india’s path to innovation in life sciences & biotechnology- moving...
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INDIA’S PATH TO INNOVATION IN LIFE SCIENCES & BIOTECHNOLOGY-
MOVING FROM BIOLOGY BIOTECHNOLOGY BIOECONOMY
S.R.RAOADVISOR
DEPARTMENT OF BIOTECHNOLOGYMINISTRY OF SCIENCE AND TECHNOLOGY
GOVERNMENT OF INDIA
Investment FocusInvestment Focus
19991999 20012001 2002200220002000 20082008
Enabling digital technologies that allow better serve customers, pursue new
market channels and improve operating
performance
Information Information TechnologyTechnology
Innovative technologies that allow grow into new products, markets or services while improving efficiency
IT Web services Security Pricing
Optimization Content
acceleration
Life SciencesLife Sciences Diagnostics Diagnostics Industrial Industrial
BiotechBiotech Drug deliveryDrug delivery
Advanced Advanced MaterialsMaterials
Light managementLight management Thin, flexible Thin, flexible
micromicro--electronicselectronics
EnergyEnergy
1980 2000
Human resource Development
Equipment and infrastructure
R&D
International coopIPR
PPP
1986 BioSafety
Technology licensing
Funds
Priority Setting Document(1986- 1996)
Vision Document (1996-2005)
National Biotechnology strategy (2006--------
1996 Transgenic Research
2002 commercial Bt cotton
Development Of Biotechnology innovation and development policy In India
Gaps between discovery to markets ……
Year Publications Technologies developed
Technologies Transferred
Products Commer-cialized
Patents Filed
Patents Granted
2002-2003 164 30 13 7 - 34 11
2003-2004 178 41 24 8 1 36 22
2004-2005 263 45 21 4 1 42 7
2005-2006 374 118 36 5 15 46 12
Total 979 234 94 24 17 158 52
R&D OutputsSample Size: 520 Projects ; Total Cost : Rs 223.00 Crores;
Total Number Of Investigators : 254
>1500 R&D projects funded so far
DBTDBT Barriers to growthBarriers to growth
Early stage R&D funding for SME’s, startups, new innovation Low density of PhDs and mid-career life scientists / innovation
leaders Low levels of PPP Interdisciplinary institutions In some areas no institutes with real biotech capacity Industry related Infrastructure Trans-boundary movement of biological materials IPR / technology transfer policies and administration in
university / institutes, legal system Regulatory system needs to be improved to become world class Overall very low level of innovation
National Biotechnology Development National Biotechnology Development and Innovation and Innovation
Strategy Strategy
An interAn inter--ministerial / multiministerial / multi--sectoral effort sectoral effort
Policy Framework Policy Framework and and Strategic ActionsStrategic Actions
DBTDBT
7
The strategyThe strategy
VisionVision“To create ecosystem of innovation for development of tools and technologies
that address the problems of the largest section of the society, provide products and services at affordable
prices and make India globally competitive in the emerging bio-economy”
DBTDBTEstablishing an ecosystem of Establishing an ecosystem of innovationinnovation-- investment areasinvestment areas
Higher and secondary life science education with biotech emphasis
Innovation leaders Technology/IP management capacity – local centres
linked to national centers Regional innovation clusters Centres of research excellence in places of education 20% DBT funding as Public Private Partnerships Innovation fellowship, grants, awards Translational capacity in basic science institutes,
science capacity in translational institutes Public understanding of biotechnology and knowledge
economy
DBTDBTInvestments in product Investments in product
rangerange Biotherapeutics and cell therapy Vaccines and adjuvants – human and animal Diagnostics, biomarkers, biosensors Transgenic crops and marker-assisted breeding Bioenergy Nutraceuticals Nano-biotechnology Bio equipments, implants and devices New, greener manufacturing processes and
technologies Genomics and proteomics science
0
200
400
600
800
1000
8th Plan 9th Plan 10th Plan 11th Plan
Government Investments increased from US 20 million in 1989 to US $ 400 million in 2008 in
Biotechnology and Life Sciences (Rs. in 100 million)
Government investments increased from US 20 in 1989 to 600 US$ million in 2010 in
DBTDBTTotal Cost Number of Projects (%)
Extramural Funding-distribution pattern across agencies (in lakhs)
Universities received 50% of projects/funds followed by research institutions and public private partnerships
>30% funds were allocated to PPP projects
DBTDBT
Web of science data of 82 life science research universities/institutions Source: DBT funded Science Observatory Project at IISc., Bangalore
Number of Publications in life sciences increased by annual rate of 16% from 2003 to 2009
DBTDBTCENTRES OF EXCELLENCE AND
INNOVATION IN BIOTECHNOLOGY
Categories Biotechnology with a specific thematic focusBiotechnology with academia-industry PartnershipAround Outstanding Scientist Specialized Centres in Biotechnology InnovationInstitutional Programme SupportMulti-institutional Network Programme
Eight Calls for Proposals. Out of 753 LOIs, 122 shortlisted for full proposals. 15 Centres of Excellence 27 in ‘Programme Support’ mode 6 around outstanding ‘Individual scientist
Stem cell research – Strategy
Basic Stem Cell Research
Stem Cell Bank
Stem Cell Therapy Production Unit
Stem Cell clinical Trials
Licensed Product Manufacture
Cell Biology Immunology Animal Modelling Epigenetics Bioengineering
Research Grade cell banking and characterisation
Clinical grade cell banking and characterisation
Production process development
Pilot scale capacity to supply stem cell clinical trials
Specialist Beds and Facilities
Safety and Efficacy
Coordination
Stem Cell Therapy Commercial or Public sponsors Therapy Surveillance
Centre for Stem Cell Research:
A CMC-DBT partnership
Use of limbal stem cells for treating ocular surface
disorders caused by limbal stem cell deficiencies (LVPEI, Hyderabad)
Programme III
Algal system for production of hydrocarbon
Programme IVEnergy Bioscience Centres & Capacity
Building
Programme IBioethanolBioethanol
• Re-engineered feed stock
• Re-engineered microorganisms
• Process optimization
DBTDBT’’s Energy s Energy Biosciences Biosciences ProgrammeProgramme
Programme IIBiodiesel
• Quality planting material
• Improved feed stock
• Process optimization
Energy innovation Challenge programme
DBTDBT
Emerging research areas Group 3 ….
Emerging research areas Group 2
Emerging research area Grops 1Common facilities
Industry
DBT Building University Interdisciplinary life sciences Departments for Education and Research (BUILDER) Scheme
Separate Departments
DBTDBT
MSc /MTech in Biotechnology 71 Universities
Industry placement 800 per year
DBT Junior Research Fellowship (DBT-JRF)-- 600
DBT Post Graduate Fellowship (DBT-PDF) 100
Young Entrepreneurs Scheme (YES) 10
Biotechnology Overseas Associateship and
Associateship for Specialized Niche Areas- in service 20
Short Term Training Courses 40
Tata Innovation Fellowship 10
Teachers training programmes 20
Star colleges 10
Innovative Young Biotechnologist Award (IYBA) 10
Rapid Grant for Young Investigators 100
New fellowships & opportunities for young in Biotechnology
DBTDBT WELLCOME TRUST-DBT INDIA FELLOWSHIPS
Linking talent to opportunityLinking talent to opportunity
• DBT and WT have jointly launched ‘WT / DBT India Fellowships’ on September 10, 2008
• Each partner to contribute £ 8 million per year over 10 years
• 70 Post-doctoral Fellowships annually in 3 categories (Early stage, Intermediate and Senior)
• SPV – Wellcome Trust/DBT India Alliance - set up as public charitable trust to deliver the programme
• Benchmark for fellowships will be as per WT norms
Darshan H. Nayak Pulin M. Raje Rahul Ribeiro Asokan Thondiyath
Nish Chasmawala
2008-10 Fellows
Srinivas Jaggu Jayant Karve Amit Sharma
2009-10 Fellows
Stanford-India Biodesign ProgrammeCreating Entrepreneurs
An effective and consistent way to deliver chest compressions to sudden cardiac arrest victims
A better way to gain intra-osseous access in emergency patients.
Non-invasive, rapid and definitive way of airway management.
Esophagus Entry
TracheaEntry
Stanford-India Biodesign ProgrammeCreating Entrepreneurs
Areas for Skill DevelopmentAreas for Skill DevelopmentIPR/technology transferBio-enterprise/ Management in BiotechnologyPlatform technologiesRegulatory proceduresBiosafetyBioethicsProcess development and up-scalingPreclinical toxicity and clinical trialsGood manufacturing practices/good laboratory
practices Biostatistics and epidemiologyStem cells and tissue engineering.
Sectoral strategies reshaped
India Health care R&D
Priorities Vaccines & Diagnostics Infectious Disease
Biology Chronic Disease Biology Food and Nutrition Stem Cell ResearchMedical Devices &
Implants Nano-medicine Bioprospecting
MechanismsInternational Collaboration Autonomous Institutions of DBT New Translational Oriented Cluster InstitutionsCentres of ExcellencePublic-Private Partnership –SBIRI, BIPPRapid Grant for Young Investigators (RGYI) scheme
12/19/2009 ISETBN NAGARJUNA
India R&D Funding by DiseasesIndia is now the fifth largest public funder of neglected disease R&D globally with an investment of $32.5m in 2008
DBTDBT
Vaccine Grand ChallengeVaccines in Trials or Transferred to
Industry• Rotaviral Diarrhoea• Japanese Encephalitis• Rabies• Dengue• Typhoid• Malaria• Leprosy• Anthrax• Cholera• Infectious Bovine Rhinotracheitis
At least 4 vaccines will commercialised by 2012
India A Vaccine Manufacturing Hub26
Agricultural Biotechnology
Building basic and early translational research capacity
Development of eco-friendly and safe technologies for improved crops for resource poor farmers and commercial needs to address:
Productivity gainsEnhanced nutritionEnsuring qualityResistance to pests and diseasesResistance to drought , salinity, high temperature etc
Technology focus: Genetic engineering Molecular marker assisted breeding Biofertilisers Biopesticides
Rice Tomato
Knowledge Generation Genome Initiative: India Moves Ahead !
Sugarcane
Chickpea
Wheat
Coffee
Chromosome 11 Chromosome 5
Complete Bacterial Genome
Silk worm
Cancer
Completed
DBTDBT
Translational SMEs Biotech ProgrammeWith new Governance
National Clinical Development Services Agency with multiple functions, and Phase I – IV capacity
To be set up in NCR Biotech Cluster
•CRO for agri-biotech translation and field trialsEstablished in partnership with ICRISAT, Hyderabad
ICRISAT Facilty
Some Indian initiativesSome Indian initiatives
• The government provision of Rs 1,000 crore (2008-2011) to promote the sector.
• The Nano Science and Technology Initiative (NSTI) has funded about 100 basic science projects worth Rs 60 crore. For establishing centres for nano science at several institutions
• The Amirta Center for Nanosciences was established in May 2006 as one of the seven nanotechnology centers is the only one in the biomedical area.
• Sabeer Bhatia of "Hotmail" fame is investing $10 billion into the setting up of a "NanoCity" an environmentally sustainable development. Modelled after Silicon Valley, Nano City will feature R&D and educational centers and corporate offices for technology, biosciences and other knowledge industries.
Nanobiotechnology90 well defined programmes supported
Medical sciences
delivery of drug/bioactive molecules, bioseparation and diagnostics, receptor mediated delivery for cancer , nano-SiRNA for cancer therapy and their toxicological study
Agriculture
Smart delivery for pesticide, detection diseases aflatoxin, waste management, development of biodegradable polymer.
Aquaculture
Nanofibres from aquatic weeds etc
Others
nanofilters for water purification, removal VOCs from air, Effluent treatment, smart packaging, development of next generation chip
Figure 1. (A) SEM & (B) TEM image of lipophilic silica nanopowder (average particle size 15nm)
1A 1B
A
Figure 2. (A) Control S. oryzae, (B) lipophilic silica nanopowdertreated S. oryzae
B
Figure 3. XRD data shows amorphous nature of lipophilicnanosilica.
Developed a spherical, amorphous, silica nanoparticles based pesticide named as Dipentox (Patent pending)
Reduces quantity of pesticides applications by 5 times due to improved delivery to target pest
Landscape of Bioinformatics Industry
12/19/2009 ISETBN NAGARJUNA
DBTDBT
Public-Private partnerships
to promotediscovery and innovation in
biotech industry
30% budget to spent on PPP
Commercial potential
1. Start-up Prototype
2. Early Stage/ patenting
3. Develop-ment and trails
4. Expansion & Growth
Grants 3 F’s, joint research
Informal VC (Business Angels) & seed corn, some formal VC, corporate venturing VC and
corporate venturing
IPO and /or Buyout
A biotechnology finance life cycle
SBIRI BIPP NIMTLI ; TDB;
Encourage proactive funding to promote SME R&D
DBTDBT
Small Business Innovation Research Initiative (SBIRI)
• To support early stage, • pre-proof-of-concept research
• To take up leads towards commercialization
MISSIONNurture innovative and emerging
technologies / entrepreneurs.
DBTDBT
37
BIOTECHNOLOGY INDUSTRY PARTNERSHIP PROGRAMME
• IP rights belong to industry
• Varying models of grants, loans or grant / loan
• Extent of support ranges between 30-50%
• Loan – upto US $ 2 million – 2% interest;
– above US $ 2 million – 3 % interest
• Royalty – 5% of net sales for 5 years or
– twice the amount of grant
DBTDBT
Biotechnology Industry Research Assistance Council (BIRAC)- End-to-end Services
Started as a pilot project and EFC ready for circulation under I&M sector
DBTDBT
• Australia
• Ca 39
UK
USA
Switzerland
IAVI,
GATES Foundation,
MVI, PATH
Wellcome Trust
Global Partnership for value addition
DBTDBT
••Translational Health Science Technology Institute, FaridabadTranslational Health Science Technology Institute, Faridabad##
••Institute for Stem Cell Science and Regenerative Medicine, Institute for Stem Cell Science and Regenerative Medicine, Bengaluru and VelloreBengaluru and Vellore##
••National Institute of AgriNational Institute of Agri--food Biotechnology and Food food Biotechnology and Food Bioprocessing UnitBioprocessing Unit##
••Regional Centre for Biotechnology Training and Education Regional Centre for Biotechnology Training and Education (UNESCO), Faridabad(UNESCO), Faridabad##
••National Institute of Biomedical Genomics, KalyaniNational Institute of Biomedical Genomics, Kalyani##
••National Institute of Animal BiotechnologyNational Institute of Animal Biotechnology
••National Institute of Marine BiotechnologyNational Institute of Marine Biotechnology
New Breed of Institutions New Breed of Institutions technology advancement and innovation technology advancement and innovation
HUMAN ACTIVITY TAKES PLACE IN CLUSTERS
Biotech Science ClustersBiotech Science Clusters
STRENGTH OF SYNERGYSTRENGTH OF SYNERGYFaridabad Health clusterFaridabad Health clusterMohali AgriMohali Agri--foodclusterfoodclusterBangalore bio clusterBangalore bio cluster
DBTDBT
DeanDean
TechPlatforms
PatientsPatientsCONSTITUENCIESCONSTITUENCIES
StudentsStudents IndustryIndustry
DeanDean
Animalfacilities
Executive DirectorExecutive DirectorDean(s)Dean(s)
Rese
arch
&Ed
ucat
ion
Trai
ning
Board of Governors
Executive/Finance CteExecutive/Finance Cte
URCB
Academic
Executive DirectorExecutive DirectorDean(s)Dean(s)
Rese
arch
&
Deve
lopm
ent
Busi
ness
Incu
bato
rs
Governing Body
Executive/Finance CteExecutive/Finance Cte
THSTI
Translational
Executive DirectorExecutive DirectorDean(s)Dean(s)
Acad
emic
Phys
icia
ns
Clin
ical
Ca
re
Governing Body
Executive/Finance CteExecutive/Finance Cte
CHC
Clinical
Health Biotech Science Cluster(Chief Executive/Dean)
Health Biotech Science Cluster(Chief Executive/Dean)
ChairChairCLUSTER BOARD
Prog 1
Prog 2
Prog 3
Prog 4Domain-specific centres Domain-specific centres Domain-specific centres
Translational Advisory Board | Science Advisory BoardTranslational Advisory Board | Science Advisory BoardSouth Node
Jakkur
N A T I O N A L T R A N S L A T I O N A L G A T E W A YN SNorth Node Faridabad
42
DBTDBT
Key Legislations And policy facilitation by Government to promote innovation
Tax exemtions and incentivesSpecial Economic Zones Act 2006Food Safety And Standards Act 2006The Drug And Cosmetics ( Amendment) Bill 2007Clinical Establishments ( Registration And Regulation Bill) 2007Public Funded ( Intellectual Property) Management Bill 2006National Biotechnology Regulatory Bill ( 2008)
Biotechnology Regulatory Authority of India Chairman
(4 members)
Economic analysis unit
Incentives developers , co investors and promoters
100 percent FDI allowed Income tax benefit any block 10 years in 15 yearsDuty free importExemption from service tax/CSTIncome from infrastructure capital fund from investment exempt from IT taxInvestment made y individuals exempted under 88 IT actDeveloper permitted to transfer infrastructure for O&MGeneration transmission and distribution of power allowedFull fredom in allocation of space and built up areaAuthorized to provide services like water electricity, restaurants etc
DBTDBT IndiaIndia’’s biotech strengths for innovations biotech strengths for innovation
Scientific work force- 300 INSTITUTIONS
100000 LABS ; 300 UNIVERSTIES;
Low cost manufacturing
3rd largest GMP facilities
Clinical and agricultural trial network
Patent protection
Gradually improving regulatory setup
Significant industry investment in R&D
DBTDBT
49
The Indian biotech industry has taken offThe Indian biotech industry has taken off
>300 companies – small and medium sector
60 have significant and growing recombinant capacity
75% companies created in last 5 years
Increasing investment activity by large industry
DBTDBTIndustry projection for biotech sector Industry projection for biotech sector ––annual turnover (US$)annual turnover (US$)
2006-07 2 billion plus
2010 3 billion
2015 10 - 15 billion
2020 15 - 20 billion
Source: ABLE, 2006 and Biosprctrum, 2007
• Genomics• RNA biology• Proteomics• Metabolomics• Computational biology• Systems biology• Synthetic biology• Stem cell biology• Novel animal models• Nanosciences – Advanced materials – Biology interface
Promotion of New Sciences for discovery and high level innovation
Futuristic High Risk TechnologiesFuturistic High Risk Technologies
Consult Our Web sitewww.dbtindia.nic.in
For more information
WTO
CODEX
CBD
TRIPS
PVPPBR—Treatiesssssss
ssssssssssssssss conventionssssss
Proponents Opponents
Collaboration &
Partnerships
TECHNOLOGYI need food then medicine
that I can access
and afford
Thanks ISETBN NAGARJUNA12/19/2009