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Final Ppt Mentoring

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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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