Low hanging fruit in infectious disease drug development.
Curr Opin Microbiol
; 11(5): 434-8, 2008 Oct.
Article
in En
| MEDLINE
| ID: mdl-18822387
ABSTRACT
Cost estimates for developing new molecular entities (NME) are reaching non-sustainable levels and coupled with increasing regulatory requirements and oversight have led many pharmaceutical sponsors to divest their anti-microbial development portfolios [Projan SJ Why is big Pharma getting out of anti-bacterial drug discovery?Curr Opin Microbiol 2003, 6427-430] [Spellberg B, Powers JH, Brass EP, Miller LG, Edwards JE, Jr Trends in antimicrobial drug development implications for the future.Clin Infect Dis 2004, 381279-1286]. Operational issues such as study planning and execution are significant contributors to the overall cost of drug development that can benefit from the leveraging of pre-randomization data in an evidence-based approach to protocol development, site selection and patient recruitment. For non-NME products there is even greater benefit from available data resources since these data may permit smaller and shorter study programs. There are now many available open source intelligence (OSINT) resources that are being integrated into drug development programs, permitting an evidence-based or 'operational epidemiology' approach to study planning and execution.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug Discovery
/
Anti-Bacterial Agents
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
Curr Opin Microbiol
Journal subject:
MICROBIOLOGIA
Year:
2008
Document type:
Article
Affiliation country:
Estados Unidos