Clinical Trials in Emerging Markets Ppt - PowerPoint

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					    Latin American Clinical Trial
    Authorizations: Overview and
    2008 – 2009 Update




Dennis Hurley, DrSc – VP of Latin America, Kendle LatAm
Alcione Braga, RPh, MBA – General Director, Kendle Brazil
Mariagabriela Alterio, MSc – Regional Director of PM, Kendle LatAm
Jacqueline Zeuner, MSc – General Director, Kendle Peru
                                  Objectives

        When we have completed this presentation, you will be
        able to:
             1.   Quantify growth of Clinical Trials activity in Emerging
                  Markets and explain principal drivers for growth.

             2.   Identify recent changes in CT Authorization regulations
                  and their effect on approval timelines and information
                  requirements: BR and MX.




www.diahome.org                                                       www.ameifac.org.mx
                  What are the Trends in Emerging Markets?

     FDA-Regulated Investigators 1996 vs. 2006 and 2004 vs. 2007

                               2006       % of Total     Annualized 10       Annualized 3 yr
                                                            yr GR                 GR
     N-America               14,555         63.2 %            1.8 %                -5.2%

     W-Europe                 3,923         17.0 %            7.5 %                -6.1%

     CEE                      1,793         7.8 %             41.4 %               15.9%
     L-America                1,095         4.8 %            27.3 %                12.1%

     Asia – Pac               1,054         4.6 %             25.6 %               10.2%

     ROW (ME/Afr)              617          2.7 %             11.0 %                3.9%

     TOTAL                   23,089

                  Sources: Tufts Center for the Study of Drug Development / ACT Sept. 2007
                           CenterWatch Monthly, August 2008
www.diahome.org                                                                                www.ameifac.org.mx
        What are the Trends in Emerging Markets? (Continued)

       •      Growing % of patients are from Emerging Markets
            Region               % of total patients enrolled in trials in 2007
                                 **
            Traditional*         58%
            Emerging             42%


       •      Not surprising when you consider that 90% of the World’s
              population live in Emerging Markets.

           * USA, Canada, W.Europe
           ** Methodology: based on FDA 1572 investigators in regions and assumption of 3 times
             as many patients per site in Emerging Markets vs. Traditional Markets.

www.diahome.org                                                                     www.ameifac.org.mx
      What are the Trends in Emerging Markets? (Continued)
     Will growth continue?
     Yes, because in Emerging Markets:
     1.    Quality is good: Recent FDA inspections show that OAIs less frequent ex-
           USA:
             From 2006 – 2009 (September):
                 - USA: 41 OAIs/753 inspections = 5.4% OAIs.
                 - Ex-USA: 1 OAI/247 inspections = 0.4% OAIs.
     2.      Saturation of sites is less:
               Region             Trial Site/1 million inhabitants
               USA                                       82
                                                                                   Based on FDA
               W. Europe                                 11
                                                                                   Form 1572 data
               CEE                                        8                        (2007)
               LatAm                                      2
               A-P                                       <1
     3.      So, on the average Emerging Market sites produce more patients per site
             per month than Traditional Market sites.
           Sources: Clinical Investigators Inspection List, FDA. (Consulted on 23/September/2009)
                   CenterWatch, August 2008 (Investigator Participation by FDA Form 1572)
www.diahome.org                                                                                   www.ameifac.org.mx
                  What are the Trends in the LatAm Region?

     Main Reasons for Increase:

     1.     Sponsor and CA trust on quality delivered: gained and
            maintained over many years.

     2.     Greater enrolment per site (3 to 5 times vs. traditional
            regions) speeds CT completion and so saves Time to
            Market.

     3.     LatAm cost at ~75% to 80% USA cost.

     4.     Same time zones and close to USA. E.g: a Phase 2A trial
            site can be contacted frequently and visited easily by
            clinical scientist from USA staff of sponsor company.
www.diahome.org                                                 www.ameifac.org.mx
             Latin America: Sequential Review Process


 Country            Approximate Timing (weeks)
                       1 2 3 4 5 6 7 8              9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41

 Argentina
                      IEC/Local EC/MoH ANMAT

 Brazil
                      Local-Central EC/MoH ANVISA                                                                                                   +
                                                                                    CONEP Approval (parallel process to MoH ANVISA)
 Chile
                      Local & Central EC/MoH ISP

 Colombia
                      Local EC/MoH INVIMA

 Mexico
                      Local EC/MoH SS

 Peru
                      Local EC/MoH INS

 EC/IRB Approval:            Minimum                 Maximum
 MoH Approval:               Minimum                 Maximum




www.diahome.org                                                                                                                       www.ameifac.org.mx
        US & European Review Process: Rate Limiting Steps


     • So in Latin America the review process is sequential: first EC
       and then MoH.
           – In the USA, each trial requires IND submission to the FDA and
             in parallel an IRB approval. The rate limiting step is mainly the
             IRB submissions and approval process.

           – In EU, there is a parallel review process, and so submissions to
             EC’s and Competent Authority (MoH) can be performed
             simultaneously (i.e: in parallel.)




www.diahome.org                                                      www.ameifac.org.mx
                  Brazil



www.diahome.org            www.ameifac.org.mx
                         Regulatory Flowchart Brazil

                  Total Set Up &            Sponsor           Time to documents translation into
                    Approval                                  Portuguese after all required documents
                                            or CRO            arrival from sponsor and dossier preparation
                  Process: 7.5 –                              before submission: 3 – 5 weeks
                  10.25 months
                                                              Investigator

                                 MoH                          Local Ethics      Time to IRB/EC
                               (ANVISA)   MoH submission       Committee        approval: 5 – 8 weeks
                                          after getting the
                                          Local IRB/EC
                                          approval: 1 week
     Time to MoH approval:                                    National Ethics
        18 – 23 weeks                                           Committee
                                                                 (CONEP)
                       Import Product

                                                                          Time to CONEP approval:
             Time to import:
                                                                               18 – 23 weeks
              3 – 4 weeks                       Study
                                                 Start


www.diahome.org                                                                          www.ameifac.org.mx
          Brazil: Recent Updates on Clinical Trial Authorization (CTA)
                                   Process

     1.    Resolution 39 went into effect on 5 July 2008.
     2.    Made the national EC (CONEP) and CA (ANVISA) reviews for
           approval a truly parallel process as in EU:
           - Potential savings of 6-8 weeks for first site (Coordinator Site) to
             reach SIV.
     3.    Granted competent authority (ANVISA) ability to approve all
           study sites in one submission and review cycle.
           - Saving 4-6 week for subsequent sites to reach SIV.
     4.    Importance: As Resolution 39 comes into full effect, it will
           reduce approval time in BR from average of 10 to
           approximately 8.5 months (Assuming no questions from
           CONEP or ANVISA).

www.diahome.org                                                              www.ameifac.org.mx
                  Mexico




www.diahome.org            www.ameifac.org.mx
                        Regulatory Flowchart Mexico

                                   Translation of docs.
     Regulatory docs.
          from sites                   2 – 3 weeks
    E.C., Hospital, study                                            Commercial
             staff               Protocol Submission to           Invoice content is
          4 – 6 weeks                     MOH                       reviewed with
                                                                       sponsor

                                MOH (COFEPRIS) Approval
                                      9 – 12 weeks

                                                           Total Set Up & Approval
                                                          Process: 3.75– 5.25 months

    * If the study needs
    medical equipment, the          Customs release
    timeline will increase to           1 – 2 days
    4.25 – 6 Months

                                 MX Drug Storage Depot

www.diahome.org                                                        www.ameifac.org.mx
     Mexico: Recent Updates on Clinical Trial Authorization (CTA)
                             Process
     1.     Custom Code 4.3 reestablished for Clinical Trial drugs & lab kits
            import and clinical sample export on 31/July/2008 specifically for
            CTS.
     2.     Consequences:
            - Reduction of 2 to 3 weeks in time required to import drugs and lab
              kits.
            - Savings of Regulatory Import hours expended (10 to 15% of total.)
            - Reduction of 2 to 3 weeks in time required to export biological
              samples including tissue samples.
            - Importance: Mexico total time from final Protocol to SIVs is reduced
              from 3.5 - 4.5 months to 3 - 4 months. I.e: as fast as quickest EU
              countries total process.
     3.     In June, 2009, regulations for review times was increased.
            COFEPRIS now has up to 3 calendar month to review protocols
            (an increase of ~2 months).

www.diahome.org                                                         www.ameifac.org.mx
                       Suggestions for Your Next Steps

       1.     Continue to work together with your country’s:
               - Regulatory Authorities
                  -   Local and National Ethics Committees
                  -   Pharmaceutical and CRO Chambers of Commerce
                  -   Patients Organizations
                  -   Medical Organizations

       2.     To make the Clinical Trial Authorization process faster
              and more in adherence to the PAHO’s “Document of the
              America’s.”

www.diahome.org                                                     www.ameifac.org.mx
                                     Why?

     “The patients are waiting .”
                  (Theresa Musser, Past President of DIA)




www.diahome.org                                             www.ameifac.org.mx
                     Contact Information



           – email: hurley.dennisp@kendle.com




www.diahome.org                                 www.ameifac.org.mx

				
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