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

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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

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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