Collaboration With Academia - From Sparring With Shadows Final

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    Collaborating with AcademiaFrom sparring with shadows to waltzing with Wanda

    Pharma R&D World Asia Congress

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    Summary Academia has always been a major source of pharmaceutical innovations With new changes in the research environment, this dependence is set to

    increase Support for academic R&D in OECD countries is decelerating India/China are ramping up support for academic R&D; this is coupled to

    rapid expansion in GDP The academic sector in emerging nations is poised to play an important

    role as a source of innovation The translational gap is still to be effectively bridged: Examples ofinnovative Indian models being created within the academic/GOI sector to bridgethis gap

    How can we use the clean stage for a waltz rather than a sparring session:

    Some examples from Merck What more could Pharma do?

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    Industry R&D owes its origins to academia

    Alfred Newton Richards, 1876 1966

    Prof of Pharmacology Univ of PennsylvaniaAnd Consultant andBoard Member, Merck and Co., Inc.

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    Dorsey, E. R. et al. JAMA 2010;303:137-143

    Support for academic R&D in the US is deceleratingFunding by source: 2003-2007

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    NIH budget appropriation (1960-2010)

    0

    5,000,000

    10,000,000

    15,000,000

    20,000,000

    25,000,000

    30,000,000

    35,000,000

    1950 1960 1970 1980 1990 2000 2010 2020

    Support for academic R&D in the US is decelerating

    Source: NIH

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    Growth of articles published in peer-reviewed journals

    %C

    HANGE

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    Why drug discovery in academia

    Increasing specialization of knowledge and research skills in life science

    Specialists have a natural home in academia

    Synergy/complementarity between applied and basic aspects

    Cost of exploratory science

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    Who will mind the translational gap?

    Academia Industry

    Educationalgovernance

    Regulatorygovernancequantity

    qu

    ality

    DATA

    GAP

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    Innovative Organization Structures

    Examples from India

    OSDD Open Source Drug Discovery

    CCAMP Center for Advanced Molecular Platforms

    THSTI Translational Health Sciences and TechnologyInstitute

    ILS Institute for Life Sciences

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    Sponsored by CSIR/GOI (USD 38 million)

    Collaborative platform for Indian scientists and theirglobal counterparts for solving problems related toneglected tropical diseases

    Aggregation of biological and genetic information tohasten drug discovery

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    MECHANICS

    The sub-division of activities into work packages enables adivide and conquer approach

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    PEER REVIEW BASEDMICROATTRIBUTION USINGWEIGHTED CREDITS

    TIERED MEMBERSHIP

    MONETARY + NON-

    MONETARY REWARDS

    SHARING REWARDS

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    Translational Health Sciencesand Technology Institute

    Faridabad, India

    Translational research focus

    Collaboration with Harvard-MIT

    Centers:Vaccine and infectious diseaseClinical Development ServicesPediatric biologyBiodesign

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    A Component of the

    Bangalore Bio-Cluster

    Invention Innovation

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    Technology Platforms

    Confocal

    & Fluorescence

    Microscopy

    (Services and Training)

    Flow Cytometry

    (Services and Training)

    Mass Spectrometry andProteomics

    (Services)

    Transgenic Fly Facility

    (Services)

    High Throughput

    Screening

    (Services)

    High-end Genomics (Next Generation Sequencing)

    Intellectual Property Management Office (IPMO) and

    Technology Transfer Office

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    Govt. of Andhra Pradesh

    PUBLIC

    University of Hyderabad

    PRIVATE

    Public-Private Partnership

    http://piramalhealthcare.com/index.aspx
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    To find solutions to improve human health

    through the application of cutting edgeresearch by integrating various disciplines ofSciences (Life, Information, Chemical &Physical)

    Translational Research

    Bridge the gap between industry andacademic centres

    Aligned to the needs of Pharma / Biotechindustry

    MISSION and OBJECTIVES

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    Merck is Dedicated to Academic Partnerships

    Merck scientists welcome the opportunity to collaborate with ouracademic colleagues to advance the state of the art in biomedical

    research.

    Together with our academic partners, we areexploring novel research models to advance

    cutting-edge science into new medicines thataddress important unmet medical needs.

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    For Academic Collaborations,

    Mercks Approach is Driven by Strategy

    Defining goals, delivering against a work plan, and respecting intellectualproperty are the keys to a successful collaboration.

    Well defined goals are critical

    Objective to produce new knowledge advancing research/productdevelopment

    May be strategic (breakthrough science) or tactical (an acceptedapproach, but elegantly executed)

    Funding is based on the work plan, not for general lab support

    Milestones / Renewal based on delivering on objectives

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    Moffitt Collaboration:

    Personalized Medicine to Treat Cancer (2006) Collaboration to link molecular technology and clinical

    data to enhance the ability to diagnose and treat patients,

    and to discover and develop new targeted therapies(Dec. 2006)

    Identify the right drug for the right patient - individualize

    treatment for patients with various types of cancer

    Partnership between patients, community

    providers, industry and government to personalizeand improve cancer care

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    Merck/Moffitt Collaboration: Direct patient selectionfrom database matching molecular signatures to

    clinical trialsProfiles stored at hospital

    Diseaserecurrence

    and trialeligibility

    Validation of molecular hypotheses

    Patient selection on available profiling data

    Trial sig B

    Clinical trial Portfolio

    Trial sig A

    Trial sig C

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    Dana-Farber and Merck CreateTeam Approach to Cancer Drug Treatment (2008)

    To improve the success rate of investigational cancer drugs enteringclinical trials, the Belfer Institute for Applied Cancer Science (BIACS)

    of the Dana-Farber Cancer Institute and Merck and Co., Inc., haveestablished a collaboration to identify promising drug targets, anddevelop therapeutic candidates to reach those targets.

    The BIACS will investigate drug targets using integrative and cross-species genomic analysis and stringent multi-level functional andclinicopathological validation testing.

    The BIACS will work together with Merck to shepherd the drug assay

    development of lead compound discovery and then work together totest these drugs in BIACS's highly sophisticated model systems thatclosely replicate human disease.

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    Driving Innovation through Partnering

    Mercks agreement with Harvard University on new treatmentsfor osteoporosis

    Example of a new breed of industry-academia alliances with closeconnections between the teams

    Jointly design project proposals, jointly do research, patent and publishresults together

    Translational Medicine: Accelerate the move from

    basic biology drug targets medicines

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    Harvard/Merck Collaboration

    Merck is using their enormous resources to help us assemblehuge expression arrays and integrate the signaling pathways in

    samples we give them.

    The two lead Harvard scientists on the project interact with Merckalmost daily. The team gets together once a month, and all

    participants have access to a virtual meeting room where they canpost data. We feel like it really is a research collaboration.

    Dr. Laurie H. Glimcher

    Professor, Harvard Medical SchoolProfessor of Immunology, Harvard School of Public Health

    Chemical & Engineering News (Nov. 17, 2008)

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    Abacus is a unique forum for exchange of ideas betweenMRL and selected Imperial College faculty

    Goals are to build an open exchange of ideas and people on afoundation of trust and collaboration resulting in inspired innovativethinking that ultimately translates into the design of novelhealthcare solutions

    Develop novel approaches that improve patient care/outcomes andare valued in the market place

    Active exchange of individuals who benefit from the exposure to the

    respective environments.

    Abacus Project -- Imperial College London

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    MERCK

    Participation in a new model ofacademic interactions

    External linkages

    Access to and collaborationwith experts outside of Merckcore competencies

    Access to unique knowledgenot targeted to a product:seed of blue skies innovation

    New ideas

    Sabbatical opportunitiesPublications

    IMPERIAL COLLEGE

    Catalyze and facilitate interactions

    between diverse departments in thearea of systems biology

    Potential for financial reward throughcommercial viability

    Publications

    Educational exchange opportunities -selected faculty and students

    Leverage additional resources frome.g government/charity

    Abacus Project -- Imperial College London

    ABACUS

    Develop novel approaches that improve patient care/outcomes and arevalued in the market place

    Active exchange of individuals who benefit from the exposure to therespective environments.

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    Medarex and Mass Biologic Labs:Agreement with Merck for Investigational Antibody

    for C. difficileInfection (April 09) Exclusive worldwide licensing agreement for CDA-1 and CDB-1, an

    investigational fully human monoclonal antibody combination developed totarget and neutralize Clostridium difficiletoxins A and B, for the treatment of

    C. difficileinfection (CDI).

    CDA-1 and CDB-1 were co-developed by Medarex and MBL. Merck gainsworldwide rights to develop and commercialize CDA-1 and CDB-1.

    Top-line results from a Phase II multicenter, randomized, double-blind,placebo-controlled trial evaluating CDA-1/CDB-1 provided evidence of astatistically significant reduction in the rate of recurrence of CDI comparedwith placebo.

    This agreement underscores Mercks ongoing commitment to infectious

    disease research and the licensing of promising candidates with the potentialto address serious unmet medical needs.

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    UTSA, Health Science Center: Collaboration with

    Merck to Develop Chlamydia Vaccine (April 09) The University of Texas at San Antonio (UTSA) and the University of Health

    Science Center at San Antonio (Health Science Center) will work with Merckon a vaccine for chlamydia, targeting the common sexually transmittedbacterium Chlamydia trachomatis.

    Merck will fund research at UTSA and the Health Science Center andcollaborate closely with their team of researchers who have demonstratedthat, in animal models of genital chlamydial infection, a vaccine composed of

    a select group of recombinant C. trachomatisantigens can successfullyaccelerate bacterial clearance, and importantly, preserve female reproductivefunction.

    The partnership is an exciting development in the fight against infectious

    disease and aligns with Mercks commitment to R&D in areas of unmetmedical need.

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    What Pharma can do (better) in Emerging

    Markets academic sector engagements Relationship building is still important

    Customize relationships to unique needs while takingadvantage of unique situations

    Help catalyze the development of novel organizationstructures (do not wait for things to happen!)

    Be sensitive/respectful towards the primary mission ofemerging market institutions