BUSINESS OPPORTUNITIES IN BIOTECHNOLOGY IN INDIA

1. BUSINESS OPPORTUNITIES IN BIOTECHNOLOGY IN INDIA P. K. Ghosh, Ph D Managing Director KEE GAD Biogen Pvt. Ltd., New Delhi (Former Adviser DBT, GOI) pkghosh@keepharma.com March 06, 2009

2. INDIAN EFFORTS TO SUSTAIN EMINENCE IN BIOTECHNOLOGY: MOSTLY A GOVERNMENT EFFORT • Government Departments • DBT • DST • DSIR • DRDO • DOE & Others • Autonomous Institutions • CSIR • ICAR • ICMR • UGC/AICTE Institutions • Other Institutions P. K. Ghosh

3. INDIAN BIOTECH IN GLOBAL CONTEXT • Publications and Patents filings on the rise • Leadership in innovation is yet narrow • R&D Institutes & Universities low in Global ranking • Research in Industry not significant yet • Innovation and Application not strongly linked • Academia not ready to take risk for a venture P. K. Ghosh

4. HEALTH & WEALTH: INDEX FOR DEVELOPMENT A Country is highly developed if it has…… • Break through remedies for major diseases like: • Cardiovascular diseases • Cancer • Viral Diseases • Killer Bacterial Diseases • Abundant availability of Clothing, Food & Drinking water • Sound Knowledge and Practice of good Hygiene • High Quality Jobs • Technologically Advanced Industries In all the above areas Biotech can make a contribution…. P. K. Ghosh

5. SKILLS THAT REVOLUTIONIZED BIOTECHNOLOGY rDNAs & MAbs Protein & DNA Chips & Microarrays PCR Technology Bio-Informatics Microscopy and Imaging LC-MS & MALDI-TOP Chromatography & Electrophoresis Flow-cytometry & Cell Sorting Techniques P. K. Ghosh Proteins & Nucleotide sequencing

6. TOP CONCERNS OF INDIAN BIOTECH INDUSTRY • Scarce availability of leaders for company specific needs • Inadequate availability of skilled work force • Limited resources for research- Internal & External • Maintenance of Confidentiality • Issues of Intellectual Property • Bridging issues between R&D Institutions & Industry • Demanding statutory requirements • Biased concerns about products by opinion makers • Limited linkage between Industry need & Public research P. K. Ghosh

7. BENEFITS OF TECHNOLOGY TRANSFER BY R&D INSTITUTES • To push discovery into the market • To attract Funding & Industrial Partnership • Budding skills can be placed into rewarding projects • To earn rewards through income & fame • Obliged to be transparent by disclosers – Projects, Employees, Sponsors etc. • Economic development and Societal uplift P. K. Ghosh

8. GM- Planting Mats. & Hybrids Micro-propagation Bio-fertilizers & Bio-pesticides Animal Improvement r-DNA Products, Vaccines & Diagnostics Monoclonal Antibodies Stem Cells Tissue Specific delivery methods Agriculture Health Care BIOTECH APPLICATIONS Environment Industry Enzymes Fermentation based Products & Food Biotech Instruments & Equipment Bio-energy & Bio-fuel Bioinformatics Bio-mining Soil & Water remediation Bio-safety & GMOs P. K. Ghosh

9. BUSINESS OPPORTUNITIES: HEALTH CARE • rDNA Products & MAbs • Cloning, Cell multiplication, Product separation & Formulations • Choice of technologies • Stem Cell Manipulation • Isolation, purification & multiplication of tissue specific stem cells • Expertise in Cell re-programming to pluripotency • Over expression of certain Genes for Cell re-programming • Retro & Non-retroviral means of over expression of target genes • Tissue Specific Delivery Technologies • Choice of Bio-degradable polymers & modification methods • Choice of technologies for production of precise Nano-particles P. K. Ghosh

10. BUSINESS OPPORTUNITIES: AGRICULTURE • GM- Seeds: Varieties & Hybrids • Choice of right materials • Cloning, Micro-propagation & Field Testing • Generation of Food & Environmental Safety Information • Extensive Public-Private Collaboration involving Opining Makers • Animal Improvement • Land & Aquatic Animals Identification for Multiplication • Choice of Exotic Animal germplasm & Multiplication methods • Feed & Fodder Production technologies P. K. Ghosh

11. BUSINESS OPPORTUNITIES: INDUSTRY & ENVIRONMENT • Industry • r-DNA methods of producing Enzymes • Fermented Food & Beverages • Software Development for use in Biotech operations • Biotech Instruments through Electronics, Software & New Materials • Biomass Multiplication & Bio-fuel • Environment • Biosafety Information generation for commercial use of GMOs • Degraded/ Polluted Soil & Water Remediation methods P. K. Ghosh

12. BIOTECH PRODUCT DEVELOPMENT TREND • Drugs & Pharmaceuticals for Human • Isolating/Developing & Multiplying Totipotent Stem Cells • Genetically Modified Seeds for Agriculture • Instruments for Biotechnology • Bioinformatics P. K. Ghosh

13. Biotech drugs innovation process Marketing feedback analysis Strong Industry Motivation for Success Production Unit setting up & implementation into valuable form Phase I, II, III Studies Marketing Strategy Animal Studies Actors Money Spent Pilot Development Technology Development & Transfer Regulatory Approval Proof of Concept R&D Institutes New Idea/ Research 0 5 10 15 Time (Years)

14. WHAT ARE THE SURVIVAL LANES? • To Intensify Basic Research • To Develop Novel Methods for Bio-generics • Mass Production of Multivalent Vaccines • Mass Production of Cheap Diagnostics • Novel Drug Delivery & Nanotechnology • GM Varieties from Public Institutions • Micro-propagation of elites • Industrial Enzymes by r-DNA technology • Mass Composting of wastes • Enzyme Enriched Food & Neutraceuticals • Bio-energy & Bio-fuels P. K. Ghosh

15. THANK YOU Turbulence ahead… P. K. Ghosh