Qualitative and Quantitative Technology Transfer Models...
This topic comes under Product Development and Technology Transfer....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in Fist year sem I....
This Presentation Contain following...
#Introduction of Technology Transfer
#Types of Technology Transfer
#Importance, Reasons of Technology Transfer
#Models of Technology Transfer
#Conclusion
#References
Thanks For Help and Guidance of Mr. Rakesh P. Dhawale Sir
and Miss. Sadaf A. Mutwalli
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Qualitative and Quantitative Technology Transfer Models...
This topic comes under Product Development and Technology Transfer....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in Fist year sem I....
This Presentation Contain following...
#Introduction of Technology Transfer
#Types of Technology Transfer
#Importance, Reasons of Technology Transfer
#Models of Technology Transfer
#Conclusion
#References
Thanks For Help and Guidance of Mr. Rakesh P. Dhawale Sir
and Miss. Sadaf A. Mutwalli
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred
Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
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Technology Transfer in Pharma Industry, Technology Transfer in Pharmaceutical Industry, Pharmaceutical Technology Transfer, Pharma Tech Transfer, Naseeb basha, Pharmaceutical Tech Transfer, Naseeb basha Technology Transfer in Pharma Industry, Naseeb basha Pharmaceutical Technology Transfer
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A Patent is an intellectual property right relating to inventions and is the grant of exclusive right, for limited period, provided by the Government to the patentee, in exchange of full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes.
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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
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
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 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
December 3, 2013
29