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April 29, 2019

Isn’t my research enough? – Success amongst the learnings

Commercialising medical research has its challenges, refer to my previous two articles which share some of the challenges, and offer some helpful resources. And “challenges” isn’t code for ‘a little tricky’ – it is estimated that only 9.6% of medicines in Phase I clinical trials actual progress to US FDA approval[1]. And

April 15, 2019

Isn’t my research enough? – Helpful resources

In my previous article, Isn’t my research enough? – Translational research meets Commercialisation,  I shared with you some of the challenges in moving beyond research to commercialised outcomes for patients. What I would like to do in this article is help you navigate some of the important stakeholders (of course, there

April 8, 2019

Isn’t my research enough? Translational Research meets Commercialisation

There is certainly more focus today on connecting medical research to commercialisation outcomes than there was 20 years ago when I undertook my PhD, yet a gap still exists. This gap has spawned the generation of Federal Government initiatives such as MTPConnect[1] and NCRIS[2], amongst others, to promote, invest, and shorten

February 13, 2019

What Regulatory Affairs leaders need to consider in relation to medicine shortages….

If you work with OTC or Prescription Medicines, I’m sure you are aware of the TGA mandatory reporting scheme for medicine shortages in effect from January 2019 https://apps.tga.gov.au/prod/MSI/search. Whilst the TGA did have some powers to publish notifications of shortages under the voluntary reporting scheme initiated in 2014, the scheme overall