How Can the Russian R&D Industry Help the Global One?

03 October 2018

CIS GMP news Magazine, Autumn 2018

Boris Sysuev, Doctor of Science, Director R&D of NovaMedica Innotech

Alexander Rudko, MBA, Head of NovaMedica Innotech

Population in the world is growing, life expectancy is Increasing- under the influence of these worldwide factors Pharma & Biotech industry is transforming in the direction of personalized medicine based on the principle of P4 (predictive-personalized-preventive-participatory). A new patient-oriented model where treatment result is focused on the patient, is spreading in the medicine. Limited access of patients to modern treatment technologies and high cost of treatment are hindering development of this model. Therefore, it is important to create drugs to treat previously incurable diseases or to upgrade known molecules without resorting to high-cost technologies. But large global manufacturers do not have the mobile potential to produce small batches of drugs for the treatment of orphan diseases or for targeted therapy.

In Russia, Pharma & Biotech industry is also undergoing rapid growth and transformation. Indeed, already today artificial intelligence technologies allow us to optimize research process, thus shortening time for the development of new dosage forms. As an example we can mention cooperation between the Technological Center of NovaMedica Innotech and the Skolkovo Innovation Center as part of the project for creation of drugs based on oligonucleotides that have anti-inflammatory and regenerative effects.

The current model of the pharmaceutical business in the context of R&D in Russia reflects the world trends. One of the striking examples is R&D Center of NovaMedica Innotech. It belongs to the group of CDMO (contract development and manufacturing organizations), whose task is to provide services following the 'one contact’ principle: pharmaceutical development, technology development, technology transfer, and manufacturing of small batches of products - both for clinical trials and for manufacturing of finished products batches (based on the GMP license).

The Center possesses a bunch of unique technologies that allow to carry out the whole cycle of pharmaceutical development, taking into account modern international requirements. The pipeline of the products under development includes tablets (with and without coating), prolonged-action tablets and other various modifications of tablets. Also, NovaMedica Innotech-has the competence to develop and produce soft gelatin capsules and hard gelatin capsules with different fillers. And the availability of pellet equipment provides opportunities in terms of range of experiment in the development of new. unique dosage forms and development of individual technological solutions for complex molecules and compositions.

On the basis of such centers, it is advantageous to implement localization programs for manufacturing of drugs in the territory of Russia, when the center performs all set of activities related to the development and technology transfer to a local site.

Availability of modern technological and analytical equipment (Bosch, Erweka, Agilent, Shimadzu, etc) at NovaMedica Innotech allows maintaining standards of quality and drug development (both new and within import substitution), as well as confirming the requirements of foreign pharmacopoeias.

Currently, Russia has a government decree that establishes special preferences for manufacturers of domestic drugs included into the EDL list - it is called 'third-is-out rule' According to this decree, the drug manufacturer which has no localization in Russia will not be able to offer its products in the state procurement system.

Using the potential of Russian R&D centers, it is possible to increase the amount of developments and the subsequent release of drugs for the treatment of orphan diseases. And due to the availability of manufacturing sites, the Technological Center of NovaMedica Innotech can in addition help to launch manufacturing of small batches of products in a short time. Large manufacturing sites lack flexibility and speed required for rapid changeover.

Summing up - Russian R&O centers can help foreign drugs get a 'residence permit' in the territory of Russia.

Russian R&D centers work in a global context, quickly track global trends and new directions in the development and manufacturing of new drugs. We are working on the creation of new dosage forms: various kinds of tablets, capsules (solid and soft), products obtained with the help of modern technological platforms, Including extrusion technology. This allows us to apply and implement innovative technologies that are in demand by global manufacturers.

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