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Manchester signs agreement with US Food and Drug Administration (FDA)

12 Jun 2015

The University of Manchester has entered into a new partnership with the US Food and Drug Administration (FDA) to train new researchers and make advances in drug safety, development and personalised dosage.

Researchers hope for new advances in drug safety and development
Researchers hope for new advances in drug safety and development

The FDA is responsible for authorising all drugs sold in the United States and 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 Inc, which is 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 in order 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.

“We are delighted to work with them as well as other pharmaceutical partners who have focus in the modelling area, such as Certara. These initiatives will help to give patients the right medicine, in the right amount and at the right time without causing undue side-effects.”

Watch below for an overview of Manchester Pharmacy School:

Notes for editors

Media enquiries to:
Jamie Brown
Media Relations Officer
The University of Manchester
Tel: 0161 2758383