Post on 26-Dec-2015
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PRESENTATION BY:
DR. PURNIMA SHARMAMANAGING DIRECTOR
BIOTECH CONSORTIUM INDIA LIMITEDNEW DELHI, INDIA
AUGUST 18, 2008
NATIONAL EXPERIENCES IN TRANSFER OF BIOTECHNOLOGIES
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TRENDS: BIOTECHNOLOGY TRANSFER IN INDIA
• New Technology Application (Increase in research investment)
• Global Technology In-licencing/JVs• Public Private Partnership for technology
development and up-gradation (Increased Private R&D funding )
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BIOTECHNOLOGY TRANSFER IN INDIA: UNIQUE ADVANTAGES
• HIGH QUALITY HUMAN RESOURCES
• GOVERNMENT SUPPORT AT HIGHEST LEVEL
• STRONG INTELLECTUAL PROPERTY (IP) PROTECTION SYSTEM
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BIOTECHNOLOGY TRANSFER IN INDIA: HUMAN RESOURCES
‘The Land of Ideas’ – Dr. R.A. Mashelkar, Former, DG,CSIR
3,00,000 biotech, bioinformatics and biological science graduates annually
NRIs leading biotech research
Reverse Brain Drain
40% increased in outsourced contract research
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BIOTECHNOLOGY TRANSFER IN INDIA: STRONG GOVERNMENT SUPPORT
Biotech is Government’s priority
Technology transfer legislation (Bayh-Dole India)
New Government schemes to catalyze technology transfers (Funds/infrastructure)
Biotechnology Industry Research Assistance Council (BIRAC) for monitoring, supporting and nurturing R&D in small and medium biotechnology companies
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BIOTECHNOLOGY TRANSFER IN INDIA: STRONG IP PROTECTION SYSTEM
Patent Validity 20 Years from the date of filing
Product Patents
Life forms except Microorganisms, not patentable
Protection of plant varieties
In case of infringements and litigation on process patents, burden of proof of non-infringement to rest with the defendant.
AMENDMENTS IN INDIAN PATENT ACT,1970
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MODELS FOR TECHNOLOGY TRANSFER
• University Model
• Public Private Partnership Model
• Technology Incubators
• Specialized Technology Transfer Agencies (BCIL)
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University Model
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IndustryUniversity/Scientist concerned
Involves direct interaction between- Scientist and Industry
Technology reaches Industry by
• Publications made by Scientist
• Patents filed
• Presentation in Conference
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Public Private Partnership (PPP) Promotion Schemes
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• Grant in aid & soft loans to industry for development, scale up & commercialization of innovative technologies developed in house/ public laboratories
- SBIRI (SMALL BUSINESS INNOVATION RESEARCH INITIATIVE) (Aims at promoting R&D in SME’s and to provide enabling mechanism to build in-house company technology capabilities)
- TDB (TECHNOLOGY DEVELOPMENT BOARD)
- NMITLI (NEW MILLENNIUM INDIAN TECHNOLOGY LEADERSHIP INITIATIVE)
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Funding options based on Life Cycle
Pre-seedfunds
1 – 5 crores
Seed and early-stagefinance
5 – 20 crores
Traditionalfinance
> 20 crores
Idea Incubation Development Finance Growth Capital
Gestation
R&D
Founders / Grants Angel Investors
/ Grants
Venture Capital Funds & Corporate Investors
Pilot Test
Roll out
Growth
Expansion
Maturity
Banks
IPO, PIPEs,Acquisition
Revenue
Time
Routine Debt
High RiskDebt / Warrants
Funding Pit
Risk Mitigation Needed
Gestation
R&D
Founders / Grants Angel Investors
/ Grants
Venture Capital Funds & Corporate Investors
Pilot Test
Roll out
Growth
Expansion
Maturity
Banks
IPO, PIPEs,Acquisition
Revenue
Time
Routine Debt
High RiskDebt / Warrants
Funding Pit
Risk Mitigation Needed
Mature Financial MarketSystematic Intervention Required
SBIRINMITLI, SBIRI PRDSF, TDDP
TDB, Venture Capital
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MODULAR LABORATORIES COMMON FACILITIES
- Specialized facilities (tissue culture, fermentation, downstream processing, phytochemical extraction, r-DNA work)
- Analytical testing/animal testing laboratory/animal house
- Common effluent treatment plant
- Bonded warehouse
- Utilities
SPECIALIZED INFRASTRUCTURE FOR TECHNOLOGY REFINEMENT AND SCALEUP AT AFFORDABLE COST
BIOTECH INCUBATORS
Contd.
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MODULAR LABORATORIES COMMON FACILITIES
- Specialized facilities (tissue culture, fermentation, downstream processing, phytochemical extraction, r-DNA work)
- Analytical testing/animal testing laboratory/animal house
- Common effluent treatment plant
- Bonded warehouse
- Utilities
SPECIALIZED INFRASTRUCTURE FOR TECHNOLOGY REFINEMENT AND SCALEUP AT AFFORDABLE COST
BIOTECH INCUBATORS
Contd.
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Biotech Incubators
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• Platforms to meld the latest in research innovation with the market place
• Provides facilities to turn ideas into a commercial reality
Advantages:
Permit company founders to conserve cash
Accelerate the commercialization of technology
Provides shared but secure laboratory facilities
Help to shift the startup's culture from an academic perspective to an entrepreneurial one
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Biotech Consortium India Ltd. (BCIL): A nodal agency for facilitating Commercialization of Biotechnology networking among Govt., Industry, Academia and other stakeholders
Incorporated : 1990
Promoter : Department of Biotechnology, Government of India
Shareholders : All India Financial Institutions
Authorized Capital
Issued, Subscribedand Paid Up Capital
: US$ 1.3 million
BiosafetyInformation
ServicesPatent Facilitation
Technology Transfer
Human Resource Development
ConsultancyProject
ManagementCertification
Services
: US$ 2.3 million
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BIOTECH CONSORTIUM INDIA
• Key Strengths…• BCIL is the primary organization in India promoting
networking activities between stakeholders in the biotechnology, Industry and academia
• BCIL has expertise in facilitating IPR protection , regulatory approvals etc.
• BCIL provides trained human resources to companies • BCIL has trained more than 1000 candidates in the last
7 years under its Biotechnology Industry Training Program in areas of R&D, marketing, production, quality control, patent processing, general management and bioinformatics
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Technology Identification
MODEL ADOPTED BY BCIL
• Scouting for patents, invention disclosures etc.• Assessment and follow up of potential ongoing projects
TechnologyEvaluation
& Packaging
• Assessment of technology based on its scientific and commercial viability• Evaluation of market for the technology• Assessment of novelty and IPR related issues• Packaging of the technology for transfer
Licensee Selection
and Pricing
• Identification of prospective licensees based on their technical capability, financial resources and area of expertise• Determination of pricing based on product development costs, market demand, growth potential, IPR status etc.
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Contd.
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Technology Transfer
Monitoring and Consultancy
Technology Transfer
Agreements
• Memorandum of understanding• Confidentiality agreements• Material transfer agreements• R&D contracts
• Fee Components: Lump Sum + Royality• Transfer of the technical know-how
• To facilitate Demonstration • Monitoring- Review meetings• Consultancy• Fund Syndication
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MODEL ADOPTED BY BCIL
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Keeping Academia & Industry motivated for expeditious Technology development & commercialization
Large scale awareness of the technology
Timely Marketing of the technology nationally/ internationally to suitable clients
Expeditious Technology evaluation and transfer
Recognition to the Inventor/Institute through good realization of tech transfer
Continuous monitoring
Timely troubleshooting
Assistance in marketing/market development
Timely Protection of Intellectual Properties
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TECHNOLOGY TRANSFER AT BCIL
Technologies Transferred
S.No Technology Technology Developer Year Licensee
1 Biopesticide TNAU,Tamil Nadu 1995 Crop Health Products Ltd., Ghaziabad
2 Biopesticide TNAU, Tamil Nadu 1995 Maharashtra Oilseed Growers Federation, Jalgaon
3 Biopesticide TNAU, Tamil Nadu 1996 Hoechst Schering AgroEvo Ltd., Mumbai
4 Biopesticide TNAU,
Tamil Nadu
1996 Godavari Sugar Mills Ltd., Mumbai
5. HIV Diagnostics (Western Blot) Cancer Research Institute, Mumbai
1997 J. Mitra & Co. Ltd., Delhi
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Technologies Transferred
S.No Technology Technology Developer Year Licensee
6 HIV Diagnostics (ELISA) National Institute of Immunology, Delhi
1998 Ace Diagnostics & Biotech Ltd., Delhi
7. BODSEED Centre for Biochemical Technology, Delhi
1999 Indo Bioactive Labs (P) Ltd., Pune
8 Hepatitis-A Diagnostics National Institute of Virology, Pune
2000 Bharat Biotech International Ltd., Hyderabad
9 Biopesticide Regional Research Laboratory, Nammu
2000 Bee Zed Biotech
10 Alphafetoprotein Diagnostics Indian Institute of Chemical Biology, Kolkata
2000 Shantha Biotechnics Pvt. Ltd., Hyderabad
TECHNOLOGY TRANSFER AT BCIL
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Contd.
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TECHNOLOGY TRANSFER AT BCIL
Technologies Transferred
S.No TechnologyTechnology Developer
Year Licensee
11 Reproductive Hormones Diagnostics Institute for Research in Reproduction, Mumbai
2000 Zydus Cadila Healthcare Ltd., Ahmedabad
12 Dengue, Jap.E, West Nile Diagnostics National Institute of Virology, Pune
2000 Zydus Cadila Healthcare Ltd., Ahmedabad
13 Recombinant Typhid vaccine AIIMS 2006 USV Ltd. Mumbai
14 Recombinant Anthrax Vaccine Jawaharlal Nehru University,
New Delhi
2001 Panacea Biotec Ltd.,
New Delhi
15. Production of Bollcure The Energy & Resources Institute, New Delhi
2007 Sri Biotech Laboratories Pvt. Ltd., Hyderabad`
16. Diagnosis of tuberculosis by smear, microscopy, culture and polymerase chain reaction
All India Institute of Medical Sciences, New Delhi
2008 Arbro Pharmaceuticals Ltd., New Delhi
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TECHNOLOGY TRANSFER AT BCIL
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Technologies Available for Transfer
1. Production of highly thermostable, recombinant enzyme Superoxide Dismutase (US Patent No. 6485950)
2. Process for the development of a series of cloning vectors to facilitate genetic manipulation of Amycolatopsis species (US Patent No. 5,985,560)
3. Process for production of recombinant anti HIV-1 glycoprotein Epap-1 targeting gp 120 region of the virus (Patent Application No. PCT/IN2006/000204)
4. Sensitive rapid diagnostic test of human papilloma virus (HPV) 5. Eucalyptus plant extract based biopesticide formulation ‘Bollcure’ effective against cotton
bollworm Helicoverpa armigera 6. New antibacterial compound “Oenostacin” isolated from the roots of Oenothera biennis,
with activity against fluroquinolone resistant bacteria and process for its chemical synthesis (US Patent No.6,365,197)
7. Method of controlling gene expression in all cells of plants including vascular bundles via a promoter derived from Rice tungro bacilliform virus (Application No. PCT/IN2005/000285)
8. Recombinant chimeric antigen as a vaccine candidate against Brucellosis 9. Nerve calming anti-depressant cream from Saliva sclarea and other natural products
10. Two novel molecules identified from Lichens having a broad spectrum antimicrobial activity
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Changing Tech Transfer Scenario
• Patent Status• Scale of Tech. Development and Validation• Freedom to operate• Market entry strategies• Complementary technologies to strengthen
portfolio• Best funding options/strategies
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TECHNOLOGY TRANSFER AT BCIL
Case Study – Post Transfer Role of BCIL
Vaccine candidate developed at Research Institution
RI enters into MoA* with BCIL for commercialization of the technology
BCIL identifies Indian biotech company & licenses tech
Licensee plans to explore US markets & approaches BCIL to allow tech sublicensing
Licensee approaches BCIL to revise the Terms
of tech transfer
BCIL strikes a deal with revised royalty enabling successful launch of the
product in the foreign market
BCIL mediates between the technology developer and the licensee and agrees to allow contract manufacturing
BCIL evaluates the request in consultation with industry experts
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TECHNOLOGY TRANSFER AT BCIL
Case Study – BCIL as a facilitator for technology validation and commercialization
Biopesticide Technology developed at Research Institution
*
Interest shown by several MNCs on terms of paying after commercialization of the technology
BCIL agreed to provide sample
• BCIL developed MTA agreement• Facilitated the supply of Sample• Evaluation to be conducted within 90 days.
•Experiments conducted on different Insects communicated on 60th day
• Biopesticide found effective
BCIL facilitated company in decision making through timely independent validation
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TECHNOLOGY TRANSFER AT BCIL
Case Study – BCIL facilitates funding for technology validation
Biopesticide Technology developed at Research Institution
*
Very high cost of generating safety & efficacy data for biopesticides
BCIL approaches Govt. to provide Grant in aid for generating data
Govt. agrees for funding•Technology transfer made attractive for SMEs
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TECHNOLOGY TRANSFER AT BCIL
Case Study – BCIL finds feasible alternate approach for successful technology commercialization
Technology Developed at Research Institute
Technology involved use of blood leucocytes for HIV
culture
Source: Blood bags
Ban on sale of Blood bags
rendered Technology Unviable
Alternative approach: To establish HIV in continuous
cell culture
BCIL ensured:
•Continuous monitoring
•Monthly meetings
•Documentation of progress
•Concerted follow-up
Kit of International Quality successfully developed and released for commercial production
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TECHNOLOGY TRANSFER AT BCIL
Case Study – Overcoming hurdles
Technology for convenient, reliable and reproducible monitoring of BOD load
Independent validation revealed the new technology to be more efficient than conventional sewage seed.
Problems in Tech-Transfer:
•Limited User segment
•Lack of awareness and market
BCIL’s Role:
•Worked Techno-commercial profile
•Estimated Market Potential
• Organised Product specific EDPs & Awareness Programmes
Successful Technology
Transfer
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TECHNOLOGY TRANSFER AT BCIL
Case Study – BCIL as an active player in Consultancy & Fund syndication
Technology developed at a Delhi based research Institution
Problem in Tech Transfer: Large Funds required for development and scale up of the Technology
BCIL’s active Role:
• Apprised the company about available
Govt. schemes for funding
• Assistance in project proposal formulation
Successful tech-transfer to the interested company
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Interest shown by potential companies
Project submitted to DBT approved for funding
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TECHNOLOGY TRANSFER AT BCIL
Case Study – Effective IP Management
Technology developed at Research Institution
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Enabling timely response to the queries raised and
efficient follow up
BCIL facilitated the procedural formalities in changing the Law firm
The hired law firm could not effectively mediate between the inventor and the patent office
for timely response to the queries raised by USPTO
Patent filed by the inventor in USATechnology transferred to
Industry
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FUTURE TRENDS IN BIOTECHNOLOGY TRANSFER
• Major destination for cutting edge technologies
• Increased global investment in technology development
• Ethical, responsible and value based technology management
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THANK YOU !