2. Five key elements of the BMT innovation ecosystem
Community of
BMT residents
InfrastructuresRegulatory environment
Training / Educational
Programs
BMT Ecosystem.
5
4 3
2
1
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
1
3. Cooperation with Government of the Russian Federation
2
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
4. Cooperation with institutional partners
3
•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 "ROSNANO
April-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
5. Cooperation with regional biomedicine and biopharmaceutical
clusters
4
Feb 2011 Agreement of joining the BMT
Cluster to the Supervisory Board of the
BFC “Severny“ signed
Feb-May 2011 Joint educational program
Apr-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 signed
Feb-May 2011 Examination of joint
projects
Apr 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
6. Creating the «educational environment» within the BMT Сluster
5
Molecular genetics
Synthetic biology
System bioinformatics
Cluster’s link-
laboratories
Cluster’s project
companies (and their
scientific partners)
«Bortnic’s
Fund»
External special system specialized
scientific knowledge providers
“Skolkovo” University Biomedical faculty
External 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
7. Educational Programs of BMT Cluster
6
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 testing
May 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
8. Projects of Biomed Cluster (20/6)
7
PROJECT TITLE FORESIGHT
PROJECT 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 FCELLS BIO-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
9. Projects of Biomed Cluster
8
PROJECT TITLE FORESIGHT COMPANY
PHARMACEUTICALS FROM THE MODIFIED BIOPOLYMER CARBOHYDRATES BIO-PHARMA VOSTOKFARM INNOVATIONS LLC
TARGETED MULTIMODAL DIAGNOSTIC AND THERAPEUTIC AGENTS ON THE
CARRIER OF "CORE-CARBON SHELL“ STRUCTURE
BIO-PHARMA
URAL 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
10. Projects of Biomed Cluster
9
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-PHARMA QUANTUM 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-HEALTHCARE INNOVATION TECHNOLOGIES LLC
FIFTEEN PROJECTS RECEIVED PARTICIPANT CERTIFICATE
11. 10
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
13. CSFs and the BMT foresights. Equipment and competencies
Early development Lead optimization Preclinical Clinical - Registration and launch
Transgenomic and postgenomic technologies
Foresight.
Biomedicine
and Bio-
pharmaceutics
Complex modeling and simulation. Biomedical Informatics
«Proteomics , and other omics
Preclinical and clinical studies. P4 Medicine. Cancer
)
Foresight
Bioinformatics
Preclinical. GLPStructural Biology»
Directed evolution Artificial
ecosystems
Scaling upй Foresight
Industrial biotechnologies
Synthetic biology
Regenerative medicine
«
AB and other novel therapies
Infection diseases»
12
14. 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)
13
15. 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 projects
Educational and retraining
programmes
14
Services
16. ResidentsInfrastructuresUniversityInvestors
Regulatory
environment
20142012 - 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 Fund
Creation of service centers of legal assistance based on
Techno park
BMT CSF development pipeline
15
17. 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.
16
18. 17
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 budget
17
19. Example. CSF of BMT Cluster
18
CSF
MAJOR
COLLABORATOR
PARTNERS
CO-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 RUB
200 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.
20. 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.
19
21. BMT. System issues
20
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.