How we discover our innovative medicines: the drug development process
Every day, scientists at Boehringer Ingelheim embark on a journey. It is a journey that can take up to 15 years and requires significant investment.1,2 Only a tiny proportion of these journeys are successful. This is the journey of drug discovery.
From Curiosity to Discovery
From initial discovery to a marketable medicine is a long and challenging road. It takes about 12 - 15 years from discovery to the approved medication and, on average, only one to two of every 10,000 substances synthesized in laboratories will be investigated in late-stage clinical trials and finally made available to patients.2
The Drug Discovery & Development Process
Before a new medicine is approved and can be prescribed by a physician it has to go through a lengthy and rigorous process involving multiple stages of research and investigation.
Discovery Research: 4-5 years
Researchers identify ‘targets’ such as genes or proteins involved in diseases and then search or ‘screen’ many thousands of potential compounds or ‘candidates’ that may act on the target and have the potential to change the course of disease.
- Target identification and validation
- Assay development
- Lead identification
- Lead optimization
- Biomarker development
- Pre-development
Development: 6-8 years
Of the thousands of compounds that are screened during early research, only about 200 will be investigated in pre-clinical trials. These studies investigate the safety and early efficacy of the compounds, before 5 to 10 candidates advance to clinical trials where they will be studied in humans.
- Pre-clinical development: 1 year
- Clinical research phase 1, 2, 3: 5-7 years
Registration: 1-2 years
The successful development of a new medicine takes around 12 years and requires significant investment. It will have been rigorously tested in the development process and only when it has been demonstrated to be effective and safe will it be submitted to the regulatory authorities for approval.
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Regulatory approval
- Phase 4 clinical trials
References
1 DiMasi et al, Journal of Health Economics, January 2016
2 The Pharmaceutical Industry in Figures. European Federation of Pharmaceutical Industries. Key Data 2018 https://www.efpia.eu/media/361960/efpia-pharmafigures2018_v07-hq.pdf