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I Seminar on
Medical Entrepreneurship & Meeting GlobalMedical Entrepreneurship & Meeting GlobalOutsourcing RequirementOutsourcing Requirement
Date: 2nd & 3rd June 2006
PRESENTATIONBy
KAMALJIT
(0921415)
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Pre-20th century medicineMan has found, by trial and error, which berries, roots, leaves and
barks could
be used for medicinal purposes to alleviate symptoms of illness.
* All ancient civilisations made discoveries in this field
* Chinese herbal remedies are probably the most well known
The Doctrine of Signatures:(propounded by Paracelsus 1493-1541 and Jakob Bhme 1575-1624)
introduced the idea that God had specially marked everything to
reveal its purpose
Iris petals - for treating bruises
Liverwort - for treating liver ailments
Goldenrod - for treating jaundice
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Willow bark and salicylic acidDoctrine of SignaturesThe Rev Edward Stone (1760s) searched
along a riverbank (i.e. a cold and wet place) for
a plant-based cure for the fevers associated
with influenza. Found that the bark of the
willow was effective in reducing fever.
Native American Cherokees used willow
bark for such purposes for centuries.
* willow bark contains salicin
* metabolized in vivo to the active agent salicylic acid * salicylic acid and more tolerable prodrug aspirin made in
late 19th
century
* mechanism of action not discovered until the 1970s.
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QuininePowdered dried bark of the cinchona tree,a native of South America, was made into
a drink and used by the Quechua Indians
ofPeru to treat fevers.
Discovered by Jesuit priests in the
1620s, Barnab de Cobo takes cinchona
bark to Europe in 1632 to treat malaria.
Quinine isolated in
1820 by Pierre Joseph
Pelletier and JosephCaventou
First Total Synthesis
(1943) RB Woodward
and WE von Doering
Kills parasites causing malaria.
Mode of action complex and still
not 100% worked out.
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Early milestones in development of
medicinal chemistryAnton van Leeuwenhoek
1632-1723
Louis Pasteur
1822-1895
Robert Koch
1843-1910
Paul Ehrlich
1854-1915
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Paul Ehrlich (1854-1915) The so-called father of modern chemotherapy. Original proponent of the magic bullet he aimed to use chemicals to treat disease. In 1910 the first fully synthetic drug was made: Salvarsan which contained arsenic!
Used for treating sleeping sickness (trypanosomiasis) and syphilis (caused by Treponema pallidum). The Nobel Prize for Medicine 1908
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Modern drug discovery
Key stages:
Programme selection (choosing a disease to work on)
Identification and validation a drug target
Assay development Identification of a lead compound
Lead optimization
Identification of a drug candidate
Clinical trials Release of the drug
Follow-up monitoring
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Principles of drug action
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What is Bioinformatics?
Is conceptualizing biology in terms of molecules(in the sense of physical-chemistry) and thenapplying "informatics" techniques (derived fromdisciplines such as applied math, CS, andstatistics) to understand and organize theinformation associated with these molecules, on alarge-scale. Bioinformatics is the field of science
in which
Biology, computer science, and information
technology merge into a single discipline. The
ultimate goal of the field is to enable the discovery
of new biological insights as well as to create
a global perspective from which unifying
principles in biology can be discerned. There
are three important sub-disciplines withinbioinformatics:
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the development of new algorithms and statistics with which toassess relationships among members of large data sets;
the analysis and interpretation of various types of dataincluding nucleotide and amino acid sequences, proteindomains, and protein structures;
the development and implementation of tools that enableefficient access and management of different types of
information.
Biological Data Computer Calculations
Bioinformatics
+
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Cancer cell growth appears to be related to evolutionary
development of plump fruits and vegetables
Large tomatoes can evolve from wild, blueberry-size tomatoes. Thegenetic mechanism responsible for this is similar to the one that
proliferates cancer cells in mammalians.
This is a case where we found a connection between agricultural researchin how plants make edible fruit and how humans become susceptible to
cancer. That's a connection nobody could have made in the past.
The past gives us knowledge and experience, and the presentgives us the power to change things; together, the past and the
present allow us to envision and shape the future
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Which Branches of Biology willBenefit from this Knowledge?
Medicine
Pharmacogenomics
Biotechnology Bioinformatics
Proteomics
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Blockbuster Drugs
Claritin
an anti-allergydrug with salesreaching $3billion in 2000
(nearly 1/3 ofScheringPloughsrevenues .
Prilosec
an ulcerdrugproduced byAstraZeneca, soldover $6.2billion worth
globally in2000 alone.
Zantac
also an ulcerdrug. Glaxosold $9 billionworth of
globally, but lostpatentprotection in1997.
Drug sales inthe US in 1997totaled morethan $69.4billion.
HIV drugs
In 1998 inthe US,NRTIs
accountedfor $885million insales, PIs
$865 millionand NNRTIsfor $100million.
The market
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Global Pharmaceutical Audited Market
(In a single year)(Sales Through Retail Pharmacies) US $ Bn % Share % Growth
United States 180.3 49.57 +6%
Japan 60.7 16.69 +5%Germany 26.9 7.40 +6%France 22.6 6.21 +5%United Kingdom 15.5 4.26 0%
Selected World 363.70 100.00 +7%
Source Data :IMS Health
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Indian Pharmaceutical Industry Manufactures over 400 APIs ( Bulk Drugs )
Manufactures over 10,000 Medicaments(Formulations)
Almost self Sufficient (95%) in DomesticRequirement
Total Pharmaceuticals Production $8.0 Bn(Approximate)
Ranks 4thGlobally in Volume Terms
Ranks 13th Globally in Value Terms
Among TOP 5 Global Producers of Bulk Drugs
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The Top 10 Pharmaceutical
C
ompanies
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Approvals Received from SomeApprovals Received from SomeDeveloped CountriesDeveloped Countries
COMPANIES / FACILITIES
FDA - UNITED STATES 75
TGA - AUSTRALIA 19
MCA- SOUTH AFRICA 45
EDQM - EUROPE 3
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Hyderabad in Indian Pharma
Contributes over 40% to National Output
Known as Hub for Production of APIs
Over 250 Active Bulk Drug Manufacturers
Strong in process development
Presence of about 5 Top Pharma Companies inHyderabad
Strong Biotech presence
Several Clinical Research / Custom ResearchCentres
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Economics of Drug Discovery Cost of discovering a drug: About $ 800 1,000 Mn
Without cost of capital, cost is about $ 400 500Mn
Development phase accounts for 28% -35% oftotal
Developing a single optimized lead costs $ 25 40Mn
This includes both development and animalstudies
Cost of development phase: Generating enoughpromising or optimized leads to go to animaltrials costs $ 10 25 Mn per study
This activity is ripe for outsourcing to qualified
service providers
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Outsourcing & Pharma..
Manufacturing outsourcing will involve the supplyof active pharmaceutical ingredients /intermediaries.
Development outsourcing will involve pre clinicaland clinical trials
Customised chemistry services will involvecontract research for molecules in the pre launchstage.
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Outsourcing & Pharma..
Research & Development- 74% of offshoredemployment
Clinical Trials- worth (US$75 million for the year2005estimated at US$281 million by 2010)
Data Management Medicalwriting,Drug Discovery Contract Manufacturing- first Indian companies to
enter into- Ranbaxy Laboratories & Lupin Laboratories
Clinical Research / Clinical Trials Contract Research & Manufacturing
Services(CRAMS)
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Cost Comparison:-
Kotak estimates reports : -
Cost of doing clinical trials in India is 40-60
per centlow
er than in develo
ped markets.
CYGNUS Research quotes:-
Cost of Manufacturing a drug in US costs60% more to that of manufacturing thesame drug in India.
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Pharma Outsourcing Market Size(Estimates by 2009)
Contract Manufacturing
A. Prescription Drugs US$ 43.9 Bn +10.8%
B. OTC Drugs US$102.0 Bn +11.3%
Contract Research US$ 21.9 Bn +8.6%
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Contract Research andManufacturing Services (CRAMS)
Contract Research (CR)
1. Drug Discovery Stage (NCE Synthesis)
2. Pre Clinical Stage3. Clinical Stage
To setup of laboratory as per requirements ofcustomers
Procurement of requisite equipments and gettingapprovals
Recruiting personnel and providing requisite training Possible returns 30-70%
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Contract Research andManufacturing Services (CRAMS)
Contract Manufacturing (CM)
A. Custo
mised manufacturingo
fIntermediates for NCEs
Expected returns more than 50%
B. Offer manufacturing facility to
companies having ANDA approvalsC. Supply of APIs toGeneric Drug
Formulators
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Why Outsourcing India?
Greatest potential for cost saving Highly trained poolof Scientists &
Professionals
Regulatory Compliance
Quality Standards,Rich biodiversity
Adopting cGMP and Good Clinical practices
Equipped with Infrastructural facilities
Good Service and On time delivery Govt. policies favoring R & D
Growth in health insurance sector
Biggest market with vast potential
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India high on the Outsourcing list for Clinical trials !
A number of 122 Clinical trials are conducted in India nextto Taiwan,Mexico,Poland,Brazil.
GlaxoSmithKline, among the worlds top ten globalpharma majors, is currently carrying out the largestnumber of clinical trials in India.
UK-based pharma major is conducting 13 drug trials inIndia for the treatment of diseases such as
cancer,arthritis,heart disease and constipation. Johnson & Johnson, Eli Lilly are conducting respectively
eight studies in India. Suven Life Sciences & Sipra Labs are also actively
invloved in the Trials.
Clinical Trials in India, costs 50% to 60% less than theaverage cost in the US.
AstraZeneca another global pharma companyoutsourcing significant number of its trials to India
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PHARMEXCILPHARMEXCILPHARMACEUTICAL EXPORT PROMOTION COUNCILPHARMACEUTICAL EXPORT PROMOTION COUNCIL
1. SET UP BY MINISTRY OF COMMERCE ON 12 MAY, 2004
2. OBJECTIVE : TO GIVE FOCUSED ATTENTION TO PHARMAEXPORTS
3. SUPPORTED BY : ALL MAJOR PHARMA ASSOCIATIONSIDMA, BDMA, OPPI, IPA, ETC. AND GOVT., OF A.P.
4. H.O. AT HYDERABAD & R.O. AT MUMBAI
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Product Groups CoveredProduct Groups Covered
Bulk drugs / drug intermediates
Drug formulations
Herbals / Ayurvedics / Homeopathic / Unani
Medicinal Plants
Bio-tech / Biological products
Diagnostics and Surgicals
Neutraceuticals
Collaborative /contract research Clinical trials
Pharma consultancy services etc.
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Assistance toExportersAssistance toExporters
Issue of RCMC certificates
Delegations to foreign countries
Buyer seller meetings
Foreign buyer details
Embassy assistance
Exhibition participationSeminars and Conferences
Technology assistance
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Advantages of entrepreneurship Enormous personal financial gain
Self-employment, own bossing, offering more job satisfaction and flexibility of the work force Employment for others, often in better jobs Development of more industries, especially in rural areas or regions disadvantaged by economic
changes, for example due to globalization effects
Encouragement of the processing of local materials into finished goods for domestic consumption aswell as for export
Income generation and increased economic growth
Healthy competition thus encourages higher quality products
More goods and services available Development of new markets Promotion of the use of modern technology in small-scale manufacturing to enhance higher
productivity
Encouragement of more researchers/studies and development of modern machines and equipmentfor domestic consumption
Development of entrepreneurial qualities and attitudes among potential entrepreneurs to bring
about significant changes in the rural areas Freedom from the dependency on the jobs offered by others Ability to have great accomplishments Reduction of the informal economy Emigration of talent may be stopped by a better domestic entrepreneurship climate Serious tax advantages
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THANK YOU
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