<ul><li>91,000 employees </li></ul><ul><li>46 M$ revenue  (2010) </li></ul><ul><li>140 countries </li></ul><ul><li>8.1 M$ ...
<ul><li>Asthma </li></ul><ul><li>Atherosclerosis </li></ul><ul><li>Diabetes </li></ul><ul><li>Hepatitis C </li></ul><ul><l...
Pipeline Merck as of Nov11
Les essais cliniques internationaux  et leur monitoring : Quels sont les facteurs clés de succès ? 
Présentation RPS <ul><li>Established in 1998 – Privately held  </li></ul><ul><li>Over 3,000 employees </li></ul><ul><li>Op...
New Model
Les essais internationnaux multicentriques <ul><li>Sponsor </li></ul><ul><ul><li>Change in the R&D Model </li></ul></ul><u...
Changes in R&D Models <ul><li>Changes due to </li></ul><ul><ul><li>Risk management strategy. Share the risk </li></ul></ul...
Significant Geographic Shift  of Clinical trials to Asia Pacific Region Source: Jefferies & Co. Inc. Survey of Outsourcing...
Outsourcing Strategies to the CROs <ul><li>Types of Outsourcing Strategies. </li></ul><ul><ul><li>Embedded Solutions </li>...
Projects <ul><li>Global Projects </li></ul><ul><ul><li>Usually performed by small and large pharma companies  together wit...
Projects – Conduct <ul><ul><li>Set up phase is more complex </li></ul></ul><ul><ul><li>Logistics  and Management are more ...
Projects – Monitoring Visits Interim Monitoring Visit Europe China Preparation Travel Time Onsite Time MVR and Follow Up 2...
Difference in Cultures <ul><li>Site and Investigators </li></ul><ul><ul><li>In China: </li></ul></ul><ul><ul><ul><li>sever...
Difference in Cultures <ul><li>CRAs Profile and Background </li></ul><ul><ul><li>In Eastern Europe CRAs tend to medical do...
International Monitoring <ul><li>Roles and Future Development </li></ul><ul><ul><li>Junior and Senior CRAs </li></ul></ul>...
International Monitoring <ul><li>Key Success Factors </li></ul><ul><ul><li>Organized and assuring everything is well docum...
International Monitoring <ul><li>CRA in 2011: Sponsor’s Expectations </li></ul><ul><li>CRA core tasks and responsibilities...
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Atelier 2 : Essais cliniques internationaux quels sont les facteurs clés de succes

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  • 2 Slides pour une présentation succinte de MSD France, à insérer selon filage prévu
  • 4eme point noté « International Monitoring » sur les dernières slides, à harmoniser ?
  • Je vous laisse cette présentation comme convenu, que je peux bien sûr appuyer ou relancer si questions.
  • Dommage que ces slides ne mentionnent pas l’Amérique du sud qui en terme d’essais cliniques, est en forte croissance. Les chiffres ne sont pas aussi marqués pour ce qui nous concerne, chez MSD (de 51 à 26% de 2008 à 2011 mériterait une vérification …)
  • Se mêle à ces considérations une question de Culture d’entreprise, d’expertise : pour simplifier, pour certaines activités (monitoring, ou autres…) un promoteur n’a pas forcement de valeur ajoutée dans l’excellence de la conduite de celles-ci, par rapport à vos structures et peut d’autant plus se concentrer sur des projets/tâches où il misera son expertise.
  • Claire flexibilité sur le Global et une mise en place accélérée en local
  • Le titre « Projects Monitoring Visits » ou sommes nous déjà dans la différence de culture ?
  • Pour précision, le Clinical Research Manager est line manager chez nous des CRAS et des Project Managers, leur rôle est ainsi le management de collaborateur et l’overview de projets locaux ou globaux
  • Ci-joint donc une slide supplémentaire sur les Sponsor Expectations pour les CRAs qui peut conclure celle-ci, à voir.
  • Transcript of "Atelier 2 : Essais cliniques internationaux quels sont les facteurs clés de succes"

    1. 2. <ul><li>91,000 employees </li></ul><ul><li>46 M$ revenue (2010) </li></ul><ul><li>140 countries </li></ul><ul><li>8.1 M$ investments in R&D </li></ul><ul><li>15 500 R&D Employees </li></ul><ul><li>Merck in US/Canada, MSD Worlwide </li></ul><ul><li>Announcement in 2009 of US Merge of Merck & Co and Schering Plough </li></ul><ul><li>MSD France implemented on July 1st 2011 </li></ul>
    2. 3. <ul><li>Asthma </li></ul><ul><li>Atherosclerosis </li></ul><ul><li>Diabetes </li></ul><ul><li>Hepatitis C </li></ul><ul><li>HIV </li></ul><ul><li>Rheumatoid Arthritis </li></ul>Innovation in Therapeutic Areas <ul><li>Alzheimer disease </li></ul><ul><li>Oncology </li></ul><ul><li>Thrombosys </li></ul><ul><li>Hypertension </li></ul><ul><li>Vaccines </li></ul>
    3. 4. Pipeline Merck as of Nov11
    4. 5. Les essais cliniques internationaux  et leur monitoring : Quels sont les facteurs clés de succès ? 
    5. 6. Présentation RPS <ul><li>Established in 1998 – Privately held </li></ul><ul><li>Over 3,000 employees </li></ul><ul><li>Operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions </li></ul><ul><ul><li>Ongoing expansion and infrastructure development in Middle East and Africa </li></ul></ul><ul><li>Recognized as one of fastest growing companies in clinical research industry, 33.7%+ CAGR from 2005-10 </li></ul><ul><li>RPS listed 8th in the Top 11* CROs (based on fiscal revenue) </li></ul><ul><ul><li>*Source: Contract Pharma June 2010 </li></ul></ul>
    6. 7. New Model
    7. 8. Les essais internationnaux multicentriques <ul><li>Sponsor </li></ul><ul><ul><li>Change in the R&D Model </li></ul></ul><ul><ul><li>Outsourcing strategies to the CROs. </li></ul></ul><ul><li>Projects </li></ul><ul><ul><li>Global studies </li></ul></ul><ul><ul><li>Regional Studies </li></ul></ul><ul><ul><li>Local studies </li></ul></ul><ul><li>Monitoring Activities in different countries. </li></ul><ul><ul><li>The influence of the culture. </li></ul></ul><ul><ul><li>The profile of the Investigators and site facilities. </li></ul></ul><ul><ul><li>The Profile of CRAs </li></ul></ul><ul><li>Role of the CRA and Future development </li></ul>Summary
    8. 9. Changes in R&D Models <ul><li>Changes due to </li></ul><ul><ul><li>Risk management strategy. Share the risk </li></ul></ul><ul><ul><li>Disconnect Product development management risk/ human resource management </li></ul></ul><ul><ul><li>Optimize the development cycle </li></ul></ul><ul><ul><li>External acquisition of NME & partnerships </li></ul></ul><ul><ul><li>Looking for more and more flexibility and capability to adapt to a changing environment (Law, country price policy, reimbursement…..) </li></ul></ul>
    9. 10. Significant Geographic Shift of Clinical trials to Asia Pacific Region Source: Jefferies & Co. Inc. Survey of Outsourcing Biopharma R&D Professionals, April 22, 2008 Confidential
    10. 11. Outsourcing Strategies to the CROs <ul><li>Types of Outsourcing Strategies. </li></ul><ul><ul><li>Embedded Solutions </li></ul></ul><ul><ul><li>Full Service - Outsource part or all scope of work </li></ul></ul><ul><ul><ul><li>Activities (Reg. Affairs, MV, PM, MW, DM, etc…) </li></ul></ul></ul><ul><ul><ul><li>Region – Part of the monitoring activities to 1 or more CROs. </li></ul></ul></ul><ul><li>Management Strategies </li></ul><ul><ul><li>Centralized – Based in the Headquarter </li></ul></ul><ul><ul><li>Decentralized – In Partnership with Country offices and/or CRO </li></ul></ul>
    11. 12. Projects <ul><li>Global Projects </li></ul><ul><ul><li>Usually performed by small and large pharma companies together with global CROs. </li></ul></ul><ul><ul><li>Large amount of countries. </li></ul></ul><ul><ul><li>Challenge due to different requirements of the countries. </li></ul></ul><ul><li>Regional Projects </li></ul><ul><ul><li>Usually performed by small and medium pharma companies or biotechs together with global/Regional CROs. </li></ul></ul><ul><ul><li>3 – 10 countries normally involved </li></ul></ul><ul><li>Local Projects </li></ul><ul><ul><li>Usually performed by Local affiliates, biotechs and Investigators together with global/Regional CROs. </li></ul></ul><ul><ul><li>3 – 10 sites in one country </li></ul></ul>
    12. 13. Projects – Conduct <ul><ul><li>Set up phase is more complex </li></ul></ul><ul><ul><li>Logistics and Management are more complicated </li></ul></ul><ul><ul><li>More and better possibilities for back up plans. </li></ul></ul>What is Most Difficult : Local or Global Studies ? <ul><ul><li>For large local studies recruitment can be challenging and difficult since it depends only on one market. </li></ul></ul><ul><ul><li>Less possibilities of rescue plans due to tight budget. </li></ul></ul><ul><ul><li>Requires a very good network of investigators </li></ul></ul>Local Global
    13. 14. Projects – Monitoring Visits Interim Monitoring Visit Europe China Preparation Travel Time Onsite Time MVR and Follow Up 2h 8h 8h 4h 4h 15h 27h 6h Example of differences
    14. 15. Difference in Cultures <ul><li>Site and Investigators </li></ul><ul><ul><li>In China: </li></ul></ul><ul><ul><ul><li>several times investigators are government officials. </li></ul></ul></ul><ul><ul><ul><li>investigators usually go out for dinner with CRAs. </li></ul></ul></ul><ul><ul><li>In Spain: </li></ul></ul><ul><ul><ul><li>Pharmacy involvement is mandatory (Spanish Regulation). </li></ul></ul></ul><ul><ul><ul><li>The communication with the EC and RA are managed by Sponsor/CRO. </li></ul></ul></ul><ul><ul><ul><li>Existence of different Official Languages, Source Data/Medical Chart can be written in any of those Official Languages. </li></ul></ul></ul><ul><ul><ul><li>Investigators performs their Clinical Trial responsibilities in their working hours of normal medical practice. Working hours (from 08:00 to 15:00). </li></ul></ul></ul><ul><ul><ul><li>Few Private Medical cabinets participates in Clinical Trials. </li></ul></ul></ul><ul><ul><ul><li>Existence of Regional RA and EC that depending on the localization of the investigator site may be involved . </li></ul></ul></ul><ul><ul><li>In Germany, Finland and Sweden investigators and site personnel tend to be more organized and less flexible. </li></ul></ul>
    15. 16. Difference in Cultures <ul><li>CRAs Profile and Background </li></ul><ul><ul><li>In Eastern Europe CRAs tend to medical doctors. </li></ul></ul><ul><ul><li>In China and Asia in General CRAs have all kinds of background. </li></ul></ul><ul><ul><li>In Spain CRAs tend to be young (25-40 years old) and Pharmacist or Biologist who have a master‘s in monitoring clinical trials. </li></ul></ul>
    16. 17. International Monitoring <ul><li>Roles and Future Development </li></ul><ul><ul><li>Junior and Senior CRAs </li></ul></ul><ul><ul><ul><li>Usually Responsible for sites in the country where he is based. </li></ul></ul></ul><ul><ul><ul><li>Mobility is difficult due to language, costs, culture, etc… </li></ul></ul></ul><ul><ul><ul><li>Senior CRA – In Europe 4-6 years experience while in China only 2 years is needed. </li></ul></ul></ul><ul><ul><li>Clinical Team Lead or Coordinator. </li></ul></ul><ul><ul><ul><li>Responsible for CRAs in regional/global studies. </li></ul></ul></ul><ul><ul><ul><li>Usually travel in the region for co-monitoring visits. </li></ul></ul></ul><ul><ul><ul><li>In Europe >5 years experience while in China only 3 years is needed. </li></ul></ul></ul><ul><ul><li>Clinical Research Manager </li></ul></ul><ul><ul><ul><li>Line Manager of the CRAs. </li></ul></ul></ul><ul><ul><li>Local / International Project Manager. </li></ul></ul><ul><ul><ul><li>Main point of contact to the client and responsible for the project. </li></ul></ul></ul>
    17. 18. International Monitoring <ul><li>Key Success Factors </li></ul><ul><ul><li>Organized and assuring everything is well documented. </li></ul></ul><ul><ul><li>Good Communication and social skills </li></ul></ul><ul><ul><li>English skills </li></ul></ul><ul><ul><li>Flexible making sure the work is done properly. </li></ul></ul><ul><ul><li>Ability to deliver according to the timelines. </li></ul></ul><ul><ul><li>Ability to understand the key points of the study. </li></ul></ul><ul><ul><li>Team work engagement. </li></ul></ul>
    18. 19. International Monitoring <ul><li>CRA in 2011: Sponsor’s Expectations </li></ul><ul><li>CRA core tasks and responsibilities knowledge is only a baseline, it’s all about : </li></ul><ul><li>Performance </li></ul><ul><li>Initiative </li></ul><ul><li>Communication </li></ul><ul><li>Commitment </li></ul>

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