1
??????? ?????????? ?? ??????????? ? ????????? ??

• ???? ?????? ??????

2
?? ??????????? ???? ???? ?? ????? ??? ???? ????
??? ???? ???? ?????
3
Biotechnology

• Any activity that substantially involves
  research, development, or manufacturing of
• biologically active molecules
• devices that employ or affect biological
  processes
• devices and software for production or
  management of specific biological information

4
Medical Biotechnology trends

• Medical Biotechnology Trends in the World
• History
• Technology Needs
• Technology trend
• Medical Biotechnology Trends in Iran

5
Drug Discovery Important Milestones

• Ancient China Herbal Medicines
• 1800 Jenner Small Pox
• 1900 Modern Drug Discovery
• Bayer aspirin
• Hoechst salvarsan
• World War I US Industry starts
• World War II Penicillin
• 1980 Important Biotech Patents
• Cohen and Boyer
• 1980 Recombinant proteins
• 1990 Nucleic Acid and antibody therapies

6
General Types of Drugs

• Vaccines
• Therapeutics
• Small Molecules
• Synthetic
• Natural Products
• Biologics (recombinant proteins)
• Antibodies
• Nucleic Acids
• Therapeutics
• Antisense
• Ribozymes
• RNAi
• Gene Therapy
• Cell and Tissue therapy
• Stem Cell therapy

7
IP on recombinant protein
Expression
DNA seq
Delivery device
Protein
drug
Platform/ process
Vehicle
Excipient
8
Current trends of PharmaceuticalsBiopharmaceutica
ls

• About 80 of investigational products are
  pharmaceuticals
• About 20 of investigational products are
  Biopharmaceuticals

9
Trends of PharmaceuticalsBiopharmaceuticals
within 20 years

• About 50 of investigational products will be
  pharmaceuticals
• About 50 of investigational products will be
  Biopharmaceuticals

10
Trends of PharmaceuticalsBiopharmaceuticals
within 40 years

• About 20 of investigational products will be
  pharmaceuticals
• About 80 of investigational products will be
  Biopharmaceuticals

11

• Brief overview of biotechnology World market
• Biotechnology in the Islamic Republic of Iran
• Challenges and Suggestions

12
??????????? ?? ????
13
World Market (cont.)
14
Biotech Drugs and Vaccines Approval
15
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16
Private funds and/or Banking loans
Product Lifecycle
Discovery Development Market
Discovery Development Market

• Universities Universities and Research
  Center

Research Organization Centers
Scientific Papers
Basic Research
Applied Research
Products
Patents
Venture capitals
Incubators and Tech Parks
Public Funds
Public Funds
Subsidized Funds
17
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18
(No Transcript)
19
Pipeline Antibodies
Billions
Marketed Products
Source B of A Estimates
20
(No Transcript)
21
(No Transcript)
22
Capacity Shortage
23
????

• ??? IP ????????? ????? ????? ?? ????? ?????
  ????????? ?? ??? ?????.
• ???? ?? ??? ????? ??? ???? ???????? ????? ??
  ????? ??? ?? ?????? ????? ??????? ????? ?????
  ??????? ????? ????? ???? ???? ??? ???? ??? ?????
  ????? ??.
• ???? Merging ? Acquisition ??? ? ???? ??????
  ???? ???? ? ???? ??? ???? ???????? ???? ????
  ????? ?????? ?? ?? ??? ??? ?????? ? ????? ????
  ??? ????? ??????? ????? ????? ?? ???? ?? ??
  ?????.

24
????

• ????? ????? ????? ??????? ?? ?????? ???????????
  ?? ??????? ?? ??? ????? ???? ????? ????? ?????
  ??? ???? ?? ????? ??? ??????
• ???? ???? ??? ??????? ??? ????? ? ????? ???? ????
  ?? ??? ????? ??? ???? ??? ?????? ??? .
• ???????? ???? ??? ????? (?????? ??? ????) ????
  ??????? ??????????? (60-40)

25

• Biotech Progress in Iran

26
Biotech progress in Iran
27
??????????? ??????

• ???? 117 ???? ?? ???? ??????????? ????? ?? ????
• ????? 16 ????? ?? ?? ???? ???? ?? ?????
• ????? 324 ???? ?? ?????? ?????? ?? ?? ??? ???? ??
  ????? ?? ??? ?? ?? 4 ??? ???? ???? ????? ????
• ??? ???????? ???? ??????

28
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29
New Recombinant protein in the Pipeline in the
next two years
30
Biotech progress in Iran
31
Export of biotech Products
32
Molecular Medicine

• Prenatal Diagnostic for the following genetic
  Disorders Beta Thelassemia Hemophilia Muscular
  Dystrophy
• Molecular Diagnostic tests including TB HCV HBV
  H.pylori CMV Leishmaniasis Toxoplasmosis

33
The Drug Discovery Process
Traditional Small Molecules
Rec protien mAb
RNAi
15-24 months 27-50
months 42-66 months Total
Discovery Time
34
??????????? ?????? ?? ?????

• ???? 150 ??????? ????? ????? ?????? ???? 8 ?????
  ???????????
• ???? ??????? ??????????? ?? ???? ?? Patent ??
  ?????? ?? ?? ??? 200 ???? ?? 2000 ???? ?? ?????
• ??? ???? ?? ???? ?? ?? ??? ????? ?????? ????
  ?????? ?????? ???? 900- 800 ??????? ????? ?? 5
  ??? ????? ??? ?????? ????? ??

35
??????????? ?????? ?? ?????

• ????? 8 ??????? ?? 2 ??????? ?? ?? ??? ????? ????
  ????? ??
• ???? ???? ?? ?????? ????? ?? 50??????? ?????
• ?? ??? 88 ????? 5 ???? ???? ????? ????? ?? ??
  ???? ???? ????? ??60 ?????? ???? ??? ? ???? ????
  ?????? ????? ?? 10 ??????? ?????
• ????? ?????? ????? ?????? ?? ??????? ????? ?????
  ???? ??? ? ?? ????? ???? ???. ??? ???? ?? ???? ??
  ?? ??? ????? ?????? ????? ?? 106- ?????? ????
  ?????? ????.

36
Private companies

• Countries No. of Companies
• USA 1400
• England 680
• Sweden 144
• Israel 160
• Iran 42

37

• Production
• Education
• Roles and regulations

38
Funds Recourses

• Public Funds (Federal or national fund)
• Research Grants
• Innovation Grants
• State funds or local grants
• Subsidized funds
• Investment grants
• Development grants
• RD grants
• Venture capitals
• Banks
• Private funds
• Holding

Basic and Applied Research
Inventions and Technology Development
Product Development
39
Product Lifecycle in Iran
Universities and Research centers

• Basic Research Applied Research
  Innovation Product

Incubators
Tech Parks
Gateway to the International Market
Patent filing or scientific papers
No Product lifecycle in Iran due to 1. Research
is young in the country 2. No clients who
believe the research capabilities in the
country 3. Academic environment is training
oriented rather than research oriented 4.
Research and technology have no effect GNP 5.
There is no proper structure is available for
product lifecycle in the country
40
Funds available for RD In Iran

• Public funds
• Institutional grants
• Less than 500 million Rials
• National grants
• Max 100 million Rials
• Private
• Banking loans
• High interest rate

41

42
Technical Skills Needed

• Recombinant DNA Technology
• Fermentation and cell culture technology
• Product purification technology
• Analytical instrumentation technology
• Quality assurance and quality control
• Equipment and process validation
• Regulatory guidelines and compliance
• Process development
• Manufacturing engineering

43
Workforce Development

• Academic programs have not been developed to
  address the needs of the biomanufacturing industry

44
Industry Needs

• Due to rapidly evolving technology and increasing
  demands for manufacturing capacity, there is a
  shortage of trained personnel in all areas of
  biomanufacturing

45

• Created added value chain idea in the Academic
  Environment
• Allocated the Innovation Grant for the first time
  in Iran
• Bridge between lab and product
• Provide services and training for Patent
• Helps our scientists to be recognized by
  international market
• Equipment grants

46
Biotechnology Centers In Iran

• Research Centers in conventional Biotech
• Pasteur Institute of Iran
• Razi Institute
• Research Centers in Modern Biotech
• Now we have 14 Biotech Departments and research
  centers in UMS

47
????? ????????? ???? ??? ????? ???? ????
48

????? ????????? ???? ??? ????? ???? ????

• ?????? ????? ?? ???? ??? ?? ????? ?? ?????
  ????(????? ??? ?????? ??? ? ?????) ?? ???????????
  ????? ( ????? ? ?????).
• ?????? ??? ????? ? ????? ? ????? ????? ??????
  ???? ???? ???? ??? ????? ???? ?? ???? ?????
  ?? ????? ????? 200 ??? ?? ??????.
• ????? ??????? ? ???????? ?????? ????? ?? ?????
  ????? ??????? ??? ?????? ? ?????? ?? ???
  ????? ????? 70 ??????? ????? .
• ??? ? ????? ??? ????? ?? ?? ????? ????? 100 ????
  ???? ?? ????? ??????? ???? ?? ????.

49
????? ????????? ???? ??? ????? ???? ????

• ???????? ????? 5-4 ???? ?? ????? ????? ???????
  ??????????? ?? ???? ?????.
• ??????? ??? ?? ????? ????? ? ?????? ??? ???? ???
  ????? ??
• ?????? ????? ?????? ???? ??????? ?? ????? ?? ????
  ????? ??

50
????? ????????? ???? ??? ????? ???? ????

• 1 ?? ??? ??????? Innovative ???? ?? ?? ??? ?????
  ?? ????? ????.
• ??? ???? ????? 6 ?? GNP ?? ????? .

51
Iran in next 20 years

• Who has only BioGeneric Manufacturers
• - Poland - Egypt - Peru
• - Korea - Brazil - IRAN
• - Mexico - Argentina - India
• - Lithuania - China - Mexico
• Who has BOTH BioGeneric Manufacturers Brand
  Holders
• - USA - Europe - Canada
• Who has non of them
• - Arabic Countries - African Countries

52
????? ?????? ?? ??? 1404

• ????? ?????? ???? ? ?????? 2500 ????? ISI ?? ???
  .
• ????? 100 Patent ??? ??????.

53

• ???????? ??? ? ???? ??? ???? ??? ??
• ???? ????? ??? ? ???? ???

54
?????

• ?????? ????? ?????? ?? ???? ??? ?????? ? ?????
• ????? ??????? ????? ?? ???? ????????? ????
  ????????? ????? ?????? ? ??????
• ?????? ????? ?? ????? ???????? ? ?????? ????
  ?????? ????? ?????? ( 400-500 ?????? ???? ?? ????
  ?????? )

55
?????

• .1 ?????? ???? ?????? ???? 40 ??????? ?????
  ?????? ?????? 8 ? 20 ??????? ????? ???? ?????? 7
  ?? ???????.
• ???) ????? ?? ?? ??? ???? ?????? ??????? ?? ?????
  ?????? ???? ? ???? ????? ?? ???? ????? ???.
• ? ) 20-10 ???? ?? ??? ???? ?? ???? ??????? ?????
  ?? ???? ????? ?? ????? ????? ?????? ????. ?? ????
  ??? ???? ??? ?? ???? ????? ????? ?? ????? ???. (
  ???? ???????? )
• . 2???? ???? ????? ???? ???? ?? ??????? ?? ??
  ????? ????? ????? ???. ????? ?????? ? ?????
  ??????? ???? ????? ??????? ???? ????? ? ????? ?
  ????? ?? ?? ???? ????????? ?????? ? ??????
• .3??? ???? ???? 120 ???????? ???? ????? ?????
  ??????????? ??????
• .4?????? ??????? ???? ??????? ??????????? ????
  ??? 10 ?? 15 ???
• .5????? ?? ????? ??? ????????

56

57
(No Transcript)
58
??????? ????? - ????? ?? ????????? ?? ????
???????????
59
?????

• ?????
• ???????
• ??? ?????
• ????
• ???????
• ???????
• ???????
• ???
• ????????
• ?????? ????? ????

60
?????

• ??????? ???? ???? ???? ? ????? ???? ?? ???? ????
  ?????? ????? ???? ?? ?? ???? ????? ????? ??? ????
  ??? ?? ????? ?????? ???.
• ????? ????? ??? ?????? ???????? ??????? ?????
  ?? ???? ??????? ?????? ?? ??????? ??? ?? ????? ??
  ?????? ?????? ????? ????? ????? ??.
• ????? ???? ??? ???????? ? ????? ??? ??????? ???
  ?????
• ????? ???? ??? ??????????? ??? ? ????? ??

61
DuBiotech
62
Jeddeh Biocity
63
?? ????