A Biomarker-Centric Approach to Drug Discovery and Development: Lessons Learned from the COVID-19 Pandemic.

Fader, Kelly A; Zhang, Jiangwei; Menetski, Joseph P; Thadhani, Ravi I; Antman, Elliott M; Friedman, Gary S; Ramaiah, Shashi K; Vaidya, Vishal S

Faced with the health and economic consequences of the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the biomedical community came together to identify, diagnose, prevent, and treat the novel disease at breathtaking speeds. The field advanced from a publicly available viral genome to a commercialized globally scalable diagnostic biomarker test in less than 2 months, while first-in-human dosing with vaccines and repurposed antivirals followed shortly thereafter. This unprecedented efficiency was driven by three key factors: (i) international multi-stakeholder collaborations, (ii) widespread data sharing, and (iii) flexible regulatory standards tailored to meet the urgency of the situation. Learning from the remarkable success achieved during this public health crisis, we are proposing a biomarker-centric approach throughout the drug development pipeline. Although all therapeutic areas would benefit from end-to-end biomarker science, efforts should be prioritized to areas with the greatest unmet medical needs including neurodegenerative diseases, chronic lower respiratory diseases, metabolic disorders, and malignant neoplasms. Significance Statement Faced with the unprecedented threat of the SARS-CoV-2 pandemic, the biomedical community collaborated to develop a globally scalable diagnostic biomarker (viral DNA) which catalyzed therapeutic development at breathtaking speeds. Learning from this remarkable efficiency, we propose a multi-stakeholder biomarker-centric approach to drug development across therapeutic areas with unmet medical needs.