Workshop on Alternate Patent Regime and Access to HealthMay 25-26, 2009

Beijing, China

Global Pharma and R&D Priorities in India

Dr. S. R. Rao, Department of Biotechnology

Government of India

Today’s Topics

• Why innovate 

• Technology and innovation  trends  

• Current

• by 2020

• India  changing priorities and mechanisms to promote innovation

• Public –private partnerships

• Conclusion

The decline in R& D productivity –innovation is key

Pharma’s  traditional  strategy of  placing  big  bets  on  a  few molecules,  promoting  them heavily and turning them into blockbusters worked well  for shareholders for many years.

However, its productivity in the lab is now plummeting, as it switches its attention from diseases that are relatively common and easy to treat to those that are much more complex orunusual..

The impact of Generic Erosion on Big Pharma Revenues

Patents  on  many  of  the medicines  the  industry  launched in the glory days of the 1990s will expire  over  the  next  few  years, leaving Big Pharma very exposed.

This  “innovation  deficit” has enormous  strategic  implications for the industry as a whole.

Cost per drug for medicines in different therapeutic area

Seven major trends socio-economic reshaping the health care marketplace

The burden of chronic disease is SoaringHealthcare policy-makers and payers are increasingly

mandating what doctors can prescribePay for Performance of different medicines on the riseThe boundaries between different forms of healthcare are

blurringThe markets of the developing world, where demand for

medicines is likely to grow most rapidly over the next 12years, are highly varied

Many governments are beginning to focus on prevention rather than treatment, although they are not yet investing very much in pre-emptive measures.

The regulators are becoming more risk-averseWorlds poor (1 billion) are still struggling to access food

and medicine

Convergence of Technologies

Industry need to become more innovative and cut its R&D costs, 

Four features will be vital:

A comprehensive understanding of how the human body works at the molecular level

A much better grasp of the pathophysiology of disease (by which we mean the functional changes associated with, or arising from, disease or injury)

Greater use of new technologies to “virtualise” the research process and accelerate clinical development; and

Greater collaboration between the industry, academia, the regulators, governments and healthcare providers.

Evolving Research Process for cost effectiveness and accelerated time to markets

current

When virtual man exists

Might look like 2020

Advanced instrumentation for R&D

Development process

current

Development process might look like 2020

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Regulatory process 2020

R&D cost/revenue curve might look by 2020

One of the key enablers of the phenomenal offshoring/ outsourcing success to India /china is the availability of large talent pool at a fraction of the cost

India – A Potential Pharmaceutical HubIndia – A Potential Pharmaceutical Hub

• Besides IT and engineering services, India has a large talent pool to cater to the demands of pharmaceutical outsourcing services

• The cost of conducting research in India is about 20–30 percent of the costs in the developed world

• Over the next five years, India is likely to mature further as a provider of services across the drug development spectrum:

- Discovery, research, pre-clinical, clinical,

process formulations, and IT among other areas

• Besides IT and engineering services, India has a large talent pool to cater to the demands of pharmaceutical outsourcing services

• The cost of conducting research in India is about 20–30 percent of the costs in the developed world

• Over the next five years, India is likely to mature further as a provider of services across the drug development spectrum:

- Discovery, research, pre-clinical, clinical,

process formulations, and IT among other areas

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Unattractive Evolving Attractive

India CzechRepublic Ireland Russia China Philippines

Infrastructure

Educational System

Cost Advantage (relative to high cost countries)

Overall

Language Compatibility

INDIAINDIA –– Health care situation, priorities and Health care situation, priorities and progressprogress

Preventive and curative care

Rising demand for multi and super-speciality services

Shift from infectious to lifestyle diseases

85% of inpatient spend on five categoriesCardiology, Oncology, Trauma, Acute Infectionsand Maternity

Growing at 13% p.aExpected to grow at 15% over next 4-5 years

Healthcare Delivery Market Size

2000-01US$ 18.7 bn

5.2% of GDP

US$ 45 bn

8.5% of GDP

2012 (projected)*

Revenues Largest service industryEmployment Second largest after education

Government & public employersPrivate providers

100% = USD 1,830 million

6337

In terms of delivery, private providers capture 63%of US$ 1,830 million spend

Healthcare - Private sector Dominates

Cabinet

Scientific Advisory Council ( cabinet) GOIPrime MinisterScientific Advisor GOI

S&T DEPTS. DEPTS.involvingScientific activities

Minister of State S&T

DOS DSIRDST DBTDODDAE

Minister S&T

CSIRAgriculture(ICAR), Health(ICMR), industry and environment

Support to health care R&D Positioning in the Government

India Health care R&D

PrioritiesVaccines & DiagnosticsInfectious Disease BiologyChronic Disease Biology Food and Nutrition Stem Cell ResearchMedical Devices & ImplantsNano-medicineBioprospecting

MechanismsInternational Collaboration Autonomous Institutions of DBT New Translational Oriented Cluster InstitutionsCentres of ExcellencePublic-Private Partnership –SBIRI, BIPPRapid Grant for Young Investigators (RGYI) scheme

Development of vaccines and diagnostics for the major infectious and non-infectious diseases

Tuberculosis, Avian influenza, Chickungunya,

Rotavirus, Typhoid, Malaria,

HPVCholeraRabies

Cholera: Threat & Solution

• Global & a National Public Health Problem • 2,36,896 infected; 6311 deaths

[WHO;2006]• Case- fatality: 2.66% • Current treatments not very effective• DBT has developed an Oral, Live,

Recombinant Cholera Vaccine • Clinical trials showed efficacy in endemic &

non-endemic population • Shantha Biotechnics, Hyderabad contract

manufacturing the Vaccine• Would be available by 2011

Advantages• Live, single dose, Good sero-conversion• Appropriate in endemic situations; fortravellers & in emergency

DEVELOPMENT OF THE FIRST COMBINED DNA BASED RABIES VACCINE

Rabies is endemic in India transmitted mainly through the bite of rabid dogs.

It is estimated that 30,000 people die of rabies every year in India and several people receive post-exposure prophylaxis.

The first combined DNA based Rabies vaccine for control of rabies in dogs has been developed at Indian Institute of Science, Bangalore in collaboration with Indian Immunologicals, Hyderabad.

Completed clinical trials and commercially launched by Indian Immunologicals, Hyderabad.

IMMUVAC-An immunomodulator

• Partners: National Institute of Immunology, New Delhi; M/s Cadila Pharmaceuticals, Ahmedabad & DBT, Govt. of India

• Based on inactivated Mycobacterium indicus pranii

• Has shown significant immuno-modulatory effects in Leprosy, Tuberculosis and Cancer alongwith chemotherapy

• Being clinically investigated against Category I, Category II MDR Tuberculosis and in Cancer

Chronic Disease Biology

Deals with life-style related diseases Main focus on Cancer, Diabetes, Cardio-vascular

diseases, neurological disorders and other auto-immune disorders.Currently more than 300 projects ongoing

In cancer about 150 projects under progressProjects are aiming at early diagnosis, prognosis,

and therapeutics.

Genomics: Opportunities and Challenges in India

Indian Resource forGenomics

Indian Resource forGenomics

Computational Skill

Computational Skill

Large PopulationExtended FamiliesGenetic Diversity

Large PopulationExtended FamiliesGenetic Diversity

Genome InformaticsGenome Informatics Molecular GeneticsMolecular Genetics

Functional Analysis of Genome sequence

Functional Analysis of Genome sequence

Genetic disorders and drug response –genetics are also priorities

Food and Nutrition – Preventive medicine  

• Low cost technologies for Public health and nutrition

• RUTF

• Ultra rice

• Designer Crops

• Neutraceuticals for wellness

• Probiotics

• Herbal immunomodulatory products

Nano Medicine in drug delivery

Major areas are :

• Nanoparticle based delivery of bioactive molecules• Nanoparticle encapsulated siRNA in treatment of cancer• Gold nanoparticles in drug delivery and diagnostics• Drug delivery and drug targetting using therapeutic

nanoparticles• Design and Development of nanoparticles targetted drug

delivery system ocular and dental diseases

•

Biodesign R&D Medical devises market is about $ 500 M with growth rate of 30%

An effective and consistent way to deliver chest compressions to sudden cardiac arrest victims

Stem cell research –Recent Priority

Basic Stem Cell Research

Stem Cell Bank

Stem Cell Therapy Production Unit

Stem Cell clinical Trials

Licensed Product Manufacture

Specialist Beds and Facilities

Safety and Efficacy

Coordination

Stem Cell Therapy Commercial or Public sponsors Therapy Surveillance

Production process development

Pilot scale capacity to supply stem cell clinical trials

Research Grade cell banking and characterisation

Clinical grade cell banking and characterisation

Cell Biology Immunology Animal ModellingEpigeneticsBioengineering

Bioprospecting Biodiversity and traditional knowledge –Technology Matrix

Poor Rich

Poor RichPoor Poor

RichRichT

echn

olog

y (G

enet

ics ,

Br e

edin

g, B

iot e

ch a

nd

Phar

mac

e utic

al)

USAJapanFrance Germany UKetc.

BrazilChinaEthiopiaIndiaIndonesiaMalaysiaMexicoetc.

North

South

Biodiversity

1 2

34Some DeserticCountries

BD Flow?

No Countries

T Flow?

Microbial prospecting for drugs and molecules

7000 isolates/month

Screening at Nicholas Piramalanti-cancer, anti-diabetes anti-inflammationanti-infective

Culture Repository (Lyophilized)at NCCS

Screening/ Identification of novel

property by PIsClones from Clones from

unculturable Diversity unculturable Diversity (Metagenomic )(Metagenomic )

(NEERI, NCCS, (NEERI, NCCS, Univ Univ Delhi, IGIB)Delhi, IGIB)

7000 isolates/month

Screening at Nicholas Piramalanti-cancer, anti-diabetes anti-inflammationanti-infective

Screening at Nicholas Piramalanti-cancer, anti-diabetes anti-inflammationanti-infective

Culture Repository (Lyophilized)at NCCS

Screening/ Identification of novel

property by PIs

Culture Repository (Lyophilized)at NCCS

Screening/ Identification of novel

property by PIs

Culture Repository (Lyophilized)at NCCS

Screening/ Identification of novel

property by PIsClones from Clones from

unculturable Diversity unculturable Diversity (Metagenomic )(Metagenomic )

(NEERI, NCCS, (NEERI, NCCS, Univ Univ Delhi, IGIB)Delhi, IGIB)

Innovation to Commercialization-stages

Survival Phase Growth PhaseBirth Phase

IdeaProof of Concept Prototype / Working Model

Pilot plant Stage /pre-Commercial Trials/ Validation

Commercial Product/ Process

Seed Financing

Venture Capital

Government Sources adequate … ??Ignition funds

for Scientist

innovators

Private Equity

Venture Capital

Government Sources

A. TDDP (PATSER)B. PRDSFC. NMITLI

Private Equity

Venture Capital

Product Licensing / Marketing

Government Sources

A. TDBB. NMITLIC. PRDSF

Key Features modern PPP for cost reduction of Key Features modern PPP for cost reduction of public good health care productspublic good health care products

Support on cost sharing basisLarge, medium and small scale industryHigh risk, discovery linked innovation Accelerated technology development Evaluation and validation of biotech products

Indigenous discovery and innovationProducts of national relevance or public good

Research resource facilities and platform technology centres

35

NEW PARTNERSHIPS: FOR EFFECTIVE IP GENERATION

FUTURE MODELS

Alliance Model

Lab’s Domain Knowledge

Co-development of projects executed by industrial partner

Industries Market Intelligence

Increase of New Process/ Product

Human resources absorbed by Industry

Industry

Marketing

Part flows back as Royalty

Wealth Creation by Industry

Alliance

CSIR Report 2005

Contd…

PARTNERSHIP:

FUTURE MODELS

R&D Service Model

Lab’s Domain Knowledge

Knowledge Based Service centresManaged by Industries with Lab’s equity in IPR/Services

Industries Marketing Skill,Manpower and Operating Expenses

IPR Generation

Industries in Core Sectors: Pharma, Genomics,

Bioinformatics etc. benefit

Marketing of IPR for Wealth Generation

Part flows back as Royalty

Alliance

Services

CSIR Report 2005

Protection of IP Public Funded R&D is By legislation is essential for protecting indigenous innovation

Indian draft bill entitled ‘Public Funded R&D (Protection, Utilization and Regulation of Intellectual Property) Bill, 2007’ is example for promotion of innovation, be introduced in the Parliament

The proposed legislation will promote, protect and optimize the potential of public funded R&D in a manner that is beneficial to the inventor(s) as well as to the public, and encourage innovation in SMEs, promote collaboration between government and non-government organisations, as well as catalyze commercialization of IP generated out of public funded R&D.

India has been witnessing offshoring/ outsourcing of processes under the entire spectrum of drug development value chain- best for cost reduction

Drugregistration

Data Management, Site Management, etc.

Development

Pre-clinical

PhaseI

PhaseII

PhaseIII

Product launch

Manu-facture

Discovery

Lead generation and optimization

Research

Target/ Lead identification

Vendor Landscape in India

Commonly outsourced

Complexity Level

Marketing/ Phase IV

39Average Good High Very HighLow

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Indian pharmaceuticals by 2012`

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China and India --- Competition or cooperation

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China and India can collaborate – can lead world markets!!

Multiple Collaborations are essential even promoting cost effective indigenous innovation across continents

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To concludeVery advanced technologies are being developed for research

process , development and regulation for cost effective production of health care products based on genomics, proteomics and metabolomics, IT and nano technology convergence and emerging areas of synthetic biology, systems biology and combinatorial chemistry.

Personalized medicine is trend of future Priorities are converging although communicable diseases are

still major disease burden in developing countries than life style disorders

Globally important pandemic potential diseases like swine flu, avian flu, SARS and zoonotic diseases like anthrax and brucellosis are new challenges to tackle

In India both life style diseases and infectious diseases are research priorities

Vaccines, new drugs/molecules, diagnostics and devices markets are growing

To conclude

Access and affordability are major challenges as drug/ vaccine development is inevitably expensive

Local capacity in any areas : R&D/ translation /technology development,/adoption/acquisition / clinical trial needs have to be developed to partner with others along the innovation value chain

IPR and regulatory facilitation rather than hurdle should be policy

Alliances, partnerships and collaborations are must

Skilled human resources to deal with various aspects of value chain of health products is prerequisite

Bioprospecting through biodiversity acts/ guidelines of Access and benefit sharing is welcome for careful use of traditional knowledge and local biodiversity supported by modern clinical science data

Even if IP is available with FTO local capacity in one of the activity along innovation chain is essential

WTO

CODEX

CBD

TRIPS

PVPPBR—Treatiesssssss

ssssssssssssssss conventionssssss

Proponents Opponents

Collaboration &

Partnerships

TECHNOLOGYI need food then medicine Medicine that I can access

and afford

Thanks Pontifical Academy of Sciences

15-19,May 2009,Rome