Farmvector of the future: clinical research

In a short time (2004-2010) he built a successful career: from a clinical research monitor to the head of the clinical department of a large contract research organization. For two years he was responsible for the quality control of clinical trials at Pfizer. In 2010, he founded his own contract research organization X7research and the NGO Public Health Research Institute.

Sergey, why has the issue of clinical trials become one of the most important aspects of the topic of drug provision?

This is an extremely complex area both from the position of regulation and from the point of view of execution. Clinical research cannot be globally automated, like processes in production. The regulatory environment is constantly changing: what the whole world has been building for a hundred years, our pharmaceutical industry has gone through 10 years as a result of the Pharma 2020 strategy. This requires continuous improvement of competencies and requirements, and so three problems of clinical research appeared: finance, time and staff .

Highly qualified staff is needed. In Russia, a large number of universities offer areas of study in the field of clinical research. However, educational programs do not include all the areas necessary for conducting research. We do not have full-fledged programs for research doctors, for data processing and pharmacovigilance, there are only separate modules.

If you turn to highly qualified specialists, you need to remember that payment in this area is not comparable in Russia and the world. International companies for research similar to ours pay 3-5 times more. Highly qualified specialists involved in the organization of clinical trials are among the highest paid professions in the world.

The primary role is played by accredited medical organizations. It must be remembered that it is the clinical center and the specific specialists working in it that are the direct executors of the clinical trial, and it is from them that the data we collect. The role of researchers has especially increased with the introduction of the principles of RBM (Risk-based monitoring). The cost of organizing the work of the research center in local research and in international research is practically the same, but the budgets of international companies are no less than two times higher than our budgets. At the same time, in order to ensure the proper level of quality and validity of the study, it is required that the budget allocated to the research should allow a sufficient number of experienced and qualified specialists to be involved in the study, and not just include employees on a residual basis.

The time factor also affects CI. It is important that the right thing appears at the right time in the right place – procrastination can disrupt the whole process. Marketing strategies often lay a certain time for a drug to enter the market for its successful sale, however, planning does not always correctly take into account the risks involved in research.

And how do these problems affect patients?
& nbsp; This is the fourth issue – informational, which is not much talked about. Amid the rapid development of the pharmaceutical industry, informational support was lost. & Nbsp; There was a stereotype that domestic drugs are not high enough and inferior to foreign ones, and this position is often formed by the media. At the same time, doctors sometimes prescribe foreign drugs with unproven properties, and at the same time do not use actually existing drugs of our manufacturers. Therefore, it is important to work with doctors, and through them to change public opinion.

There are groups of drugs for patients with severe illnesses, including HIV and oncology, and such patients are waiting for a chance for treatment. So another problem appeared – sometimes there is a drug, but it is impossible to purchase. In some countries, patents are circumvented for social reasons to help people, but this is a complex issue that concerns both ethics and regulatory issues. We must talk about it, discuss and find solutions.

There is also a positive trend regarding the quality of the clinical trial process. A mistake in the design of the study threatens to fail at the final stage. We are constantly confronted with this and see how the attention of regulatory authorities to the production and related processes of pharmaceutical business is growing. This is beneficial to the industry. For patients, this is reflected in the form of a decrease in the amount of poor-quality products on the shelves of pharmacies.

Tell us what goals are currently facing regulators and the clinical research business.

The goal for regulators and pharmaceutical business is the same – the health of the nation. In the process of organizing the rules of the EAEU industry in the Russian Federation, a number of blind spots were revealed. Correcting the situation will improve the quality of products brought to market. My colleagues and I note the high professionalism of the regulatory authorities and adequate approaches to solving global problems. For business, these changes also benefit: Russian companies are starting to meet international standards, they have the opportunity to go beyond the borders of the Russian Federation. Over the past year, the number of requests for analysis of drugs has increased to enter the markets of Europe and the United States. If 2 years ago these were one-time projects, now these are regular requests with interesting drugs.

Harmonization of regulatory rules is important for Russia. In the EAEU, the rules are well harmonized with international regulations, primarily European ones. By accepting these rules and building a business according to them, we gain access to the whole world.

And how successfully are the market participants implementing the tasks?

The approach to clinical research has improved markedly, and at all stages: from planning and preparing documentation to the final report. Companies that do not meet the level leave the market. Pharmacovigilance requirements increase after the drug enters the market, and this forces companies to be in good shape. & Nbsp; An international trend has appeared in our market: we do not just release the drug, but are responsible for what happens.

The success of the results is obvious, look at the implementation of the Pharma 2020 strategy. By the number of registered generics, Russia in 2018 is the first in the world. The government has done serious work involving a large number of regional clusters, which have ultimately demonstrated good productivity. I emphasize separately the positive development of the cluster path, which was shown, among other things, by the Kaluga cluster, the St. Petersburg cluster, and also PharmMedPolis in the Republic of Tatarstan.

Are there any difficulties between regulators and business in solving the general task of optimizing clinical trials in Russia? What trade-offs are suggested?

The development and registration of drugs lasts a long time: for generics – from 2 years, and for a new development – even up to 7-10 years. At the beginning of the project, some rules may exist, but after 5-7 years completely different ones. As a result, companies do not receive a registration certificate. This problem is solved in other countries: a full-fledged dialogue is organized between business and regulatory bodies at all stages with the possibility of correcting errors not in the end, but in the process.

Now there are compromise solutions, for example, the rules of the EAEU, which have already entered into force. Thanks to them, many gray areas were removed. These rules allow, until 2025, to decide whether the drug will be re-registered, and to choose in accordance with which legislation it will be used further. This is a step forward from the position of regulatory in Russia.

What problems are currently in limbo? When do you think they will be resolved?

There are several problems: childhood forms, orphan diseases, the organization of pharmacovigilance, the quality implementation of telemedicine, personalized medicine, the issues of gene therapy, the emergence of new original drugs, export and digitalization. I will dwell on some of them in more detail.
Baby forms . In Russia, in this area they are far behind, and this especially concerns me as a father. There are no children’s dosages, and in the 21st century it is necessary to deal with the division of tablets. The kinetics of drugs is completely non-linear, so this problem is very acute.

Orphan drugs . The life of people who are faced with a lack of drugs depends on them. This problem needs to be solved systematically, and business and regulatory issues should come first, because such drugs should appear as quickly as possible. Often the number of such patients is not more than a hundred, and it is difficult to conduct a full-fledged study.

The development of new drugs requires large investments with high risks. Of the thousands of molecules, only one comes to registration. In Russia, an imperfect financing system is in place, according to which one hundred percent return is needed, and we have to think about changing attitudes toward investing in original drugs. If you want to have big profits, you need to invest in a large number of developments.

Digitalization is happening gradually, this is a trend. We will be faced with new regulations, they will be associated with processing, data quality, embedded algorithms for working with data, transparency and the ability to interpret correctly.

In Pharma-2030, these issues are taken into account; there are KPIs on them. Looking at the effectiveness of Pharma 2020, there is confidence that they will be allowed. But any problem transforms over time, posing ever new challenges, perhaps even more complex. This is our life, and we must exchange views in order to keep track of the changes that are taking place.

& nbsp;
In your opinion, what will the field of clinical research look like in 5 years? 10 years old?

Artificial intelligence and Big Data will greatly contribute to the development of the industry. Medicines are already inventing and testing on virtual computer models with high-precision results. In 10 years, this will become the R & amp; D activity of all pharmaceutical companies. Clinical trials will use data collection tools directly from patients, such as diaries, fitness bracelets, and other wearable gadgets.

The main trends of the next 5 years will be models already adopted by the FDA, with which you can test and understand how substances interact in the human body. Created computer programs simulating the structure of the protein. Another area is Big Data, which will allow you to analyze information on the Internet, on forums, collect data on the effectiveness and safety of drugs, and may even find new solutions.

In the future 10 years, I think there will be an information breakthrough, an information singularity. Many programs will be with artificial intelligence, and our electronic assistants will be able to offer increasingly effective solutions. Prophylaxis will become more powerful, advanced dispensary observation, and genetic engineering will occupy an important place. Life experience shows that it is more effective to find a disease at an early stage and prevent it than to try to cure it in the later stages. In this way, serious problems can be avoided in simple ways.

The future of clinical research lies in personalization and individual approach to the patient. Already, many Sponsors welcome the reduction in the number of patient visits to the clinic: visits that do not require the participation of the attending physician can be carried out at home with the patient. A wide range of procedures can be carried out at home: instrumental diagnostics, taking blood, administering drugs, monitoring the completion of questionnaires and diaries, and assessing the patient’s condition. Thus, home visits provide an opportunity to save time that is required for the trip and for the patient to stay in the clinic, which is a great advantage when participating in clinical trials. Registration of sick leave and additional work passes are not required. Patients can be more at home with loved ones, rather than spend valuable time on the road and stay in the clinic. A significant advantage of home visits is an increase in the recruitment of patients with rare diseases, patients living in remote places and corners of our country, and patients experiencing difficulties in traveling long distances.

Uber and YandexTaxi aggregators quietly appeared and entered our lives. Yesterday we called and agreed on trips, and now we have a simple application. The system has become more convenient and efficient. The same will be in the pharmaceutical industry. I am pleased to see the future become the present in front of our eyes.

What principles of clinical trials could we adopt from our foreign colleagues? And what are the advantages in this area specifically in Russia?

We could adopt the financing structure for the development of new drugs. A scheme in which investors invest in one or more drugs is ineffective. The money invested in the development, even if unsuccessful, remains inside the country in the form of scientists, their work and acquired experience. The country will not lose anything, it will invest in its own development, and this is actively practiced in the world.

The advantage of Russia is the speed, efficiency and effective collaboration between business and government, which led to noticeable results. I hope that we will become an example for countries that will go the same way. We have learned not only how to make pills, but also how to make substances. We are already moving towards the moment when within one country there will be a complete supply of both substances and finished dosage forms.

Tell us what solutions X7 offers r esearch? What goals have already been achieved?
We have become a center of competent solutions for pharmaceutical companies. X7research offers comprehensive solutions, from the concept of introducing a generic or new drug to the market, to obtaining a registration certificate and tracking the entire life cycle. All companies are slightly different, and help is often needed in different aspects, so we offer solutions in different combinations. We conducted a huge amount of research on generics and innovative drugs, and this is valuable for our company’s experience for the entire pharmaceutical industry.

Last year, we opened a medical center that offers research at all stages. We have our own pharmacovigilance system for companies – this has become a global trend. We also became a platform for 7 universities for the training of professional personnel. We were one of the first companies to offer an online clinical research course, over 5,000 people have completed it in 5 years. This led to our cooperation with the First Moscow State Medical University. Sechenov, where we also developed educational programs. Now there is both an advanced course of good clinical practice and a school of medical writers, and we are happy to conduct them and offer them to form personnel.

& nbsp;

We participated in writing the Pharma-2030 clinical research strategy. X7research also supports the digitalization trend of our industry, and we are involved in the development of electronic systems using artificial intelligence.

HELP

& nbsp; Clinical trials (CIs) are an important step in developing a market launch for a drug. They are necessary to prove the safety and effectiveness of the new drug. The result of CI depends on whether the drug will be sold on the market, whether it will satisfy society and, in particular, regulators. Improving the quality requirements of world-class research is a need for both patients who need high-quality drugs and the pharmaceutical companies themselves who are fighting for market share in the Russian Federation, the EAEU and the world.