Publish Date: 
Thursday, November 15, 2018 - 11:30

US$1.75 Million in Funding Awarded by US FDA for topical product research

Recently, the US Food and Drug Administration (FDA) announced US$1.75 Million in funding towards two research projects led by Professor Michael Roberts. 

Professor Roberts is an Australian National Health & Medical Research Council Senior Principal Research Fellow who leads research teams at the University of Queensland Diamantina Institute (UQ-DI) based at the Translational Research Institute (TRI), and the University of South Australia (UniSA), based at the Basil Hetzel Institute (BHI).  

Dr Yousuf Mohammed at The University of Queensland Diamantina Institute, co-principal on one of these grants, and Dr Jeff Grice, who will manage the second grant, are also based at TRI.

This round of funding from the US Federal Drug Administration (FDA) Generic Drug User Fee Amendments (GDUFA) saw 23 international collaborative research contracts and grants awarded, with most grants going to US institutions. 

Professor Michael Roberts (left) and his teamThe first grant awarded to Professor Roberts and his team will focus on gaining a better understanding of how differences in composition of topical drug formulations can impact on product performance. This work will aid the FDA to extend in vitro bioequivalence approaches for comparing new topical dermatological products against reference products, and may also assist with generic product development by identifying limits for critical inactive ingredients that may affect overall product performance.

The second grant will go towards further development of a quality-by-design approach, similar to that used in aircraft design, in which an understanding of the interactions of active pharmaceutical ingredients with the skin is used to accurately and quantitatively predict product performance before launch, thereby leading to a greater certainty and lower costs for any subsequent clinical trial that may be undertaken to validate the performance for a particular product in vivo. A key regulatory outcome from the work will be development of a virtual bioequivalence modelling and simulation tool that predicts the impact of variations in topical product innovator and generic topical and transdermal drug product formulation differences on their performance in vivo

In addition, Professor Roberts and his team will also collaborate with US-based company Certara on another dermal bioequivalence project that has received funding from the GDUFA scheme (more details here). Certara is a global leader in model-informed drug development, regulatory science, real-world evidence and market access.

Congratulations to Professor Roberts, Dr Mohammed, Dr Grice and their team. 

For more information on the funded projects and a full list of funds awarded by the GDUFA in 2018, click here.

Photo of Professor Roberts (left) and his team