How does the work of a research scientist get to the patient in the clinic? It’s a great question!
It’s by a process called technology transfer, by in which, a lab result (“the technology”) needs to be transferred from hands (lab) to hands (company) in a protected format (IP: intellectual property protection). Maybe at this point, this process is obvious to you, or maybe you have several questions like: “Why does it need to be transferred? Why do you call it technology? Why does it need protection? Shouldn’t science be free?
If you have these questions in mind, I will gladly answer them, as I too had them and it’s very important to understand what comes next.
Technology refers to the “practical application of knowledge” (Merriam-Webster dictionary), but more specifically, in the context of this post, it refers to technology (compound, small molecule, process, protocol, model, etc.) that can significantly improve the diagnosis, treatment or prevention of a certain disease and is innovative enough, meaning that the inventive step (the part that is truly new and created by that lab/person in particular), is different and a significant improvement from what is already public knowledge or existing in the market.
When a scientist achieves a lab result that can be considered an innovative technology, for it to be properly developed, tested for safety and effectiveness (clinical trials), approved by regulatory bodies (FDA, EMA) and reach market access (governments and insurance companies agree to cover it/ doctors agree to prescribe it), it needs to be transferred from the laboratory where it was developed to a company that has the resources and know-how to do it properly. This is why we call it, technology transfer, because the technology will be transferred from department to department, then to a different institute or company and then to the market.
If the technology is not innovative enough, scientists will publish the result and it will still contribute to overall knowledge and improvement, it just won’t need to go under this process because if it isn’t innovative enough, it means that it isn’t good enough to reach the patient. The process of technology transfer is extremely expensive, so much so, that it’s unthinkable for a non-profit or a government to cover all the expenses related to it. This is why for-profit companies take the responsibility and both the loss and profit that comes with technology transfer. This is also why, if the technology isn’t protected properly and/or a patent is not possible (p.e. because it isn’t innovative), companies aren’t able to profit from its development and therefore aren’t able to endure the costs of the tech transfer process. Behind the profit of one successful technology in the market, there are probably 10 others that failed and caused big losses.
Angry or frustrated that we are talking about profit?
Let’s see it from the opposite perspective: From the patient to the lab
For every patient that gets treated, part if not most of the costs are covered by either the government or insurance companies. At this level, there are a few key concerns: clinical outcome (effectiveness and safety), quality of life improvement (reduction in side effects, time of treatment or need for palliative treatments) and cost itself. These concerns are shared by the above stakeholders (patients/doctors/hospitals, governments and insurance companies).
Any new treatment, diagnostic tool, medical device and so on, needs to bring a considerable improvement in clinical outcome or quality of life that compensates the cost in comparison to what exists (standard care). This makes natural sense since no one would invest more time and money into a solution that only improves something by a very small margin that maybe it won’t even be used. How confident would the doctors be prescribing a new drug that only slightly improves in comparison to the standard? How confident would be the patients in taking it?
Based on this, is set that innovation is not only important for the companies bottom-line but mostly for the patients too.
Technology transfer is a vital part of improving people’s life with innovative scientific work and is sadly misunderstood by many. I hope this post has helped you understand the process of how our work in the lab gets to the patients.