This presentation deals with broad pricipals of technology Management

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An overview
on
Technology Transfer
(Part-I)
Ravi Dhar, Ph.D., f-STEM
(rdhar_in@yahoo.com)
28.10.2014

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Resource Acknowledgements
NIH PubMed
Scientific Community across world
Memorial Sloan Kettering Cancer Center
DBT
BIRAC Library Service
NII
Various Websites
Nature Biotechnology & other Journals
 Biotech News (DBT)
Healthcare Biotechnology, CRC Press
GHI & OTT, Boston University
OTT, NIH
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3. Resource Acknowledgements
•Nature Biotechnology
•J. Commercial Technology
•Dr. Ravi Dhar: (www.biospectrumindia.com/biospecindia/news/156942/a-bill-promises)
•LESI
•NII/ BU/NIH/MSK
•BIRAC
•Various websites
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4. Technologies:
 Drug Molecules/ Vaccines/ Self disposing Stitches/ Medical Devices/ GM Crops
 Glybera formally became the first gene therapy to be approved in a regulated market, as the European Commission gave the rubber stamp to the treatment for the ultra-rare inherited disorder lipoprotein lipase deficiency (LPL) (November,2012)
Therapeutic Antibodies/Disease testing kits/ Pace maker
Stem Cells used for carrying toxic drugs for cure of Brain cancer
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5. Quote on Technology- "This 'telephone' has too many shortcomings to be seriously considered as a means of communication. The device is inherently of no value to us." [Western Union internal memo, 1876] (http://darrel.knutson.com/jokes/quotes/misquotes.html)
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Industrial Revolution
Knowledge Revolution

7. “Technology transfer is the process of developing practical applications of the results of scientific research which are easy to handle, are of societal relevance & are affordable”.
Conceptually the activity has been practiced for many years. In ancient times, Charka, Archimedes or Arabian technologies were notable for applying science to practical problems.
However, in the present times, the volume of research is very high, so are the failures (e.g., Vioxx) which should be kept in mind”
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8. Technology transfer is the process by which basic
science research and fundamental discoveries are
developed into practical and commercially relevant
applications and products.
Technology Transfer personnel evaluate and manage
invention portfolios, oversee patent prosecution,
negotiate licensing agreements and periodically review
cooperative research agreements already in place.
Part of the technology transfer process involves the
prosecution of patents which is overseen by the national
Patent and Trademark Office.
Individuals with advanced degrees in the biomedical
sciences are needed to review and process patents in
the biotechnology field. Source: Unknown
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10. Forms in which Knowledge is transferred:
General Information 17%
Specific Information 56%
Procedures/Practice 27%
Hardware Objects 28%
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11. Basic Science Research
Fundamental Discoveries
Commercially
Relevant
Applications
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12. Innovation Individuals Universities Institutes Industries Invention/ Technology Investment Enterprise Royalty Reap the Fruits of Innovation
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13. Relevance in Current Global Scenario  Requirement of people friendly technologies
for health care etc.
 Growth of biotech institutes
 Increase in number of skilled & semi-skilled
people
 Increase in international & national
collaborations
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Technology Transfer Process
New Drug Molecule/Vaccine/Therapeutic Agent
(Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)>
Invention Disclosure
Assessment/ Screening
Patent Protection
Negotiation
Licensing & Monitoring
Technology Upscaling
(Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability)
Product Development & Commercialization/Marketing
Revenue & Monitoring

15. Technology Transfer Process
Research gives rise to a Technology
Pre-Disclosure
Invention Disclosure
Assessment/ Screening
Protection
Marketing to Find or Form A Licensee
Existing Business* *Form Start-Up Business/Company
Licensing & Monitoring
Commercialization
Revenue & Monitoring
Deduct Expenses & A Part Reinvested in Research & Education
(http://www.nii.res.in/faculty-06/RaviDhar.htm)
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India

17. Technology Scenario in India
Historic
Pre-independent India
Post Independent India
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18. Technology Transfer in India (Historical)
 Life Philosophy : Vasudeva Katumbham
(the universe is my home; concept of
selflessness)
 Technologies in ancient India: Kajal;
Ashoka Pillar; surgical methods & tools;
concept of “ 0 “ etc.
 Documentation poor or eroded !!
 Let us change now!
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19. Evolution of Innovations in India (Recent) Three Key Players (1907 - 2014): Industry Tata Iron & Steel(1907) Hindustan Aeronautics(1940) First IBM imported(1961) Indian Railway Reservation System(1987) Software Development (1986) Issuance of H-1 Visas to Indian’s Universities Thomson Engineering College, Calcutta, Bombay, Madras(1947) IISc Bangalore(1911), C.V. Raman gets Nobel Prize (1930) IIT (1949), Computer Society of India(1965), ERNET (1986) Government Telegram(1951), Railways (1953) Atomic Energy Commission(1948) APSARA(1956), SRO(1961) Automation Committee Report(1972) SLV Launch(1980), PSLV Rocket(1994), Moon mission (2008) SW Technology Parks(1991), PSVL, Mars Mangalyaan (2014) Biotechnology Revolution (1998 onwards)
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20. Protection of Inventions: Pre-independent India Technology dissemination inhibited/ plugged by modifying the Labor Welfare Rules in British India - 1942
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21. Post Independent India
o It takes little while to build up resources
o Affordable Drugs
o Patent Laws of 1970
o Lack of Funding in S&T sector
o Agriculture was a priority
o Governance problems
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22. Post Independent India (Recent)
Public research – Quest for self reliance.
Military, health care, agriculture …
Socialist economic policy within a democratic
political framework…..
Central control.. State production – control of
private production. No focus on technology
transfer.
Change of direction in 1991…
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23. Effect of Economic growth (I)
 24 years of successive growth phase
 Successive upward movement in technology
application
 Access to global technologies accelerate “in-
licensing” in several sectors.
 Engineering, chemicals, life science products,
mining and metals.. significant technology up
gradation.
 Combined efforts of public and private sector.
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24. Current Status (I)
India has many things to do as it gets in the
frontline of economic powers – one of them
is accelerating technology transfer process
and mechanism
Narrow the distance between today’s reality
and tomorrow’s potential.
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25. Private sector Research (I)
Size limits commitment to Research..
1991 policy allows global private investment in
research
Joint ventures stimulate technology transfer
Indian companies with licensing track record known
for accelerated research investment.
Myth that technology sourcing will limit in-country
capability is broken..
India Inc., accesses several global technologies in
frontier segments, many from global public research
enterprises.
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26. Biotech Sector (I)  National Biotech Policy  National Policy of Human Clinical Trials  National/ State Tech Parks & Incubators  Policy on Stem Cells  National Biotech regulatory Authority??  ASSOCHAM Delhi Declaration 2006  Improved Sales Tax Laws  Efforts for One Window Clearance! (www.cerna.ensmp.fr/Documents/AM-JR-MHZ-BiotechReport.pdf)
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Cena_hand.pdf

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Black Hole Rips a Star; Courtesy : NASA

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(Source: Nature Biotechnology)

30. Biotech Clusters in India
Bangalore
Hyderabad
Ahmadabad
Delhi
Pune
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31. Current Hub Of Biotech Activity in India - Bangalore
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32. Western India : Revenues US $ 800 million
Aurangabad : Agri-/bio-manufacturing;
Mumbai : Bio-pharmaceuticals & Stem Cell Research;
Ahemdabad/ Baroda : Agri-biotech, Bio-pharmaceuticals, Enzymes,
Bio-information & Contract Research
Pune : Agri-biotech, Bioinformatics, Bio-processing,
Stem Cell Research & Vaccines
Southern India : Revenues US $ 600 million
Chennai : Bioinformation, Bio-pharmaceuticals,
Genomics, Marine Biotech. 48 Firms
Hyderabad : Vaccines
Mysore : Bio-diesel
Bangalore : Industrial Biotech
Northern India : Revenues US $ 130 million
Delhi/ Gurgaon/ Noida : Agri-biotech, Bio-fuels, Genomics
Lucknow : Bio-information & Bio-pharmaceutics
48 Firms
115 Firms
120 Firms
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33. Emerging Trends in Research Models(I)
Indian S&T strength
Trends in technology development
Enabling mechanisms
Emerging segments for technology leadership
Research models – cross country, cross functional
Contract and collaborative research
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34. Enhanced level of risk taking in research (I)
Positive change to risk averse mindset
80s and 90s- demonstrate Indus entrepreneur success
in silicon valley – 6% of total value come from indus
entrepreneurs..
India joins global consortium with significant funding and
long term commitment ….
(telecom, public health(AIDS), genomics, environment)..
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36. Have we discovered Original Drug Molecules ? A) Negative Attitude: Generally ‘NO’ few years ago! Why ! (Chalta Hai Attitude) ? B) Positive Attitude: 10 out of 60 molecular or protein structures of genomes of infectious diseases solved in India  Ranbaxy  Dr. Reddy’s  Biocon  Panacea  (5-6 Drug Molecules for FDA approval in USA : Progress) ????
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37. First Indigenous Non-Chemical Entity
First Homegrown NCE (New Chemical Entity):
Name : Balaglitazone (DRF: 2593) – a Drug
Properties : Anti-type 2 Diabetes Drug
Jointly developed by :
a) Dr. Reddy’s Laboratories (India) b) Rheoscience (a Dutch Pharma Co.)
(“The Times of India, New Delhi, India; August 2nd, 2007)
2012: Issues??????
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41. The future as we perceive (I)***
 India will be among the major out-licensing destinations.
 Focus on cutting edge research – telecom, aerospace, information technology, applications, human health, biotechnology, natural resource management….
 Global collaborative research will be the focus.
 Public research will complement private research with resources and basic research capabilities.
 Technology transfer will be augmented through responsive, accountable technology management organs.
 Global investment will drive Indian research for global good.
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42. The future as we perceive (I)(Contd)
India will a strong destination for in-licensing and out-licensing
Public and private resources will complement future research efforts
International investments will drive technology transfer growth
Ethical, responsible and value based technology management will drive economic growth.
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Think Big

44. How to Protect Inventions ?
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Secrecy
Secure
data
Strengthen
Technology

45. Importance of Proof of Concept  Before demonstrating proof of concept (POC)- Low value  Once POC demonstrated – product value increases
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46. Disposal of Technologies We may get a Patent for a Technology; or License it to an Industry after :-  Evaluation : Apply “Go- No Go –Kill” concept  Upscale  License  Monitor  Royalty
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47. Showcase your Technologies to the market
 Participate in Trade Shows
 Organize Trade Shows
 Publish Articles
 Write Technology available in business journals
 Advertise new inventions in web based market places to expose people to availability
 Arrange conferences to highlight scientific & technology transfer achievements
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48. Technology Valuation
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49. Value Grid mapping of Technology /
Product Portfolios
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50. Traditional Technology Valuation
 Cost Method
 Industry Standard Royalty Rates
 Discounted Cash Flows
 Relief from royalty
 Decision trees Additional Valuation Considerations:
 Citation Analysis
 Technology Strength
 Innovation Cycle Time
 Technology Cogency
 Sustainability in Opposition
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51. Organizations with Integrated Innovation & IP Management have High Quality (economically valuable) Patent Portfolios
Patent Quality Impact on Performance
(+)
High Potential
(++)
Innovation Leaders
Losers
(-)
Activists
(--)
(low) (high)
Patents/R&D Expenditure
Ernst, 2008; Chicago
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Technology Mapping/Transfer
Identify Organization
Identify Technology
Identify Industrial Partner
Negotiate
Transfer to Industry
Negotiate

53. Follow up on a technology - Maintain close rapport with the inventor - Update your database on invention disclosures - Understand the modifications - Be in close touch with industry - Identify the players in commercial sector
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54. Protection of Innovations
Patenting
 Confidential Disclosure Agreements (CDAs)
 Licensing
 All of the above
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55. Patents  Novelty  Inventive step  Enablement :- no requirement of “undue experimentation”  Industrial Applications
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56. Technology Transfer Process Research Pre-Disclosure Invention Disclosure Assessment/ Screening Protection Marketing to Find or Form A Licensee Existing Business* *Form Start-Up Business/Company Licensing & Monitoring Commercialization Revenue & Monitoring Reinvest in Research & Education
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Source: http://www.rti.org/pubs/WFU_TTreport.pdf

59. 16/4/2014
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Level of
Maturity
of Technology
Is Essential for
consideration for further
Development by a
Licensee

60. Technology Screening/ Evaluation
 Technology Maturity
 Competing Products
 Competing Patents
 Competing R & D
 Market Barriers
 Commercialization Strategy Considerations
 Potential Targets
(V. Imp.: Outsourcing only under Strict Confidential Agreement)
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61. Technology Transfer Process
Technology
(A Vaccine/Therapeutic Agent/GM Crop/Medical Devices etc)
(Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)>
Invention Disclosure
Assessment/ Screening
Patent Protection
Licensing & Monitoring
Technology Transfer
(Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability)
Product Development, Production & Commercialization
Revenue & Monitoring
(http://www.nii.res.in/faculty-06/RaviDhar.htm)
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University/
Institute/
Organization
Established or Start-up Company /Entrepreneur or a Big Company

62. Technology/Innovation Management Process
1.Idea/Proof of Concept : Technical Assessment
2.File a Patent (Prior Art Search: Novelty/non-Obviousness/Utility) /  (Publish Manuscript)
3.Grant Process at Patent Office : Be patient
4.Find an Industrial Partner : Be Patient or float your Start-
5. up Company
6.MoUs_NDA : TTO or Attorney or Agencies
7.Licence , DA : TTO or Attorney
8.Exchange Know-how_MoUs : You and Industry
9.Demand Signing Amount : You + Industry+ University
10.Furnish Data (Importance of Record Book): You + Industry
11.Freedom to Operate Analysis : TTO/ Patent Attorney
12.Industrial Partner will Validate Data>Upscale>Pilot run
13.Milestone Payments : You + University
14.Industry will Manufacture, Commercialize, Market Product
15.Distribution of Royalty on Sales : You + University + Industry
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Value of Technology
(Drug/Vaccine/Medical Device/GM Crop)
Proof of Concept
Untested Product/
Animal or Field Trials
Product Level(Low)
High Category Concept/HighValue
Low Category/Low Value
Tested Product / Human Clinical Trials Phase I
Product Level (Better)
Value Low
Value Preposition Debatable
Value Debatable??
Higher Value Preposition
Field Tested Product/ Human Clinical Trials Phase III

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65. Technology Transfer Agreements
MoUs : Memorandum of Understanding
CDAs : Confidential Disclosure Agreements
MTAs : Material Transfer Agreements
IIAs : Inter-institutional Agreements
CRADAs : Coop. Research & Develop. Agreement
(sponsored research agreements)
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Technology Transfer Offices

67. Technology Transfer Offices
Organizational Structure
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68. Technology Transfer Offices Different Models India: DRDO, Delhi NII, Delhi CSIR, Delhi IISC, Bangalore U.S.A. BU NIH Stanford MIT NYU SUNY
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69. Deficiencies in the Current Tech Transfer System/ Offices - Need of a Data Bank for our Patents & Technologies - Learn how to Identify & Evaluate technologies - Promote commercialization of these technologies - Faculty and students should foster an entrepreneurial environment - Least interactions between the research community, corporate and financial communities at the moment - Absence of a Regional Technology Transfer Capital Finance Pool of the of the participating organizations/countries; and - Invest assets in venture capital partnership and co-investment opportunities as per requirement of the region. - Build capacity to train personnel in Technology Transfer Issues - Understand the conflict of interest issues - Manage technologies generated at participating organizations
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70. Restructuring the current Technology Transfer Offices
 Change in mind set
 Technology transfer office should be
separated from institutes so as to
function independently
 People with multi-skilled capability
need to run the show
 Decentralize
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71. Capabilities of the Staff in Modern
Technology Transfer Offices
 Patience & Good Attitude
 People friendly
 Capability to multitask
 Capacity to maintain confidentiality
 Should understand science
 Should understand legal implications
 Should have capacity to sit for long
hours on computer searches
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Support Groups
For
Technology Transfer

73. Framing Technology Transfer Groups for Support India Government support : DBT, CSIR, ICMR, IARI Private Partners e.g. : Sathgaru, Skyquest U.S.A. !!! AUTM !!!
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74. National Knowledge Commission (“Be recognized as a player in the creation, application and dissemination of knowledge”) ******* National Innovation Foundation (more than 100 technologies registered from India & Abroad)
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75. Global Aspects of Technology Transfer  The impact of WTO-TRIPS on developing countries  Update on Bayh-Dole and its impact on development of useful health technologies**  The role of compulsory licensing and parallel trade in biotechnology diffusion  Key issues in ensuring availability of health products in developing countries  International treaties and technology transfer  Case studies from developing countries  Barriers for technology transfer to developing countries  New research methods for analyzing technology transfer  Technology transfer for bio-terrorism
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76. Corporate Technology Transfer Debates
Technology Used for Import Substitution
•Interest of MNCs : Price & Accounting Problems
•Restrictions on export
•Gave rise to Indian Patent Laws of 1970
•However, in Medicine we still see Significant Import Substitution
Technology used for Export
•Interests Aligned – both want best technologies
•Dominant pattern with Globalization
•Laws of 1970’s disappeared (http://www.who.int/intellectualproperty/events/en/JohnBarton.pdf)
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77. Public Private Partnerships
Question of Survival
Question of Self Esteem
Some of us are inquisitive
Some of us genuinely want India to progress PPP is sensible to utilize resources of both groups
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78. Developed World
Public Sector
Developed World Private Sector
Developing World Private Sector
Developing World
Public Sector
The Public Private Partnerships
The New Paradigm
(http://www.who.int/intellectualproperty/events/en/JohnBarton.pdf)
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BIRAC

79. Organizational Structure (as in BU)
Technology Transfer Protects intellectual property: Patenting; marketing of technologies; and negotiation of licenses with industry or faculty start-ups.
Innovation and Entrepreneurship Advice, guidance and support to those in the research community exploring the possibility of starting a new company.
Business Incubation Offers early-stage companies state-of-the-art office space, laboratories and a host of support services for launching new technology ventures.
Corporate Business Development Seeks to establish partnerships with industry around the creation and development of Institute or Universities’ applied technologies.
Venture Capital Investments Invests Institute assets in top tier venture capital funds, makes co- investments in early-stage companies and raises capital for Institute start-ups.
(http://www.nii.res.in/faculty-06/RaviDhar.htm)
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Possible Organization for Developing
Technology Transfer Office
in
Academic Environment
for India

81. Director/ Head
Technology Transfer (Identify an Invention for Protection)
Entrepreneurship & Business Incubation
Business Development &
Venture Capital
International Technology Related Collaborations
Technology Licensing
Assistance of Legal Experts
(India & Participating countries)**
Creation of Technology Bank on Health/Agriculture/Environment/ Aqua/ Industrial Technologies
Technology Location/ Detection & Evaluation
Sensitization: Workshops & Training Programs
Subject
Expert
Committees
Technologies from
Universities/Institutes
(DBT Funded)
Administrative Offices at X/ Y/ Z
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RD/2008

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Technology transfer Office – India
Separate Office
Separate Officer
Secrecy & Protection of Data
Technology Transfer Policy

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84. Inventorship issues Did the person :
Contribute specific ideas that resulted in development
Contribute more than labor to one or more of the inventive or technically significant features of the invention
Make practical and/or concrete suggestions that contributed to the invention?
Provide a specific design or experimental improvement that made the invention operable?
Conceive an inventive step or part of the invention that you can identify?
Have some role in the final conception of an invention as it is (will be) patented?
If answer to one or more questions is “yes” the person is an inventor otherwise he is not an inventor Other issues:
In spite of the fact that a person answers “yes” to the following question, he/ she is not an inventor:-
Did his ideas serve as a general goal or objective of the research?
Were you retained or employed to reduce the concept to practice?
Did you contribute ideas while the invention was being developed, but those ideas don’t contribute to the invention in it’s final form or as disclosed in the patent application
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85. Licensing Demonstrate the Proof of Concept Network for Commercialization Negotiate Fix Royalties Pay Taxes Enjoy Life
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86. Role of Licensing Office (contd.) What should not be done ( !!) - Analysis of prior art - Preparation of Patents - Detailed marketing studies - Preparation of business plans - Calculation of Royalty
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87. Issues in licensing
 Standstill agreements
 Field of use
 Scope of agreement
 Sub-licensing considerations
 Structuring of indemnities
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88. Negotiating Licenses: Issues
Determining when/what to negotiate
Strengthening walk-away points and
avoiding argument dilution
Detecting and defeating lies
Managing concessions
Value creating and value sharing
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93. Effect of Global Alliances & Current Indian Biotechnology Scenario Warrant Modifications of our of our Technology Transfer Offices Indian Bio-Tech Market (2007) : US $ 2 Billion (2015) : US $ 20 Billion
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95. Technology Transfer Office is no more in a Room or a Building Example:  JEV vaccine NII + Panacea India Example: (www.meningvax.org)  Meningitis vaccine for Africa [PATH/ WHO+ CDC, UNICEF, MSF, World Bank+ African holders][Price $ US 0.40 per dose] - Dutch Company : to produce PS (protein conjugate vaccines) - NIH, USA : develop conjugation method - Serum Institute of India : to provide TT & manufacture vaccine - Rotavac  Technologies related to Agricultural Produce/ DuPont India/GM crops
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If India has to change we should integrate!*

97. Optimization of Resources &
Virtual Organizations
(Pool Resources from different countries and help each others)
DNDi (TB + other) : Drugs for Neglected Diseases Initiative
AERAS : Global TB Foundation (Bill & Melinda Gates)
MMV : Medicines for Malaria Venture (1999)
VDP : Vaccine Development Program
IPM : International Partnerships for Microbicides (2002)
FIND : Foundation for Innovative New Diagnostics (2003)
BVGH : BIO Ventures for Global Health
PIPRA : Public Intellectual Property resources for Agriculture
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98. What do All These Organizations Do?
 To Identify Targets for Development of New
Drugs & diagnostics
 Identify Market Opportunities for Neglected
Diseases
 Work with Companies to build Global Health
Strategies
 Expanded Access to Information & Resources
 Facilitate New Partnerships
 Secure Finances for above
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Strike a Balance

101. “Anyone who shows interest in the fellowship,” Dhar says, “should be ready to change his mental orientation, should have determination to spend long hours on patent Web sites, to understand how to support start-up companies, and also develop a close rapport with venture capital firms.” Boston University Today, University Headlines, October 24, 2006
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102. Acknowledgements
DBT
BIRAC Library Services
Dr. Altaf Lal, US Embassy, New Delhi
Dr. Karen H. Antman, BU
Dr. Gerald T. Keusch, BU
Dr. Ashley Stevens, BU
Dr. Catherine Ives, BC
FICCI/ CII
NIH, USA
Dr. Luis Salicrup, NIH, USA
AUTM, U.S.A.
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Thank You (rdhar_in@yahoo.com)