The trajectory to a safe and effective new medicine is long, expensive and full of obstacles. It takes many steps to determine the quality, efficacy and safety of a medicine, understand its pharmacology and bring it.
Traditionally, the process starts with target identification, followed by screening and selection of new molecules affecting the identified target, preclinical testing of selected candidates, clinical testing during phase I-II-III trials, (inter-)national market approval by regulatory authorities, health technology assessment, and use in patients during which phase IV research with pharmacovigilance continues. This process may take 3-15 years. The KNAW was asked to identify how efficiency gains could be made through innovation in medicine development and how (Dutch) science can contribute. A committee addressed these questions and the report is now complete. Members of hDMT took part in a Round Table discussion on what kinds of models might be suited for inclusion in the drug development pipeline to increase the likelihood that new medicines reach the market. These included Organs-on-Chip and organoids as well as models and artificial intelligence.
The advice will be presented on October 5th 2021 at a seminar which can be followed live at the KNAW after registration.
Source: KNAW website.