A Biomarker-Centric Approach to Drug Discovery and Development: Lessons Learned from the Coronavirus Disease 2019 Pandemic
| Autor: | Jiangwei Zhang, Kelly A. Fader, Shashi K. Ramaiah, Gary S. Friedman, Ravi Thadhani, Elliott M. Antman, Joseph P. Menetski, Vishal S. Vaidya |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Genetic Markers
0301 basic medicine medicine.medical_specialty Coronavirus disease 2019 (COVID-19) Disease Antiviral Agents 03 medical and health sciences 0302 clinical medicine Drug Development Drug Discovery Pandemic medicine Animals Humans Intensive care medicine Pandemics Pharmacology Drug discovery business.industry Public health COVID-19 Civil Defense COVID-19 Drug Treatment Data sharing 030104 developmental biology Drug development Molecular Medicine Biomarker (medicine) business Biomarkers 030217 neurology & neurosurgery |
| Zdroj: | Journal of Pharmacology and Experimental Therapeutics |
| ISSN: | 1521-0103 0022-3565 |
| Popis: | 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, and first-in-human dosing with vaccines and repurposed antivirals followed shortly thereafter. This unprecedented efficiency was driven by three key factors: 1) international multistakeholder collaborations, 2) widespread data sharing, and 3) 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 severe acute respiratory syndrome coronavirus 2 pandemic, the biomedical community collaborated to develop a globally scalable diagnostic biomarker (viral DNA) that catalyzed therapeutic development at breathtaking speeds. Learning from this remarkable efficiency, we propose a multistakeholder biomarker-centric approach to drug development across therapeutic areas with unmet medical needs. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|