“Globalization of Clinical“Globalization of Clinical Research ...Globalization Agenda WW...

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“Globalization of Clinical “Globalization of Clinical Research: Impact on Latin America” Elsa María Fernanda López Assoc. Director GRO OSM Latin America & GMBA Mexico PAREXEL International Mexico S.A. de C.V.

Transcript of “Globalization of Clinical“Globalization of Clinical Research ...Globalization Agenda WW...

  • “Globalization of Clinical“Globalization of Clinical Research: Impact on Latin America”

    Elsa María Fernanda LópezAssoc. Director GRO OSMLatin America & GMBA Mexico

    PAREXEL International Mexico S.A. de C.V.

  • Globalization Agenda

    WW Situation vsEmerging Markets Clinical Trials in 

    L i A i

    Globalization Progress / Systems

    Impact, Latin America Challenges, 

    Opportunities

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  • Why Globalization?• Economy: mandates• R&D: more demandingg• Mergers, Acquisitions, Partnerships, Alliances: efficiency saving• Critical staff: retention & expertise• Market: highly competitive• Market: highly competitive• Rework & Inconsistencies: elimination• Predictability & Quality: improvement

    V l f i• Value for money: increase• Long-trustable relationships: building

    “Leading companies are now focused on globalization, agility, managing diversity and dispersed workforces, driving innovation and professional development for leaders at all levels”.

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    Source: Bersin & Associates, 2010

  • WW Clinical Trials

    • 115,737 studies• 169 countries• LA: 5.3% (total)

    Source: www.clinicaltrials.gov, April 2011

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  • WW Country RankingRANK REGION # OF STUDIES % % ACCUM.

    1 United States 51,958 44.89% 44.89%

    2 Canada 7,930 6.85% 51.74%

    3 Germany 7,118 6.15% 57.90%

    4 France 6,080 5.25% 63.15%

    5 Belgium 3,066 2.65% 65.80%

    6 United Kindom 5,284 4.57% 70.36%

    7 Italy 4,017 3.47% 73.83%

    8 Spain 3,558 3.07% 76.91%

    9 Holland 3,317 2.87% 79.77%

    10 Australia 2,980 2.57% 82.35%

    17 Brazil 2,128 1.84%

    26 Mexico 1 323 1 14%

    5.29%

    26 Mexico 1,323 1.14%

    31 Argentina 1,127 0.97%

    41 Chile 596 0.51%

    45 Peru 525 0.45%

    Source: www.clintrials.com

    45 Peru 525 0.45%

    47 Colombia 429 0.37%WW TOTAL 115,737 100%

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  • The Rise of Emerging MarketsROW areas of Major pharmaceutical companies expected to grow significantly: the 17 “Pharmerging Markets” (IMS).

    17 developing markets will generate almost 50% of global annual industry revenue growth by 201317 developing markets will generate almost 50% of global annual industry revenue growth by 2013.

    Health forecasted to grow at a 15+% annual rate and generate approximately $175 billion in 2011 revenues.

    The “Big 5” Western European markets Japan Canada and the US expected to grow at only 1% 5%The Big 5 Western European markets, Japan, Canada and the US expected to grow at only 1%-5% annual rates in 2011 (though they will remain much larger in revenue terms).

    China is the industry’s 3rd largest single country market after the US and Japan.

    O h l k d B il (8 h) R i (11 h) I di (12 h) d h ( M i T k )Other large markets today: Brazil (8th), Russia (11th), India (12th), and others (e.g. Mexico, Turkey) will only get larger as their economies and middle classes develop. From a profit pool perspective these countries will likely trail established markets for years to come.

    Developing markets will in fact likely never be the primary source of profits for the traditional f fpharmaceutical companies, however, will be an important part of the equation going forward.

    Industry’s largest companies must begin to develop recipes for profitable growth and success in Pharmerging countries.

    Drug Information Association www.diahome.orgSource: CT Partners-IMS-, Feb2011

  • Geographic OutsourcingGeographic Outsourcing

    51%20%

    26%

    20%

    37%22%

    7%

    37%

    17%

    EUA UE Asia/Pacific ROW

    2008 2011

    EUA UE Asia/Pacific ROW

    Source: Jefferies & Co., Inc. Survey of Outsourcing Biopharma R&D Professionals, 2008

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  • Emerging Sites / PatientsFinland, Brazil & Mexico top per site recruitment; visualisationBy Nick Taylor30-Nov-2010

    “Finland, Brazil and Mexico recruit more patients per site than any othercountry where clinical trials are frequently conducted, according to EMA data”

    In a recent report the European Medicines Agency (EMA) published data on the number of trials, site and patients from each country included in marketing authorisation applications (MAA). OutsourcingPharma has analysed the data to find recruitment per site for each country.

    After countries that, on average, conducted fewer than five trials a year are excluded, Finland, Braziland Mexico emerge as recruiting the most patients per site Finland tops the list with an average of 31and Mexico emerge as recruiting the most patients per site. Finland tops the list with an average of 31patients per site from 2005 to 2009, after a 23,422 person vaccine trial is excluded. Trailing Finland are Brazil and Mexico which both recruited 25 patients per site. Other countries ofnote include: China and Hong Kong, which both averaged 24 patients; Denmark, 23; and Poland, 22.

    I t t li i l t i l it i P t l it d f i ti t f 2005 t 2009 B lIn contrast, clinical trial sites in Portugal recruited an average of six patients from 2005 to 2009. BelowPortugal, with the lowest recruitment rate, is Ireland, which averaged five patients per site.

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  • Latin America

    Brazil

    The region represents a high concentration of Clinical Research

    50%

    Costa RicaGuatemala

    ColombiaPeruChile

    ArgentinaMexico 50%

    89%

    JamaicaUruguay

    CubaDominican Republic

    EcuadorPanama

    Venezuela

    NicaraguaParaguayBahamas

    HaitiBolivia

    HondurasEl Salvador

    Jamaica

    0 200 400 600 800 1000 1200 1400 1600 1800 2000

    Trinidad & TobagoBelize

    Nicaragua

    # of clinical Trials (annual)

    Source: National Institutes of Health (NIH), 2009

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  • Population & Potential Market

    Ecuador3%

    Bolivia2%

    Paraguay1%

    Uruguay1%Mexico 3%2%1%1%Mexico

    22%

    BrazilColombia

    10%38%

    Argentina8%

    Peru6% Venezuela

    6%

    Chile3%

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  • Clinical Studies in Latin AmericaCountry Population(000)1

    ClinicalStudies

    SalesUnits1

    CT per capita 2(000) Studies (Millions)

    p(Pop.)

    Brazil 193,785 1,928 1,769 0,10

    Mexico 109,586 1,244 910 0,11e co 09,586 , 9 0 0,

    Argentina 40,341 1,042 532 0,26

    Chile 16,970 569 220 0,34

    Peru 29,163 483 96 0,17

    Columbia 45,660 379 304 0,08

    Sources: EPAL, IMS & NIH; 2009

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  • Working Model / Progress

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  • Study Start-Upy

    • Apply local/regional expertise to speed start-up– Assess feasibility

    Id tif d i iti t it ( f d it t k)– Identify and initiate sites (preferred sites network)– Negotiate investigator / site agreements– Submit ethics and regulatory documents

    T i R i l l ti– Train on Regional regulations– Brand new sites training / support– Feed Investigators data base / clean busy-non performing sites

    • eDocument Management & Trial Management System– Easy access to high quality and complete information

    S i i i i ll– Save time, gain consistency, improve overall process

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  • Site ManagementEDCCTMSIn house 

    electronicelectronicCRFCRF

    Safety/Documents AutomationIVRS/IWRSWeb Portal

    monitoring

    Strong and effective site relationships

    Investigator Data management

    O itOn site

    Monitoringwww.diahome.org

    Drug Information Association

  • Electronic Document

    •Central repository for– Trial Master File

    Major benefits:– Fast distribution of documentsTrial Master File

    – Project Management Documents

    Fast distribution of documents– Easy navigation through study

    files– Sharing across locations

    S– Savings in pass-through costs– Reduced paper, print, copy,

    courier charges, archiving fees

    – 21 CFR part 11 compliant – Document version control – Audit trail

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  • Trials Management Systems

    – Investigator– Investigator – Progress – Regulatory Documents

    Cli i l C– Clinical Cost – Clinical Supplies– Sites

    Milestone planning, issues managementOn-line monitoring reports & reviewRemote & in-house monitoring activitiesQ lit iQuality issues

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  • Holistic Approach to Quality

    • Process Improvement Focus– Process flow-based Controlled Documents– Process improvement-focused groups– Lean Six Sigma-based training program– Root Cause Analysis

    • Sources of Process Improvement Information– Spontaneous Employee Feedback– Customer Satisfaction Survey programCustomer Satisfaction Survey program– Project Quality Risk Score– Audit and Inspection database– Corrective Action and Preventive Action program (CAPA)

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  • Quality Learning Curve

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  • EMA GCP InspectionsEastern-Europe-non EU 2 Croatia 1 Serbia 1

    Middle East/Asia/Pacific 25 China 4 India 9

    CIS 10 Russia 8 Ukraine 2 North America 63

    Korea (South) 1 Malaysia 1 Philippines 4 Chinese Taipei 1

    Canada 13 USA 50 Central/South America 11Argentina 2

    Thailand 3 Turkey 2 Africa 5Ghana 1

    Brazil 2 Chile 1Colombia 1Costa Rica 1

    Morocco 1 South Africa 3

    Mexico 3 Peru 1

    The increase in inspections outside EU (total 116) since 2006, follows the p ( )implementation of a formal system of routine GCP inspection.

    Drug Information Association www.diahome.org Source: European Medicines Agency, 2010

  • Impact: Mission, Vission, Values

    VALUES: TIMELINES

    MISSION: PROFESSIONALISM (SITES/CROs) TIMELINES

    WELL DEFINED PROCESSESSTABILITY

    TALENT IDENTICATION & RETENTION, TRAINING & SUPERVISION

    INSPECTIONS /FDA READY

    MAIN LA GOALS:

    VISION: WORKING PARTNERS

    “BEST IN CLASS”“UNIFY EFFORTS”WORKING PARTNERS,

    QUALITY FRAMEWORKUNIFY EFFORTS

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  • Challenges

    DIFFERENT REGULATIONSPOLITICS STABILITYECONOMIC STABILITYCULTURE, DIVERSITYNATURAL DISASTERS

    DIFFERENT REGULATIONSCOMMUNICATION ISSUESEDUCATION & TRAININGINFRASTRUCTURE & TECH.NATURAL DISASTERS

    EPIDEMICSSAFETY

    INFRASTRUCTURE & TECH.QUALITYPROCESSES BUROCRACY

    UNPREDICTABILITY

    COUNTRY / NATURE CONTROL

    CLINICAL RESEARCH STAFF CONTROL

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  • Opportunities

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  • Darwin´s Theoryy

    “When you stop learning you stop developing and you stop growing”When you stop learning, you stop developing and you stop growing

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