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: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs; Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions; Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-524-L04-P; CME 1.00; RN 1.00

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

Recognize 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; Discuss how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Speaker

Bioethics Perspective
Lindsay McNair, MD, MPH, MS

Patient and Health Literacy Perspective
Catina O'Leary, PhD

IRB perspective
David Borasky, MPH

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-526-L04-P; CME 1.00; PDU 1.00 PMI 2166X8AYYG; RN 1.00

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

Speaker

Panelist
Liang Zhao, PhD

Panelist
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA

Panelist
Meghana Chalasani, MHA

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-531-L04-P; CME 1.00; RN 1.00

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. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Ingrid Markovic, PhD

Panelist
Leanne Hickman

Panelist
Jennifer McCafferty, PhD

Panelist
Sean Barry, PhD

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-534-L04-P; CME 1.00; RN 1.00

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

Discuss the significant social progress and momentum in the world's fastest growing continent, as well as implications for healthcare development, patient needs and opportunities, and life science innovations. Recognize the vision, achievements, lessons learned, and future goals shared by this cross-section of global and on-the-ground change makers.

Speaker

Panelist
Huwaida Bulhan, MD, MPH

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca Vermeulen, RPh

Panelist
David Mukanga, PhD, MPH

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-548-L04-P; CME 1.00; RN 1.00

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

Describe what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Discuss how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon, MS

Overview of ICH Q6
Andrew Chang, PhD

Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche

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

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-556-L04-P; CME 1.00; RN 1.00

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; Recognize the importance of change control and risk assessment for data governance and eSystems/ DHTs; Identify routine GCP inspection requests.

Chair

Mandy Kaur Budwal-Jagait, MSc

Speaker

FDA Perspective
Kassa Ayalew, MD, MPH

Panelist
Peter Twomey, MA, MPharm

PMDA Perspective
Hina Fukuta, RPh

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-569-L04-P; CME 1.00; RN 1.00

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; Recognize approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Speaker

Establishing a National Clinical Laboratory Network of Validated Assays
Chris Karlovich, PhD

Regulatory Considerations and Strategies for Rare Biomarker Validation
Dun Liang, PhD

Discuss challenges and best practices for CDx validation
Elaine Katrivanos

Provide global regulatory expectations, challenges, and approaches
Chris Bray

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-565-L04-P; CME 1.00; RN 1.00

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

Discuss AI applications in drug discovery, clinical trials, regulatory, manufacturing, and pharmacovigilance; Explain 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: Accelerating Clinical Trials Through Smarter Site Selection
Kevin Bugin, PhD, MS, RAC

Harnessing AI and Automation in Regulatory:  Insights from the Recent DIA RIM Intelligent Automation Survey
Cary Smithson, MBA

Industry Perspective
Cedric Berger, PhD, MBA

AI-Driven Drug Development: Transforming Life Sciences with Data and Innovation
Sridevi Nagarajan, PhD, MS, MSc

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-575-L04-P; CME 1.00; RN 1.00

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) 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

Describe 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.

Chair

Michael McDonald, PhD

Speaker

Panelist
Brendan Cuddy, MSc

Supporting regulatory convergence and reliance through Pharmaceutical Quality Knowledge Management
Theresa Mullin, PhD

PQKM collaborative assessment pilot programme - Regulator's perspective and udpates
Sean Barry, PhD

PQKM pilot programmes – Industry perspective
Susanne Ausborn, PhD

Panelist
Evdokia Korakianiti, PhD, MSc

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-576-L04-P; CME 1.00; RN 1.00

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
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-595-L04-P; CME 1.00; RN 1.00

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

Explain 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

Speaker

Panelist
Kelly Fitzgerald, PhD

Panelist
Donna Libretti Cooke, JD

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-596-L04-P; CME 1.00; RN 1.00

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

Recognize expectations for real-world data (RWD) quality assessments in studies intended for regulatory submissions; Identify available tools and frameworks for implementing RWD quality assessments; Explain ways to incorporate RWD quality assessments into internal workflows using practical approaches.

Chair

Eleanor Caplan, PharmD, PhD

Speaker

Regulatory Perspective
Luis Pinheiro, PharmD, MSc

Balancing Patient Centricity with Data Quality Requirements and Standards
Jennifer Farmer, MS

Learnings About Meeting RWD Fitness Standards From FDA Use Cases
Ulka B Campbell, PhD

Can we Separate Relevance From Reliability in Data Quality Assessments? Quality-by-Design in Secondary use of Health Data
Pamela Dobay, PhD, MSc

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-622-L04-P; CME 1.00; RN 1.00

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

Recognize 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

Speaker

Sharing Clinical/Investigator Perspective
Thos Cochrane, MD, MBA

Sharing an IRB Perspective
Linda Reuter, MS

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-25-646-L04-P; CME 1.00; RN 1.00

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

Chair

Anton Mihic, MSc

Speaker

Panelist
Donna Boyce, MS, RAC

Panelist
Lisa Ruiz, PhD, MBA

Panelist
Alison Maloney, PhD, MBA, MS

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-649-L04-P; CME 1.00; RN 1.00

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

Describe the potency requirements for CGT products; Discuss the latest FDA’s guideline regarding potency testing and industry perspectives; Explain the Role of Surrogate Assays enhancing the overall potency assurance strategy; Examine the approaches adopted by sponsors to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Potency matrix for a complex mechanism of action: case-study for a multi-component plasmid immunotherapy for prevention or delay of type 1 diabetes
David Campard, PhD, MSc

Comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices
Maria Amaya, PhD, MS

Developing a matrix approach for potency assessment in allogeneic cell therapy: a case study in standardization and predictive analytics
Simge Baloglu, PhD, MS

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-657-L04-P; CME 1.00; RN 1.00

Join us for an engaging discussion on an ongoing DIA study on enhancing the integration of tolerability patient experience data into immune-oncology clinical trials. This session will explore the study’s efforts to address regulatory requirements for the collection of core tolerability patient experience data and the need for a comprehensive, multidimensional approach to assessing tolerability in cancer treatments. With a multistakeholder focus, the study aims to define tolerability more holistically by incorporating treatment-related factors, convenience, and patient beliefs. Learn about the study’s progress, next steps, and its potential to align with regulatory needs while addressing real-world patient concerns.

Learning Objectives

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

Chair

Maria Paula Bautista Acelas, MSc

Speaker

Panelist
Alison Cave, PhD

Moderator
Rohini Sen, PhD, MS

Unlocking Insights: Progress and Key Findings from the Tolerability Study
Ryan Murphy, PhD

Panelist
Catherine Coulouvrat, DrMed

Panelist
Lia Ridout

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-665-L04-P; CME 1.00; RN 1.00

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

Discuss considerations specific to adaptive design using Bayesian methods; Recognize opportunities and challenges of using Bayesian methods in the regulatory setting.

Chair

Amy Xia, PhD

Speaker

E20 Updates
Amy Xia, PhD

FDA Bayesian Updates
Mark Rothmann, PhD

Bayesian Trial Design Case Studies
John Zhong, PhD