DIA 2025 Global Annual Meeting

Component Type: Forum
Level: Basic

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.

Component Type: Forum
Level: Intermediate

Opportunities and challenges for using RWE from the perspective of drug development, regulatory considerations, health technology assessments, clinician and patients will be discussed, including new collaborations between regulators and HTA.

Learning Objectives

Describe how RWE is being used through the medicinal product lifecycle by showing relevant examples; Evaluate the utility of RWE for benchmarking disease progress and/or to use as an external comparator; Understand how HTA evaluate RWE and current collaborations with regulators.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Component Type: Forum
Level: Intermediate

In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.

Learning Objectives

Provide an international regulatory update on Project Orbis; Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative; Explain how sponsors can benefit from participating in Project Orbis.

Component Type: Forum
Level: Intermediate

Among the largest areas of concern with the Inflation Reduction Act (IRA) are potential unintended consequences to pharmaceutical innovation. This forum will convene industry experts to explore the impact of and potential adjustments to the IRA.

Learning Objectives

Discuss the unintended consequences of the IRA on innovation; Examine potential legislative solutions.

Chair

SARAH K Martin, PhD, MS

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: Forum
Level: Intermediate

The forum will explore key legislative proposals affecting FDA regulation of drugs and devices, while FDA and industry prepare to negotiate the next round of user fees and performance goals.

Learning Objectives

Describe key legislative initiatives that could alter FDA's regulation of drugs and medical devices; Understand the interplay between current FDA legislative proposals and the upcoming FDA user fee negotiations and legislation; Consider the impact of legislative proposals on FDA and regulated industries.

Chair

Jeffrey Francer, JD, MPA

Component Type: Forum
Level: Intermediate

Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.

Learning Objectives

Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6 Good Clinical Practice, E17 Multi-Regional Clinical Trials and Q9 Quality Risk Management; Identify opportunities for greater regulatory harmonization to advance global drug development.

Chair

Amanda Marie Roache, MS

Component Type: Forum
Level: Basic

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

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: Forum
Level: Basic

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

Understand 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; Adapt to and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Component Type: Forum
Level: Intermediate

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Explore participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce

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: Intermediate

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Component Type: Forum
Level: Intermediate

This session examines the relationship between protocol complexity, participant burden, and enrollment challenges, alongside the development and impact of participant feedback questionnaires. Patient advisors and attendees will interpret results and discuss improvements in trial performance.

Learning Objectives

Assess patient participation burden based on protocol design characteristics and requirements; Identify design elements driving elevated levels of burden and impacting clinical trial performance; Manipulate results into practical improvements for clinical research projects; Express the value of participant feedback and compose rationale for inclusion of feedback in future studies; Develop strategies to reduce and address clinical trial and portfolio-wide participation burden.

Chair

Lani Hashimoto

Speaker

Participant Feedback Forum: Active Interpretation of Signals by Patient Advisors and Attendees
Lani Hashimoto

Addressing Participation Burden in Clinical Trials: Primary Causes, Outcomes and Mitigation Strategies and Practices
Abigail Dirks, MS

Component Type: Forum
Level: Basic

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

Gain insight into 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; Understand the impact of AI/ ML on time savings, investment, and deployment of organizational resources.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Speaker
Amanda Donovan

Speaker
Nareen Katta, MBA, MS

Component Type: Forum
Level: Intermediate

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

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: Intermediate

Tufts Center for the Study of Drug Development (TCSDD) Working Group on Vendor Qualification will present updated Research Findings and Interactive Discussion on Addressing Industry-wide Challenges Associated with Qualification.

Learning Objectives

Understand the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Understand the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Component Type: Forum
Level: Intermediate

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators; Share resources to assist teams in navigating regulatory documentation.

Chair

Jane Myles, 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: Forum
Level: Intermediate

This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.

Learning Objectives

Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.

Chair

Samantha Roberts, PhD

Component Type: Forum
Level: Intermediate

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Component Type: Forum
Level: Intermediate

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Component Type: Forum
Level: Intermediate

Federally Qualified Health Centers and Community Health Workers are vital in reaching underserved populations, often serving as the first point of contact for healthcare in these communities. By partnering with these trusted entities, the REACH Consortium can bridge the gap between clinical research and underrepresented groups, ensuring that clinical trials are more inclusive and reflective of the populations they aim to serve. This session is crucial as it highlights the role of grassroots partnerships in advancing health equity and showcases effective models that can be replicated in other regions.

Learning Objectives

identify key components of the partnership between the REACH Consortium, FQHCs, and CHWs; Leverage the strengths of Federally Qualified Health Centers and Community Health Workers to effectively raise awareness and promote participation in clinical trials among underrepresented populations; Foster greater inclusivity and accessibility for diverse populations in clinical research.

Chair

Perla Nunes

Component Type: Forum
Level: Intermediate

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Become familiar with current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Understand common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Component Type: Forum
Level: Intermediate

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Understand the present landscape, opportunities, and challenges of obesity drug development; Delve into discussions on the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Component Type: Forum
Level: Intermediate

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Component Type: Forum
Level: Intermediate

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

Learn about the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; learn about global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Component Type: Forum
Level: Intermediate

A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol DCT and outline potential mitigation activities.

Learning Objectives

Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Develop fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Component Type: Forum
Level: Intermediate

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Component Type: Forum
Level: Intermediate

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Amy Bertha