Mayne Pharma received support to gain US FDA approval for a drug capsule to be marketed in the USA, registration of a patent for a new formula, and multiple high impact research papers through a SIEF STEM+ Business project.

Challenge

Australian specialist pharmaceutical company Mayne Pharma focuses predominantly on oral formulations and creams. Seeking to maximise outputs from its South Australian manufacturing plant, the company needed to build new collaborations with the research sector to strengthen its pipeline of products and the output of its Australian facilities, with a focus on high-volume export markets such as the United States.

Mayne Pharma had previously engaged with the Australian Centre for Pharmacometrics (ACP) at the University of South Australia collaborating on the emerging field of pharmacometrics; the scientific analysis and interpretation of data produced in pre-clinical and clinical trials to aid efficient drug development and to support regulatory submissions.

Pharmacometrics has the potential to speed up drug candidate selection and inform formulation and dosage decisions, reducing the time and cost of getting new drugs to market without compromising on patient safety.

Mayne Pharma recognised they required a knowledgeable researcher that could be embedded in both organisations to fully understand and leverage pharmacometrics' potential.

Solution

Through previous engagement with the ACP, Mayne Pharma had consulted with then PhD student Ahmad Abuhelwa in the area of oral drug delivery and found him to be extremely competent.

To continue the relationship, Mayne Pharma were eager to secure a SIEF STEM+ Business grant to support Dr Abuhelwa's continuing research and build on their successful collaboration with the University of South Australia.

Results

Dr Abuhelwa embraced the opportunity and, after laying careful foundations and engaging strongly with Mayne Pharma's scientific and production staff, has achieved an impressive array of results. Dr Abuhelwa generated a report that was a key factor in gaining United States FDA approval to market the Adelaide manufactured SUBA Itraconazole capsule product in the USA. Mayne Pharma has also registered a patent for a new product with Dr Abuhelwa and his supervisor Assoc Prof David Foster recognised as co-inventors.

Furthermore, Dr Abuhelwa has produced multiple high-quality research papers with the support of Mayne Pharma, boosting his academic reputation and supporting the credibility of the company's products. The project has so far delivered significant benefit for all involved and the impacts will be formally measured on an ongoing basis.

"I am satisfied with the project and the outcomes. The industry collaboration exposes me to real world problems and how to solve them. The university provides me with other opportunities necessary for my professional development. For example, I have established collaborations with other research groups."

— Dr Ahmad Abuhelwa, Research Fellow, University of South Australia

"I believe this is an excellent program. It offers a very nice balance by exposing the Fellow to a range of opportunities and insight [within] industry, commercial, research, regulation and academia. In addition, it allows myself as the Academic Partner deeper insight into the world of industry."

— Assoc Prof David Foster, Australian Centre for Pharmacometrics Research Group leader, University of South Australia

This program is supported by the Science and Industry Endowment Fund (SIEF) .

For further information and to apply, please get in touch with our dedicated STEM+ Business Manager.

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