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

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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

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Infr

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Uni

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In

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R

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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.