The old adage that if you fail to plan you are planning to fail is attributed to US founding father Benjamin Franklin.
We’d hope Ben might be impressed with the extent of planning for success that goes into Australian biotech these days.
This sort of planning does need to balance optimism and reality.
In biotech, while your objective might be the commercialisation of research, there are many other players and factors outside your control that add to the difficulty of planning.
If you are focused on chronic disease like we are and you are confident in your research, you can get impatient about how long surrounding processes can take but that really is where the value lies.
It is only by undertaking clinical trials and working with regulators that research can have an opportunity to be commercialised in global markets.
These processes take time and need to be funded so other avenues of research commercialisation also need to be explored.
We are approaching this in two ways – using research-based intellectual property to create nutraceuticals for sale through practitioners and pharmacies, including our recently announced partnerships with Priceline and TerryWhite Chemmart pharmacies, as well as seeking wider application of our nano-particle medicine delivery system, NanoCelle™.
Building success factors into this work also involves adopting a portfolio approach, with several projects progressing at a different pace at the same time.
If we do imagine where we might be in a year’s time, there are several projects at a stage where they could begin to have an impact, on people’s health and wellbeing and commercially.
It is helpful with timelines in chronic disease research that health authorities are prepared to assist with fast-tracking towards drug approvals where there is a demonstrated community need.
This doesn’t mean shortcutting – clinical trials need to be undertaken but provided safety and efficacy can be demonstrated then large number trials may not be necessary.
Community attitudes are shifting on cannabis and this is having an effect on governments in a number of countries looking at how regulation can be adjusted to make cannabis more widely available for medicinal purposes.
There is also increasing research corroboration internationally of our bacteria-based direction with the development of medicines from the microbiome, as was shown recently in Nature Microbiology in relation to depression.
If we were to look through our crystal ball to a year from now it is possible, allowing for all those external factors we can’t control, that we will have a cannabis-based pain management drug close to approval, we will be well progressed with a trial for the treatment of depression, our nutraceuticals will be in over 2000 Australian pharmacies, NanoCelle™ will be ready to apply to more medicines and our obesity/diabetes medicine will be in a Phase 2 trial.
To give some details from this crystal ball gazing, a year from now:
Clinical trials with cancer patients for our cannabis-based pain management medicine, should be completed and drug approval in Australia under consideration, with applications for approval in the US and Europe also underway
A clinical trial for a differently formulated cannabis-based medicine for cancer treatment side effects, will have completed.
A Phase 2a clinical trial for the treatment of depression, using Medlab’s NRGBiotic™ in conjunction with a standard anti-depressant, may be completed, paving the way for a drug application
Medlab’s nutraceutical range will be in over 2500 Priceline/Chemmart, Terry White and independent pharmacies nationally, giving a consequent uplift in sales revenue
NanoCelle™, which has shown that delivery of a nano-particle spray of medicine into the back of the cheek can achieve faster entry into the bloodstream, will be progressed towards wider application, with vitamins, statins, insulin, testosterone and antihistamines, in place of traditionally digested tablets and capsules and potentially reducing side effects
Medlab’s probiotic MultiBiotic™ will under a clinical investigation for oncology treatment related mucositis
This will be quite interesting progress if our crystal ball gazing is accurate and at the same time, aspects of the surrounding context of these developments will remain constant – there are increasing costs world wide in relation to the extent of depression and obesity as well as addiction to opioids.
We can all benefit in any progress towards solving these issues.