03 December 2008

Preclinical studies of nanopreparations

On November 26, the round table organized by RUSNANO, "Qualitative preclinical research in Russia" brought together for the first time representatives of all parties interested in research on the safety and effectiveness of medicines. These are those who create medicines, develop regulatory standards for checking their safety and effectiveness, carry out this check, as well as representatives of the pharmaceutical business and the investment community, and, finally, those who prescribe medicines to patients ― doctors. In total, more than 60 people participated in the round table.

Preclinical studies are the first barrier on the way of potentially dangerous drugs to the patient, and RUSNANO Corporation is extremely interested in the reliability of such checks. Medical projects today account for 15% of all funding applications submitted to the Corporation.

"The infrastructure base, in particular, preclinical testing centers, is a necessary component of the implementation of medical projects," Deputy Director General of RUSNANO Andrey Malyshev said in a welcoming address to the participants of the round table.

The round table included discussions on the real state of preclinical research centers and the improvement of the regulatory framework for preclinical research in Russia, as well as on the issues of biosafety of nanodrugs that stand around the world.

The project "Strategies for the development of the pharmaceutical industry of the Russian Federation for the period up to 2020" provides for an increase in the share of domestically produced medicines in the Russian market from 20% to 50%. This large-scale task puts forward new requirements for the preclinical research industry. Dmitry Kolobov, Head of the Pharmaceutical Industry Department of the Department of Chemical and Technological Complex and Bioengineering Technologies of the Ministry of Industry and Trade of Russia, outlined the goals that the Strategy sets for the domestic pharmaceutical industry. "Currently," Kolobov stressed, "the share of imported medicines exceeds 80%. The Russian economy is forced to lose more than $11 billion, which is an unacceptable luxury in a difficult global financial situation. Moreover, about 50% of these funds go to pay for imported generics and brand generics - those drugs that our pharmaceutical manufacturers can and should make."  

Baron Lobstein, a specialist in the Department of Ecology, Science, Technology and Healthcare of the US Embassy, in his address to the participants expressed hope for the development of a fruitful Russian-American partnership in the field of nanotechnology. He also noted: "Over the past 14 years, the United States has been cooperating with Russia in improving infrastructure and training specialists in GLP and bioethical aspects of preclinical and clinical trials."

The round table actively discussed the issues of compliance of the Russian rules for conducting preclinical studies with the international requirements of Good Laboratory Practice (GLP). The improvement of domestic standards will inevitably raise the entry barrier to the market, but will increase the quality of manufactured medicines, which means their competitiveness in the domestic and foreign markets.

The problems of nanotoxicological studies of the safety of medicinal substances raised by the speakers aroused the keen interest of the audience. With the increase in the number of medicines, the number of victims of undesirable side effects may significantly increase. Tatiana Nikolenko, Director of Infrastructure Programs at RUSNANO, drew attention to the adjustments that the development of nanotechnology will inevitably make to the standards of drug testing. "The intensive development of nanotechnology is taking place against the background of a practical lack of knowledge about the impact of nanoparticles on human health. The first studies have already shown that new formulations of traditional medicines acquire previously non-inherent properties and biological effects. Our position on this issue is clear: the introduction of new drugs is impossible without ensuring the safety of their use. Understanding the importance of this problem led us to organize today's event."

In his report, the head of the Laboratory of Drug Toxicology of the Research Institute of Pharmacology of the Russian Academy of Medical Sciences, Corresponding Member of the Russian Academy of Medical Sciences, Andrey Durnev, stressed: "The prospect of widespread use of nanoparticles in the development and production of medicines requires the creation of fundamentally new approaches to the preclinical assessment of the safety of their use."

"It is not necessary to talk about the competitiveness of the domestic pharmaceutical industry without high-quality animals on which preclinical tests are carried out. Currently, state regulation prescribes conducting research on "healthy animals", without specifying the parameters of this health. In addition, the concepts of "health" and "quality" are not the same thing, since the concept of "quality" includes (in addition to health) genetic aspects and aspects of keeping laboratory animals during breeding and use. These issues should be resolved at the state level and with state support," said Georgy Telegin, head of the laboratory animal nursery of the branch of the Institute of Bioorganic Chemistry of the Russian Academy of Sciences, the only rodent nursery in Russia accredited according to international standards.

Corresponding member of the Russian Academy of Medical Sciences Tatiana Guskova drew attention to the fact that during tests on rodents, undesirable effects of the action of active substances on the body are missed. "In Russia, it is necessary to expand the capabilities of nurseries for breeding other test systems, such as beagles, minipigs, monkeys; as well as vivariums, on the basis of which it is possible to assess the safety of medicines," Guskova is sure.

The state of preclinical research centers is also assessed by the qualification of personnel. In most Russian centers, teams of employees with extensive experience in toxicological research have been preserved since Soviet times. But the issue of updating personnel and teaching them modern methods is acute. Vice-Rector of the MMA. Sechenova Renad Alyautdin believes that the Medical Academy is a reliable source of personnel in the field of pharmacology and toxicology. 

To date, 49 Russian institutions are included in the "List of organizations and institutions conducting preclinical studies of medicines". The discussion at the round table showed that even the best of them, the Pushchinsky preclinical testing center, is loaded by 30-40% today. "Demand should generate supply. In order to increase the capacity of preclinical research, it is necessary to create innovative pharmaceutical companies at the start-up stage, so that they generate this demand," Dmitry Kravchenko, General Director of the Research Institute of Chemical Diversity, ChemRar Research Center, emphasized.

Long cycle of development and testing of pharmaceuticals (at least 5-7 years) reduces the attractiveness of innovative developments in this area for venture investors. "Acting as a co-investor in medical projects, RUSNANO reduces the risks of its partners and thereby contributes to the entry of domestic pharmaceutical manufacturers into the domestic and foreign markets. This is our active position in solving the issues raised by the government," says Nikolenko.

Following the results of the round table "Qualitative preclinical research in Russia", it is planned to issue a final document with the main results of the discussions and the conclusions reached by its participants.

RUSNANO Press CenterPortal "Eternal youth" www.vechnayamolodost.ru


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