PROPOSALS FOR FP7 PROGRAM
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Chemical Diversity Research Institute (CDRI)
Rabochaya St. 2, Khimki, Moscow Region
114401 Russia
+7(495) 995-4944
+7(495) 626-9780
sva@iihr.ru
www.iihr.ru
Andrey V. Sosnov, CDRI Deputy Director
THE BIOSCREENING CENTER
Chemical Diversity Research Institute, Ltd., Khimki, Moscow Region, Russia
At the end of the XX century, the largest pharmaceutical companies started to use
high-throughput biological screening (HTS) as an industrial technology for research and
development of synthetic therapeutic agents in pre-clinical stages. HTS is an automated
process of testing libraries of chemical compounds against specific biological targets. Modern
HTS systems can analyze up to 1 million of individual samples against a definite target per
day. The obtained hit compounds are then used in a hit-to-lead optimization stage. The
resulting lead-compounds are investigated in-depth in pre-clinical tests to afford clinical
candidates.
Chemical Diversity Research Institute (CDRI) has all necessary conditions for
successful realization of the innovation programs in biotechnological and pharmaceutical
industries. In 2006, we initiated a project of establishing the National Bioscreening Center
(NBC) in Russia. The main purpose of NBC is to establish an integrated high-tech R&D
complex based on modern research technologies. As a result, various drug discovery and
development organizations will get a powerful source of active compounds to be investigated
in pre-clinical and clinical trials.
The main directions of the NBC’s activity are:
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Services related to high-throughput screening of chemical libraries against specific
biotargets; detailed results of experiments with descriptions, recommendations and statistic
data are provided.
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Biological assay development.
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HTS methods development according to specifications delivered by the customer.
Governmental, academic institutions and commercial organizations operation in the
field of biological, chemical and pharmaceutical sciences are the core parts of the
organizational structure of NBC. International biotechnological/pharmaceutical contract
research organizations are strategic partners of this initiative.
THE CHEMOGENOMICS NETWORK
Chemical Diversity Research Institute, Ltd., Khimki, Moscow Region, Russia
The decoding of human genome stimulated the competition between developed
countries in the field of drug discovery and development in XXI century. The entire process is
characterized by long duration, high cost and little chance of success especially in initial preclinical stages. About $0,5-1,0 billion and 10-15 years are usually needed to launch one drug
substance into the market. This process includes several stages: (1) identification of biological
targets for drug action and assay development; (2) synthesis of chemical libraries; (3)
biological screening of synthesized compounds (in vitro high-throughput tests); (4) preclinical
tests
of active compounds
in animals;
(5) clinical investigations;
(6)
commercialization of the new medicine. As an applied discipline in the field of chemical
pharmacology, chemogenomics operates in the first three stages and studies complex genomic
response of biological systems to the action of chemical substances. Constitutive parts of
chemogenomics are genomic and proteomic studies. Chemical and biological informatics,
combinatorial chemical synthesis and biological tests are as the main instruments of
chemogenomics.
There is a considerable gap between scientific investigations in initial stages of drug
discovery and pre-clinical and clinical phases. This gap sometimes refereed to as “Death
Valley”, since the funding of scientific investigations in this stage is associated with high
risks. Chemogenomics operates just in this gap. To solve this problem, the integrated national
structures are being established in the world pharmaceutical industry. The Center for
Chemical Genomics (Germany) and the “Road Map” program (USA) are the most prominent
examples. The main aim of such national structures is to promote transfer from scientific
knowledge about genome to drug-like prototypes and to reduce the gap between fundamental
science and real needs of pharmaceutical companies.
At this time, there exist all the necessary conditions for successful establishing an
analogue of these initiatives in Russia:
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Wide experience in realization of big infrastructure high-tech projects;
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Powerful biological and chemical scientific schools;
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The need of big innovation projects for the national economy;
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Active support of the high-tech initiatives by the governmental institutes;
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Rapid emergence of Russian national innovation companies in the field of life science.
Non-governmental Chemical Diversity Research Institute (CDRI) is an example of
high-tech innovation company in Russia. The main CDRI`s specialization is laboratory
investigations in initial stages of new drug R&D by using innovative research technologies.
CDRI suggests to create the National Chemogenomics Network (NCN) in the Russian
Federation. The main aims of the project are:
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The infrastructure organization for development of researches in the field of Life
Science and the milieu of forward “knowledge generation”;
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Development and implementation of new high technologies for successful competition
on international market of innovations;
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The technological modernization and the creation of new competitive biotechnological
economy sector;
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The research and development of domestic new-generation medicines.
Specific features of the project are:
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Multiple-aspect current tasks, plurality of branch directions, coming-to-be of new
markets, potential to R&D realization on different stages of innovation cycle;
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The implementation of various funding tools;
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A large number of potential participating organizations.
The project realization model includes four base platforms:
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Biological services (system biology, molecular design, molecular and cell biology);
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Chemical services (combinatorial synthesis of chemical libraries);
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Informational services (data bases);
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Technological services (computational and high-throughput screening, drug dosage
form production).
In the framework of the Project, scientific cooperation activities will include:
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Joint research projects with leading scientific and research as well as clinical centers;
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Custom commercial projects with chemical and pharmaceutical companies;
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Grants with support of Russian and international scientific funds;
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Training projects with institutes of higher education.
At present the project has received approval in Ministry of public health and social
development, Ministry of education and science, Ministry of trade and economic development
of the Russian Federation, Russian Academy of medical sciences and other profile
organizations.
About CDRI
Chemical Diversity Research Institute (CDRI) is one of the major Russian research organizations
specialized in the field of preclinical development of novel drugs. The wide range of CDRI
capabilities includes solid- and liquid-phase combinatorial synthesis, high-throughput biological
screening, physico-chemical compound properties optimization, pharmacokinetic research, etc. To
broaden scientific expertise and engage the knowledge of Russian scientists in research projects
optimization, CDRI collaborates with higher educational and research institutions for joint research
and educational programs. CDRI is focused on the delivery of new scientific innovation and a range of
products and services that meet the drug discovery needs of its partners.
CDRI offers well integrated Discovery outSource TM research service offering. We emphasize:
- track record of 15 years in life sciences;
- broadest portfolio of developed chemistry systems (over 8500 discernable heterocyclic library
designs) and reactions;
- largest size of discovery chemistry collection (>1,000,000 samples of compounds) applicable
as standalone libraries, and with chemistry and bioscreening discovery service packages;
- highest rate of new chemistry development (>1500 new libraries per year).
Discovery outSource TM services includes:
- Medicinal Chemistry;
- Expertise to pre-IND candidates;
- Early assessment of “drug-likeness”, SAR, iterative hit to lead and lead development;
- Rational drug design, modeling capabilities;
- Synthetic Chemistry;
- Parallel synthesis;
- Library protocol development, optimization and execution;
- Parallel synthesis (20-1000 analogs/scaffold);
- Individual samples of compounds;
- Core and terminal building blocks;
- g to kg scale-up and GLP protocol development options.
Discovery Libraries (>1,000,000 samples of compounds, grow by 15-30K samples of new compounds
monthly):
- Diverse - characterized by diversity, novelty and lead-likeness – the largest commercially
available compound collection;
- Targeted - GPCR, Kinase, Phosphatase, Protease, Ion Channels, Nuclear Receptors,
Peptidomimetics, other specific targets;
- Natural and nature-like libraries;
- Pathway based – Hh, Wnt, others. Pre-Clinical Biology Services:
- Protein isolation and purification;
- Assay Development and optimization;
- HT screening (hit identification);
- In vitro pharmacology – experimental and predictive ADME/Tox;
- In vivo pharmacology -- DM/PK/Tox & efficacy;
- Bio-Analytical.Computational chemistry.
Global Logistics Services.