Fifth Asian Biotechnology and Development Conference , Sri Lanka Dec. 15-18, 2010 International Crops Research Institute for the Semi-Arid Tropics Patancheru 502 324, Andhra Pradesh, India DBT P latform for T ranslational R esearch on T ransgenic C rops (PTTC) Kiran K. Sharma Kiran K. Sharma Genetic Transformation Laboratory, ICRISAT Genetic Transformation Laboratory, ICRISAT k.sharma@cgiar.org k.sharma@cgiar.org Pooja Bhatnagar-Mathur, ICRISAT Pooja Bhatnagar-Mathur, ICRISAT S.R. Rao - Department of Biotechnology. GoI S.R. Rao - Department of Biotechnology. GoI
Producing Transgenic Plants Efficient tissue culture system for regenerating shoots • I ntroduction of gene into plant cells • Selection of transform ed cells or tissues • Regeneration of putatively transform ed w hole plants • Transfer to greenhouse and advancem ent of generations • Molecular and genetic characterization • Selection of events under greenhouse conditions • Contained field testing under natural conditions • Open field testing for agronom ic perform ance • Food and Environm ental safety • Release, introgression into new varieties, & Com m ercialization •
DBT
DBT
Indian Research Scenario DBT Pub. Pvt. Total Crops Pub. Pvt. Total Crops FIELD CROPS FRUITS 1 0 Banana 3 0 Wheat 1 3 30 5 Citrus 1 0 Rice 35 1 2 0 Muskmelon 1 0 Ragi 2 1 10 2 Pomegranate 1 0 Sorghum 12 1 5 1 Watermelon 2 0 Mustard 6 2 8 0 8 Subtotal 2 0 Maize 2 50 8 OTHER CROPS Subtotal 58 VEGETABLES Chickpea 5 2 7 4 5 Pigeonpea 13 1 Brinjal 9 14 3 0 Groundnut 9 0 Black Pepper 3 9 1 0 Cassava 2 0 Bell Pepper 1 2 0 6 Soybean 2 1 Okra 6 3 2 2 Sunflower 1 1 Cabbage 4 2 1 0 Mulberry 0 0 Carrot 1 0 2 3 Cotton 11 50 Cauliflower 5 61 4 0 Coffee 1 0 Chillies 4 1 20 7 Cardamom 1 0 Tomato 27 1 45 55 99 Sutotal 8 0 Potato 8 45 23 68 148 86 234 Subtotal Total The figures include basic research Source: IGMORIS and public domain
Transgenic Crops Research in India DBT 6 technologies (cotton) already approved (5 private & 1 public) • 4 technologies waiting for commercial approval (all private) • 29 technologies approved for field testing in 2010 (4 in BRL • stages and all belong to private) The figures include basic research Source: IGMORIS and public domain
AgBiotech driven by lengthy Product Development Cycle and Large Investment Process* DBT $20-40M On Average: On Average: On Average: On Average: (90%) (Probability of Success in %) • Regulatory • Regulatory • Regulatory Time to market: 8-10 years Time to market: 8-10 years Time to market: 8-10 years $15-30M submission submission submission (75%) Total expense: ~$100M • Seed bulk-up Total expense: ~$100M Total expense: ~$100M • Seed bulk-up • Seed bulk-up • Pre-marketing • Pre-marketing • Pre-marketing • Trait integration • Trait integration $10-15M • Field testing • Field testing • Regulatory data • Regulatory data (50%) generation generation • Trait • Trait development development • Pre-regulatory • Pre-regulatory $5-10M data data Spending • Large scale • Large scale (25%) transformation transformation • Gene optimization • Gene optimization $2-5M • Crop • Crop (5%) transformation transformation • High throughput • High throughput screening screening • Model crop testing • Model crop testing Year 0 2 3 4 5 6 7 8 9 10 1 Phase I Phase III Discovery Phase II Phase III Phase IV Discovery Phase I Phase II Phase IV Proof of Concept Early Development Advanced Development Regulatory Submission Gene/Trait Identification Proof of Concept Early Development Advanced Development Regulatory Submission Gene/Trait Identification Source: S.R. Rao-DBT * Numbers (time duration, spending, and probability of success) are all estimates. The actual for individual projects vary.
Developing new Biotechnology is not cheap! Most current research is being done by private sector companies in the developed world DBT Distribution of Total R&D Expenditure in Science and Technology Percentage Public Private India 95 05 Mexico 88 12 Indonesia 96 04 Zimbabwe 86 14 USA 30 70 Switzerland 26 74 • In most of the developing countries, public sector invests in research and development. • Private sector investment is beginning to increase due to globalization and reforms in some of them. Source: S.R. Rao-DBT
Bottlenecks DBT Failure to test the concepts on a large scale • Failure to translate concepts into commercial • products Barriers of IP/Trade/interest of private sector • Biosafety regulations/Food safety • Risk assessment and risk management • Training & Capacity building • Partnerships for product development & • deployment Commercialization limitations, a serious barrier •
Problems in commercialization DBT Lack of proper understanding of issues related to: � Intellectual property rights Priority setting for Transgenic Plants � Regulatory aspects � Roadmap for lab to farmers’ field � Market demands � Public-private partnerships in R&D
Solutions Solutions Deployment of transgenics Deployment of transgenics DBT 1. Overcome delays in moving GM crops to farmers. 2. Food safety & Research issues linked to risk assessment and risk management. 3. Training on the development and deployment aspects. 4. Public awareness (media workshops; training of policy makers, trainers, NGOs etc…. ). 5. Socioeconomics & potential impact. 6. Partnerships for product development & deployment [Commercialization] i. Public sector partners (groundnut and chickpea) ii. Transgenic Research Consortia (hybrid pigeonpea; other crops) iii. Facilitate technology development & commercialization (ASP@ICRISAT)) iv. Facilities for translation of transgenic products (PTTC)
Technology Transfer Technology Transfer DBT � Develop strong relationships between: Basic Research � Technology Development � Technology Transfer � Technology Diffusion � Focus on human resource development. � Create congenial environment for encouraging R & D through the development of infrastructure and incentives. � Interface public and private sectors for enhanced synergies in technology development and deployment.
An ICRISAT-DBT Initiative PTTC DBT Mission To “translate transgenic technology and harness its products to meet the needs of agricultural growth” Principles 1. Create and charter an entity with express purpose of “translating” genetic engineering research into a practical, value adding technology 2.The entity would embody the requisite scientific and business skills that are appropriately balanced
Translational Research? DBT To promote an existing transgenic technology into a value added product of commercial use
Roadmap DBT The main drivers of innovation are priority and potential new technology Implementation Design strategy Assess market PTTC potential intervention Assessment of point the technology R & D of a new technology Proof of concept Innovation= Invention + Commercialization
Concept DBT
Operational Model DBT Selected Technology from Public Selected Technology from Public Selected Technology from Public Sector Research Institute Sector Research Institute Sector Research Institute Services Services Services PTTC PTTC Funding Regulatory Funding Funding Regulatory Regulatory Agencies Bodies Agencies Agencies Bodies Bodies • Research & Development • Research & Development • Research & Development Resea Resea Resea ch & Development pment • Field Evaluation • Field Evaluation • Field Evaluation Field Field ld aluation • Safety Assessments • Safety Ass • Safety Assessments afety fety Ass fet fety fety • IP Evaluation Partners • IP Evaluation • IP Evaluat P Eva uat Eva Ev Partners Partners International International International (ICAR, ICMR, • Regulatory Approvals (ICAR, ICMR, (ICAR, ICMR, • Regulatory • Regulatory Approvals Regulatory Regulatory Regulatory Regulatory Experts Experts Experts CSIR, SAUs, etc.) CSIR, SAUs, etc.) CSIR, SAUs, etc.) Partnership Partnership (Public-Private (Public-Private /Public-Public) /Public-Public) PTTC PTTC PTTC S ustenance S ustenance S ustenance Fund Fund Fund Product Product Product
Objectives DBT � To develop and deploy state-of-the-art infrastructure for conduct of transgenic research. � To act as a clearinghouse for technology inputs, transgenic research leads/ prototypes with proof of concept derived from Indian research institutes, universities, and other likely sources. � To evaluate specific concepts, ideas and technologies, and advance the promising transgenic events through a development cycle with adequate safety assessments. � To “evolve” the technology to a point where a practical application can be demonstrated, and transfer this “evolved” technology for product development and distribution to appropriate agencies
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