, regulatory, manufacturing, and pharmacovigilance; Explore practical use cases of AI in Regulatory Operations; Discuss advancing fit-for-purpose, risk-based frameworks for AI and global regulatory alignment.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

AI Innovation in Drug Development: Cutting-Edge Use Cases and Regulatory Insights
Kevin Bugin, PhD, MS, RAC

Component Type: Session
Level: Advanced

This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test

Learning Objectives

Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Explore approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Component Type: Session
Level: Advanced

The ICMRA PQKM project is enabling greater regulatory and manufacturing agility to address issues impacting supply and availability of medicines. This session from ICMRA regulators will provide an update on the latest progress made within the project

Learning Objectives

Understand the latest developments in the ICMRA Pharmaceutical Quality Knowledge Management (PQKM) project, including workstreams within ICMRA, ICH, IPRP and PIC/S to support a PQKM capability; Discuss the long-term potential for the PQKM project to enable a global pathway for submission and assessment of CMC post-approval changes, thereby supporting greater regulatory harmonisation and reliance.

Component Type: Forum
Level: Advanced

The benefit-risk assessment of a new medicinal product or intervention is crucial through all stages of its development and ultimately leading to regulatory approval. This process can be complex, as it involves trade-offs between often conflicting multiple efficacy and safety endpoints, along with different methodologies for assessing benefits and risks. Therefore, clearly and transparently describing the benefit-risk profile and communicating the trade-offs using all available evidence is essential for regulatory decision-making and individual patient management. Bayesian inference, in addition to conventional approaches, offers a natural framework for conducting quantitative assessments of the benefit-risk trade-off. It allows for the formal use of prior information and the integration of various sources of information and uncertainty, while also linking to optimal decision theory. With a growing focus on improving the process of benefit-risk assessment at the FDA, sponsors are increasingly making efforts to apply quantitative benefit-risk assessments, often utilizing a Bayesian framework. This session will present innovative Bayesian methods for benefit-risk assessment, along with empirical examples. Industry and regulatory experts will reflect on their diverse research experiences with Bayesian benefit-risk methods, highlighting its strengths, limitations, and potential future applications. The impact of these methodological advancements as evident in stakeholders' enhanced ability to make informed decisions regarding benefit-risk assessments, ultimately contributing to improved patient safety and healthcare outcomes will be shared. General recommendations for planning and implementation of Bayesian benefit-risk assessments, including regulatory perspectives, will touch upon all areas of the structured benefit-risk assessment process starting from defining key outcomes and eliciting preference information through to the final integrated analysis of benefits and

Learning Objectives

Explain the critical importance of quantitative benefit-risk assessment and its impact; Describe how Bayesian methods can provide a natural framework for such quantitative assessments, along with empirical examples; Discuss strengths, limitations and general recommendations, including regulatory perspectives, for planning and implementation of Bayesian benefit-risk assessments.

Chair

Madhurima Majumder, PhD

Speaker

Speaker
Bennett Levitan, MD, PhD

Speaker
Saurabh Mukhopadhyay, PhD

Speaker
Sai Dharmarajan, PhD

Component Type: Forum
Level: Advanced

We present trends and insights from an analysis of participant payment language of more than 7,500 consent forms reviewed by a large, independent IRB and discuss the ethical implications of insufficient compensation for trial participants.

Learning Objectives

Explore trends and insights in clinical trial participant payments based on 7500 clinical trial ICFs collected and analyzed between 2019 and 2024; Examine the language used to describe payments and how that impacts participants; Discuss ethical issues and assumptions about IRB approval of participant compensation for research.

Chair

Kelly Fitzgerald, PhD

Component Type: Session
Level: Advanced

This panel will explore available regulatory guidance for Real-World Data (RWD) quality assessments and how available implementing tools and frameworks may be applied for different types of RWD and use cases to help drug developers meet regulator expectations.

Learning Objectives

Understand expectations for real-world data (RWD) quality assessments in studies intended for regulatory submissions; Identify available tools and frameworks for implementing RWD quality assessments; Incorporate RWD quality assessments into internal workflows using practical approaches discussed in the session.

Chair

Eleanor Caplan, PharmD, PhD

Component Type: Forum
Level: Advanced

This session will provide an overview of an ongoing DIA study on enhancing the integration of patient experience data to understand Tolerability in immune-oncology clinical trials.

Learning Objectives

Understand the significance of advancing patient-centric tolerability measurement in immune-oncology trials to enhance patient outcomes; Gain insights into ongoing the study and future steps aimed at addressing the real-world needs of patients through a multistakeholder framework.

Chair

Maria Paula Bautista Acelas, MSc

Component Type: Forum
Level: Advanced

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Understand the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Component Type: Session
Level: Advanced

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare and contrast operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Understand successes and challenges with different operating models.

Chair

Alison Maloney, PhD, MBA, MS

Component Type: Session
Level: Advanced

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Gain Insight into the global regulatory landscape on potency requirement for CGT products; Understand the latest FDA’s guidelines regarding potency testing and industry perspectives; Explore the Role of Surrogate Assays enhancing the overall potency assurance strategy; Learn from Industry Peers: Examine the approaches adopted by members of BIO companies to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Component Type: Session
Level: Advanced

In this session, we will provide a brief overview of the evolving ICH E20 effort with the goal to provide a transparent and harmonized set of principles for the design, conduct, analysis, and interpretation of adaptive clinical trials.

Learning Objectives

Considerations specific to adaptive design using Bayesian methods will be discussed. Opportunities and challenges of using Bayesian methods in the regulatory setting will also be highlighted.

Chair

Amy Xia, PhD