The document summarizes the Cluster of innovative biopharmaceutic «Park of active molecules» (PAM). PAM is a voluntary association of entities in innovative biopharmaceuticals located in Obninsk, Russia. It aims to improve members' complementary competences in areas like molecule development, biopharmaceutical services, and supporting biomedical research. PAM's infrastructure includes centers for drug delivery systems, pre-clinical and clinical studies, and contract manufacturing to support members' work. It also partners with research organizations and companies around Russia and the world to further members' projects.
2. Cluster of innovative biopharmaceutic «Park of active molecules»
Definition and general terms of
Cluster «Park of active molecules»
competences without borders
• Cluster PAM – voluntary association of legal entities regardless of
their forms of ownership and location, directly or indirectly
employed in the field of innovative biopharmaceuticals, with
complementary competences and mutual business relationship.
• Cluster PAM has local technology infrastructure (Obninsk, the
Kaluga region) and research & development network
(distributed) infrastructure.
• Cluster PAM has clearly detailed basic competences that will
improve and grow, particularly through integration with the best
Russian and international technological and research &
development centers, builds relationships with similar clusters on
basis of open partnership and mutual co-operation.
3. Cluster of innovative biopharmaceutic «Park of active molecules»
Basic competences
competences without borders
1. Providing services of molecules growing
– Molecules “growing” – carrying out of full scope of work,
including examination, dossier preparing, «packaging»,
investment project monitoring.
Molecules growing
(Managing company по Product
Idea
работе с проектами) (IP+dossier)
Big Pharma
Residents and partners of the
cluster PAM
4. Cluster of innovative biopharmaceutic «Park of active molecules»
Basic competences
competences without borders
2. Providing the full range of services for work with active
molecules
– Basic principals - efficiently, qualitatively, rationally.
Realization of this principal is possible due to synergies of
Member’s competences.
PAM’s members
астник ПАМ
PAM’s members
Marke Managing
company
t
PAM’s members
PAM’s members
5. Cluster of innovative biopharmaceutic «Park of active molecules»
Basic competences
competences without borders
3. Support center of investigations in the field of
biopharmaceuticals
– Basic principals – selection and development of own
promising directions of PAM’s cluster, taking into account of
Big Pharma wishes and collaboration with maximum possible
quantity of research centers, investigators, working in these
directions.
Ministry of Education Ministry of Industry Funds State programs
And Science and Trade
Research center
е
MC PAM , Testing laboratory
НТС
Research co-financing
ОРХ И МЕД
Big Pharma
Results
( IP, know-how)
-
6. Cluster of innovative biopharmaceutic «Park of active molecules»
The main PAM’s infrastructure elements
competences without borders
Technology center of finished
dosage form development
Institute of
technological
engineering
Production of sterile lyophilized
preparations
Administration building,
engineering services
Center of extraction
Center of Drug Delivery system
development
Institute of laboratory analysis
Multifunctional contract
manufacturing of АФС
Institute of pre-clinical and
clinical studies
Institute of promotion and
marketing
7. Cluster of innovative biopharmaceutic «Park of active molecules»
Network Partnership of PAM center
competences without borders
Engelhardt Institute of Molecular Federal Centers
Biology RAMS
Russian Academy of Science
Shemyakin and Ovchinnikov
Institute of Bioorganic Chemistry
RAMS Research Centers of Pharma Independent Competence
companies Centers
Bach Institute of Biochemistry
Ministry of Ministry of
RAMS
Education and Healthcare1 Center of Trans-genomic
Science
Russian Academy of Medical
Science
«Pharmstandart" and Post-genomic
Institute of Molecular Genetics technologies
RAMS
Centers of Pre-clinical
Rospotrebnadzor, State
Kurchatov Institute (particularly
center “Bioengineering")
Lomonosov Moscow State
Research Center for Applied «R-Pharma" studies(Puschino,
University Microbiology and Biotechnology Chernigolovka, MSU)
Novosibirsk Institute of Cytology
and Genetics Center of Structural Biology
Branch of Shemyakin and
St-Petersburg State University Institute of Immunology “Petrovaks pharm"
Ovchinnikov Institute of
Bioorganic Chemistry RAMS
(Puschino) Center of personalized
therapy of diseases and
Institute of chemical physics Research Institute of Genetics Moscow Medical University “Biocad" cancer
problems RAMS
(Chernogolovka)
Center of Regenerative
Other RAS centers2 Mechnicov Research Institute of
Kaluga University “Bioprocess" Medicine and cell
Other research centers of RAS3 Vaccines and Sera RAMS
technologies
Tomsk Biomedical Technopark
(Tomsk University and Medical Institute “Vector» (Novosibirsk)
Other manufactures of
Institute) innovative products
Other research centers of RAS3
Other state scientific and
Gercen Institute of Oncology
educational centers
1 including affiliate companies, particularly Federal Medical and Biological Agency, Ministry of Health and Social Development and Rospotrebnadzor
2 Other RAMS authorities include:Institute of Biochemistry and Genetics,Vavilov Institute of General Genetics, Zelinsky Institute of Organic Chemistry, Institute of Gene Biology, Institute of Chemical
Biology and Fundamental Medicine
3 Other RAMS authorities: Research Institute of Medical Genetics, Research Institute of pharmacology, Gamaleya Research Institute of Epidemiology and Microbiology, Blohin Russian Research Institute
of Oncology
7
8. Cluster of innovative biopharmaceutic «Park of active molecules»
Co-operation with investigators
competences without borders
1. Acquaintance
Business angels
Inve
2. Examination
Managing
stor
company
Investment funds
3. Structuring relations
Ideas man
Project
company
4. Project realization
5. Attracting investors
Managing
company
Business plan
6. Exit
Project road map
Structuring relations
Attracting Development
Development Pre-clinical
investments of
of analysis and Promotion,
and manufacturin Registration Production
and control clinical marketing
process g
methods studies
structure process
9. Cluster of innovative biopharmaceutic «Park of active molecules»
Business model of project implementation
competences without borders
Europe and USA
Studies according to FDA PRODUCT for
requirements up to phase II of strategic
clinical studies investors
9,0
Russia
8,0
1 stage: 2 stage: 3 stage: 4 stage:
выручка, млн. евро
Examinatio Preclinical Clinical studies, Product
n 7,0
of studies, FPP registration commercializati
IDEA project, pharmaceutical (up to 2 years) on, promotion PRODUCT
6,0
molecules substances (1 year)
(up to 6 registration
5,0 1,2
months) (1,5 years) 1,1
4,0 1
1,8 2
3,0 0,8 1,6
0,6 1,2
2,0 0,5
0,4 0,9
1,0 0,5 0,7 2 2,2 2,4
0,9 1,1 1,5
0,8
1 year 2 years 3 years 4 years 5 years
0,0
1 год 2 год 3 год 4 год 5 год 6 год 7 год
10. Cluster of innovative biopharmaceutic «Park of active molecules»
competences without borders
PARTNERSHIP
AGREEMENT
•
24а, Kurchatova st.,
• Obninsk,
• Kaluga region
• Tel./fax (48439)68192, 62755
• e-mail: medbiopharm@medbiopharm.ru