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SEMINAR ONSEMINAR ON
TRANSFER
OF
TECHNOLOG
Y
TRANSFER
OF
TECHNOLOG
Y
PRESENTED BY-
CHANDAN Kr. SINGH
M.Pharm ( 2nd
SEM)
1
September 21, 2013
September 21, 2013 2
¤ INTRODUCTION
¤ WAYS “TECHNOLOGY” IS TRANSFERRED
¤ TECHNOLOGY TRANSFER AGENT
¤ TYPES OF TECHNOLOGY
¤ CONSTITUENTS OF TECHNOLOGY TRNSFER
¤ CONENTS OF TECHNOLOGY TRANSFER
¤TECHNOLOGY TRANSFER TEAM & RESPONSIBILITY
¤ FUNCTIONS OF TECHNOLOGY
¤ FACTOR AFFECTING TECHNOLOGY
¤TECHNOLOGY TRANSFER CHECKLIST
¤ EXAMPLES OF TECHNOLOGY TRANSFER
¤ REFERENCES
CONTENTS
September 21, 2013
3
INTRODUCTION
It is a process which is mainly concerned with the transfer
of technology from the research areas to the “Production
and Quality Assurance” environment .
The Process by which existing knowledge , facilities
or capabilities developed under R & D funding are
utilized to fulfill public and private need.
“Technology Transfer” includes a range of formal &
informal cooperation between technology developers
and technology seekers.
September 21, 2013
4
Varied Roles
IDEA
Research
Development
Production
Manufacturing
Distribution
Start-up
Firms
R & D
Firms
Larger
Companies
Universities
Research
Institutes
MARKET
September 21, 2013
5
Ways “Technology” is Transferred
 Consulting
 Graduating students (“moving heads”)
 Faculty moving on (“moving heads”)
 Collaborative research
 Patenting and licensing
 Service and outreach (“extension”)
 Spin-off companies
September 21, 2013
6
Technology Transfer Agents
R&D Units
• Universities
• Public Research
Centers
• Technology
Institutes
(institutions, labs
etc)
R&D Units
• Universities
• Public Research
Centers
• Technology
Institutes
(institutions, labs
etc)
Companies
• Supplier of
technology
and R&D to third
parties
• Spin-off, start-ups
• Large R&D
department
• Competitors,
suppliers…
(technological
alliances)
Companies
• Supplier of
technology
and R&D to third
parties
• Spin-off, start-ups
• Large R&D
department
• Competitors,
suppliers…
(technological
alliances)
September 21, 2013
7
TYPES OF TECHNOLOGY
1) EMERGING TECHNOLOGY- is an innovative technology
that currently is undergoing bench scale testing, in which a
small version of the technology is tested in a laboratory.
2) INNOVATIVE TECHNOLOGY- is a technology that has
been field tested and applied to a hazardous waste problem at
a site, but lack a long history of full-scale use.
3) ESTABLISHED TECHNOLOGY- is a technology for
which cost and performance information is readily only after
a technology has been used at many different sites and the
result fully documented is that technology considered.
established.
September 21, 2013
8
CONSTITUENTS OF TECHNOLOGY
TRANSFER PROCESS
Technology Transfer
Technology Promotion
Technology Deployment
Technology innovation
Technology Development
Technology Research
Technology Assessment
Technology Information and
Communication
Technology Investment
Technology Collaboration
Technology
Commercialization
September 21, 2013
9
September 21, 2013
10
CONTENT OF TECHNOLOGY TRANSFER
6 P
September 21, 2013
11
Proper Research – By proper research we mean firstly that in
which the result are reproducible and issues such as scale up,
stability etc and other practical now has been addressed, also that
in which problem were taken up in first place.
Proper Research – By proper research we mean firstly that in
which the result are reproducible and issues such as scale up,
stability etc and other practical now has been addressed, also that
in which problem were taken up in first place.
Proper work- This refer to institutional and guidelines regarding
IP Protection licensing modalities etc. which must be in place
beforehand. In the absence of these, decision get delayed, lack of
fairness in decision e.g. case of X institute, which came up with
good technology but since no guidance were there, kept running
around for two years and then gave up.
Proper work- This refer to institutional and guidelines regarding
IP Protection licensing modalities etc. which must be in place
beforehand. In the absence of these, decision get delayed, lack of
fairness in decision e.g. case of X institute, which came up with
good technology but since no guidance were there, kept running
around for two years and then gave up.
September 21, 2013
12
Pricing – most difficult and critical area of Transfer of
technology.
- Too high price can put off buyer, leaving the technology
unsold.
- Too price a result in revenue loss.
- There are basically two model regarding pricing
1)Price charged for a technology should depend upon
market force i.e. impact of the technology irrespective of
amount spent on developing it.
2)Price charged should include all expenses involved in
developing it.
Publicity – It is important to identify and then approach
buyer i.e. adopt targeted Publicity and not blanket publicity.
Specific journal, website, letters to manufacturer, personal
selective visit etc. are some common approach which help in
locating buyer.
September 21, 2013
13
Partnership – this means working along with industry.
Industry takes it up, manufacturer and makes available to
society. Partnership are important to ensure your
technology is successfully adopted simply conveying the
details may not be sufficient.
Partnership – this means working along with industry.
Industry takes it up, manufacturer and makes available to
society. Partnership are important to ensure your
technology is successfully adopted simply conveying the
details may not be sufficient.
People’s Acceptance – It is no use trying to develop a
technology which people will not accept e.g. due to religious
reason/social concern etc. genetically modified food,
irradiated vegetables processed beef in India, improved
capsule made of non-vegetarian material.
September 21, 2013
14
LIST OF INSTITUTE IN INDIA ASSISSTING IN TECHNOLOGY
TRANSFER
 Asia pacific centre for Transfer of technology ( APCTT)
 Technology Bureau for small enterprises ( TBSE)
 National Research & Development corporation
 Foundation for Innovation and Technology Transfer
Process
technologist
• central focus for transfer activities
• collates documentation from donor site
• perform initial assessment of transferred project
for a) feasibility
b) compatibility with site capabilities
c) establishes resource requirements
Representative Review documentation to determine compliance with
Marketing authorization (MA)
Review analytical methods with QC to determine
capability, equipment training requirements.
Initiate conversion of donor site documentation into
local system/format
Initiate or confirm regulatory requirement, e.g. change
to manufacturing license , variations to MA if process
changes needed, etc.
September 21, 2013
15
Proposed Team Member and Their Responsibilities
Production
representative
Review process instructions (with process
technologist) to confirm capacity/
capability
Considers any safety implication e.g.
solvents, toxic, sanitizing materials
Consider impact on local standard
operating procedures (SOPs)
Consider training requirement of
supervisors/ operator
Engineering
representative
Review (with production representative)
equipment requirement
Initiate required engineering modification/
change/ part purchase.
Review preventative maintenance/
calibration impact, e.g. use of more
aggressive ingredients: more temperature
sensitive process, and modifies
accordingly.
September 21, 2013
16
September 21, 2013
17
FUNCTION OF TECHNOLOGY TRANSFER
TEAM
1) Coordinate- Coordinating between technology users and
developer, between researcher and manufacturers is important
element of technology transfer.
2) nurture- A main ingredient for moving technology from a
research laboratory to a new business enterprises successfully
in an environment that is supportive for entrepreneurship.
3) LinK- Cataloging resources related to business enterprises &
connecting would be entrepreneurship / researcher and other
technology developers to outside group & organization which
can help in the process of starting new product, companies etc.
such linkage provide referrals for individual business
counseling, sources of financing.
September 21, 2013
18
FACTOR AFFECTING TECHNOLOGY
TRANSFER
TIPS Method ( Technology implementation Potential
for Success)
TIPS Method ( Technology implementation Potential
for Success)
September 21, 2013
19
teCnoLoGY tranSFer
CHeCKLiSt
September 21, 2013
20
September 21, 2013
21
EXAMPLES OF TECHNOLOGY TRANSFER
CHINA
L – Phenyl alanine
By enzyme method
(Ref : APC – 4041 – TOF)
# Chinese company offer
technology for the production
of L- Phenyl alanine by the
enzyme method.
Area of Application
# Food industry
Advantage-
 Low input
 Advanced process
 No environmental contamination
 Clear production
September 21, 2013
22
Stage of development
 commercialized
Economic data
 Total project cost 4 million
 Equipment 1.38million
Transfer form
 Known how, consultancy, equipment,
training
Target country
 world wide
Language
 English
September 21, 2013
23
A Novel, Non-infringing Process for the
manufacture of levobupivacaine
A Novel, Non-infringing Process for the
manufacture of levobupivacaine
NIPER, mohali offer a non-infringing process for the
manufacturer of an improved widely used local anesthetic,
levobupivacaine.
The process uses a chiral catalyst for asymmetric
synthesis of the product.
Area of Application
 Local anesthetic product widely used in hospital in
surgical procedure.
September 21, 2013
24
Advantage of technology
 Uses easily available raw material
 Faster compared to existing process as no
resolution involved.
 Cheaper as use of expensive resolving agent is
altogether eliminated
 Non-infringing new process
September 21, 2013
25
Stage of Development
 Process at laboratory scale
 Scale up to be done
 Facilities for scale up exist at institute ( pilot plant
available)
Economic Data
 Product name – Chirocane, ( approved clinically)
 No manufacturer in India till date
Transfer form
 Technology licensing and Known how
September 21, 2013
26
Manufacturer of Pharmaceutical Raw Materials,
Pharmacopoeial Fine Chemicals,
Active Nutraceuticals,
Laboratory Reagents (Bulk)
(LR /AR/ ACS/FCC)
September 21, 2013
27
Nutraceuticals
Pharmacopoeial Fine Chemicals
EDTA Fine Chemicals
Phosphates Fine Chemicals
Azithromycin APIs

Sorbic Acid & Potassium Sorbate

Potassium Phthalimide
Citrate Fine Chemicals
Inositol & Inositol Nicotinate
September 21, 2013
28
TECHNOLOGIES TRANSFER :
Bimal pharma PVT. Ltd. A team of technically highly
qualified technocrats in the pharmaceutical field, having
experience of manufacturing of API, intermediates,
pharma fine chemicals and pharma formulations, for
more than 25 years, they offer complete “turn-key”
project services including detailed engineering,
complete demonstration of manufacturing processes of
all apis; intermediates for apis; pharma fine chemicals
and pharma formulations.
They are also experts in supplying the best quality
intermediates / penultimate stages, along with
technologies to make final apis to suit your US FDA /
WHO-GMP approved manufacturing units for different
countries.
September 21, 2013
29
REFERENCES
1) Ira R. Berry, “ Technology Transfer Consideration for
Pharmaceuticals”, Encyclopedia of Pharmaceutical
Technology, Third Edition, 02 oct. 2006, pp. no. 20-30.
2) http://www.gdrc.org/uem/techtran.html
3) Luis Alberto del Río, Salazar N., and Trives C.“Guidelines for
a pharmaceutical technology transfer towards a drug
manufacturing plant”, Comunicaciones técnicas, Bol. Soc.
Quím. Méx. 2007, 1(1), pp no. 27-31
4) http://bud.tic.ab.ca/venquest/yqt_home.htm
September 21, 2013
30

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Technology transfer

  • 1. SEMINAR ONSEMINAR ON TRANSFER OF TECHNOLOG Y TRANSFER OF TECHNOLOG Y PRESENTED BY- CHANDAN Kr. SINGH M.Pharm ( 2nd SEM) 1 September 21, 2013
  • 2. September 21, 2013 2 ¤ INTRODUCTION ¤ WAYS “TECHNOLOGY” IS TRANSFERRED ¤ TECHNOLOGY TRANSFER AGENT ¤ TYPES OF TECHNOLOGY ¤ CONSTITUENTS OF TECHNOLOGY TRNSFER ¤ CONENTS OF TECHNOLOGY TRANSFER ¤TECHNOLOGY TRANSFER TEAM & RESPONSIBILITY ¤ FUNCTIONS OF TECHNOLOGY ¤ FACTOR AFFECTING TECHNOLOGY ¤TECHNOLOGY TRANSFER CHECKLIST ¤ EXAMPLES OF TECHNOLOGY TRANSFER ¤ REFERENCES CONTENTS
  • 3. September 21, 2013 3 INTRODUCTION It is a process which is mainly concerned with the transfer of technology from the research areas to the “Production and Quality Assurance” environment . The Process by which existing knowledge , facilities or capabilities developed under R & D funding are utilized to fulfill public and private need. “Technology Transfer” includes a range of formal & informal cooperation between technology developers and technology seekers.
  • 4. September 21, 2013 4 Varied Roles IDEA Research Development Production Manufacturing Distribution Start-up Firms R & D Firms Larger Companies Universities Research Institutes MARKET
  • 5. September 21, 2013 5 Ways “Technology” is Transferred  Consulting  Graduating students (“moving heads”)  Faculty moving on (“moving heads”)  Collaborative research  Patenting and licensing  Service and outreach (“extension”)  Spin-off companies
  • 6. September 21, 2013 6 Technology Transfer Agents R&D Units • Universities • Public Research Centers • Technology Institutes (institutions, labs etc) R&D Units • Universities • Public Research Centers • Technology Institutes (institutions, labs etc) Companies • Supplier of technology and R&D to third parties • Spin-off, start-ups • Large R&D department • Competitors, suppliers… (technological alliances) Companies • Supplier of technology and R&D to third parties • Spin-off, start-ups • Large R&D department • Competitors, suppliers… (technological alliances)
  • 7. September 21, 2013 7 TYPES OF TECHNOLOGY 1) EMERGING TECHNOLOGY- is an innovative technology that currently is undergoing bench scale testing, in which a small version of the technology is tested in a laboratory. 2) INNOVATIVE TECHNOLOGY- is a technology that has been field tested and applied to a hazardous waste problem at a site, but lack a long history of full-scale use. 3) ESTABLISHED TECHNOLOGY- is a technology for which cost and performance information is readily only after a technology has been used at many different sites and the result fully documented is that technology considered. established.
  • 8. September 21, 2013 8 CONSTITUENTS OF TECHNOLOGY TRANSFER PROCESS Technology Transfer Technology Promotion Technology Deployment Technology innovation Technology Development Technology Research Technology Assessment Technology Information and Communication Technology Investment Technology Collaboration Technology Commercialization
  • 10. September 21, 2013 10 CONTENT OF TECHNOLOGY TRANSFER 6 P
  • 11. September 21, 2013 11 Proper Research – By proper research we mean firstly that in which the result are reproducible and issues such as scale up, stability etc and other practical now has been addressed, also that in which problem were taken up in first place. Proper Research – By proper research we mean firstly that in which the result are reproducible and issues such as scale up, stability etc and other practical now has been addressed, also that in which problem were taken up in first place. Proper work- This refer to institutional and guidelines regarding IP Protection licensing modalities etc. which must be in place beforehand. In the absence of these, decision get delayed, lack of fairness in decision e.g. case of X institute, which came up with good technology but since no guidance were there, kept running around for two years and then gave up. Proper work- This refer to institutional and guidelines regarding IP Protection licensing modalities etc. which must be in place beforehand. In the absence of these, decision get delayed, lack of fairness in decision e.g. case of X institute, which came up with good technology but since no guidance were there, kept running around for two years and then gave up.
  • 12. September 21, 2013 12 Pricing – most difficult and critical area of Transfer of technology. - Too high price can put off buyer, leaving the technology unsold. - Too price a result in revenue loss. - There are basically two model regarding pricing 1)Price charged for a technology should depend upon market force i.e. impact of the technology irrespective of amount spent on developing it. 2)Price charged should include all expenses involved in developing it. Publicity – It is important to identify and then approach buyer i.e. adopt targeted Publicity and not blanket publicity. Specific journal, website, letters to manufacturer, personal selective visit etc. are some common approach which help in locating buyer.
  • 13. September 21, 2013 13 Partnership – this means working along with industry. Industry takes it up, manufacturer and makes available to society. Partnership are important to ensure your technology is successfully adopted simply conveying the details may not be sufficient. Partnership – this means working along with industry. Industry takes it up, manufacturer and makes available to society. Partnership are important to ensure your technology is successfully adopted simply conveying the details may not be sufficient. People’s Acceptance – It is no use trying to develop a technology which people will not accept e.g. due to religious reason/social concern etc. genetically modified food, irradiated vegetables processed beef in India, improved capsule made of non-vegetarian material.
  • 14. September 21, 2013 14 LIST OF INSTITUTE IN INDIA ASSISSTING IN TECHNOLOGY TRANSFER  Asia pacific centre for Transfer of technology ( APCTT)  Technology Bureau for small enterprises ( TBSE)  National Research & Development corporation  Foundation for Innovation and Technology Transfer
  • 15. Process technologist • central focus for transfer activities • collates documentation from donor site • perform initial assessment of transferred project for a) feasibility b) compatibility with site capabilities c) establishes resource requirements Representative Review documentation to determine compliance with Marketing authorization (MA) Review analytical methods with QC to determine capability, equipment training requirements. Initiate conversion of donor site documentation into local system/format Initiate or confirm regulatory requirement, e.g. change to manufacturing license , variations to MA if process changes needed, etc. September 21, 2013 15 Proposed Team Member and Their Responsibilities
  • 16. Production representative Review process instructions (with process technologist) to confirm capacity/ capability Considers any safety implication e.g. solvents, toxic, sanitizing materials Consider impact on local standard operating procedures (SOPs) Consider training requirement of supervisors/ operator Engineering representative Review (with production representative) equipment requirement Initiate required engineering modification/ change/ part purchase. Review preventative maintenance/ calibration impact, e.g. use of more aggressive ingredients: more temperature sensitive process, and modifies accordingly. September 21, 2013 16
  • 17. September 21, 2013 17 FUNCTION OF TECHNOLOGY TRANSFER TEAM 1) Coordinate- Coordinating between technology users and developer, between researcher and manufacturers is important element of technology transfer. 2) nurture- A main ingredient for moving technology from a research laboratory to a new business enterprises successfully in an environment that is supportive for entrepreneurship. 3) LinK- Cataloging resources related to business enterprises & connecting would be entrepreneurship / researcher and other technology developers to outside group & organization which can help in the process of starting new product, companies etc. such linkage provide referrals for individual business counseling, sources of financing.
  • 18. September 21, 2013 18 FACTOR AFFECTING TECHNOLOGY TRANSFER TIPS Method ( Technology implementation Potential for Success) TIPS Method ( Technology implementation Potential for Success)
  • 19. September 21, 2013 19 teCnoLoGY tranSFer CHeCKLiSt
  • 21. September 21, 2013 21 EXAMPLES OF TECHNOLOGY TRANSFER CHINA L – Phenyl alanine By enzyme method (Ref : APC – 4041 – TOF) # Chinese company offer technology for the production of L- Phenyl alanine by the enzyme method. Area of Application # Food industry Advantage-  Low input  Advanced process  No environmental contamination  Clear production
  • 22. September 21, 2013 22 Stage of development  commercialized Economic data  Total project cost 4 million  Equipment 1.38million Transfer form  Known how, consultancy, equipment, training Target country  world wide Language  English
  • 23. September 21, 2013 23 A Novel, Non-infringing Process for the manufacture of levobupivacaine A Novel, Non-infringing Process for the manufacture of levobupivacaine NIPER, mohali offer a non-infringing process for the manufacturer of an improved widely used local anesthetic, levobupivacaine. The process uses a chiral catalyst for asymmetric synthesis of the product. Area of Application  Local anesthetic product widely used in hospital in surgical procedure.
  • 24. September 21, 2013 24 Advantage of technology  Uses easily available raw material  Faster compared to existing process as no resolution involved.  Cheaper as use of expensive resolving agent is altogether eliminated  Non-infringing new process
  • 25. September 21, 2013 25 Stage of Development  Process at laboratory scale  Scale up to be done  Facilities for scale up exist at institute ( pilot plant available) Economic Data  Product name – Chirocane, ( approved clinically)  No manufacturer in India till date Transfer form  Technology licensing and Known how
  • 26. September 21, 2013 26 Manufacturer of Pharmaceutical Raw Materials, Pharmacopoeial Fine Chemicals, Active Nutraceuticals, Laboratory Reagents (Bulk) (LR /AR/ ACS/FCC)
  • 27. September 21, 2013 27 Nutraceuticals Pharmacopoeial Fine Chemicals EDTA Fine Chemicals Phosphates Fine Chemicals Azithromycin APIs  Sorbic Acid & Potassium Sorbate  Potassium Phthalimide Citrate Fine Chemicals Inositol & Inositol Nicotinate
  • 28. September 21, 2013 28 TECHNOLOGIES TRANSFER : Bimal pharma PVT. Ltd. A team of technically highly qualified technocrats in the pharmaceutical field, having experience of manufacturing of API, intermediates, pharma fine chemicals and pharma formulations, for more than 25 years, they offer complete “turn-key” project services including detailed engineering, complete demonstration of manufacturing processes of all apis; intermediates for apis; pharma fine chemicals and pharma formulations. They are also experts in supplying the best quality intermediates / penultimate stages, along with technologies to make final apis to suit your US FDA / WHO-GMP approved manufacturing units for different countries.
  • 29. September 21, 2013 29 REFERENCES 1) Ira R. Berry, “ Technology Transfer Consideration for Pharmaceuticals”, Encyclopedia of Pharmaceutical Technology, Third Edition, 02 oct. 2006, pp. no. 20-30. 2) http://www.gdrc.org/uem/techtran.html 3) Luis Alberto del Río, Salazar N., and Trives C.“Guidelines for a pharmaceutical technology transfer towards a drug manufacturing plant”, Comunicaciones técnicas, Bol. Soc. Quím. Méx. 2007, 1(1), pp no. 27-31 4) http://bud.tic.ab.ca/venquest/yqt_home.htm