The development of biological products is a risky business
"With a targeted approach, there is always a big risk of missing"
Galina Papernaya, "Moscow News", 26.04.2012
Vitaly Prutsky, head of Information Support for R&D at AstraZeneca in Russia and Eastern Europe, notes that the risk of being defeated when creating a biotechnological drug is still very high.
– When they talk about the medicine of the future, modernization, high-tech areas of business, they always remember biotechnologies. It is clear to everyone that biotechnology is something that requires large financial investments. But how this industry works, what it produces, what exactly its development promises to Russian patients, all this remains unclear.
– We often mean completely different things by biotechnologies. The production of ethyl alcohol from sawdust is also a biotechnology. Or the classic preventive vaccines that were invented at the end of the XIX century. The volume of production of such products, which no one will call innovative now, exceeds the volume of truly modern biotechnological products by several orders of magnitude. And such products are fundamentally different, for example, from the smallpox vaccine, primarily because they are right now at the junction of scientific discovery and technology, pure science and business.
In fact, these are mass technologies of the future that are emerging today. Until recently, we read about the invention of a vaccine against the human papillomavirus, and today it is already a widely used thing in medical practice. But about the viral nature of type I diabetes, the first scientific papers have just been published. But time will pass, I am sure, and a publicly available drug will appear that takes into account this discovery.
– Biotechnological drugs are often called targeted, using this term in discussions about the "personalized medicine" of the future. Tell me, what does this mean?
– As you know, in the event of, for example, cancer in cells, the natural mechanism of self–destruction - apoptosis - is disrupted. Such a failure occurs according to certain scenarios, many stages of which have already been studied to date. Targeted (from target – the target, the target), that is, the targeted drug is always "sharpened" for a certain failure of this program and affects it. The strength of this approach is that the drug acts mainly on the affected area, and not on the whole body. Most often, such a drug is an antibody that gets on the surface of a cancer cell, binds to it and returns it the ability to die.
– So targeted and biotechnological drugs are the same thing?
– We can say that all the most modern biotechnological drugs (monoclonal antibodies) are targeted by definition. But it does not follow from this that all targeted drugs are necessarily a product of biotechnology. There are a significant number of targeted drugs obtained by chemical synthesis.
– And from the patient's point of view, what is the main difference between chemical and biotechnological drugs?
– Biological drugs have a great advantage – significantly fewer side effects. This is due to the fact that the antibody binds to the molecular target with a high degree of selectivity. You need to understand that any tumor is a mixture of cancer cells of different types. By making the drug target only one or two groups of cells that are dangerous to the body, we do not affect all the others, no less dangerous.
With such a subtlety of the targeted mechanism of action, the success of therapy greatly depends on the accuracy of diagnosis. Even before starting treatment, we need to know exactly which cocktail of narrow-profile drugs we should treat a particular patient with. Any biotechnological drug is ideal only for a small group of patients with a certain diagnosis, and it does not have a pronounced effect on the health of other patients with the same diagnosis. Therefore, targeted therapy is usually combined with general chemotherapy.
– Why are there still very few biotechnological drugs on the market today?
– With a targeted approach, there is always a great risk of missing. It is only necessary to determine the target insufficiently precisely, for example, a certain type of cancer cell. The risk of being defeated when creating a biotechnological drug is always very high, and "big pharma" only five or seven years ago began to take this topic seriously.
The most promising projects in the field of personalized medicine are still at the stage of preclinical trials or early stages of the clinic. For example, one of the most widely discussed now is cancer therapy, combining nuclear technologies with biotechnologies. An antibody specific to a receptor located on the surface of a tumor cell is supplied with an isotope that emits alpha particles. Such particles exist in the body for no more than ten hours, act at a very close distance, are easily excreted and do not lead to the accumulation of radiation. They bring a radiation source directly to the surface of the affected cell. The idea is not new, but it is practically unrealizable before the advent of modern medical biotechnologies.
Clinical trials of a drug that should work on this principle, as I know, will soon begin on the basis of a new scientific center in Russia. But it is impossible to say now how specific the antibodies will actually be for the cancer cell receptors. There is a danger that cells with isotopes will go not only to their destination and will not be able to assemble in the right place at the same time.
Portal "Eternal youth" http://vechnayamolodost.ru28.04.2012