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NATIONAL EXPERIENCES IN TRANSFER OF BIOTECHNOLOGIES. PRESENTATION BY : DR. PURNIMA SHARMA MANAGING DIRECTOR BIOTECH CONSORTIUM INDIA LIMITED NEW DELHI, INDIA AUGUST 18, 2008. www.bcil.nic.in. TRENDS: BIOTECHNOLOGY TRANSFER IN INDIA.

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slide1

NATIONAL EXPERIENCES IN TRANSFER OF BIOTECHNOLOGIES

PRESENTATION BY:

DR. PURNIMA SHARMA

MANAGING DIRECTOR

BIOTECH CONSORTIUM INDIA LIMITED

NEW DELHI, INDIA

AUGUST 18, 2008

www.bcil.nic.in

trends biotechnology transfer in india
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 )

www.bcil.nic.in

biotechnology transfer in india unique advantages
BIOTECHNOLOGY TRANSFER IN INDIA: UNIQUE ADVANTAGES
  • HIGH QUALITY HUMAN RESOURCES
  • GOVERNMENT SUPPORT AT HIGHEST LEVEL
  • STRONG INTELLECTUAL PROPERTY (IP) PROTECTION SYSTEM

www.bcil.nic.in

slide4

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

www.bcil.nic.in

slide5

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

www.bcil.nic.in

slide6

BIOTECHNOLOGY TRANSFER IN INDIA: STRONG IP PROTECTION SYSTEM

AMENDMENTS IN INDIAN PATENT ACT,1970

  • 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.

www.bcil.nic.in

models for technology transfer
MODELS FOR TECHNOLOGY TRANSFER
  • University Model
  • Public Private Partnership Model
  • Technology Incubators
  • Specialized Technology Transfer Agencies (BCIL)

www.bcil.nic.in

university model
University Model

University/Scientist concerned

Industry

  • Involves direct interaction between- Scientist and Industry
  • Technology reaches Industry by
    • Publications made by Scientist
    • Patents filed
    • Presentation in Conference

www.bcil.nic.in

slide9

Public Private Partnership (PPP) Promotion Schemes

  • 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)

www.bcil.nic.in

funding options based on life cycle

Idea Incubation

Development Finance

Growth Capital

Pre-seed

funds

1 – 5 crores

Seed and early-stage

finance

5 – 20 crores

Traditional

finance

> 20 crores

Funding options based on Life Cycle

Systematic Intervention Required

Mature Financial Market

TDB, Venture Capital

NMITLI, SBIRI PRDSF, TDDP

SBIRI

biotech incubators
BIOTECH INCUBATORS
  • 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

Contd.

biotech incubators12
BIOTECH INCUBATORS
  • 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

Contd.

slide13

Biotech Incubators

  • 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

www.bcil.nic.in

slide14

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$ 2.3 million

: US$ 1.3 million

Project Management

Consultancy

Technology Transfer

Certification Services

Biosafety

Information Services

Human Resource Development

Patent Facilitation

www.bcil.nic.in

biotech consortium india
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
slide16

MODEL ADOPTED BY BCIL

Technology

Identification

  • Scouting for patents, invention disclosures etc.
  • Assessment and follow up of potential ongoing projects
  • 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

TechnologyEvaluation

& Packaging

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.

Contd.

www.bcil.nic.in

slide17

MODEL ADOPTED BY BCIL

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

Technology

Transfer

Monitoring and

Consultancy

  • To facilitate Demonstration
  • Monitoring- Review meetings
  • Consultancy
  • Fund Syndication

www.bcil.nic.in

keeping academia industry motivated for expeditious technology development commercialization
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

www.bcil.nic.in

slide19

TECHNOLOGY TRANSFER AT BCIL

Technologies Transferred

Contd.

www.bcil.nic.in

slide20

TECHNOLOGY TRANSFER AT BCIL

Technologies Transferred

Contd.

www.bcil.nic.in

slide21

TECHNOLOGY TRANSFER AT BCIL

Technologies Transferred

www.bcil.nic.in

slide22

TECHNOLOGY TRANSFER AT BCIL

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

www.bcil.nic.in

changing tech transfer scenario
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
slide24

BCIL identifies Indian biotech company & licenses tech

Licensee plans to explore US markets & approaches BCIL to allow tech sublicensing

TECHNOLOGY TRANSFER AT BCIL

Case Study – Post Transfer Role of BCIL

RI enters into MoA* with BCIL for commercialization of the technology

Vaccine candidate developed at Research Institution

Licensee approaches

BCIL to revise the Terms

of tech transfer

BCIL evaluates the request in consultation with industry experts

BCIL mediates between the technology developer and the licensee and agrees to allow contract manufacturing

BCIL strikes a deal with revised royalty enabling successful launch of the product in the foreign market

www.bcil.nic.in

slide25

TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL as a facilitator for technology validation and commercialization

Interest shown by several MNCs on terms of paying after commercialization of the technology

Biopesticide Technology developed at Research Institution

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

*

www.bcil.nic.in

slide26

TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL facilitates funding for technology validation

Very high cost of generating safety & efficacy data for biopesticides

Biopesticide Technology developed at Research Institution

BCIL approaches Govt. to provide Grant in aid for generating data

Govt. agrees for funding

  • Technology transfer made attractive for SMEs

*

www.bcil.nic.in

slide27

TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL finds feasible alternate approach for successful technology commercialization

Technology involved use of blood leucocytes for HIV culture

Source: Blood bags

Ban on sale of Blood bags

rendered Technology Unviable

Technology Developed at Research Institute

  • BCIL ensured:
  • Continuous monitoring
  • Monthly meetings
  • Documentation of progress
  • Concerted follow-up

Alternative approach: To establish HIV in continuous cell culture

Kit of International Quality successfully developed and released for commercial production

slide28

TECHNOLOGY TRANSFER AT BCIL

Case Study – Overcoming hurdles

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

Technology for convenient, reliable and reproducible monitoring of BOD load

  • BCIL’s Role:
  • Worked Techno-commercial profile
  • Estimated Market Potential
  • Organised Product specific EDPs & Awareness Programmes

Successful Technology Transfer

www.bcil.nic.in

slide29

TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL as an active player in Consultancy & Fund syndication

Problem in Tech Transfer: Large Funds required for development and scale up of the Technology

Technology developed at a Delhi based research Institution

Interest shown by potential companies

  • BCIL’s active Role:
  • Apprised the company about available Govt. schemes for funding
  • Assistance in project proposal formulation

Project submitted to DBT approved for funding

Successful tech-transfer to the interested company

www.bcil.nic.in

slide30

TECHNOLOGY TRANSFER AT BCIL

Case Study – Effective IP Management

Patent filed by the inventor in USA

Technology developed at Research Institution

Technology transferred to Industry

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

Enabling timely response to the queries raised and efficient follow up

www.bcil.nic.in

future trends in biotechnology transfer
FUTURE TRENDS IN BIOTECHNOLOGY TRANSFER
  • Major destination for cutting edge technologies
  • Increased global investment in technology development
  • Ethical, responsible and value based technology management

www.bcil.nic.in