The medical industry is begging to be disrupted
Since the Covid-19 outbreak, one has been wondering, how can science and technology solve this? We have all the scientific advances we have today, and it is estimated for vaccines to take more than a year to be available in the market.
Wired magazine published an article about the potential Covid-19 vaccines and where the bottlenecks are in their development process. As for the actual creation of the vaccines, it seems that the genetic sequencing has speeded up this part of the process already.
The reason it usually takes so long comes down to a combination of factors. The first is getting a candidate vaccine that’s ready to test. This part of the vaccine development process, known as discovery, used to take years of careful benchtop biology. Scientists had to isolate and grow viruses in the lab. But now, with genetic sequencing, new protein-visualizing microscopes, and other technology advances, it’s possible to skip that step. Arriving at a vaccine candidate can sometimes be done in weeks.
It’s not the development, it’s the testing
What is actually slowing the final product down is the testing part and the regulations that dictates it.
All those advances, though, can’t speed up the time it takes to meticulously monitor how well these candidate vaccines work in people. Clinical trials, a prerequisite for bringing a vaccine to market, are the real bottleneck. Each happens in three stages. Phase 1 involves just a few dozen healthy volunteers, and is meant to evaluate whether the vaccine is safe. That takes about three months. If the healthy volunteers don’t suffer any adverse effects, it’s on to Phase 2. This time, several hundred people will get the shot, ideally in an area experiencing a Covid-19 outbreak, so scientists can gather data on how well it spurs the production of antibodies and fends off the disease for these trial subjects. That’s another six to eight months. If everything still looks good, Phase 3 is to recruit a few thousand people in an outbreak zone and repeat the experiment. That’s another six to eight months — if you don’t have any problems recruiting patients or with your vaccine supply. Then a regulatory agency, like the US Food and Drug Administration, has to review all the data before making a decision about whether to approve the vaccine. That can take months to a year.
As a non-expert, I cannot stop myself from liking what Trump said during the meeting held in the White House to discuss his Administration’s response to covid-19. When he was told that a vaccine will a year to a year and a half to develop, no matter how fast we go, he replied:
I like the sound of a couple months better, if I must be honest.
Of course the experts know better than Trump, and we should trust them. But, the hackers should look for where the bottlenecks are and try to tackle them. If I am to start a bio-med company, I wouldn’t focus on new technologies for creating vaccines, but would try to find ways to speed up the testing process. Can any of these tests be simulated rather than being run on humans? It sounds unlikely given the complexity of the human body, but who am I to say that no one can come up with a solution along these lines still? Can humans be replaced by something else for testing? Can vaccines be developed in a way, that we need to test them once, and when they get updated with a new virus only the updates need to be tested? Okay, I am starting to sound stupid now, so I will stop with my non-expert obviosly-delusional ideas.
High risk, high reward, low competition
I am currently thinking a lot about risk and competition. I’d argue that high risk businesses result in high barrier to entry, hence low competition and low innovation. Honestly, I need to find literature to validate this point of view. But for now, this sound obvious to me. And thus, I feel what is holding the innovation in medicine back in the high risk imposed by the slow testing process. If you have to test a medicine for a year before getting it approved, this means you are also uncertain whether there will still be a need for that medicine in a year or not. As a result, the companies working on vaccinations are limited.
In the end, all what I want to say, that there is big problem with the current testing procedures, and someone with more practical ideas should disrupt this part of the process. And for the regulatory bodies, they need to help the ones disrupting this part of the process by providing updated frameworks for them to work within.