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BMT cluster. Report
Igor Goryanin. June 2011
Five key elements of the BMT innovation ecosystem
Community of BMT residents
InfrastructuresRegulatory environment
Training / Educational Programs
BMT Ecosystem. 5
4 3
2
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Business incubators Venture Capital Funds Strategic industrial
investors Institutional Partners Experts
Residents of the cluster (project companies)
Association of the resident’s partners (biomedical and pharmaceutical clusters)
Center for formalizing of IP Policy
Service Center of support of the Cluster residents (tax, legal, customs consultants)
Infrastructure link-laboratories
Centers for Shared Facilities (CSF), or Centers of Excellence (CoE)
R & D centers . Key partners
SIST (educational programs) International traineeship Internships International
Conferences/Roadshows
Institutes of commercialization
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Cooperation with Government of the Russian Federation
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April 2001: Agreement, on cooperation and coordination of joint activities in the innovative development of health signed .
•May 2011: Coordinating Council for Biomedical Technologies established
The Ministry of Health and Social Development
Ministry of Industry and Trade
Status of relationship Development plan
• March 2011: Working group (on coordination of joint activity in the field was established.
•June 2011: Head of Cluster BMT elected to join the Working Group of the Commission on Modernization and Technological Development under the management of RF President .
▪ Joint expertise and support of innovative projects.
▪ Creation of a single register of the biomed projects..
▪ Joint participation in the development of biomedical CSF’s and CEOs
▪ Unified information platforms
Ministry of Economic Development
February - May 2011: • Working Group on the development of the Law ”Cellular technology” • Platform "Medicines of the Future“ • Working Group “Drug manufacturing and R&D “ with the Commission on Modernization and Technical development under the management of RF President .
▪ Active participation and implementation of proposals of the Skolkovo Fund in Interdepartmental governmental Working Groups and committees on Biomedicine and biopharmaceuticals
• Joint expertise and support of innovative projects•Joint participation in CSFs of Excellence•Coordination in priorities of innovation•Unified information platforms
Partners
Cooperation with institutional partners
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•March 2011: Agreements with Infrastructural RVC Venture Funds: Biofund RVC, Maxwell Biotech, BioProcess Capital Ventures - were signed. • May 2011: Joint expertise and structuring of 7 projects •Structuring of possible RVC participation . CSF "Preclinical studies with GLP standards”
▪ Co-financing of at least 3 projects in conjunction with RVC Funds.
▪ Participation of RVC Funds in one of CSF .
JSC “RVC”
JSC “RUSNANO”
March 2011г: Agreement of creation Coordinating Council for Biomedical Technologies was signed. April - May 2011: Joint expertise and structuring of 3 projects with "ROSNANOApril-May 2011: Jjoint (with IGB RAS), educational module, "System analysis of genomic data”, in collaboration with Cold Spring Harbor Laboratory (USA)
▪ Joint projects directory.▪ Co-financing of at least 2 projects▪ Starting with
2 joint educational practice-oriented modules .
EMBL (European Molecular Biology Laboratories ) -
European leading interstate Centre for Molecular Biology
• April 2011: Agreement with the EMBL was signed.•April - May 2011: Consultations on the establishment of of EMBL R&D Institute in Skolkovo•April - May 2011: Participation of the EMBL in the CSF "Structural biology ” (in collaboration with the MIPT and ONEXIM Group)
▪ Participation of EMBL in CSF "Structural biology in collaboration with the MIPT and ONEXIM Group)
▪ EMBL R&D Institute ▪ in Skolkovo ▪ Joint training courses
Status of relationship Development planPartners
Cooperation with regional biomedicine and biopharmaceutical clusters
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Feb 2011 Agreement of joining the BMT Cluster to the Supervisory Board of the BFC “Severny“ signedFeb-May 2011 Joint educational programApr-May 2011 Some of the BFC “Severny” participants got the resident status
▪ MIPT▪ Chemrar▪ PROTEK▪ Pharmzashita▪ Akrikhin
Biopharmcluster“Severny”
(MIPT)
Status of relationship Participants Development plan
▪ Joint support for the best innovative projects of BFC “Severny”
▪ Using best practices (a business incubator, technopark, CSF, educational programs) i
Ural Pharmcluster
Kalugsky Pharmcluster
Feb 2011 Agreement of the Supervisory Board of the Ural Pharmcluster signedFeb-May 2011 Examination of joint projectsApr 2011 Some of the Ural Pharmcluster participants get the resident status of the Fund
▪ Zavod Medsintez LLC▪ IOS RAS▪ Zavod Dizet LLC▪ Unona Holding
Company
▪ Joint support for the best innovative projects
▪ Using the regional practices
May 2011 Agreement of joining the BMT Cluster to the Kalugsky Pharmcluster “Innovative biopharmaceutics” signed
▪ «Hemofarm» (STADA, Germany)
▪ «Berlin-Chemie/Menarini» (Italy)
▪ «Novo Nordisk» (Denmark)
▪ Astra Zeneca (UK)
▪ Joint support for the best innovative projects
▪ CSF in Nuclear Medicine
Partners
Creating the «educational environment» within the BMT Сluster
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Molecular genetics
Synthetic biology
System bioinformatics
Cluster’s link-laboratories
Cluster’s project companies (and their
scientific partners)
«Bortnic’sFund»
External special system specialized scientific knowledge providers
“Skolkovo” University Biomedical facultyExternal personnel source for to organize the participation in the
educational programs
Educational module
Providers of the systematic and scientific knowledge and practices
Latest methodology of the Oncology diagnostics and therapy
Latest medical cell technologies
Cluster’s CSF’s
Educational module
Educational module
Educational module
Educational module
practice
practice
practice
practice
practice
Providers of the infrastructural platform for the lecture courses and the practice seminars holding on
RUSNANO
RVC
Ministry of the
Healthcare
Provider of the consumers for
the system knowledge
BMT cluster
Russian partners: the universities and he R&D centers
Foreign university partners
Providers of the best educational practices
System biopharmaceutics Educational module practice
Educational Programs of BMT Cluster
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March 2011 The final of the first session of the qualifying competition program. The program, “The Talent pool of young scientists of BMT Cluster “ (UMNIK-Skolkovets), in which 34 young professionals were selected, Bortnik’s Fund
RUSNANO, Institute of Gene, Cold Spring Harbor Laboratory
Status of relationship Development Plan
March-May 2011 Practice-oriented educational module of “Statistical analysis of genomic data” is under testingMay 2011 first students (BMT Cluster residents, RUSSNANO project companies, MIPT students, “Umnik-Skolkovets” graduates)
▪ Integration of the “Statistical analysis of genomic data” into CSF for “Medicine bioinformatics” of BMT Cluster
▪ Development. testing and, running of a new educational programs
ASTRA ZENECA Co (UK)
March 2011 BMT Cluster joining Supervisory Board of «Knowledge Vanguard» Virtual University, established by Astra Zeneca with the participation of RUSNANO, RVC, the Ministry of Health and Social Development of Russia
April 2011: Applications expertise within the competition of research projects in cardiology and oncology
•Conducting 2nd session of the "Talent Pool“ program•Choosing of the foreign universities-partners, the agreements signing for training of young scientists, graduates of "UMNIK-Skolkovets”, student exchange programs, development of internship programs and trainings
Partners
▪ Completion of the contest and awarding the winners.
▪ Involvement of the winners in the educational and grant programs of BMT Cluster.
▪ Development of ASTRA ZENECA’s training programs in within the framework of the Coordinating Council of BMT Cluster and the Ministry of Health and Social Development of Russia
Projects of Biomed Cluster (20/6)
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PROJECT TITLE FORESIGHTPROJECT BUDGET, MM RUB
AMOUNT FROM THE FUND APPROVED, MM RUB (2011-2013)
AMOUNT OF 1ST TRANCHE, MM RUB
SYNTHETIC PEPTIDE DRUGS BIO-PHARMA 795 675 170
PHOTOBIOLOGICAL MICROBIAL FCELLSBIO-INDUSTRIALS
600 420 90
DEVELOPMENT OF NOVEL ANTI-HYPOXIA-ADENOSINERGIC TECHNOLOGIES, DRUGS AND VACCINES FOR THE TREATMENT OF CANCER, INFECTIOUS DISEASES AND SEPSIS
BIO-PHARMA 240 200 74
DEVELOPMENT OF AUTHENTIC MEDICINAL DRUGS FOR THE TREATMENT OF INFECTIOUS DISEASES OF VIRAL AETIOLOGY AND DEVELOPMENT OF DIAGNOSTIC METHODS FOR VIRUS DISEASES
BIO-PHARMA 960 400 130
BIOTECHNOLOGY DETECTING AND NEUTRALIZING DANGEROUS INFECTIOUS AGENTS
BIO-HEALTHCARE
420 220 77
DEVELOPMENT OF BIODEGRADABLE POLYMER INTRACORONARY IMPLANTS
BIO-HEALTHCARE
105 69 21
TOTAL: 1984 562
FINANCING WERE APPROVED BY INVESTMENT COMMITTEE FOR SIX PROJECTS
Projects of Biomed Cluster
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PROJECT TITLE FORESIGHT COMPANY
PHARMACEUTICALS FROM THE MODIFIED BIOPOLYMER CARBOHYDRATES
BIO-PHARMAVOSTOKFARM INNOVATIONS
LLC
TARGETED MULTIMODAL DIAGNOSTIC AND THERAPEUTIC AGENTS ON THE CARRIER OF "CORE-CARBON SHELL“ STRUCTURE
BIO-PHARMAURAL NUCLEAR MEDICINE
CENTER LLC
DEVELOPMENT OF A NEW LINE OF BIOLOGICAL PRODUCTS ON THE BASIS OF CORD BLOOD STEM CELLS FOR TREATMENT OF ONCOLOGICAL AND HEMATOLOGICAL PATIENTS AFTER CHEMO-AND RADIOTHERAPY, USING THE METHODS OF IMMUNOMAGNETIC SEPARATION, CULTURING, GENETIC TESTING, EVALUATION OF TELOMERASE ACTIVITY, CRYOPRESERVATION
BIO-HEALTHCARE CELLULAR INNOVATIONS LLC
DEVELOPMENT AND IMPLEMENTATION OF A PERSONALIZED DIAGNOSIS AND TREATMENT OF ONCOLOGICAL DISEASES
BIO-HEALTHCARE UNIVERSAL BIOSYSTEMS LLC
DEVELOPMENT AND COMMERCIALIZATION OF INNOVATIVE TARGETED DRUG FOR THE TREATMENT OF KIDNEY CANCER
BIO-PHARMA ONKOMAKS LLC
LACTOFERRIN AND OTHER REGULATORY AND THERAPEUTIC HUMAN PROTEINS FROM TRANSGENIC GOATS’ MILK. DEVELOPING SCIENTIFIC AND TECHNOLOGICAL BASIS FOR A BIO-TECH TRANSGENIC INDUSTRY IN RUSSIA
BIO-HEALTHCARE TRANSGENFARM LLC
DEVELOPMENT OF A MODEL OF VENOUS VALVE PROSTHESIS BIO-HEALTHCARE SPC AMFION LLC
FIFTEEN PROJECTS RECEIVED PARTICIPANT CERTIFICATE
Projects of Biomed Cluster
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PROJECT TITLE FORESIGHT COMPANY
DEVELOPMENT OF PHARMACEUTICALS FOR TREATMENT OF BACTERIAL AND FUNGAL INFECTIONS ON THE BASIS OF THE PATENTED ANALOG NATURAL PEPTIDE LL-37
BIO-PHARMA BIOCHART LLC
DEVELOPMENT AND COMMERCIALIZATION OF NOVEL DRUG FOR MULTIDRUGRESISTANT TUBERCULOSIS TREATMENT
BIO-PHARMA INFEKTEKS LLC
DEVELOPMENT OF NEW PHARMACEUTICAL COMPOSITIONS AND DRUGS FOR THE TREATMENT OF NEUROLOGICAL DISEASES
BIO-PHARMA LEKSYSTEMS LLC
DEVELOPMENT OF THE NEW DRUGS BASED ON DERIVATIVES OF N-ACYL BIOGENIC AMINES AND THEIR ANALOGUES
BIO-PHARMA FARMALLIANCE LLC
ANTIVIRAL DRUGS DEVELOPMENT BASED ON INHIBITION OF MATRIX PROTEINS
BIO-PHARMAQUANTUM
PHARMACEUTICALS
DEVELOPMENT OF PHARMACEUTICAL COMPOSITION (CMX-157) FOR TREATMENT AND PREVENTION OF HIV INFECTION INCLUDING HIGH-RESISTANT FORMS
BIO-PHARMA HELIX VENTURES
Information platform for biomedical research BIOINFORMATICS BIOSOFT.RU LLC
DEVELOPMENT OF BRAIN-COMPUTER INTERFACE TECHNOLOGY FOR PROSTHETIC LIMBS AND MANIPULATORS CONTROL
BIO-HEALTHCAREINNOVATION TECHNOLOGIES
LLC
FIFTEEN PROJECTS RECEIVED PARTICIPANT CERTIFICATE
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Leading Universities
Major biomed and pharmaceutical companies
Regional Pharma Clusters
Ural PharmCluster (Yekaterinburg)
Pharm Cluster Severny (North of Moscow)
Institutional partners
Collaboration with key partners
Agreement will be signed Jun, 17 ($15M)
Agreement will be signed soon (15FTE in R&D M&S Centre)
General MoU
General MoU
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BMT Infrastructure is practically missing
CSFs and the BMT foresights. Equipment and competencies
Early development Lead optimization Preclinical Clinical - Registration and launch
Transgenomic and postgenomic technologies
Foresight. Biomedicineand Bio-pharmaceutics
Complex modeling and simulation. Biomedical Informatics
«Proteomics , and other omics
Preclinical and clinical studies. P4 Medicine. Cancer)
Foresight Bioinformatics
Preclinical. GLP Structural Biology»
Directed evolution Artificial ecosystems
Scaling upй Foresight
Industrial biotechnologies Synthetic biology
Regenerative medicine
«AB and other novel therapies
Infection diseases»
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Basic Principles of BMT CSF functioning
CSF research areas should be in the BMT foresights. CSF should provide services, research and educational programmes
1)
Capital expenses for major consumables and equipment are covered by the Fund. Operational budget to be provided by residents companies and external customers.
Infrastructure facilities, the equipment and maintenance services of CSFs are to be 100% owned by the Skolkovo Foundation or/and its wholly owned subsidiary.
3)
Residents of the Skolkovo should have a first right to use CSFs services and competencies. There should be a strong demand for competences of CSF
4)
CSF should provide and maintain excellence in access to modern biomedical equipment, research infrastructure, highly qualified staff, and services on the world level
5)
2)
CSF establishment in the field of interest is supported by independent scientific experts6)
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Using existing competencies and adding novel ones.
Research and Development
Existing equipment New Equipment
BMT CSF
Existing methodologies and techniques
Staff Skills and experience
Commercialisation experience
Existing scientific collaborations
Project companies. CSF customers
New qualified staff
Key partners
Effective management
Innovation projectsEducational and retraining
programmes
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Services
Res
iden
ts
Infr
astr
uctu
res
Uni
vers
ity
In
vest
ors
R
egul
ator
y en
viro
nmen
t
2014 2012 - 20132011
Infrastructural Link-Labs (Project based).
Centers for Shared Facilities (CSF) or CoE
Functioning of the BMT infrastructural Ecosystem
Educational programs based on the project companies community and infrastructure partners
Creation of Departments of Skolkovo University
Projects
Link-labs are based on project companies
activities
Part of the R & D centers establishes on
the basis of Centers for Shared FacilitiesR & D centers with key partners
Develop and implement the modules of special lectures and seminars (including "remote web – courses”)
Co-investors and strategic projects partners
Venture Capital Funds
Institutional Partners (RUSNANO, RVC, VEB)
Creating a network of business incubators
Long-term relationships with strategic investors
Support by the functional units of the FundCreation of service centers of legal assistance based on
Techno park
BMT CSF development pipeline
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BMT CSF Example. Management
CSF Advisory Council
CSF Director
Sector Head
Director R&D R&D
Educational and training courses
Sector Head Sector Head Sector Head
CSF Scientific Council
Director. Training
Director. Services Services. Customers
Skolkovo Foundation
Administration.
IP Centre
CSF advisory council: responsibilities• Budget control. Finance• Administration. Planning.• R&D and other services management• Co-investment and other grants management
Collaborative Agreements include• Temporal leasing of the equipment to key
collaborators/owners of buildings.• Major principles of the access and usage of the
equipment.
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BMT CSF. Example of general organisational structure
Owners of infrastructure and buildings (Main collaborators)
The Skolkovo Fund budget
Fund subsidiary company
R&D Budget:
Salaries for engineers and scientists working on the Fund equipment
Equipment
BMT cluster
Consumables for the Fund equipment
Budget form Fund project companies
Budget of resident companies
Budget of main collaboratorsExisting equipment
Unified equipment facilities
Staff Existing best practicesInfrustructure
Skolkovo Fund. Cluster BMT. Technopark
Skolkovo University. Skolkovo Open University
R&D
Service provider for Fund residents and Fund project companies
Training programmes
Ph students, young researchers
The Skolkovo Fund budget18
Example. CSF of BMT Cluster
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CSFMAJOR
COLLABORATOR
PARTNERSCO-INVESTOR, SUM OF
PROCEEDS IN 2011 FROM CO-INVESTOR
SUM OF PROCEEDS
FROM SKOLKOVO
FOUNDATION IN 2011
Structural Biology. Membrane protein and their complexes
MIPT
- Institute of Structural Biology (IBS, France) - EMBL, Grenoble - Research Centre (FZ-Juelich, Germany) - SCRIPPS Institute , (USA) - ONEKSIM group
ONEXIM GROUP: 100 MM RUB
MIPT: 160 MM RUB200 MM RUB
Pre-clinical research. GLP standards
IBC RAS (Pushchino)
- Astra Zeneca - RVC JSC - ITEB RAS (Pushchino) - Ministry of health, Russia
RVC JSC:150 MM RUB 150 MM RUB
Among the potential CSF of BMT Cluster “Center for Structural Biology of membrane proteins and complexes“ and "Center of preclinical studies in the GLP standards” are the most elaborated
Strategic co-investors In two pilot CSF identified.
The need for CSF establishment
Implementation of development strategy▪ Center for Shared Facilities (Center of Excellence) - a key element in implementation of the strategy
to create an innovative ecosystem by integrating services, education, research and innovation (commercialization) functions.
▪ Effective use of the Fund assets in development of infrastructure
▪ Effective use of time until 2014 to educate and train own qualified staff on the own equipment
▪ CSF – qualified and high-liquid endowment of the future SIST
The reasons to start in 2011
▪ Implementation of the development strategy- 011, announced and approved by the Council. Effective use of 2011 year budget.
▪ The presence of a significant amount of infrastructural facilities (existing CSF, university laboratories and research centers) that possess the required competencie. Many companies and institutional investors launch a series of infrastructure projects. The optimal time to enter into alliances with major co-investors to create CSF and CeO centers.
▪ Strong demand from Skolkovoparticipants
▪ The possibility of Russia Health Ministry participation
▪ A long lapse of time required for delivery and installation of laboratory equipment. The need to order the equipment in the 1H 2011 In order to run it in the 4Q 2011.
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BMT. System issues
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The requirement to coordinate and enhance state support of the
The leading countries actively support the creation of large BMT CSF as the
organizer and the customer of innovations in the biomedicine and
biopharmaceuticals
Example – EMBL (European Molecular Biology Laboratories) - Europe's leading
interstate Centre for Molecular Biology and Biomedicine (includes 80 European
research institutes and independent research groups)
Proposals
To approve the concept to establish BMT CSF within the budget approved by
the Fund in March 2011
To use the experience and best practices of CSF establishment of world's
leading centers with help of Scientific Advisory Board.