Preclinical and Translational Sciences
Lindsay King, Ph.D. (he/him/his)
Senior Director
Pfizer Inc
Boxborough, Massachusetts
Jaya Vaidyanathan, PhD
Associate Director for Therapeutic Review
Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
Silver Spring, Maryland
For more than 20 years biomarker have held the promise of enabling patient selection and stratification and serving as surrogate endpoints. While precision medicine has become a critical part of Oncology program with some notably successes, it has been more challenging to routinely implement in drug development for many other disease areas. Today AI is being applied to large molecular data sets to identify signatures of disease and response to therapy. The amount of data that could be generated with novel technologies is immense but also expensive. This presentation will provide an overview of the of biomarker in clinical development, the critical role of biomarker measurement and technologies and some of the current challenges in successful implementation to enable efficient drug development. It will include case studies exploring the value of target engagement/POM and DDI biomarkers as well as the promise of biomarker signatures.