This project, in association with the Academy of Medical Sciences, defined the desirable changes to the European regulatory route for the co-development of therapeutics and ‘companion’ diagnostics – a process known as stratified medicine. Using case studies, this work explored the current regulatory barriers to the successful development of stratified approaches.
The blockbuster model of drug development is being replaced by efforts to target new agents to specific subsets of disease. Stratified medicine means the genetic testing of large groups of patients to try and predict how they are likely to respond to treatments. Researchers want to find out if some treatments are more likely to work for particular genetic profiles.
Such patient stratification will require pairing of new tests and agents. But at present we do not have the appropriate regulatory mechanisms to deal with this new approach, where patient populations must be stratified before the right therapeutic can be delivered.
New regulations are needed to deal with the emergence of stratified medicine in a range of therapeutic areas of importance, such as cancer, cystic fibrosis and muscular dystrophy.
Read the full project report here (Chapter 4: Regulation)
For more information on this project email Prof Richard Barker