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Quantitative Pharmacology (QP)

Clinical Trial Diversity & Inclusion: How Clinical Pharmacology Can Support the Implementation of Regulatory Guidance on Diversity Plans

Tuesday, March 26, 2024
8:30 AM – 5:30 PM MDT
Acknowledgement: Rashmi Mehta, PhD – GSK – for contributing to the ASCPT pre-conference workshop since its inception, as the co-chair (could not attend).

Breakout Session Moderators

Ravi Shankar P. Singh, PhD
Shweta R. Urva, PhD
Lakshmi S. Vasist, PharmD
Sebastian Haertter, PhD

Session Description

In a recent FDA draft guidance (April 2022), the FDA recommends that sponsors developing investigational medical products enroll an adequate number of trial participants from under-represented populations and prepare a diversity plan. Generating a diversity plan in early clinical development can be a challenging task as safety and tolerability of investigational products across diverse populations is not fully established.

In this pre-conference, experts from industry, academia, IQ, and regulators will discuss how to utilize clinical pharmacology tools in drug development to implement the guidance and generate diversity plans. Case study presentations will demonstrate how clinical pharmacology concepts can be used to increase enrollment of under-represented populations in clinical trials by enhanced understanding of the disposition of molecules, performing risk assessments using M&S (determine restrictions on concomitant medications or in organ impairment), developing well-designed clinical trials (e.g. inclusion of Asian cohort in Phase 1 study), and applying technologies to enable DCT. An interactive workshop session will reinforce the key learning points of the presentations and case studies.

Learning Objectives

1. Obtain an understanding of how to utilize clinical pharmacology tools to implement the guidance on diversity plans to increase the participation of under-represented populations in clinical trials.
2. Learn from case studies where clinical pharmacology practices have resulted in increased enrollment in subsequent trials
3. Foster collaboration and advance the efforts towards increased diversity in clinical trials.

Session Schedule

8:30 AM – 8:40 AM MT
Opening & Welcome
Aarti Sawant, PhD

8:40 AM – 9:05 AM MT
Advancing Health Equity through Clinical Trial Diversity
Neali Lucas, PhD

9:05 AM – 9:30 AM MT
Diversity: From a Clinical Pharmacology Lens
Anu Ramamoorthy, PhD

9:30 AM – 9:55 AM MT
Advancing Their Utilization in Clinical Pharmacology – Industry Perspectives
Brian Corrigan, PhD

9:55 AM – 10:25 AM MT
Panel Discussion

10:25 AM – 10:40 AM MT
BREAK

10:40 AM – 10:45 AM MT
What Makes a Patient Population Diverse? Current Status and How Can Clin Pharm Principles Help to Broaden Diversity in Clin Trials
Sebastian Haertter, PhD

10:45 AM – 11:05 AM MT
Representation of Elderly Patients in Clinical Trials
Sebastian Haertter, PhD

11:05 AM – 11:25 AM MT
Significance of Interethnic Comparison of Pharmacokinetics – PMDA Perspective
Yasuto Otsubo, PhD

11:25 AM – 11:45 AM MT
Enrolling Patients with Organ Impairment in Phase 2/3 Trials - Challenges and Potential Solutions
Islam Younis, PhD

11:45 AM – 12:05 PM MT
Drug Metabolism and Transporter Considerations in the Context of Diversity and Inclusion in Clinical Trials
Sreeneeranj Kasichayanula, PhD

12:05 PM – 12:25 PM MT
Translational Approaches to Ensure Equity
Michael A Pacanowski, PharmD, MPh

12:25 PM – 1:30 PM MT
LUNCH

1:30 PM – 2:45 PM MT
Hands-On Workshop

2:45 PM – 3:30 PM MT
Discussion from Hands-On Workshop

3:30 PM – 3:45 PM MT
BREAK

3:45 PM – 4:30 PM MT
Panel Discussion

4:30 PM – 4:35 PM MT
Wrap Up
Aarti Sawant, PhD

4:35 PM – 5:30 PM MT
Attended Posters and Refreshments