In recent decades, medical product development has increasingly embraced approaches that collect data mirroring real-world scenarios. US Food and Drug Administration (FDA)’s updated Draft Guidance “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” represents a significant step toward achieving greater generalizability of evidence for intended patient populations.
For successful implementation, an integrated and clear strategy is essential. It is crucial to engage partners who can effectively recruit, motivate and retain patients from underrepresented populations, but also analyze data within a new paradigm — one that embraces greater heterogeneity.
In this webinar, the expert speakers will delve into how clinical trial sponsors and contract research organizations (CROs) can approach compliance with FDA’s guidance on developing and implementing diversity action plans. Specifically, this webinar will explore the concept of an “Integrative Approach” that not only aligns with diversity action plans but also the promotion of equity in healthcare delivery and access.
The panelists will navigate the FDA diversity action plan guidance and seek to establish considerations for an integrative approach framework to enhance and improve patient-centric approaches to drug development — from trial design to patient outreach, recruitment, retention, variable data analysis and interpretation.
Register for this webinar today to explore how clinical trial sponsors and CROs can align with the FDA’s updated guidance on diversity action plans in clinical studies.
Speakers
(Moderator) Sarah Thompson Schick, Counsel, Life Sciences Health Industry Group (LSHI), Reed Smith LLP
Sarah Thompson Schick advises companies developing and manufacturing medical products where FDA regulatory and compliance intersects with strategic business decision-making. Sarah counsels on matters such as good clinical practice and clinical trials, pharmacovigilance, medical communications and health care economic information, good manufacturing practice (drugs and medical devices), advertising and promotion, patient support programs and ClinicalTrials.gov registration and reporting.
She has written and spoken extensively on clinical trial modernization and diversity, including the implications of the recent Food and Drug Omnibus Reform Act (FDORA) and current draft FDA guidance. Sarah advises on product development and approval, contractual matters, compliance programming and risk management. She also has experience handling regulatory issues in the context of corporate transactions, securities disclosures and litigation. Sarah received a JD from the University of Virginia School of Law, and a BS (Public Administration) and MS (Health Systems Management) from George Mason University.
Message Presenter
Tinaya Gray, Global Head Diversity in Clinical Trials, ICON plc
With over 25 years of experience in industry research, Tinaya Gray has developed a deep expertise in strategic development within the pharmaceutical and CRO sectors. Her career reflects a steadfast commitment to community health equity, with three decades dedicated to anti-poverty initiatives, racial equality and justice reform.
Currently, as the Global Head of Diversity in Clinical Trials, Tinaya is the visionary leader behind ICON’s Diversity in Clinical Trials Solutions program — PACE – Patient Access & Clinical Trial Equity. In this role, she oversees the strategic and operational frameworks essential for executing inclusive research.
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Siân Ratcliffe Smethurst, PhD, SVP, Head of Quantitative Sciences & Development Operations (QSDO), Biogen
Siân Ratcliffe Smethurst leads a global team focused on the strategic planning, execution and analysis of clinical trials at Biogen, covering all phases of development in areas like MS, immunology, rare diseases and neuroscience. She drives innovative projects to transform clinical trials and accelerate drug development.
Prior to Biogen, Siân spent over 20 years at Pfizer, holding senior leadership roles in clinical operations, medical writing, safety risk management and regulatory strategy. She has led 17 NDA submissions, over 70 IND filings and managed numerous global regulatory interactions across multiple therapeutic areas. In addition, Siân has co-led a number of cross-industry initiatives for TransCelerate, BIO, ICH and public-private partnerships.
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Dominique Demolle, PhD, CEO, Cognivia
Dominique Demolle is the Chief Executive Officer at Cognivia. Dominique holds a PhD in Biochemistry from the University of Brussels. She has held various leadership positions at Eli Lilly and Company and has extensive knowledge in global early-phase drug development.
Dominique has consulted with pharmas and biotechs before founding Cognivia. Dominique has contributed to the clinical development of dozens of drugs and several launches. Most recently, she has been recognized as one of the 2022’s Most Inspiring People in the life sciences for the annual PharmaVoice 100 awards.
Message Presenter
Ruby Madison Ford, Research Analyst, Tufts Center for the Study of Drug Development
Ruby Madison Ford is a Research Analyst at the Center, specializing in grant-funded research projects. She has expertise in survey and database design, quantitative and qualitative data analysis and literature reviews.
Madison’s research focuses on topics such as patient recruitment and retention, as well as the participation and representation of racial minorities in clinical trials. She earned her BS in Public Health from The University of Alabama in 2021 and completed her MPH in Health Management and Policy at Georgia State University in May 2023.
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Who Should Attend?
This webinar will appeal to professionals in the following fields or those with the following job titles:
- Pharmaceutical/Biotechnology companies
- CROs
- C-Suite/VPs and Directors/Managers/Regulatory Affairs professionals
- Clinical Project Managers/Clinical Scientists
What You Will Learn
Attendees will learn about:
- The importance of a coherent and comprehensive diversity action plan-integrated approach
- Valuable insights from regulatory, industry and academic leaders
- How to mitigate the data variability impact on clinical trial data interpretation when implementing a diversity action plan
Xtalks Partner
Cognivia
Each patient is unique and different. Cognivia develops validated technologies that de-risk study conduct and clinical data interpretation. Cognivia’s technology combines a unique evaluation of patient traits and characteristics with machine learning to predict their behaviors when participating in clinical trials. Placebell, Cognivia’s flagship placebo response and patient “characterization” technology, calculates an individual patient score at baseline. This score serves as a covariate to “see through” the noise caused by patient variability. Compl-AI predicts nonadherence and dropout risk, enabling clinical trial managers to personalize patient engagement strategies. These solutions and Cognivia’s expert data analysis services empower pharma, biotech, and device companies to conduct more successful clinical trials and address unmet patient needs.
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