In Translational Research

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 are others) to be aware of.

  • The NHMRC[1]  – National Health and Medical Research Council- perhaps you are most familiar with this stakeholder. Did you know that in addition to funding research projects, the NHMRC also provides evidence-based health advice to Australians?
  • MTP Connect[2]. Established in 2015, MTPConnect’s remit is broadly to facilitate commercialisation in the medical technology and pharmaceutical sector. MTP Connect publishes reports and advocates for a more favourable commercialisation environment.
  • NCRIS[3] – the National Collaborative Research Infrastructure Strategy (NCRIS) – The Australian government invests in research infrastructure to aid the development of medicines and medical technologies via Therapeutic Innovation Australia (TIA)[4]. TIA helps researchers from the public and private sectors to access specialised facilities and expertise necessary for therapeutic development. TIA can also assist in referring researchers to other NCRIS-funded capabilities such as ‘omics or imaging.
  • Ausbiotech[5] – Member-based associations such as Ausbiotech connect members with relevant stakeholders and offer learning and networking opportunities, in addition advocating for the sector advocacy. Ausbiotech, in particular, represents organisations across the pipeline from research to commercialisation.
  • Regulators – Regulators decide, based on scientific and medical principles, whether or not a medicine or medical technology can be marketed. Understanding concepts like GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice), manufacturing process and test method validation, risk-benefit considerations etc can help you appreciate some of the downstream considerations. Additionally, Regulators often publish valuable information such approvals and summaries of data assessments.  Which Regulator(s) to focus on depends on the ultimate market(s) of the commercialised product, and this may not be determined for some time. A good place to start is the Australian regulator, the Therapeutic Goods Administration (the TGA, for those in the know), which has a SME Assist service for small to medium enterprises, researchers and start-ups[6], and an option to subscribe to email updates[7].

Some additional tips…

Three questions to consider

  • What is your network like outside your immediate area of research?
  • Who in your organisation is connected to a key stakeholder?
  • What publically-available information can help you broaden your sector knowledge?

………

[1] https://nhmrc.gov.au/about-us

[2] https://www.mtpconnect.org.au/Category?Action=View&Category_id=86

[3] https://www.education.gov.au/national-collaborative-research-infrastructure-strategy-ncris

[4] https://www.therapeuticinnovation.com.au/

[5] https://www.ausbiotech.org/

[6] https://www.tga.gov.au/sme-assist

[7] https://www.tga.gov.au/sme-assist-email-list

………

In addition to Regulatory and Related Consultung Services, Mary offers industry-readiness programs for people looking to enter the pharma, biopharma, biotech, med tech and wellness organisations. Contact Mary for a complimentary industry-readiness check or discussion on how this program may be applied to your organisation. 

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