Manchester signs research and teaching agreement with FDA

The University of Manchester has entered into a new partnership with the US Food and Drug Administration to train new researchers and make advances in drug safety, development and personalised dosage. The FDA will be working with the University’s Pharmacy School to develop new research initiatives as well as enrolling students and staff in the Administration’s joint fellowship programmes.

Alongside the FDA initiative, the University has also signed a partnership with US-based Certara, a leading company in model-based drug development, to provide a lecturer in precision dosing for the school for three years. This lecturer will specifically focus on teaching students and forming research partnerships on individual dose optimisation, to demonstrate its application, particularly in relation to cancer, paediatric pharmacotherapy and applications of biologics.

Personalised or stratified medicine is an important emerging discipline and focuses on making sure that drugs are tailored to the genetic profile of patients to make them more effective. By studying large numbers of patients, researchers can break them down into smaller groups and develop substances that produce better results.

Both new partnerships are being spearheaded by Professor Amin Rostami. He said: ‘These partnerships will create further strength in overall eHealth initiatives started in Manchester. Regulatory science has been benefiting from new modelling approaches and US FDA has had a leading role in this area. These initiatives will help to give patients the right medicine, in the right amount and at the right time without causing undue side-effects.’