Conference Schedule

Key Content Discussion Topics:

  • Clinical Considerations and Population Specific Disease Characteristics
  • Benchmarking and Statistical Analysis Considerations
  • Inclusion Exclusion Protocol Criteria

Adhere to the very latest FDORA guidance and achieve meaningful representation in clinical studies, while relying on all stakeholders to do their part

  • Discuss how and when to collect and present the prevalence or incidence data on a disease or condition by demographic subgroup
  • Gain critical insights into the best possible data sources and assessment methodologies
  • Explore a pragmatic approach that balances FDA’s intend to increase diversity in clinical trials with bringing urgent medical treatments to patients as soon as possible

Recognize that feedback from real-world clinical experience is crucial for comparing and improving the use of drugs, vaccines, medical devices

  • Acknowledge how to take advantage of the far broader options now available to trial sponsors
  • Go over at length the hurdles of Social Determinants of Health (SDOH) and see why they must be understood to be solved
  • Engage in a conversation about how the industry must spearhead the movement to move beyond this

Unnecessary prescriptions are producing antibiotic-resistant bacteria. Find out if access to point-of-care testing can change the picture

  • Gain insight into adapting the draft guidance which provides a framework for a Diversity Plan focused specifically on racial and ethnic characteristics
  • Understand how to support the objectives of this new guidance by highlighting methodological implementation of the Diversity Plan
  • Discover how to put in place the opportunities for studies to facilitate their implementation and expansion

To achieve greater diversity and inclusion in clinical trials, we must understand the history behind a major issue in disadvantaged populations: medical mistrust.

  • Understand the Past and explore historic examples of medical mistreatment, particularly as they relate to clinical and scientific research
  • Address the Present and recognize the remnants of past failures and give credit to advancements and progression in the proper direction
  • Prepare for the Future, discuss opportunities for improvement and identify key resources for development while establishing boundaries to avoid repeating history

There is a need for a comprehensive understanding of health trends and challenges through robust data and analysis. This facilitates evidence-based decision-making, supports impactful strategies, and enables effective policy engagement. The emphasis on this session will include an overview of the need for:

  • In-Depth Understanding of Health Trends: Comprehensive data collection on health issues, including disease prevalence and mortality rates, provides a clear picture of global and local health trends. This knowledge is crucial to understand the evolving health landscape.
  • Evidence-Based Decision Making: The use of advanced analytical tools and health metrics allows for data-driven decision-making. This provides in aligning research and development strategies with real-world health needs.
  • Collaboration and Policy Engagement: Data can serve as a common ground for Pharma companies to engage with policymakers, healthcare providers, and international bodies. This collaboration can lead to more cohesive and impactful health strategies.

For many reasons, the medical device industry faces a unique journey towards representative enrollment. During this session we will:

  • Discuss challenges that Med Tech faces towards achieving representative enrollment.
  • Share our experience on what's worked well... and what hasn't.
  • Identify opportunities to partner across the industry to address barriers to success.

Precision medicine requires the referencing of sequencing data to arrive at a targeted therapy, however we can all agree that the genetics samples and health data utilized for the analysis has significant diversity gaps, we have a commitment to address the disparity (Lee et al 2022)

  • There are several ways to define diversity in the context of precision medicine, becoming familiar with these varied approaches can advise both trial design and recruitment strategies.
  • Recruitment strategies geared a improving the diversity of patient participation in precision medicine research must include mapping out the biocultural journeys of target populations. This approach can aid the development of research scientific aims that serve the population.
  • Diversity in Precision Medicine should not only address diverse patient enrollments but should also address diversity patient needs and risk/benefit ratios in clinical research.

This session highlights the use of partnering as an effective tool to help drive diversity. Join this dynamic keynote session where a speaker will engage an executive panel, and share experiences and perspectives on advancing diversity in clinical trials, including:

  • Key Strategic Pillars for Diversity and Inclusion in Clinical Trials
  • Making Your Team Part of the Increased Awareness and Action That Improve Representation in Clinical Trials
  • Increasing the Diversity of Data Sources to Enhance Diverse Patient Participation
  • During this session, internal and external collaborations as well as data driven approaches and analytics tools will be discussed.

Increase enrollment and retention of patients from racially and ethnically diverse populations by Identifying and engaging the most promising sites in underserved communities. Grasp a patient-centric approach by seeking patient input throughout the development process.

  • Understand and overcome the challenges and barriers to trial diversity
  • Consider game changing real-world examples where patient-focused approaches improved diversity
  • Participate in a strategy shifting discussion about how technology and Social Determinants of Health (SDOH) data analytics can play a role in success

Participate in a discussion about how to create an ethnically sensitive Clinical Trial Brochure. Learn to leverage insights from our Employee Resource Group (ERG) members to understand the mosaic perspective of diverse patient journeys and tailor the brochure content accordingly.

  • Lead large-scale strategic initiatives aimed at improving the efficiency of clinical trials by implementing innovative processes and technology
  • Explore ways to play an instrumental role in the Diversity and Inclusion in Clinical Trials
  • Actively work to diversify participation in clinical trials while promoting equal representation within the field and lead efforts in developing and mapping out processes to achieve these goals

  • Gain an insider’s perspective with a complete overview of health disparities and one of the most pressing areas of diverse trials: Social Determinants of Health (SDOH)
  • Learn from large direct to consumer/patient community engagement by highlighting the Walgreens Clinical Trials approach
  • Grasp key lessons of community engagement from the second-largest pharmacy store chain in the United States

Addressing Challenges of DEI in Rare Research

  • Challenge 1: A diagnostic odyssey
  • Challenge 2: Regulatory restrictions
  • Challenge 3: Balancing the burden for patients and families