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competences without borders


          Cluster
      of innovative
    biopharmaceutic
«Park of active molecules»
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.
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
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
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)
                                                                   -
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
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
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
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
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

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Amp eng

  • 1. competences without borders Cluster of innovative biopharmaceutic «Park of active molecules»
  • 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