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How Biomarkers Can Be Leveraged to Improve Return on Investment in Drug Development
Session Chair(s)
Eva M. Finney
Director, Global Project & Alliance Management
Merck & Co., Inc., United States
Diminishing returns on investment have plagued the pharmaceutical industry in the last decades. This forum will explore how appropriate use of biomarkers can increase return on investment, either by facilitating earlier “no go” decisions, reducing clinical trial costs, improving the probability of success, accelerating drug development for faster time to market, or increasing access to the drug once on market. Case studies using molecular imaging will be presented. Execution challenges associated with incorporating biomarkers and companion diagnostics into a clinical program will be highlighted, as well as some solutions to these challenges. Finally, a regulatory perspective will be offered of the utility of biomarkers in clinical trial designs, including discussion of challenges and best practices for drug/test codevelopment.
Learning Objective : Explain how biomarkers can be used to improve probability of success or accelerate a drug development program; Describe some of the challenges, and solutions, around development and use of an appropriate biomarker during a clinical program; Describe the role of imaging biomarkers in a clinical trial; Discuss the regulatory considerations for biomarker and diagnostic development within a drug program.
Speaker(s)
The Benefits of Imaging Biomarkers in Oncology Clinical Trials
Robert Scarimbolo
BioClinica, United States
Manager, Molecular Imaging
Effective Project Execution for Companion Diagnostics
Rachel Yarger, MBA, PMP
Luminex Corporation, United States
Senior Project Manager
Utility of Biomarkers and Their Associated Diagnostics in Drug Development Programs: A Regulatory Perspective
Christopher Leptak, MD, PhD
Greenleaf Health, Inc., United States
Executive Vice President, Drug and Biological Products
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