The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey
| Autor: | J. Eric McDuffie, William J. Reagan, Joanna Harding, James D. Smith, Dominique Brees, Tanja S. Zabka, Magali Guffroy, Deidre A. Dalmas, Jean-Charles Gautier, Lila Ramaiah, Alison Wolfreys, John E. Burkhardt, A. Eric Schultze, Warren E. Glaab |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Knowledge management
Drug Industry Drug-Related Side Effects and Adverse Reactions Health authority Drug Evaluation Preclinical 010501 environmental sciences Toxicology Asset (computer security) 030226 pharmacology & pharmacy 01 natural sciences Biomarkers Pharmacological 03 medical and health sciences 0302 clinical medicine Resource (project management) Surveys and Questionnaires Animals Humans Tissue Distribution 0105 earth and related environmental sciences Clinical Trials as Topic business.industry General Medicine Investigational New Drug Application Clinical trial Drug development Pharmaceutical Preparations Clinical safety Business Inclusion (education) Forecasting |
| Zdroj: | Regulatory toxicology and pharmacology : RTP. 120 |
| ISSN: | 1096-0295 |
| Popis: | Pharmaceutical and biotechnology companies rarely disclose their use of translational emerging safety biomarkers (ESBs) during drug development, and the impact of ESB use on the speed of drug development remains unclear. A cross-industry survey of 20 companies of varying size was conducted to understand current trends in ESB use and future use prospects. The objectives were to: (1) determine current ESB use in nonclinical and clinical drug development and impact on asset advancement; (2) identify opportunities, gaps, and challenges to greater ESB implementation; and (3) benchmark perspectives on regulatory acceptance. Although ESBs were employed in only 5–50% of studies/programs, most companies used ESBs to some extent, with larger companies demonstrating greater nonclinical use. Inclusion of ESBs in investigational new drug applications (INDs) was similar across all companies; however, differences in clinical trial usage could vary among the prevailing health authority (HA). Broader implementation of ESBs requires resource support, cross-industry partnerships, and collaboration with HAs. This includes generating sufficient foundational data, demonstrating nonclinical to clinical translatability and practical utility, and clearly written criteria by HAs to enable qualification. If achieved, ESBs will play a critical role in the development of next-generation, translationally-tailored standard laboratory tests for drug development. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect