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 the bridge between medical research and patient outcomes.
Let’s be clear – good research is absolutely fundamental to commercialisation, and there’s plenty of good research around. In Australia, we are top five globally in biotechnology[3] – and have been for three consecutive years – as measured by intellectual property, intensity, enterprise support, workforce/education, productivity, policy and stability.
Good research, however, is only one phase of the commercialisation journey.
If we work with the assumption that you have good research underpinning a potentially great new medicine or medical technology, why might your research not be enough?
Here are just a few reasons why…
-
- Challenges in progressing to proof-of-concept or prototype
- Complexities in scale up to commercial manufacture
- Toxicity studies reveal unacceptable risks
- Clinical trials reveal unacceptable efficacy and/or safety profiles
- The target population or medical condition is unclear
- The expected return on investment isn’t attractive to potential partner organisations
Translational research is a fairly risky proposition, with risk declining (but not completely removed) during the development phase. Understanding downstream factors which must complement and align with your research can help you hold a rounded perspective to guide your research towards commercialisation success and great patient outcomes.
Here are a few more tips…
FIVE QUESTIONS TO HELP BRIDGE YOUR RESEARCH TO COMMERCIALISATION OUTCOMES
- What is your 30 second response to tell me about your research? Is it easily understood by a lay person and does it link to a healthcare outcome?
- Who are the key stakeholder groups outside my immediate area of research?
- How much research is enough to present a compelling basis for further development?
- How protected is my research (think Intellectual Property)?
- What sources can I consult to help me understand some of the potential downstream development challenges?
Upcoming related articles
- Isn’t my research enough? – Helpful resources
- Isn’t my research enough? – Success amongst the learnings
[1] https://www.mtpconnect.org.au/
[2] https://www.education.gov.au/national-collaborative-research-infrastructure-strategy-ncris
[3] 2018 Annual Report, AusBiotech
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.