Medicines from the printer and by QR code
Kristina Firsova, Invest-Foresight
The market in various industries strives to provide the consumer with personalized solutions (goods and services) in response to the growing demand for them. This also applies to medicine: it also becomes aimed at each individual. In 2020, the global personalized medicine market was estimated at $493.1 billion; according to analysts, it will regularly grow by 6.2% until 2028, in particular due to the pharmaceutical sector. We understand why this happens and how difficult it is to achieve a personal approach.
Why and who needs personalization
There is no branch in medicine where an individual approach would be superfluous. Doctors and scientists have recognized the uniqueness of the human body before, but now they are doing it more and more actively. There is more talk that the same medicine (not even the substance itself, but the drug as a whole) it can cause two people to have completely different reactions: it will help someone, but someone will not get a therapeutic effect and in addition will face side reactions. Or there may be a different rate of action of the same remedy for different people. There are many reasons – age, height, weight, peculiarities of metabolism, genetic code, microflora (microbiome).
Another point arising from the previous one is the incorrect dosage of drugs in standardized pharmacotherapy. If you take any instruction (excluding children's), there will at best be a division into three categories: children under 12 years old, adults and adolescents over 12 years old and the elderly. Even the doctors themselves often prescribe clearly according to the instructions, without taking into account other factors. There may be different consequences here: weak effect of the drug, too strong, slow, fast, a large number of side effects, overdose. The reason is that in the standard instructions, the amount of active substance in the tablet is selected based on the height and weight of the average man. As a result, women, teenagers and people with a lack of weight (a different constitution) receive an excess of medication. And obese patients are a disadvantage.
Adverse reactions are also a big problem of standardized medicine. If conditional vitamin complexes can be relatively safely alternated in search of the optimal set of components and dosages until the patient gets the desired effect, it is often dangerous with medications. Especially when it comes, for example, to hormonal drugs or others aimed at correcting the work of the endocrine system. A pill selected "according to the standard" will help one person, and another will knock down hormones even more, and this will be irreversible. Not because the doctor did not study well at the university, but because a certain drug does not suit a particular organism or is prescribed in the wrong dosage.
"The main task now is specificity and accuracy of delivery. Targeted therapy solves the issue of the action of antibodies that target certain fragments, for example, specific tumors. The leading trend in pharmacology is to reduce the toxic load on the body as a whole and increase efficiency – the so–called "drone delivery to the focus of the disease"," he shares Olga Osokina, founder of the HealthTech company AIBY.
How to make pharma personalized
It is impossible to produce an individual medicine for each patient – there are no resources for this in medicine and it is unlikely that they will ever appear. However, it is possible to predict the body's response to a particular active substance in order to correctly prescribe therapy and dosages. The issue of individual dosages can be solved by the method of creating medicines on a 3D printer. The first such drug appeared in 2015 – it was the epilepsy drug Spritam, developed by Aprecia Pharmaceuticals. And two years later, medical scientists from the University of Copenhagen, together with doctors from the Finnish Abo Academy, developed a way to produce personalized medicines using QR codes. In 2020, the idea of creating medicines on a printer was implemented by a Russian startup PharmPrint.
"Special biochernils containing the necessary dose of the active substance are loaded into the inkjet printer, after which a QR code from these inks is applied to an edible base. It is assumed that the code will be selected individually – based on the amount of medicines a person needs. This will not only minimize the likelihood of unwanted reactions or lack of effect, but also protect the consumer from fakes," explains Valentina Buchneva, head of the Eurasian division of the pharmaceutical company Bosnalek.
Deep biomarker analysis technologies can be used to develop personalized medicines that allow prescribing more effective therapy with a lower risk of adverse reactions. This will require wearable devices that continuously collect data from the patient, and the subsequent processing of the information received. In the meantime, digital technologies for analyzing the genes of microorganisms in the microbiota are becoming widespread. This allows you to see the full picture of the biocenosis of the internal environment of a particular person and choose drugs that will not harm his natural microflora. In addition, there is pharmacogenetic testing – a study based on the analysis of human DNA, which is carried out in Skolkovo. Specialists determine markers of the body's sensitivity to various drugs and form recommendations that will help in the selection of medicines throughout a person's life.
"In the creation of a personal drug, mainly gene technologies will be used: when analyzing a particular patient's DNA, it will be possible to select an individual treatment regimen, a molecule and the necessary dose of a particular drug. In the future, this will give everyone the opportunity to have a genome transcript in their medical records. Personalized treatment in the field of orphan (rare) diseases is most in demand. Serious research is being conducted in this area and is already being applied in practice," he believes Tatiana Khodanovich, CEO of Pharmedu.
Financial issue and other problems
The cost of using gene technologies is gradually decreasing; today it has decreased significantly, if compared with the moment of decoding the first genome. For example, the sequencing process (determining the amino acid or nucleotide sequence of proteins, DNA and RNA) has become 15 times cheaper – only $ 1000, but the figure may decrease by another 10 times. Genetic tests are becoming widespread, their number is growing by the thousands, they are beginning to be used for the treatment of ordinary patients – not only in the course of research. But production is still extremely expensive. In addition, there is the problem of rising prices.
"Data from Pharmaceutical Research and Manufacturers of America (PhRMA) indicate that the production of a new drug costs about $900 million, while 20 years ago this amount did not exceed $ 300 million. The sharp jump in prices is caused not only by inflation, but also by changes in production technologies, certification and demand of the trained consumer," says Olga Osokina, founder of the HealthTech company AIBY.
However, not everything rests on money: science is simply not able to solve some issues yet. For example, the search for a molecule optimized to provide the desired effect on the selected target in the conditions of the human body. Firstly, it takes a lot of time. Secondly, new biotechnologies are needed, so breakthrough molecules are created too rarely. Scientists have studied the structures of peptides and their mechanism of action, but have not yet developed an accurate transport, have not learned how to deliver them to targets without a general negative effect on the body as a whole. Therefore, the drugs come out effective, but unsafe. Delicate work is needed to study what exactly triggers hormone synthesis: how to deliver protein to the damaged area without the synergistic effect of the cloud – without touching the nearest organs and without letting the toxin into the blood.
Nevertheless, medicine is developing at a rapid pace: wearable devices and applications are appearing that allow collecting analytics about the patient and developing more effective drugs. A person comes to the doctor, he sees the whole story, sometimes even in real time, and can prescribe treatment as targeted as possible. The time and costs of preclinical studies are reduced thanks to the same data analytics. But the path to an absolutely personalized pharma is still very long.
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