amp eng

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»

• 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.



Basic competences

1. Providing services of molecules growing

– Molecules “growing” – carrying out of full scope of work,

including examination, dossier preparing, «packaging»,

investment project monitoring.

Idea Product

(IP+dossier)

Molecules growing

(Managing company по

работе с проектами)

Residents and partners of the

cluster PAM

Big Pharma



Basic competences

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

PAM’s members

астник ПАМ

PAM’s members

Managing

company

PAM’s members

Marke

t



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.

Basic competences

Research co-financing

MC PAM ,

НТС

Results ( IP, know-how) -

е

Big Pharma

Ministry of Education

And Science

Ministry of Industry

and Trade Funds State programs

ОРХ И МЕД

Testing laboratory

Research center



The main PAM’s infrastructure elements

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 7

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

Other RAS centers2

Federal Centers Engelhardt Institute of Molecular

Biology RAMS

Branch of Shemyakin and

Ovchinnikov Institute of

Bioorganic Chemistry RAMS

(Puschino)

Other research centers of RAS3

Research Institute of Genetics

Other state scientific and

educational centers

Kaluga University

Tomsk Biomedical Technopark

(Tomsk University and Medical

Institute)

Lomonosov Moscow State

University

St-Petersburg State University

Moscow Medical University

Mechnicov Research Institute of

Vaccines and Sera RAMS

Institute “Vector» (Novosibirsk)

Rospotrebnadzor, State Research Center for Applied Microbiology and Biotechnology

Institute of Immunology

«Pharmstandart"

“Petrovaks pharm"

Other manufactures of

innovative products

“Biocad"

“Bioprocess"

Research Centers of Pharma

companies

Russian Academy of Science

Russian Academy of Medical

Science

Gercen Institute of Oncology

Shemyakin and Ovchinnikov

Institute of Bioorganic Chemistry

RAMS

Bach Institute of Biochemistry

RAMS

Institute of Molecular Genetics

RAMS

Kurchatov Institute (particularly

center “Bioengineering")

Ministry of

Healthcare1

Ministry of

Education and

Science

Novosibirsk Institute of Cytology

and Genetics

Institute of chemical physics

problems RAMS

(Chernogolovka)

Other research centers of RAS3

«R-Pharma"

Center of Trans-genomic

and Post-genomic

technologies

Independent Competence

Centers

Centers of Pre-clinical

studies(Puschino,

Chernigolovka, MSU)

Center of Structural Biology

Center of personalized

therapy of diseases and

cancer

Center of Regenerative

Medicine and cell

technologies

Network Partnership of PAM center



Co-operation with investigators

Inve

stor

Structuring relations

Ideas man

Business plan

Project road map

Project

company

Investment funds

Business angels

Managing

company

Managing

company

1. Acquaintance

2. Examination

3. Structuring relations

4. Project realization

5. Attracting investors

6. Exit

Attracting

investments

and

process structure

Development

of

manufacturin

g

process

Development

of analysis

and control

methods

Pre-clinical

and

clinical

studies

Registration Production

Promotion,

marketing



Business model of project implementation

1 stage:

Examinatio

n of

project,

molecules

(up to 6

months)

2 stage:

Preclinical

studies,

pharmaceutical

substances

registration

(1,5 years)

3 stage:

Clinical studies,

FPP registration

(up to 2 years)

4 stage:

Product

commercializati

on, promotion

(1 year)

0,8 0,9 1,1 1,5 2 2,2 2,4 2,6 2,9 3,2 3,30,5 0,7

0,91,2

1,61,8 2

2,22,4

2,6 2,9

0,40,5

0,6

0,8

11,1

1,21,4

1,51,6

1,8

0,0

1,0

2,0

3,0

4,0

5,0

6,0

7,0

8,0

9,0

1 год 2 год 3 год 4 год 5 год 6 год 7 год 8 год 9 год 10 год 11 год

вы

ру

чка

, м

лн

. е

вр

о

Йодказеин Флавоцен Селексен

1 year 2 years 3 years 4 years 5 years

IDEA PRODUCT

Russia

Studies according to FDA

requirements up to phase II of

clinical studies

PRODUCT for

strategic

investors

Europe and USA



PARTNERSHIP

AGREEMENT

• 24а, Kurchatova st.,

• Obninsk,

• Kaluga region

• Tel./fax (48439)68192, 62755

• e-mail: [email protected]