DIA 2025 Global Annual Meeting

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.