The entire civilized world believes that biomedical researches shall be the priority of state policy in scientific research. Research in this area is the key to sustainable development and often considered to be the national security component. Both private pharmaceutical companies and the government encourage R&D in this field in every possible way. This is being done almost everywhere, but not in Ukraine. National biomedical researches and innovations are currently somewhere lower than dirt, and it is unclear how to get them out from there.
Biomedical researches of a healthy person
Biomedical researches are the clear example of how science, business and governmental institutions shall cooperate to reach a common goal – market launch of innovative medical products and pharmaceuticals.
Let’s first look what shall be done through to commercialize a new medicinal product. As a general rule, doctors, public health authorities or private pharmaceutical companies are the first one to initiate this process. Basic science shall work at the first stage, whoever the customer might be.
Molecular target on which new pharmaceutical shall have effect will be defined. On frequent occasions, it is some protein or gene responsible for its synthesis, activity of which shall be blocked or, vice versa, it shall be boosted to recover from disease. But to find this target we shall be aware of what is going on in healthy cells and in case of disease. Researchers in the areas of molecular biology, genetics, bioinformatics, and biochemistry deal with this task. They use tons of test tubes and chemical reagents, consume megawatts of electricity on supercomputers, grow cells and torture test mice in a creative way. As a result information about the molecular target of the prospective drug is obtained.
At the second stage applied science is getting down to work. We already know where the target is, but we shall hit it somehow. Here is where we start looking for an active substance. Synthetic chemists, pharmacologists, and IT guys are dealing with this issue. Present-day pharmacology is nearly always using computer-aided drug design – simulations of target molecule’s interactions with millions of known chemical compounds. These candidate compounds are transferred to synthetic chemists and pharmacologists to conduct the first “full-scale trials” on cell cultures and ill-fated laboratory mice. In case of success medical professionals start working and clinical trials stage begins.
Clinical trials is a very sophisticated industry, which is positioned at an intersection between the applied science and practical medicine. Every in-depth clinical trial needs participation of medical researchers, medical clinicians, specially trained managers, experts in medical statistics and medical ethics, lawyers and even psychologists. All the trials are subject to tight regulation by the state authorities. You shall interact with them. Whereas, they shall act in a professional and adequate manner. As a general rule, such trials last several years, while chances of success are rather small.
After all, if clinical trials are successful, then it gives rise to the stage of commercialization and production setting. This is where science ends and we move towards strict market-based mechanisms and business processes.
There are no severe rules here – various such research stages may be funded both from one and various sources. Broadly speaking, complete production cycle of a new pharmaceutical lasts not less than five years. In other words, it is not a matter of short payback time.
Risks are also extremely high – less than 1% of promising pharmaceuticals reach the drugstores. All the process looks like an assembly line – dozens of promising candidate substances are constantly emerging at various stages. On numerous occasions the intermediate stages are outsourced to specialized companies and laboratories working on a continuous basis for different customers. All this chain shall work cohesively. If any link in the chain is loosed, then the entire “conveyor” stops.
What you see is what you get
What links of this chain may be found in Ukraine and what is their current state?
We should start by stating that we have not a single sane customer of new biomedical developments. Public hospitals are not interested – they are barely keeping up with routine work, reporting, and reforms. Private hospitals purchase off-the-shelf technologies from abroad. The state does not place orders for new developments too, since it is cheaper to purchase ready-made ones (and to “siphon off” some of the money). Supposedly, there are few major pharmaceutical enterprises, but they are satisfied by manufacturing of well-known pharmaceuticals, and do not even think about some serious innovations or, heaven forbid, investment in researches and trials.
Basic biological science still exists in Ukraine. Sometimes, it even reaches good world-class level, but none of the research institutions has complete set of technologies, equipment, and experts to conduct the full cycle of up-to-date biomedical research. Currently, public core funding allocated for experimental biology, cannot even feed laboratory mice and scientists themselves. National competitive funding may only cover expenditures for paper and ink cartridges to draft reports. As a result everyone who still manages to work somehow, is entirely dependent on international grants which require full-time work. It is physically impossible to find surplus funds and an extra pair of hands.
It is often mentioned that Ukraine already has quite a few well-equipped private diagnostic laboratories – so why don’t they sit on this vacant chair? The problem is that diagnostic and research laboratories are two pretty different things. Advanced research laboratory requires tens of millions of dollars worth equipment and operating funds about one million of dollars per year. Without any profit – mere expenditures. There are no private laboratories of this kind in Ukraine.
Ukraine has no state segment of applied biomedical science. What we have is vacuum between basic academic institutions and medical practitioners. Public and private hospitals and the institutes of the National Academy of Sciences of Ukraine may conduct clinical trials of prospected drugs, but there is no one to find and to synthesize these drugs. There are several commercial firms specializing in chemical synthesis and computer-aided screening for pharmacology, but almost all of them work for outsourcing only. It may sound banal, but potential domestic customers do not even have money to pay for such services. These firms are the dramatic example of how this field may be expanded quickly provided good investments.
The rescue of a drowning man is the drowning man’s own job
The stage of clinical trials in Ukraine exists in one way or another. Many institutes of the National Academy of Medical Sciences of Ukraine, establishments of the Ministry of Healthcare of Ukraine, and private hospitals conduct clinical trials of technologies and pharmaceuticals of world’s leading manufacturers. The problem is that our scientists work at “low-level”. They do not develop research protocols by themselves, but simply transfer raw data to “higher-ups”. Participation in such researches and trials is an excellent additional financial support for a number of people.
Full-blown clinical trials are performed rarely in Ukraine, and their quality is far from perfect. At the same time, institutions of the Ministry of Healthcare of Ukraine and of the National Academy of Medical Sciences of Ukraine are constantly reporting about successful developments and innovations. The quality of these developments is clear from the fact that most of them fail to be disclosed in more or less decent international scientific journals – almost all such works are published in local low-quality journals. They are often just a profanity for the reporting purposes.
Even the commercialization does not go smoothly. One would think – what is the problem of-taking-off-the-shelf technology and implementing it? But this is a challenging task since you will definitely bump up against bureaucracy, general inertia of medical industry, and unclear market openings for “domestic” products. Each new medicine should be licensed, and this incredibly long and boring procedure is scaring off potential investors. It is much easier and cheaper to import an analogue licensed in the EU than to license your own medicine. It is also a daunting challenge to put new drug into use – hospitals do not really want any changes and are skeptical about domestic products.
The prospects remain low and it is hard to understand what shall be done with all this. Problems are deep rooted along all levels, and I doubt if Ukraine will ever launch fully-featured national “big pharma conveyor”. However some parts of this conveyor could be established.
When it comes to basic biomedical researches, the highest hopes are placed on the change of the state funding mechanism of science and on the new National Research Foundation. If direct competition of projects is implemented without “priority areas” and non-transparent quota allocation for scientific directions, then successful biomedical laboratories will stand a greater chance of increasing their funding.
An intermediate level that is mostly based on IT is doing quite well even now. Bioinformatics, genomics, computer-aided drug design and screening, neurosciences, etc. are not fundamentally different from other IT fields . Personnel problem is the key challenge here. Our universities do not train relevant experts while ordinary software developers will not help since people with good academic background in biology, mathematics, physics, and chemistry are required. We simply have no such all-in-one professionals. Moreover, horrific state of basic sciences in universities is only exacerbating the problem. If the business will participate in training professionals in this field, then it may succeed.
The situation with clinical trials and medical science is pretty simple. Our medical scientists have to learn how to conduct clinical full-blown trials at the world-class level. This can only be achieved if we get rid of simulation of “kind of scientific” reporting and start promoting publications in decent international journals for those, who can really work at the high level. Nobody but the government is in position to trigger this process.
Finally, it should be acknowledged that there remains significant scope for small startups in addition to “big pharma”. Sure thing, these will mainly be some electronic devices and online services for health monitoring, information support to hospitals, flow of medical records, laboratory diagnostics, applied genomics and bioinformatics, diagnostic and laboratory equipment, etc. But the more of them we have, the greater is the confidence in national medical development as a whole.