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New studentship at York to support FDA regulatory science

Posted on 12 October 2021

The University of York is part of a consortium that has won a $2 million research contract from the US Food and Drug Administration (FDA) to improve Covid-19 models.

Preclinical models have been critical for narrowing down the list of candidate vaccines and therapies that advance to human studies, however, there is tremendous scope to improve these model readouts with recent advances in the disciplines of systems biology and machine learning. This holistic approach involves computational and mathematical analysis and modelling of inherently complex biological systems, and will be led by Australia’s science agency, the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

Regulatory science

CSIRO scientist and Honorary Professor Seshadri Vasan, from our Department of Health Sciences, is the principal investigator of this project. He said it will develop the underpinning regulatory science to support the FDA in evaluating the suitability of animal models used to assess potential vaccines and therapeutics for Covid-19.

Professor Vasan said: “The project will generate evidence-based recommendations to help the FDA and other regulators evaluate preclinical data with even greater confidence and accuracy through the latest advances in science.”

The FDA project will co-fund a masters studentship at the University of York from 2022 to 2023 to understand the burden of increasing model readouts on the preclinical pipeline.

Preclinical models

“By strengthening the preclinical models with additional readouts, we may inadvertently increase the burden on small innovative companies to perform rapid preclinical evaluation of their candidates, therefore suitable mitigation steps will be required,” Professor Vasan added.

Professor Patrick Doherty, co-investigator on the FDA project and the head of the Department of Health Sciences, said: “We are particularly keen to see early career researcher involvement through a studentship to help clarify and understand the impact of health policy and funding policy changes required to mitigate these factors.”

The postgraduate studentship will waive domestic and international fees and provide a generous stipend. It will be announced through the University’s postgraduate research funding pages in mid-2022.

Notes to editors:

The US$ 2 million FDA contract is awarded to the CSIRO from October 2021 to September 2024 (Principal Investigator: Professor Seshadri Vasan). CSIRO’s Australian partners include Barwon Health (Professor Eugene Athan), James Cook University (Professor Maxine Whittaker), Murdoch Children’s Research Institute (Professor Vera Ignjatovic), Swinburne University of Technology (Professor Enzo Palombo), University of Melbourne (Dr Adam Wheatley) and University of New South Wales (Dr Rohitash Chandra). International partners include Birla Institute of Technology and Science in India (Dr Vinti Agarwal), Inovio Pharmaceuticals in USA (Dr Trevor Smith), University of Oxford (A/Professor Teresa Lambe), University of Texas Medical Branch (Professor David Beasley), and University of York (Professor Patrick Doherty).