Professor Plettenburg visited MUW for the second time, again at the invitation of the Doctoral School MUW and dr. hab. Macieja Dawidowskiego from Chair of Drug Technology and Pharmaceutical Biotechnology. He gave a lecture on April 11.
- I would like to thank the students who chose a chemistry lecture instead of the sunny weather outside - he joked at the outset.
Time and money
- How much money do you think needs to be put into a drug candidate to possibly enter the market? - asked the speaker - You need to invest between 1.3 and 1.5 billion euros. And, of course, failure must be expected. The money is mainly consumed in the clinical trial phase (in Phase 1, as well as in Phase 2 and Phase 3). The chance of success is about 8%, which seems particularly slim considering that research on a new drug takes about 10 to 15 years.
Less than 20 years ago, it was assumed that, thanks to, among other things, the development of and access to the latest technologies, the discovery of new drugs would be something commonplace. This has not been the case. And despite the ever-increasing resources invested in research, there are - only - about 40 such discoveries per year.
Why can it fail?
Among other things, the speaker discussed in detail the possible reasons for failures in new drug trials, noting that a significant part lies in the lack of ineffectiveness, which turns out to be the case in both phase 2 and phase 3 clinical trials.
- If we talk about failure in terms of efficacy, we are talking about poor translatability, which could mean that we underestimated the differences between mice and humans, didn't understand the biology of the disease well enough, or underestimated the heterogeneity of the patients - explained Prof. Oliver Plettenburg.
Designing for discovery
In further parts of the lecture, the speaker talked about key challenges in pharmaceutical research, and mentioned some examples of academic contributions to drug discovery laboratories of publicly funded organizations. He talked in detail about how to find a good starting point, how to define the research question, define the objective, the target group, what the phases of a clinical trial should look like.
- Wanting to launch a new drug, in a situation where there are already a dozen substances with this effect, you have to prove its additional benefits, such as fewer side effects, smaller doses, better combination with other drugs, better therapeutic effect - Professor Plettenburg stressed - It is no longer enough to simply have another drug, it has to be better in some aspects.
Industry and academia - working on a new drug
Finally, Professor Plettenburg spoke about the differences in the process of drug discovery and implementation by academia and industry. On the one hand, we have a streamlined research infrastructure with a high degree of automation, established quality standards and a substantial budget, but also limited options for out-of-the-box approaches. On the other: curiosity and pure scientific interest with a high degree of innovation, but also a lack of knowledge about the key parameters for optimization.
He quoted Bob Lazarus of Genentech, who said, "It is easy to create an inhibitor, but difficult to create a drug."
- But it is possible - stressed Prof. Oliver Plettenburg.
To achieve this, a complementary team is absolutely required, consisting of specialists in many fields, guided by curiosity and medical needs rather than budget, as well as a trust-based work environment where people share information, as well as perseverance.
- I feel that there has never been a better time to prove new concepts - the speaker concluded - And you as new scientists will be able to implement them to improve the lives of patients.