The pharmaceutical landscape has changed dramatically over the past century. From the first vaccines and penicillin to immune and gene therapy; from ‘the first patient who…’ via routine therapies to personalized medicine. What’s next, and which developments are most promising?
‘Where pharma will be going? That is impossible to predict’, says pharmaceutical scientist Henk-Jan Out. ‘We’ve seen discoveries that have turned the entire field upside down, and this could happen again anytime.’ For almost 20 years, Out worked in Oss for Organon, Schering-Plough and Merck, including as clinical research director. He also chaired the Dutch Association for Pharmaceutical Medicine (NVFG) and was professor at the Radboud University in Nijmegen. In 2016, he published a book on the merits of the pharmaceutical industry.
‘That being said, of course there are recent developments that intrigue me’, says Out. ‘For example, I am very impressed by the success of mRNA vaccines. This concept has gained momentum during the covid pandemic. We now have a completely new view of how vaccines work, and of how we can use our own bodies to produce certain proteins. Very interesting and promising.’
‘I am especially impressed by the mRNA vaccines’
Huge potential, limited possibilities
In addition, Out sees great potential in CRISPR-Cas as a sophisticated ‘cut and paste’ technology for tinkering with DNA. ‘This is a truly innovative technology that offers all kinds of new possibilities’, he says. ‘This approach could become decisive for the success of other major developments, such as gene therapy and cancer treatments.’ So far, CRISPR has only proven itself in laboratories, as Out notes, and it remains to be seen whether the approach will be able to make a difference in the clinic. ‘But in any case the potential is enormous. Even if it’s just in scientific research.’
The path has been cleared for advanced, personalized treatments, with almost unlimited technical possibilities, says Out. But there are some caveats. ‘Feasibility is becoming increasingly relevant’, he says. ‘The affordability of healthcare is under pressure. And due to increasingly complex regulations, stricter safety requirements and the growing role of insurance companies, it is becoming more and more difficult for companies to bring a new drug to the market. It is becoming increasingly risky – about 90 to 95% of the candidate drugs never reach the market – which means that it is less and less attractive to invest money in drug development. There are analysts who say: in ten years’ time, this model of drug development may be outdated.’
‘Feasibility is becoming increasingly relevant’
Out doesn’t have a quick solution at hand. ‘All other approaches have their challenges’, he says, ‘for example, the concept that society as a whole should bear more financial risks. Or that we collectively decide that we no longer invest in therapies that only offer marginal improvement for patients. But the latter is often difficult to assess beforehand, because you never know how clinical trials will turn out. These are all things that you have to consider when you talk about ‘the medicine of the future’.’
In any case, innovation should always be rewarded, concludes Out – and there should always be sufficient transparency regarding eventual drug prices and insurance policies. ‘This always pays off in the end.’