Clinical Trial Assay Development for Precision Medicine: Insights from Pharma & Diagnostics Experts

Explore the latest insights and case studies on different approaches to clinical trial assay development, validation, and deployment in trials for both oncology and chronic disease indications from both a biopharma and diagnostics perspective.

This webinar will cover several key topics related to biomarker-driven clinical trials. Attendees will learn how to maximize success in these types of trials globally, with a specific focus on the importance of China. Additionally, there will be a discussion on the regulatory challenges associated with the latest thinking on IVDR Europe.

Join this webinar to get an in-depth look at the opportunities and challenges of clinical trial assay development & validation and the critical steps involved to ensure that they are ready for stratification use within clinical trials.

Speakers

Kedar Vyavahare, Senior Director, Precision Medicine Franchise Leader, Cardiovascular, Renal & Metabolism (CVRM), AstraZeneca

Kedar Vyavahare has worked for over 17 years in the field of precision medicine and diagnostic development. Currently Kedar holds the post of Senior Director Precision Medicine Franchise Leader at AstraZeneca where he has a global responsibility to create strategy and deliver a portfolio of precision medicine projects to improve clinical outcomes for patients with chronic diseases.

Prior to joining AstraZeneca in 2022, Kedar has worked in various pharmaceutical, medical devices and in vitro diagnostics (IVD) companies including Fresenius Medical Care, Takeda Pharmaceuticals and Werfen Group, where Kedar led successful development of a variety of IVD products. These products were developed for a variety of applications such as precision medicine, patient home monitoring tools and tests for early patient diagnosis. Kedar holds a Master of Science in Biomedical Engineering from the US and a Bachelor of Engineering from India.

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Michael Teufel, Executive Director, TMCP Integrator, Biomarker Lead, Oncology, Boehringer Ingelheim USA

Michael Teufel has worked for over 15 years in the field of precision medicine and diagnostic development. Currently Michael holds the post of Executive Director Translational Medicine and Clinical Pharmacology at Boehringer Ingelheim where he has a global responsibility to create strategy and deliver a portfolio of precision medicine projects to improve clinical outcomes for patients in oncology programs.

Prior to joining Boehringer Ingelheim in 2020, Michael has worked at Sanofi Oncology and Bayer Pharma, where he led successful biomarker strategies leading to 4 sNDAs and 2 NDAs including successful approval of a CDx. Michael holds a PhD in Molecular Genetics from Germany.

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Dr. Leeona Galligan, VP of UK Operations, Almac Diagnostic Services

Dr. Leeona Galligan (PhD, FRCPath) has worked for over 15 years in the field of translational molecular oncology and holds the post of VP UK Operations at Almac Diagnostic Services where she has overall responsibility for all laboratory based technologies and services supporting Almac’s biomarker discovery, development and delivery.

Prior to joining Almac in 2009, Dr. Galligan obtained a PhD in molecular haematology from Trinity College Dublin. She subsequently completed a postdoctoral fellowship on the molecular mechanisms of drug resistance in colorectal cancer at Queen’s University Belfast and has completed a four year training programme in specialist haemato-oncology laboratory services. She maintains registration with the UK Health and Care Professions Council as a Clinical Scientist and has been awarded Fellowship of the Royal College of Pathologists (FRCPath) through examination in haemato-oncology and laboratory management.

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