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Effective Discovery, Development and Use of Biomarkers in Early Drug Development
Session Chair(s)
Stacie J. Bell, PhD
Director, Clinical Pharmacology and Development
Samumed LLC, United States
In this symposium, multiple facets of biomarker development and use will be addressed. The research surrounding identification of possible biomarkers and early evaluation will be outlined, as well as the expertise and resources required (often in collaboration) to execute these assessments. We will specifically highlight novel quantitative imaging biomarkers and techniques, as well as a rapid, multiplexed quantitative proteomics assay solution. Finally, the regulatory considerations for biomarker impact on the drug development plan and new drug application filing will be outlined, along with concerns for informed consent processes and subject samples.
This symposium has been developed with the DIA Clinical Pharmacology and Translational Medicine Communities.
Learning Objective : Identify key characteristics of biomarkers for elucidating disease biology and drug efficacy; Define required expertise and implementation for biomarkers in clinical trials, particularly early or small trials; Discuss the value and role of proteomics and quantitative imaging as biomarkers; Explain regulatory requirements and informed consent process best practices for inclusion of biomarker assessments.
Speaker(s)
A Quantified Picture is Worth a Thousand Words: Generating Efficient Signals of Efficacy
Gregory V Goldmacher, MD, PhD, MBA
Merck & Co. Inc., United States
Senior Director, Translational Biomarkers
Implications for Useful Biomarker Discovery and Early Clinical Development
Gordon Vansant, PhD
EPIC Sciences, United States
Director, Business Development
Effective Development and Utilization of Biomarkers in Early Drug Development
Susan Zondlo, PhD
QPS, LLC, United States
Associate Director, Biomarkers, Translational Medicine Department