Moving the Needle for Enhancing Oncology Dose Optimization: A Fireside Chat with ASCPT's Scientific Thought Leadership

Session Description

Project Optimus is a major FDA initiative aimed at ensuring dose optimization in oncology drug development, moving away from the maximum tolerated dose paradigm and prospectively characterizing dose-response for efficacy and safety for patient-focused maximization of benefit versus risk. With growing appreciation of the breadth and depth of biological heterogeneity of cancers both in the tumor and the immune system coupled with increasing -omics profiling in biomarker-driven oncology drug development, it is important to consider biological heterogeneity of the disease and the patient population as important covariates in optimizing dosage. This problem sits neatly at the intersection of translational/ precision medicine and quantitative clinical pharmacology, and will importantly need to be approached with a patient-focused mindset. ASCPT as the premier professional organization for clinical pharmacology and therapeutics is best positioned to host a discussion of opportunities for our constituent disciplines (e.g., translational science, clinical pharmacology, pharmacometrics) to synergistically address this problem with a multi-disciplinary approach. This session will bring together the Editors-In-Chief of the three ASCPT Journals to catalyze a robust discussion of the problem of dose optimization in oncology. The session will include very brief (~8 minutes each) TED-style talks by the 3 speakers who collectively bring world-renowned thought leadership in clinical pharmacology, translational medicine, and pharmacometrics/ pharmacostatistical sciences. Ahead of the Annual meeting, a survey will be launched on this topic open to membership of ASCPT. Results of the survey will catalyze an engaging fireside chat with the panel of ASCPT thought leaders and may include point-counterpoint dialog (~30 minutes). Potential topics for the fireside chat include: 1) addressing the competing priorities of dose/schedule optimization and tumor molecular profile/ patient selection, 2) value of tumor pharmacodynamics in informing dose selection, 3) need for randomization for dose optimization, 4) pros/ cons of pre- versus post-approval dose optimization.

Learning Objectives

1. Define strategies and tactical plans in translational and clinical development for dose optimization of oncology therapeutics in the context of biological diversity of tumors and the immune system as relevant to the drug's mechanism of action.

2. Lead development of a multi-disciplinary collaborative and highly co-ordinated biomarker-driven, model-informed, and patient-focused dose optimization plan for next-generation cancer therapeutics in the context of a broader end-to-end asset strategy.

Session Schedule

8:15 AM - 8:19 AM ET
Introduction
Neeraj Gupta, PhD and Karthik Venkatakrishnan, PhD

8:19 AM - 8:25 AM ET
Moving the Oncology Dose Optimization Needle: Opportunities for Biomarker-Informed Translational Development
John Wagner, MD, PhD

8:25 AM - 8:31 AM ET
Moving the Oncology Dose Optimization Needle: Opportunities for Patient-Focused Quantitative Clinical Pharmacology
Piet Van der Graaf, PharmD, PhD

8:31 AM - 8:37 AM ET
Moving the Oncology Dose Optimization Needle: Opportunities for Pharmacostatistical Models and Novel Trial Designs
Priya Jayachandran, PharmD

8:37 AM - 8:43 AM ET
Moving the Oncology Dose Optimization Needle: Cross-pollination and learnings from a non-oncology FDA perspective
Shirley Seo, PhD

8:43 AM - 8:48 AM ET
Presentation of Survey Results
Neeraj Gupta, PhD and Karthik Venkatakrishnan, PhD

8:48 AM - 9:00 AM ET
Fireside Chat

9:00 AM - 9:15 AM ET
Q&A and Closing Remarks