The ‘translational gap’, moving an innovation in the life sciences from proof of concept to widespread clinical adoption, has been called healthcare’s greatest challenge.
It can take more than a decade and cost up to 2 billion dollars to bring a new therapy to market.
And what’s even more daunting is that the chances that any one innovation will make it into the clinic is 10% or less.
Advancing life science innovations is a costly and slow process. It is no wonder that investors like Warren Buffet has sworn off investing in the life sciences and for good reason.
Should you just accept this as “just the way it is”?
‘Minding the gap’
One of my first trips was to London for one of the early meetings of the Unbiased Biomarkers in the Prediction of Respiratory Disease (U-BIOPRED) project.
London has an iconic public transport system, ‘the tube’. You don’t have to travel far on ‘the tube’ before you will hear “Please mind the gap between the train and the platform”.
As it turns out, “mind the gap” was somewhat symbolic.
At the time, I thought of U-BIOPRED as a research project like any other. But that was naive.
First of all, the simple fact that it was a 39 partner organisation consortium made up of multiple different stakeholders, set it apart from a routine research project.
Getting that many different stakeholders to work together was difficult. So, why do it that way?
The simple answer is because it had to be done.
To be more precise, it had to be done as a large multi-stakeholder project if we were going to achieve the vision of U-BIOPRED.
The goal of U-BIOPRED is to re-classify severe asthma as a group of sub-phenotypes, (different forms of asthma), by integrating data from the clinic, patient reported outcomes, and different ‘omic’ profiles.
The idea the you can target and treat different asthma sub-phenotypes runs contrary to the tenets of clinical practice. When we were developing the project, lots of people told us that our concept of combining all the different types of data into a biomarker, or ‘handprint’ was not feasible.
Now at this point we have done what was said to be ‘impossible’. In fact, similar approaches are now being undertaken in multiple different diseases. However, there remains much more to be done before this becomes part of clinical practice.
What I now appreciate is that projects like U-BIOPRED are really about bringing together a critical mass of disciplines and stakeholders to bridge the ‘translational gap’.
Such projects are and effective way to assemble the 4 elements you need to traverse the translation gap:
- Scientific validation
- Regulatory approval
- Clinician/patient acceptance
- Payer acceptance
[images style="0" image="http%3A%2F%2Fwww.biosciconsulting.com%2Fwp-content%2Fuploads%2F2018%2F05%2FTranslational-gap-1024x306.png" width="1024" align="center" top_margin="0" full_width="Y"]
You can build a road using pick axes and shovels, but it would take a long time. Bulldozers and other machines make building a road much more efficient.
What you need is the equivalent of a bulldozer to help you get your innovations through the translational gap.
The collaborative multi-disciplinary and multi-stakeholder open innovation project as the ‘bulldozer’ for bridging the ‘translational gap’
All the elements of the translational gap can be more efficiently and effectively put in place through collaborative open innovation projects.
The first element, scientific validation, is the most difficult.
While scientific discoveries require creativity and novel approaches, scientific validation is generally more resource intensive.
Working with multiple stakeholders is a way to gather the necessary resources. This also includes broader collaborations such as crowd funding.
Routine regulatory approvals require the assembly of lots of data and working with multiple stakeholders can help.
Initiatives such as the COPD Biomarker Qualification Consortium (CBQC) are good examples of how multi-stakeholder collaborations can accelerate the process.
Furthermore, if you want to change what regulators accept as evidence, then you need alignment across an entire disease community.
Even with the best scientific validation and regulatory approval, if clinicians, patients, and payers do not know about and/or accept an innovation it will have no impact. This is now more than ever before a real risk.
As technology advances, it is relatively easy to develop a radically different approach that will be perceived as alien to clinicians, patients, and payers unless you involve them in the journey.
While engaging with disciplines and multiple stakeholders may seem straightforward, it is not.
The complexity of collaborating your way across the ‘translational gap’
Getting diverse stakeholders to agree and move in the same direction requires effective interaction, and the ability to focus.
The effective project delivers on the aspirations of each stakeholder and the broader project objectives.
Even broader types of collaboration such as crowdfunding require at a minimum that those who are going to fund you understand and making sure that your project is meaningful to them.
But the potential is enormous. While getting multiple disciplines and multiple stakeholders can seem like a weakness for these types of projects, it is also their strength.
Diverse experts and stakeholders working together generates levels of creativity and productivity that are hard to match.
By improving the effectiveness of multi-disciplinary and multi-stakeholder interactions you can deliver on even the most ambitious projects including those that aim to reduce the translational gap
‘Minimizing the gap’ together
Together we can do something about the lengthy and difficult ‘translational gap’.
This is the first of a series of articles about how you can ‘mind the gap’ including interviews with innovators who are working to minimize the translational gap.
For our part, here are BioSci Consulting we are a building a number of project development alliances where multiple disciplines and multiple stakeholders work together to proactively develop projects and then work to get them funded.
If you would like to form or join a project development alliance, or just want to learn more about bridging the translational gap fill in the form below or email me directly: firstname.lastname@example.org