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Biotechnology Areas of Cooperation & Partnership #1
Biotech Growth in India <ul><li>~ 200 BT companies in India </li></ul><ul><li>> 75% - established in the last 5 years. </l...
Indian Biotech Products & Services: The Indian Biotech business stands at  US$150  m today... … and is expected to be $ 75...
Achievements ~ 50 Biotech PCT Patents have been filed in India ~ 20 r-DNA product clinical trials are on-going in India ~ ...
New Delhi Pune Chennai Bangalore Hyderabad CCMB BHARAT BIOTECH SHANTHA  BIOTECH  DRL  BIOLOGICAL E KNOWLEDGE PARK S-P BIOT...
Biotechnology India’s Capabilities #6
Key advantages <ul><li>Very well trained pool of personnel for all disciplines </li></ul><ul><ul><li>Established strength ...
Bio-resources <ul><li>Human resources ~ large English speaking skill base: 3 million graduates, 700,000 post graduates & 1...
Bio-resources <ul><li>Low cost of innovation ~ employment costs of post graduates and PhD level scientists and engineers i...
#10
Bio-resources <ul><li>Extensive clinical trials and research ~ Indian companies, hospitals & clinics are beginning to comp...
Bio-resources <ul><li>TRIPS compliant Patent regime ~ expected by 2005. India ranks No:3 in Asia in patent filings. </li><...
Biotechnology Prospects for partnership #13
BIOGENERICS <ul><li>India - established track record of process engineering skills </li></ul><ul><ul><li>Comparable manufa...
India’s well developed fermentation and purification skills are being leveraged to  a globally competitive bioprocessing p...
Contract Manufacturing <ul><li>Large number of biotech products development  </li></ul><ul><li>and clinical trials in Germ...
<ul><li>Large pharma companies- increasing trend towards outsourcing </li></ul><ul><ul><ul><li>R&D annual spend:US$ 70 bil...
<ul><ul><li>Compound Discovery & Development </li></ul></ul><ul><ul><ul><li>Screening requirements of of the top 10 pharma...
India is fast emerging as the hotbed of clinical research. One new CRO is being created every month... #19 CLINICAL DEVELO...
``India is an attractive destination for clinical trials due to speed of patient enrollment and the quality of investigato...
<ul><ul><li>Volume of life science related data doubles every six months </li></ul></ul><ul><ul><li>Advantage India </li><...
<ul><ul><li>Drug delivery systems </li></ul></ul><ul><ul><li>Diagnostics </li></ul></ul><ul><ul><li>Genetically modified c...
#23 Contract Research
Biotechnology Impediments to Commercialization #24
<ul><li>Distance </li></ul><ul><ul><li>Need to increase communication </li></ul></ul><ul><li>Perception hurdle </li></ul><...
Biotechnology Recommendation for policy makers #26
<ul><li>Need to move toward a global IPR regime </li></ul><ul><li>Also important to communicate to the rest of the world I...
<ul><li>Harmonization with international regulatory norms – Acceptability of data generated by recognized laboratories </l...
Thank You. #29
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Biotech areas

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Transcript of "Biotech areas"

  1. 1. Biotechnology Areas of Cooperation & Partnership #1
  2. 2. Biotech Growth in India <ul><li>~ 200 BT companies in India </li></ul><ul><li>> 75% - established in the last 5 years. </li></ul><ul><li>Revenue forecast : $150m </li></ul><ul><li>Exports : $60m </li></ul><ul><li>VC funding- modest at $20 million </li></ul><ul><li>Total investment - $100 million. </li></ul><ul><li>Employment strength of scientific personnel in the BT sector - ~ 15,000 </li></ul>#2
  3. 3. Indian Biotech Products & Services: The Indian Biotech business stands at US$150 m today... … and is expected to be $ 750 m by 2005 and $1500 m by 2007… Bio-forecast #3 $ 150 $ 100 $ 150 $ 350 $1500m $750m $150m 2002 2005 2007 R&D Products & Services Ag Biotech Industrial Biotech Medical Biotech
  4. 4. Achievements ~ 50 Biotech PCT Patents have been filed in India ~ 20 r-DNA product clinical trials are on-going in India ~ 10 r-DNA products have been approved in India There are 6 r-DNA products being manufactured in India (Hep B, Interferon, GCSF, EPO, SK, BT cotton) There are 6 companies manufacturing recombinant vaccines There are 2 companies that will manufacture r-Human Insulin There are 2 companies developing Monoclonal Antibodies There are ~25 companies marketing Biotech products #4
  5. 5. New Delhi Pune Chennai Bangalore Hyderabad CCMB BHARAT BIOTECH SHANTHA BIOTECH DRL BIOLOGICAL E KNOWLEDGE PARK S-P BIOTECH PARK TCS ANNA UNIVERSITY MADURAI KAMARAJ UNIVERSITY SPIC PUNE UNIVERSITY ALFA LAVAL PRAJ INDUSTRIES SERUM INSTITUTE WOCKHARDT MIDC BIOTECH PARK IISC NCBS JNCASR IBAB ASTRA ZENENCA AURIGENE AVESTHAGEN BANGALORE GENEI BIOCON, SYNGENE GANGAGEN JUBILANT BIOSYS METAHELIX SARTORIUS STRAND GENOMICS BIOTECH PARK CROs: CLINIGENE, CLINITEC, LOTUS LABS DBT NII CBT DABUR GENOMED PANACEA BIOTECH JUBILANT Bio-clusters #5
  6. 6. Biotechnology India’s Capabilities #6
  7. 7. Key advantages <ul><li>Very well trained pool of personnel for all disciplines </li></ul><ul><ul><li>Established strength in IT; Bioinformatics/ Chemoinformatics </li></ul></ul><ul><ul><li>Established strength in manufacturing </li></ul></ul><ul><ul><li>Cost-effective manufacturing </li></ul></ul><ul><ul><li>Ideal source with distinct advantages for forming an alliance for drug discovery and development </li></ul></ul>#7
  8. 8. Bio-resources <ul><li>Human resources ~ large English speaking skill base: 3 million graduates, 700,000 post graduates & 1500 PhDs have qualified in bio-sciences and engineering. </li></ul><ul><li>Biotech Industry: Manpower </li></ul>#8
  9. 9. Bio-resources <ul><li>Low cost of innovation ~ employment costs of post graduates and PhD level scientists and engineers is a fraction of those in Europe and USA. </li></ul><ul><li>Lucrative policies & incentives ~ from center and state governments. 150 per cent weighted tax deduction applicable for companies investing in research and development (R&D) activity. </li></ul><ul><li>Diverse skill sets ~ Ranging from biologists, geneticists, medical practitioners,clinicians, paramedics, statisticians, informaticians, biophysicists, chemists, pharmacologists, computer scientists and software engineers. </li></ul><ul><li>Supportive Regulatory regime ~ Approval of Bt cotton for commercial cultivation paves way for other GM crops. </li></ul><ul><li>3 recombinant biologicals approved. Hep B vaccine, EPO and Interferon Alpha 2b.Stem cell research is an approved domain. </li></ul>#9
  10. 10. #10
  11. 11. Bio-resources <ul><li>Extensive clinical trials and research ~ Indian companies, hospitals & clinics are beginning to comply with GCP guidelines. </li></ul><ul><li>Bio-diversity ~ India’s human gene pools offer an exciting opportunity for genomic research. Unique and diverse plant, animal and microbial bio-diversity also provides exciting research opportunities </li></ul><ul><li>International and domestic VCs ~ are beginning to show interest in the Indian Biotechnology segment </li></ul>#11
  12. 12. Bio-resources <ul><li>TRIPS compliant Patent regime ~ expected by 2005. India ranks No:3 in Asia in patent filings. </li></ul><ul><li>Strong Bio-processing skills ~ Indian pharma sector is globally competitive in fermentation derived pharmaceuticals – can be leveraged for the production of biogenerics. </li></ul><ul><li>International collaborations ~ European, US and other International companies have forged successful collaborations with Indian companies. </li></ul><ul><li>Contract research services ~ offers low cost of innovation to overseas customers </li></ul>#12
  13. 13. Biotechnology Prospects for partnership #13
  14. 14. BIOGENERICS <ul><li>India - established track record of process engineering skills </li></ul><ul><ul><li>Comparable manufacturing units at a fraction of the capital cost </li></ul></ul><ul><ul><li>Indian companies have successfully demonstrated capabilities in development and manufacture of cost effective biologicals such as hepatitis B vaccine, insulin, interferon, EPO, etc. </li></ul></ul><ul><ul><li>Investing in R&D for development of novel products </li></ul></ul>#14
  15. 15. India’s well developed fermentation and purification skills are being leveraged to a globally competitive bioprocessing platform... Bio-Processes in India #15 Biocon Shantha Biotech Serum Institute Shantha Biotech Bharat Biotech Wockhardt Panacea Biotech Dr. Reddy’s VACCINES RECOMBINANT THERAPEUTICS MONOCLONAL ANTIBODIES Biocon Wockhardt Dr. Reddy’s Shantha Biotech Bharat Biotech Hep B, Combi-vaccines Rabies, Leprosy Human Insulin, EPO, GCSF, SK, HGH, Interferon  2B Enti-EGF & others
  16. 16. Contract Manufacturing <ul><li>Large number of biotech products development </li></ul><ul><li>and clinical trials in Germany </li></ul><ul><ul><li>Select Indian Pharma companies are already supplying quality bulk intermediates and API’s to big pharma companies in EU & US </li></ul></ul><ul><ul><li>With suitable technology, this can be extended to biotech as well </li></ul></ul>#16
  17. 17. <ul><li>Large pharma companies- increasing trend towards outsourcing </li></ul><ul><ul><ul><li>R&D annual spend:US$ 70 billion </li></ul></ul></ul><ul><ul><ul><li>Rapid increase in drug discovery targets </li></ul></ul></ul>Contract Research #17 Optimized Lead Molecules Medicinal Chemistry ANIMAL STUDIES: Proof of Concept Animal Pharmacology Animal Toxicity/PK Process Development & Scale-up Human Clinical Trials (Phase I -IV)
  18. 18. <ul><ul><li>Compound Discovery & Development </li></ul></ul><ul><ul><ul><li>Screening requirements of of the top 10 pharma companies will increase from 10-15 million primary screens per year to 200 million within 1-2 years </li></ul></ul></ul><ul><ul><li>Process Development & Synthesis </li></ul></ul><ul><ul><ul><li>India’s expertise in chemical synthesis can be utilized for development of cost-effective processes for new drugs and intermediates </li></ul></ul></ul><ul><ul><li>Clinical trials </li></ul></ul><ul><ul><ul><li>One of the areas with greatest potential </li></ul></ul></ul><ul><ul><ul><li>Advantage India </li></ul></ul></ul><ul><ul><ul><ul><li>Vast and diverse genetic pool </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Cost effective </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Increasing trend towards ICH/GCP </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Trained physicians, ethics committees, Hospital infrastructure </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Diversity of patient pool </li></ul></ul></ul></ul>#18 Contract Research
  19. 19. India is fast emerging as the hotbed of clinical research. One new CRO is being created every month... #19 CLINICAL DEVELOPMENT Siro Clinpharm Clinigene Quintiles Synchron Pfizer Clintec Covance Eli Lilly Novartis AstraZeneca Quintiles GSK Pfizer Novartis Eli Lilly DiagnoSearch Clinworld Infotech NEW DRUG TESTING BIO STUDIES BIOMETRICS/ DATA MANAGEMENT SITE MANAGEMENT Lambda Clinigene Lotus Labs Vimta Labs Apothecaries Synchron Wellquest Neemans
  20. 20. ``India is an attractive destination for clinical trials due to speed of patient enrollment and the quality of investigators.” Pawel Dyras V.P. Clintec &quot;We have 17 large and small clinical trials in Phase II & III ongoing in India. ” Rajiv Gulati, Eli Lilly, India “ Folks at Biocon’s Syngene were certainly as fast as folks elsewhere, had a higher success rate and were almost an order of magnitude less expensive.” Peter Cohan, V.P. Discovery, SYMY “ It was the availability of high quality scientific talent and not the lower operational costs that led us to invest in a $40 million R&D centre at Bangalore.” Sir Tom McKillop, CEO AstraZeneca #20 Quotes
  21. 21. <ul><ul><li>Volume of life science related data doubles every six months </li></ul></ul><ul><ul><li>Advantage India </li></ul></ul><ul><ul><ul><li>Proven strength in IT </li></ul></ul></ul><ul><ul><ul><li>Large and trained pool of skilled IT manpower </li></ul></ul></ul><ul><ul><ul><li>Data handling, data mining, genotyping, fingerprinting, DNA sequencing and software development </li></ul></ul></ul>#21 Bioinfomatics
  22. 22. <ul><ul><li>Drug delivery systems </li></ul></ul><ul><ul><li>Diagnostics </li></ul></ul><ul><ul><li>Genetically modified crops </li></ul></ul>#22 Potential Growth Areas Specific Area of investment Est. investment in next 5 years (Rs. Million) Vaccines 300-400 Diagnostics 500 Bioactive therapeutic proteins 1000 Seeds (Hybrids, GM) 1500 Biopesticides 800 Biofertilizers 200 Amino acid production 700 Production of speciality biochemicals and plastics 1000
  23. 23. #23 Contract Research
  24. 24. Biotechnology Impediments to Commercialization #24
  25. 25. <ul><li>Distance </li></ul><ul><ul><li>Need to increase communication </li></ul></ul><ul><li>Perception hurdle </li></ul><ul><ul><li>Especially IPR issues </li></ul></ul><ul><li>Regulation </li></ul><ul><ul><li>Adherence to GCP/ICH guidelines </li></ul></ul>#25 Impediments to Commercialization/ joint development
  26. 26. Biotechnology Recommendation for policy makers #26
  27. 27. <ul><li>Need to move toward a global IPR regime </li></ul><ul><li>Also important to communicate to the rest of the world India’s commitment to IPR protection </li></ul><ul><li>Preparedness to handle IPR post 2005 era </li></ul><ul><li>Infrastructure </li></ul>#27 IPR
  28. 28. <ul><li>Harmonization with international regulatory norms – Acceptability of data generated by recognized laboratories </li></ul><ul><li>There is an increased move towards a process of harmonization that will place Biotech processes and developments in the country on a global platform; new Science & Technology policy allowing for key technologies to be leveraged </li></ul><ul><li>Transparency of regulatory processes – Application information and key decisions to be accessible to public domain </li></ul><ul><li>The Department of Biotechnology (DBT) has taken active strides to make the process of regulation simpler & more accessible; more frequent meetings of sub-committees, greater use of IT, active processing of applications </li></ul>#28 Regulation
  29. 29. Thank You. #29

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