28.11.2019
The Round table “From scientific idea to investment project” has taken place in frames of the Third International Medicine Investment Forum (IMIF). The round table was moderated by the President of the Association of Biomedical Cell Products (BMCP) Manufacturers, Advisory council member of Agency for Strategic Initiatives’ (ASI), Alexey Martynov.
During the event introduction, Alexey Martynov identified the range of problems that arise on the way from the very birth of the scientific idea to its transformation into the ready-to-market new product.
The range of such problems could include current regulatory standards, development of the laboratory technological regulations, scaling of the technologies - from laboratory to manufacturing, - and, probably the most important for the current Russian situation, search for funding for project implementation.
The first speaker was Alexey Lyundup, Head of Resource Sharing Centre “Regenerative medicine” advanced cell technologies department of I.M. Sechenov First Moscow State Medical University. Mr. Lyundup made a report about successful implementation of the biomedical cell product prototype for treatment of the diabetic food disease. He reviewed proven treatment practices of intractable malady – diabetic food disease that very often results in a limb amputation. The implementation of the BMCP - innovative pharma product, - enabled:
Firstly, to heal the ulcers for which there has been no cure with the conventional treatments in use;
Secondly, the swiftness of healing was three times higher than the average;
Thirdly, over the next three – four years there were no setbacks occurred.
General Director of “L-BIO” LLC. (The resident of Skolkovo project), Professor Igor Levshin made a report about the results of successful implementation of the brand new medication (hybrid molecule of thiazolidine and triazole) for treatment of invasive mycoses. This combination has already shown its expanded anti-candida activity, all the pre-clinical trials have been conducted; clinical tests are under the preparation. The product is planned to enter to the market in 2026 – 2027.
Olga Grigorieva, Deputy General Director of OY “Generium”, stated that in 2015 their enterprise created a production site for cellular products that fully complies with international GMP standards. However, in virtue of preparation of the BMCP documentation in this period, they were able to submit a dossier for obtaining a license for this production only in the end of 2018. License acquisition is planned in the beginning of 2020. Only after that, OY “Generium” will be able to perform the pre-clinical trials of its study result – an allogenic biomedical cell product for regeneration of cartilaginous tissue.
Maria Guseinova, Production design engineer of “Tektum” LLC, described the “Development of the polymer compound with microbicidal properties for oxidized titanium implants” project realization. There was developed a polymer coating with gentamycin antibiotic substance. Research and Advanced Development activities are fully implemented; the pre-clinical trials stage is also passed. However, some problems make a negative influence on the successful work. One of the most important problems is transfer of the right for the research results to the investors (especially it concerns the state scientific and research institutions).
Director of Research Institute of Pharmacy and Translational Medicine of I.M. Sechenov First Moscow State Medical University by the Ministry of Health of the Russian Federation, Vadim Tarasov made a report named “Cooperation between science and business”. In his view, the main reason of frequent failures during launch of the new perspective scientific research results into the market is crucial difference between academic specialists – new ideas creators and developers of the laboratory and manufacturing technologies. Each group has its own aims and responsibilities. As a rule, research scientists does not have necessary competence to continue technology development, arrange pre-clinical and clinical trials, and launch the final product to the market. In this situation there should be formed a team consisting of those specialists, who is required on each stage of “product life” – from an idea to issuing of the State Registration Certificate and its commercialization.
Igor Pomytkin, Leading research scientist of Advanced Cell Technologies department of I.M. Sechenov First Moscow State Medical University by the Ministry of Health of the Russian Federation, illustrated successful go-to-market strategy for allogenic biomedical cell product for Crohn’s disease treatment using as an example the biomedical cell medicine - “Alofisel”, - (developed by Spanish research scientists). During the period from the very beginning of project development up to launch of the final product to the market there were spent 17 years and 325 million euro.
Executive Director of Non-commercial Partnership “The Association of biomedical, cell technologies and regenerative medicine experts” Yuri Sukhanow outlined the possible future perspectives of launch of the biomedical cell products to the market. During the report, Mr. Sukhanov elaborated on one of the government financing mechanisms, in which he was directly involved – a complex research-and-technology Program of full innovative cycle “Development of the biomedical cell technologies for regenerative medicine for 2020 – 2025 years”. The Round table attendees accepted such opportunity to receive a financial help from the government with great interest, however the information, received from the speaker, was not reassuring – nobody has announced a tender, the projects have already been selected (the criteria are unclear) and analyzed by the commission consisting from the three experts, according to the speaker. It appears that such high-potential program for biomedical cell technologies development left beyond of the BMCP-developers’ vision. The reasons, resulting in this situation, are not very clear.
Irina Ivanova, Executive partner of GC “LFC”, Member of the Expert council for public private partnership development by the Ministry of Economic Development of the Russian Federation, presented the detailed analysis of sources and tools for the project development financing in the Russian Federation. The key message, based on the rendered report, is 52% of projects financing in Russia accrue to the internal (borrowed) funds of the developers, state participation is limited to 16%. The situation is opposite in the developed countries, - the state is responsible for the main part of cost loading.
Executive Director of Primer Capital, Elizaveta Rozhdestvenskaya gave her view of survivability of scientific ideas in biotechnologies sphere. Same as Vadim Tarasov, she thinks that there is a crucial lack of specialists in biotechnological companies, who have necessary competence to arrange pre-clinical trials, develop pre-clinical trials protocols, and develop necessary technologies. That is the main reason why the huge amount of perspective projects do not reach their tangible embodiment.
Alexey Kulikovskiy, Representative of the Small Business Development in the Research-and-Technology Sphere Assistance Fund, gave an overview of the assistance provided by the Fund to the innovative companies during 25 years of its existence. There are 6900 start-ups supported, it is more than 30 thousand projects. The amount of projects financing varies from 500 thousand to 50 million of Russian rubles in conformity with stages of the supported projects. The Fund’s budget in 2019 – approximately 13 billion of Russian rubles.
Assistant Director for innovational activities of Federal Research Centre “Puschino Scientific Center for Biological Researches of the Russian Academy of Sciences” (FRC “PSCBR RAS”), Amiran Keshelev submitted a detailed analysis of disadvantages of the existent innovations support complex tools. According to his position, the dialog between the fundamental science and business is not possible currently, over the matter of long period of investment return. The research scientists themselves do not have enough knowledge to scale up the laboratory technologies to industrial ones. The existing government support measures are mainly aimed at very large companies, while innovations are usually born in small start-up companies.
At the end of the Round table, the Participants expressed their hope that the problems, identified during the presentations and discussions, could be solved, and, perhaps, with help of the solutions that were proposed by the speakers and active participants. Anyway, the State is and remains to be the main and decisive player here.
The forum was organized in cooperation with the Council of the Federation Committee on Social Policy and I.M. Sechenov First Moscow State Medical University with support of the State Duma of the Federal Assembly of the Russian Federation, the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Economic Development of the Russian Federation, the Ministry of Education of the Russian Federation, the Federal Service for Surveillance in Healthcare, the Chamber of Commerce and Industry of the Russian Federation, the Federal Compulsory Medical Insurance Fund and the Rostec State Corporation.
The purpose of the Forum is to attract attention of the Ministry of Health of the Russian Federation, investment funds and commercial structures to the existing opportunities and perspective projects in medical, pharmaceutical and biotechnologies sphere.Source: GMP News
