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December 3, 2013

SEMINAR ON
SEMINAR ON

TRANSFER
TRANSFER
OF
OF
TECHNOLOG
TECHNOLOG
Y
Y
PRESENTED BYCHANDAN Kr. SINGH
M.Pharm ( 2nd SEM)

1
CONTENTS
€ 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
December 3, 2013

2
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.

December 3, 2013

3
Varied Roles
IDEA
Start-up
Firms
R&D
Firms

Research
Development

Universities
Research
Institutes

Production

Larger
Companies

Manufacturing
Distribution
MARKET

December 3, 2013

4
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
December 3, 2013

5
Technology Transfer Agents
R&D Units
R&D Units
‱ Universities
‱ Universities
‱ Public Research
‱ Public Research
Centers
Centers
‱ Technology
‱ Technology
Institutes
Institutes
(institutions, labs
(institutions, labs
etc)
etc)

December 3, 2013

Companies
Companies
‱ Supplier of
‱ Supplier of
technology
technology
and R&D to third
and R&D to third
parties
parties
‱ Spin-off, start-ups
‱ Spin-off, start-ups
‱ Large R&D
‱ Large R&D
department
department
‱ Competitors,
‱ Competitors,
suppliers

suppliers

(technological
(technological
alliances)
alliances)

6
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 TECHNOLOGYis 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.
December 3, 2013

7
CONSTITUENTS OF TECHNOLOGY
TRANSFER PROCESS

Technology Transfer
Technology Promotion
Technology Deployment
Technology innovation
Technology Development
Technology Research
Technology Assessment

December 3, 2013

Technology Information and
Communication
Technology Investment
Technology Collaboration
Technology
Commercialization

8
December 3, 2013

9
CONTENT OF TECHNOLOGY TRANSFER

6P

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10
Proper Research – By proper research we mean firstly that in
Proper Research – By proper research we mean firstly that in
which the result are reproducible and issues such as scale up,
which the result are reproducible and issues such as scale up,
stability etc and other practical now has been addressed, also that
stability etc and other practical now has been addressed, also that
in which problem were taken up in first place.
in which problem were taken up in first place.

Proper work- This refer to institutional and guidelines regarding
Proper work- This refer to institutional and guidelines regarding
IP Protection licensing modalities etc. which must be in place
IP Protection licensing modalities etc. which must be in place
beforehand. In the absence of these, decision get delayed, lack of
beforehand. In the absence of these, decision get delayed, lack of
fairness in decision e.g. case of X institute, which came up with
fairness in decision e.g. case of X institute, which came up with
good technology but since no guidance were there, kept running
good technology but since no guidance were there, kept running
around for two years and then gave up.
around for two years and then gave up.

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11
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.
December 3, 2013

12
Partnership – this means working along with industry.
Partnership – this means working along with industry.
Industry takes it up, manufacturer and makes available to
Industry takes it up, manufacturer and makes available to
society. Partnership are important to ensure your
society. Partnership are important to ensure your
technology is successfully adopted simply conveying the
technology is successfully adopted simply conveying the
details may not be sufficient.
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.

December 3, 2013

13
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

December 3, 2013

14
December 3, 2013

Proposed Team Member and Their Responsibilities
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
‱

Process
technologist

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.
15
Production
representative

Engineering
representative

December 3, 2013
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

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.
16
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.
December 3, 2013

17
FACTOR AFFECTING TECHNOLOGY
TRANSFER
TIPS Method (( Technology implementation Potential
TIPS Method Technology implementation Potential
for Success)
for Success)

December 3, 2013

18
December 3, 2013

teCnoLoGY tranSFer
CHeCKLiSt

19
December 3, 2013

20
EXAMPLES OF TECHNOLOGY TRANSFER

# Chinese company offer
technology for the production
of L- Phenyl alanine by the
enzyme method.

CHINA
L – Phenyl alanine
By enzyme method
(Ref : APC – 4041 – TOF)

Area of Application
# Food industry

Advantage





Low input
Advanced process
No environmental contamination
Clear production

December 3, 2013

21
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

December 3, 2013

English
22
A Novel, Non-infringing Process for the
A Novel, Non-infringing Process for the
manufacture of levobupivacaine
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.

December 3, 2013

23
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

December 3, 2013

24
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


December 3, 2013

Technology licensing and Known how

25
Manufacturer of Pharmaceutical Raw Materials,
Pharmacopoeial Fine Chemicals,
Active Nutraceuticals,
Laboratory Reagents (Bulk)
(LR /AR/ ACS/FCC)

December 3, 2013

26
Nutraceuticals
Pharmacopoeial Fine Chemicals
EDTA Fine Chemicals
Phosphates Fine Chemicals
Azithromycin APIs

Sorbic Acid & Potassium Sorbate

Potassium Phthalimide
Citrate Fine Chemicals
Inositol & Inositol Nicotinate

December 3, 2013

27
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.

December 3, 2013

28
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 tĂ©cnicas, Bol. Soc.
QuĂ­m. MĂ©x. 2007, 1(1), pp no. 27-31
4) http://bud.tic.ab.ca/venquest/yqt_home.htm
December 3, 2013

29
December 3, 2013

30

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Technology transfer

  • 1. December 3, 2013 SEMINAR ON SEMINAR ON TRANSFER TRANSFER OF OF TECHNOLOG TECHNOLOG Y Y PRESENTED BYCHANDAN Kr. SINGH M.Pharm ( 2nd SEM) 1
  • 2. CONTENTS € 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 December 3, 2013 2
  • 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. December 3, 2013 3
  • 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 December 3, 2013 5
  • 6. Technology Transfer Agents R&D Units R&D Units ‱ Universities ‱ Universities ‱ Public Research ‱ Public Research Centers Centers ‱ Technology ‱ Technology Institutes Institutes (institutions, labs (institutions, labs etc) etc) December 3, 2013 Companies Companies ‱ Supplier of ‱ Supplier of technology technology and R&D to third and R&D to third parties parties ‱ Spin-off, start-ups ‱ Spin-off, start-ups ‱ Large R&D ‱ Large R&D department department ‱ Competitors, ‱ Competitors, suppliers
 suppliers
 (technological (technological alliances) alliances) 6
  • 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 TECHNOLOGYis 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. December 3, 2013 7
  • 8. CONSTITUENTS OF TECHNOLOGY TRANSFER PROCESS Technology Transfer Technology Promotion Technology Deployment Technology innovation Technology Development Technology Research Technology Assessment December 3, 2013 Technology Information and Communication Technology Investment Technology Collaboration Technology Commercialization 8
  • 10. CONTENT OF TECHNOLOGY TRANSFER 6P December 3, 2013 10
  • 11. Proper Research – By proper research we mean firstly that in Proper Research – By proper research we mean firstly that in which the result are reproducible and issues such as scale up, which the result are reproducible and issues such as scale up, stability etc and other practical now has been addressed, also that stability etc and other practical now has been addressed, also that in which problem were taken up in first place. in which problem were taken up in first place. Proper work- This refer to institutional and guidelines regarding Proper work- This refer to institutional and guidelines regarding IP Protection licensing modalities etc. which must be in place IP Protection licensing modalities etc. which must be in place beforehand. In the absence of these, decision get delayed, lack of beforehand. In the absence of these, decision get delayed, lack of fairness in decision e.g. case of X institute, which came up with fairness in decision e.g. case of X institute, which came up with good technology but since no guidance were there, kept running good technology but since no guidance were there, kept running around for two years and then gave up. around for two years and then gave up. December 3, 2013 11
  • 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. December 3, 2013 12
  • 13. Partnership – this means working along with industry. Partnership – this means working along with industry. Industry takes it up, manufacturer and makes available to Industry takes it up, manufacturer and makes available to society. Partnership are important to ensure your society. Partnership are important to ensure your technology is successfully adopted simply conveying the technology is successfully adopted simply conveying the details may not be sufficient. 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. December 3, 2013 13
  • 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 December 3, 2013 14
  • 15. December 3, 2013 Proposed Team Member and Their Responsibilities 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 ‱ Process technologist 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. 15
  • 16. Production representative Engineering representative December 3, 2013 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 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. 16
  • 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. December 3, 2013 17
  • 18. FACTOR AFFECTING TECHNOLOGY TRANSFER TIPS Method (( Technology implementation Potential TIPS Method Technology implementation Potential for Success) for Success) December 3, 2013 18
  • 19. December 3, 2013 teCnoLoGY tranSFer CHeCKLiSt 19
  • 21. EXAMPLES OF TECHNOLOGY TRANSFER # Chinese company offer technology for the production of L- Phenyl alanine by the enzyme method. CHINA L – Phenyl alanine By enzyme method (Ref : APC – 4041 – TOF) Area of Application # Food industry Advantage    Low input Advanced process No environmental contamination Clear production December 3, 2013 21
  • 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  December 3, 2013 English 22
  • 23. A Novel, Non-infringing Process for the A Novel, Non-infringing Process for the manufacture of levobupivacaine 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. December 3, 2013 23
  • 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 December 3, 2013 24
  • 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  December 3, 2013 Technology licensing and Known how 25
  • 26. Manufacturer of Pharmaceutical Raw Materials, Pharmacopoeial Fine Chemicals, Active Nutraceuticals, Laboratory Reagents (Bulk) (LR /AR/ ACS/FCC) December 3, 2013 26
  • 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 December 3, 2013 27
  • 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. December 3, 2013 28
  • 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 RĂ­o, Salazar N., and Trives C.“Guidelines for a pharmaceutical technology transfer towards a drug manufacturing plant”, Comunicaciones tĂ©cnicas, Bol. Soc. QuĂ­m. MĂ©x. 2007, 1(1), pp no. 27-31 4) http://bud.tic.ab.ca/venquest/yqt_home.htm December 3, 2013 29