Drug Discovery in CIS – ISTC Landscape

Moscow

23/06/2009

T. Gremyakova

International Science & Technology Centre

14.07.2009 2

Technical directions of the Biomedical Technical directions of the Biomedical ISTC projectsISTC projects

Biosafety/Biosecurity

14%

Agriculture and food14%

Surveillance13%

Omics6%

Diagnostics11%

Vaccines6%

Drugs19%

Medicine7%

Ecology4%

Bioremediation3%

Biodiversity3%

19941994--2009 2009 720 720 projects, projects, $210 $210 mlnmln

14.07.2009 3

$0

$5,000,000

$10,000,000

$15,000,000

$20,000,000

$25,000,000

$30,000,000

$35,000,000

VECTOR SRCAMB VNIIF IBCh Institute ofImmunological

Engineering

RCTHRB Institute of HighlyPure

Biopreparations, StPetersburg

RCMDT Ivanovsky Instituteof Virology,

Moscow

Federal Centre forAnimal Health,

Vladimir

Main ISTC beneficiars in BIO

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Sustainable future of ISTC recipients – HOW?

• Innovation projects• Infrastructure projects (safety, quality, communications)• Commercialization of project results• International quality (GLP, GMP, GCP), ethical and safety standards• IPR protections• Presentation of the institutes at the international business forums (Bio-USA,

Bio-Europe, Bio-Asia, Bio-Japan, Bio-Canada) – booths, presentations, informational materials, business match-making,

• Training (business, quality, biosafety/biosecurity, ethics/bioethics, humane animal care and use)

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Combating global diseases-ISTC priority

• Disease surveillance

• Detection and Diagnostics• Drugs and Vaccine Discovery

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Drug Discovery - statistics

Technical directions

17

1413

1110

1010

98

7

0 5 10 15 20

CNS DiseasesDelivery systems

Infrastructure, qualityin silico

Cell therapyAntimicrobials

Technology dev.Immune prep.

AnticancerAntivirals

Amount of projects

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Drug Discovery - Infrastructure• Inst of Bioorganicic Chemistry, Puschino (DOS) –SPF r odents Breeding Facility• Laboratory of Biological Trials1. State Research Center for Applied Microbiology,Ob olensk (DTRA)2. State Research Center for Virology and Biotechnol ogy VECTOR, Koltsovo (DARPA) State Research

Center for Molecular Diagnostics and Therapy, Mosco w (DTRA)3. State Research Institute of Highly Pure Bioprepar ations, St. Petersburg (DARPA4. State Research Institute of Immunological Enginee ring, Lyubuchany (DARPA)5. Research Center of Toxicology and Hygienic Regula tion of Biopreparations, Serpukhov (DTRA, BII)

Harmonization of the Conditions to Perform Pre-Clinical Trials According to the Russian and US Standards6. Research Institute of Microbiology and Virology, Almaty7. Central Tuberculosis Research Institute, Moscow ( DHHS)8. All-Russia Scientific Veterinarian Institute, Kaz an (NTI)9. Institute of Physiologically Active Substances, C hernogolovka - (BII) Identification, Addition and

Realization of the Nascent Value of Novel Compounds as Drug Candidates Through Preclinical Safety and Efficacy Testing and technology Transfer

10. Federal Centre for Animal Health, Vladimir (Baye r)

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Drug Discovery - InfrastructureCentre for TB Clinical Trials

Project # 2879Development of a ResearchCenter for TuberculosisClinical Trials Through theConduct of a Study of a Modified Treatment Regimenfor WHO Category 1 Patients

Moscow Medical Academy+

Obolensk

Training of the personal in GCP,

Access

#2174 Synthesis, characterization oftargeted delivery tomacrophage receptorsand evaluation of anti-tubercular activity ofthe conjugates of anti-tubercular antibioticswith ligands tomacrophage

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Drug Discovery - research:New antiviral preparations –Russia- Smallpox

N

N

N

N

NHCH2CH2R

OHO

HO OH

N

N

N

N

OHO

HO OH

Cl

NH2CH2CH2R

диоксан

IIa: R=COONH4IIb: R=NMe3

+Cl-

IIc: R=NMe2(MeO)3PO

N

N

N

N

NHCH2CH2R

OHO

HO OH

O

Ia: R=COONH4Ib: R=NMe3

+Cl-

COOOH

Cl

MeOH/H2O

Concentration

0,001 0,01 0,1 1 10 1000

0,5

1

1,5

OS-2735 (MK-2)

y = ( (A - D)/(1 + (x/C)^B ) ) + D: A B C D R^2

activity VV (infected VV: Concentration vs Values) 0,185 0,835 1,346 1,154 0,883

toxicity (uninfected: Concentration vs Values) 1,474 0,416 53082,37 -8,596 0,947

activity CPV (infected CPV: Concentration vs Val... 0,245 3,954 10,297 0,951 0,98

activity Ectr (infected Ectr: Concentration vs Valu... 0,151 2,569 4,751 0,83 0,974

IPR

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Drug Discovery - research:Russia – anticancer preparations

• # 3548 Novel Antitumor Heterocyclic Agents, Including Fluorine-Containing

Compounds, Acting Via Inhibition of Protein KinasesKhimrar, Moscow reg.#3104 Production of Recombinant Mullerian Inhibiting Substance (MIS) for the

Treatment of Human CancersInstitute of Highly Pure Biopreparations, St Petersburg

#3777 Development and Application of QSAR Rodent Toxicity Models for Chemical Compounds

Institute of physiologically active substances, Che rnogolovka, Moscow region

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Drug Discovery - research:New antiviral preparations –Armenia and Byelorussia

0

0,2

0,4

0,6

0,8

1

1,2

1,4

1 2 3 4 5 6 7 8 9 10 11

Control

BAF

ACV

#B-1206 Development of effective antiviral agents of a new type,

Byelorussian State University, BRIEM

OH

OH OH(CH2)n

NH /Et3H(CH2)n

N

n = 2 (N-11)n = 1 (N-12)

A-1677 The Synthesis of Potential Biologically Active HeterocycleSubstituted a-Amino Acids and Peptides. Investigation of their Antibacterial, Antiviral and Antitumor Properties (Funded December, 2008)

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Drug Discovery Research –Central Asia

• Unique natural sources of biologically active herbs• Collaboration with private and governmental bodies in

US and EU

New antibiotics, antidiabetics, anticancer, cardio preparations

Kr-1684 Cell Biotechnology of Plant-Based Medicines: Elite Lines ofGermplasm and Hairy Root Cultures of Endemic and Rare PlantSpecies of Kyrgyzstan of the Genus of Scutellaria

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Drug Discovery - newDrug Design and Development Targeted Initiative

Call for proposals – main technical topics:� Innovative projects - considering previous results and global

importance including in silico design, toxicity forecasting; screening of collections for natural products, optimizing of compounds collection, identification effective chemical compounds and their chemical tuning to improve in vitro efficacy, to identify new prokaryotic targets and metabolic pathways, defining resistance breaking drug properties, developing of newin vitro screening activities, efficacy and safety tests, etc.

� International quality standards - infrastructure upgrades, quality improvements and business development.

� Commercialization, technology transfer , consulting, business promotion.

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ISTC Workshop program -2009 (www.istc.ru)• Combating Global infections, September 21-24, 2009, I rkutsk

• Global Disease Surveillance, reporting, forecasting, local and international networking – Zoonoses (Lessons learnt – SARS +Avian flu + influenza)– Food-borne diseases – Reference collections of microorganisms

• Detection and diagnostics, centers of excellence, na tional reference labs for diagnostics of socially important human diseases, zoonotic live-stock diseases

• New drugs and vaccines• Infrastructure• Certification and accreditation• Business, quality and biosafety trainings

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Open for cooperation

http://www.istc.ru

Tatiana Gremyakova, PhD, Dr Sc (med)ISTC Chief Science Co-ordinator (Biotech&Med)