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Design considerations for early phase clinical trials of immuno-oncology drug

Join speakers James Matcham and Michael Fossler for the third webinar of Cytel and Lide Biotech's webinar series, which explores the use of co-clinical trials in expediting drug development for cancer patients. Co-clinical trials uses functional diagnostic testing and clinical trials, conducted simultaneously, to enable real-time data integration to accurately stratify and customize treatment for patients individually. 

A key aim in early oncology drug development is to estimate the Recommended Phase 2 Dose (RP2D) and to investigate which patient populations are optimal for further treatment. The FDA’s Project Optimus initiative also sets expectation to evaluate a wider range of doses in development rather than focusing on using maximum tolerated dose approach for pivotal trials.  During the third webinar in this series, our speakers will outline the types of dose escalation designs that are available and highlight the evolving Basket designs that investigate biomarker defined patient populations. The role of PK/PD modelling in determining the RP2D and schedule will also be emphasized.

In this webinar the speaker will discuss:

  • Dose Escalation Design Options
  • Basket Study Design Options
  • PK/PD Modelling for identifying the RP2D

 

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Michael Fossler

Michael J. Fossler is Executive Consultant and Vice-President, Strategic Consulting at Cytel. He received the Pharm.D.(1992) and Ph.D. (1995) degrees from the University of Maryland. From 1995 to 2000, Dr. Fossler was employed by the FDA as a clinical pharmacology reviewer inthe Division of Metabolic and Endocrine Drug Products. In 1998, he was promoted to Senior Reviewer, and joined the Pharmacometrics group at FDA, where he was responsible for reviewing and performing population PK/PD analyses. He left the Agency in 2000 and joined the Clinical Pharmacokinetics Group at Dupont Pharmaceuticals, where he had major responsibility for PK/PD analyses in the cardiovascular and anti-inflammatory areas.

James Matcham

James Matcham joined Cytel in April 2020 as a Senior Principal in the Strategic Consulting team. He began his career with 5 years working as a Research Fellow at the Applied Statistics Research Unit at the University of Kent. He then completed 21 years at Amgen where he worked on the development and regulatory/reimbursement approval of many of their biotechnology products, representing the company at regulatory submissions in the US and the EU and eventually chairing the company’s International Protocol Review Committee. His last few years there were spent working to improve literature review, the use of adaptive and early phase design, network meta-analysis, Bayesian methods and quantitative decision making. More recently he spent 6 years at AstraZeneca as Head of Early Clinical Development Biometrics, responsible for clinical development plans, decision making and the design and analysis of phase 1, 2a and 2b trials. During this time he pioneered the use of quantitative decision making and the use of innovative clinical trial design and advanced analytics.

James has been a member of UK society for Pharmaceutical Statisticians (PSI) for over 30 years, serving on the Scientific and Training Committees as well as the Board of Directors. He has also served on the Professional Affairs Committee of the Royal Statistical Society and contributed to other industry-wide activities. He has been a Chartered Statistician of the Royal Statistical Society for over 25 years and has over 30 publications in refereed scientific journals and two contributed book chapters.

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