DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-510-L04-P; CME 1.00; RN 1.00

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Chair

Sarah Vaughan

Speaker

Panelist
Monica Munoz, PharmD, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-511-L04-P; CME 1.00; RN 1.00

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.

Chair

Tae Hyun Jung, PhD

Speaker

Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD

Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-525-L04-P; CME 1.00; RN 1.00

Through this session, we will explore the advantages of incorporating AI and digital pathology for drug and biomarker discovery as part of a long-term companion diagnostic (CDx) partnership. We will also explore potential regulatory challenges in this ever-evolving space.

Learning Objectives

Discuss the importance of a complete development lifecycle of drug and companion diagnostic; Describe a complete development lifecycle of a drug and companion diagnostic; Describe potential regulatory challenges facing AI, Digital Pathology, and CDx development.

Chair

Greg Morehouse, MS

Speaker

Panelist
Brendan O'Leary

Panelist
Mark Stewart, PhD

Panelist
Elaine Katrivanos

Panelist
Andrew Ciupek, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-532-L04-P; CME 1.00; RN 1.00

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-533-L04-P; CME 1.00; RN 1.00

Data science, AI and LLMs are redefining how we conduct clinical development to be faster, more efficient and more patient-centric. The National Insititute of Health, in partnership with the private sector, is leading the charge in driving change.

Learning Objectives

Describe examples of NIH innovation in tech-enabling clinical development through the application of data science, AI and LLMs; Identify potential opportunities for future public-private partnerships to accelerate tech enablement of clinical development.

Chair

Peter Ronco

Speaker

Panelist
Warren Kibbe, PhD, FACMI

Panelist
Susan Gregurick

Panelist
Kathleen Gavin, PhD, MS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-535-L04-P; CME 1.00; RN 1.00

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PhD, MS, RPh, FISPE

Beyond Signal Detection: Signal Management at FDA - From Identification to Action Using Multiple Data Sources
Lisa Wolf, PharmD

Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PhD, MS

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-545-L04-P; CME 1.00; RN 1.00

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch, MA, MBA

J&J Experience
Joseph Markmann, PhD, MBA

BMS Experience
Sandra Krogulski, MA

Novartis Experience
David Yao, PharmD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-561-L04-P; CME 1.00; RN 1.00

Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.

Learning Objectives

Recognize the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Describe ways to develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.

Chair

Anna Bode, PhD

Speaker

Panelist
Jessica Federer, MPH

Panelist
Nicole Richie, PhD

Panelist
Martin Hodosi, MSc

Panelist
Melissa H. Laitner, PhD, MPH

Panelist
Neosho Ponder, PhD

Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-25-577-L04-P; CME 1.00; RN 1.00

Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.

Learning Objectives

Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.

Chair

Leanne Woehlke, MA

Speaker

Pause, Breathe, Connect
Jess Thompson, MBA, MS, PMP

The Effects of Mindful Breathing on Stress and Well-Being
Eddie Stern

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-581-L04-P; CME 1.00; RN 1.00

Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.

Learning Objectives

Describe the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Discuss the impact of AI/ ML on time savings, investment, and deployment of organizational resources.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Panelist
Mukul Virmani, Esq, MS

Use Case Examples within Clinical Development
Emily Carter, MBA

Organizational Use Case
Luciana Petcu, MS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-597-L04-P; CME 1.00; RN 1.00

The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.

Learning Objectives

Discuss the basics of health literacy and how they relate to health outcomes; Explain ways to apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.

Chair

Chantelle Rein-Smith, PhD

Speaker

Panelist
Anna Osinski

Panelist
James Lindsay Cobbs

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-607-L04-P; CME 1.00; RN 1.00

Regulatory decisions are often a widely discussed topic, but have you considered how a breadth of experience in the career journeys of regulators positively influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths in the critical work that they do. This is your opportunity to hear directly from regulators from the UK, Canada & Brazil about what they do, how they got there and what they have experienced and learnt along the way!

Learning Objectives

Recognize how breadth of experience within regulators supports medicines development for patients and society; Identify how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators).

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Sommerer

Panelist
Marcelo Moreira, MS

ANVISA Career Pathway: Impact to Medicines Development
Bianca Zimon, LLM

MHRA Career Pathway: Impact to Medicines Development
Mandy Kaur Budwal-Jagait, MSc

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-610-L04-P; CME 1.00; RN 1.00

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

Speaker

Panelist
Rebecca Noss, MS

Panelist
Narayan Nair, MD

Panelist
Jeremy Jokinen, PhD, MS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-613-L04-P; CME 1.00; RN 1.00

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 Digital Protocols: Am I Ready?
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
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-625-L04-P; CME 1.00; RN 1.00

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
Alex Bliu, PhD

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Anja Schiel, PhD

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-630-L04-P; CME 1.00; RN 1.00

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
Cheryl Grandinetti, PharmD

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

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Kenneth Wiley, JR, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-635-L04-P; CME 1.00; RN 1.00

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

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
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-636-L04-P; CME 1.00; RN 1.00

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.

Chair

Sarah Vaughan

Speaker

Industry Perspective
Khaudeja Bano, DrMed, MD, MS

WHO Perspective
Hiiti Sillo, MSc, RPh

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-648-L04-P; CME 1.00; RN 1.00

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

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

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

Panelist
Ria Siagian

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-650-L04-P; CME 1.00; RN 1.00

In the rapidly evolving landscape of medical product development, the utilization of synthetic data and digital twins has gained increasing interest as a transformative approach to accelerate the development and approval of medical products. 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. Dr. Khaled El Emam, Professor at the University of Ottawa, will present his latest research on generating synthetic data to augment clinical trials. Additionally, he will explore practical applications of synthetic data generation using real-world data. Dr. Arman Sabbaghi, Associate Professor at Purdue University, with prior experience at Unlearn, will present AI-Generated Digital Twins to deliver more efficient clinical trials. He will discuss the innovative statistical methodologies and novel trial designs that combine historical data, artificial intelligence (AI), and randomization to deliver smaller, faster, and more powerful RCTs that are built with regulatory guidance in mind. Dr. Ye Li, Mathematical Statistician, CDER, FDA will present statistical challenges leveraging machine learning in clinical trials. Several key factors that may influence the application of ML and AI algorithms in analyzing efficacy data will be discussed, including estimand and type I error rate control, as well as the importance of interpretability and reproducibility of ML/AI models to ensure robust and reliable results. Furthermore, she will address corresponding considerations related to these factors when using Digital Twins.

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

Applications of Synthetic Data in Clinical Trials and Real-World Studies
Khaled El Emam, PhD

Statistical Methods for Unleashing AI-Generated Digital Twins to Deliver More Efficient Randomized Controlled Trials
Arman Sabbaghi, PhD, MA

Leveraging Machine Learning in Clinical Trials: Statistical Challenges
Ye Li, PhD

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-651-L04-P; CME 1.00; RN 1.00

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

Panelist
Tywnia Brewton

The Executive Mentor Perspective
Leslie Sam

The Mentee Perspective
Sarah Tremethick