A Unique Indian Public-Private Partnership

New Millennium Indian New Millennium Indian Technology Leadership Technology Leadership

InitiativeInitiative

Dr. D. Yogeswara RaoHead

Technology Networking and Business Development DivisionCouncil of Scientific & Industrial Research

New Delhi

OBJECTIVE OBJECTIVE

To secure for India, a To secure for India, a leadershipleadership positionposition in niche in niche areas, based onareas, based on technology technology throughthrough TEAM INDIA TEAM INDIA efforteffort

DISTINCTIVE FEATURES• Proactive• Project development through national consultation &

churning• Investment in areas where India has a sustainable

comparative advantage • Invitation (not application) to the best• Close monitoring & foreclosure• Govt. / CSIR seeks no direct returns • Equitable IPR sharing

PROJECTS PROJECTS

•• Nationally evolved Nationally evolved

•• InIndustry originateddustry originated

THE PRESENT STATUS

PROJECTSPROJECTS :: 3333

PARTNERSPARTNERS :: 222 222

(167 PUBLIC + 55 PRIVATE)(167 PUBLIC + 55 PRIVATE)

OUTLAYOUTLAY :: Rs. 2.2 billionRs. 2.2 billion

DATE OF START OF THE PROGRAMME : MARCH 2001

India so far operated here

NMITLI

High Low

Low

Market Certainty

Tech

nolo

gy C

erta

inty

POSITIONING NMITLI : PROJECTS

NMITLI

Concept Proving

TDB/INDUSTRY/VC

Prototyping

Pilot Plant

Pre-Commercialization

Financing Commercialization through Banks

1 10 100 1000

NMITLI : Multiplier effect in the Technological Innovation and Commercialization Chain

Relative Financial Scale

ICICI/IFCI/TDB

0

1

2

3

4

5

6

7

Agric

ultu

re &

Plan

tBi

otec

hnol

ogy

Biot

echn

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Bioi

nfro

amtic

s

Dru

g &

Phar

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eutic

als

Che

mci

als

Mat

eria

ls

IT a

ndC

omm

unic

atio

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Ener

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Mis

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nous

Area

Num

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Number

SPREAD OF PROJECTS

HEALTH SECTOR

NMITLI LAYING ITS BETS ON

• Diseases of the Poor

• Leveraging Traditional Medicine

• Special niches based on Indian strengths

• Special Indian Needs

LATENT M TUBERCULOSIS : NEW TARGETS, DRUG DELIVERY SYSTEMS, BIO-ENHANCERS AND THERAPEUTICS

Special Indian niches/needs• Large disease burden

• Availability of high level knowledge base

• Lack of interest by MNCs / TNCs

Objectives:• To improve current treatment of TB by further shortening the total duration of the

treatment

• To provide effective treatment for latent tuberculosis infection

• To improve treatment of patients with multi-drug resistance (MDR)

• To ensure cost effectiveness and safety of the drug molecule developed

Strategy:• Identification of new drug targets

• Development of new therapeutics using novel chemistry

Contd….

• Application of bio-enhancers as an adjunct to chemotherapy

• Development of new drug delivery systems

Status:• Discovery of a new drug molecule, first in last 40 years

• Reduces treatment duration from 6 months to 2 months (in combination)

• IND cleared and clinical trials planned

• 4 new drug targets are being validated

• Efficacy of a new bioenhancer (across all the 4 drugs being tested)

• Dry powder inhalation delivery system for TB drugs- preclincialstudies are underway

LATENT M TUBERCULOSIS : Contd…

‘Team India’ effort involves 12 institutional partners and one industrial partner

PSORIASIS

• A single plant based oral herbal formulation identified• Reverse pharmacology approach adopted• IND filed in December 2003; Cleared in March 2004• Phase I clinical trials – completed • Phase II clinical trials planned

Status :

Project network involves two institutional partners and one industrial partner

Stimulants:• Leveraging Indian traditional knowledge• Causes and pathogenesis not-clearly understood• No preventive/ curative therapy exists• Large affected population (ww 1-2%)• Estimated market size (US $ 3-4 b)

India has global patent positioning

Bio-molecule free from pre-pro lysostaphin- a niche

High global market potential for both human and dairy applications

Status:Large scale production of >99% protein using novel downstream process

Drug related characterization and efficacy studies completed

Regulatory studies are underway

IND filing scheduled for March, 2005

LYSOSTAPHIN : NOVEL BIOTECH THERAPEUTIC MOLECULE

Special Indian niches/needs

NEW TARGETS AND MARKERS FOR CANCER USING GENOMICS & PROTEOMICS

• Large patient pool

• Need for early diagnostic markers

• Excellent market potential

Objectives: • A multi-centric joint effort between clinical oncologists, surgeons,

pathologists, molecular biologists, geneticists & epidemiologists from a network of 3 institutions, 3 hospitals & one industry

• Types of Cancer being studied are glioma, oral cancer & gall bladder

• Differential gene expression studies directed towards a) cell cycle control genes b) signal transduction pathway genes c) biochemical global gene expressions and d) apoptosis related genes.

• Proteomics is used to compare the proteomic profile of a cancer cell in comparison to a normal cell.

Special Indian niches / needs

Contd..

Status:

• Several genes & proteins are identified in glioma and head & neck

• Validation of identified genes and proteins on larger sample size is underway

• Development of micro-chip for diagnostic/ prodiagnosticapplication is underway

Cancer: A team effort of clinical oncologists, surgeons, pathologists, molecular biologists

BLLOD AND TISSUE BANKSAMPLE COLLECTION, CHARACTERIZATION

AND DOCUMENTATION

RGCI- DABURBRAIN, GALL BLADDER

MANIPAL HOSP.BRAIN

TMCHEAD & NECK; GALL BLADDER

GENOMICS AND PROTEOMICS

GENOMICSIISc

PROTEOMICSCCMB

GENOMICSCCMB

DATA DATA DATA

DATA INTEGRATIONTARGET, MARKER IDENTIFICATION AND VALIDATION

CCMB, IISc, DABUR, TMC, SSIMS, RGCIIPR

MARKETABLE PRODUCTDABUR

Status:• Passport data prepared for herbs used

• Raw materials & finished products standardized with modern analytical tools

• Limited toxicity studies completed

• Phase 2(a) studies – Completed for Arthritis; At advanced stage for other two

• Selected preclinical studies are underway

• Clinical studies, phase 2 and 3 are being planned

NOVEL HERBAL THERAPEUTICS FOR DEGENERATIVE DISORDERS

Objective• Scientific validation of poly-herbal Ayurvedic formulations for Arthritis,

Hepatocellular protection and Diabetes following reverse pharmacology

Special Indian niches/needs • Leveraging Indian traditional medicinal knowledge

• No effective treatment in modern medicine

Involves 18 institutional and 8 industrial partners

Special Indian niches/needs • Need for a low-cost decentralized diagnostic methods for early intervention • Potentially great social impact• Large patient pool• Availability of cutting edge scientific knowledgebase

Objectives: • Devise a microchip containing the responsible genes for glaucoma and infectious

eye-diseases to facilitate an easy and rapid diagnosis.

Project Components:

- Inherited eye diseases (glaucoma)- Infectious eye diseases- Low vision enhancement devices

Status :• Short listing of candidate genes and pathogens was accompolished• Validation of candidate genes on larger population groups is underway

EYE AND VISION

A network of 13 Research Institutions and 3 Industrial Partners

ASHWAGANDHAINDIAN TRADITIONAL MEDICINAL PLANT

Special Indian niches/needs• Ashwagandha comparable to Ginseng• Used in over 200 traditional medicinal formulations• Potential competitor to ginseng with market valued at US $5 b

Objectives:• Positioning Ashwagandha in global herbal market through

systematic scientific validation

Status:• Over 150 accessions collected from all over India and

chemoprofiled• Contrasting chemotypes identified • Pharmacological studies of selected plants underway

Indian niches/needs• Excellent expertise in software & Biotechnology• Low cost competitive alternative to the high cost imported software

needed

Salient Features:• More comprehensive than existing software suites• Will run on variety of platforms including PC• Highly modular structure• Comprises 8 major components, 58 sub-modules, 165 individual

algorithms• NMITLI brings together the distinctive knowledge segments as

‘Team India’ (21 Research Institutions and 3 Industrial Partners)

BIO-SUITE A VERSATILE, PORTABLE SOFTWARE SUITE FOR BIOINFORMATICS

Software was launched in ‘Bio’ at San Francisco (June 2004) & by President, India in Hyderabad (July 2004)

CONCLUSIONS

• NMITLI successful in launching India’s largest PPP in post independent India

• Sea change in thinking – from imitation to innovation

• Revising ‘bar’ on performance & delivery

• Early success of NMITLI influencing other funding agencies to replicate NMITLI models