91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D - PowerPoint PPT Presentation

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91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D PowerPoint Presentation
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91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D

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91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D
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91,000 employees 46 M$ revenue (2010) 140 countries 8.1 M$ investments in R&D

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  1. 91,000 employees • 46 M$ revenue (2010) • 140 countries • 8.1 M$ investments in R&D • 15 500 R&D Employees • Merck in US/Canada, MSD Worlwide • Announcement in 2009 of US Merge of Merck & Co and Schering Plough • MSD France implemented on July 1st 2011

  2. Asthma Atherosclerosis Diabetes Hepatitis C HIV Rheumatoid Arthritis Innovation in Therapeutic Areas • Alzheimer disease • Oncology • Thrombosys • Hypertension • Vaccines

  3. Pipeline Merck as of Nov11

  4. Les essais cliniques internationaux  et leur monitoring :Quels sont les facteurs clés de succès ? 

  5. Présentation RPS • Established in 1998 – Privately held • Over 3,000 employees • Operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions • Ongoing expansion and infrastructure development in Middle East and Africa • Recognized as one of fastest growing companies in clinical research industry, 33.7%+ CAGR from 2005-10 • RPS listed 8th in the Top 11* CROs (based on fiscal revenue) • *Source: Contract Pharma June 2010

  6. New Model

  7. Les essais internationnaux multicentriques Summary • Sponsor • Change in the R&D Model • Outsourcing strategies to the CROs. • Projects • Global studies • Regional Studies • Local studies • Monitoring Activities in different countries. • The influence of the culture. • The profile of the Investigators and site facilities. • The Profile of CRAs • Role of the CRA and Future development

  8. Changes in R&D Models • Changes due to • Risk management strategy. Share the risk • Disconnect Product development management risk/ human resource management • Optimize the development cycle • External acquisition of NME & partnerships • Looking for more and more flexibility and capability to adapt to a changing environment (Law, country price policy, reimbursement…..)

  9. 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. Outsourcing Strategies to the CROs • Types of Outsourcing Strategies. • Embedded Solutions • Full Service - Outsource part or all scope of work • Activities (Reg. Affairs, MV, PM, MW, DM, etc…) • Region – Part of the monitoring activities to 1 or more CROs. • Management Strategies • Centralized – Based in the Headquarter • Decentralized – In Partnership with Country offices and/or CRO

  11. Projects • Global Projects • Usually performed by small and large pharma companies together with global CROs. • Large amount of countries. • Challenge due to different requirements of the countries. • Regional Projects • Usually performed by small and medium pharma companies or biotechs together with global/Regional CROs. • 3 – 10 countries normally involved • Local Projects • Usually performed by Local affiliates, biotechs and Investigators together with global/Regional CROs. • 3 – 10 sites in one country

  12. Projects – Conduct What is Most Difficult : Local or Global Studies ? Global Local • For large local studies recruitment can be challenging and difficult since it depends only on one market. • Less possibilities of rescue plans due to tight budget. • Requires a very good network of investigators • Set up phase is more complex • Logistics and Management are more complicated • More and better possibilities for back up plans.

  13. Projects – Monitoring Visits Example of differences Interim Monitoring Visit China Europe 4h 2h Preparation 15h 8h Travel Time 27h 8h Onsite Time MVR and Follow Up 6h 4h

  14. Difference in Cultures • Site and Investigators • In China: • several times investigators are government officials. • investigators usually go out for dinner with CRAs. • In Spain: • Pharmacy involvement is mandatory (Spanish Regulation). • The communication with the EC and RA are managed by Sponsor/CRO. • Existence of different Official Languages, Source Data/Medical Chart can be written in any of those Official Languages. • Investigators performs their Clinical Trial responsibilities in their working hours of normal medical practice. Working hours (from 08:00 to 15:00). • Few Private Medical cabinets participates in Clinical Trials. • Existence of Regional RA and EC that depending on the localization of the investigator site may be involved . • In Germany, Finland and Sweden investigators and site personnel tend to be more organized and less flexible.

  15. Difference in Cultures • CRAs Profile and Background • In Eastern Europe CRAs tend to medical doctors. • In China and Asia in General CRAs have all kinds of background. • In Spain CRAs tend to be young (25-40 years old) and Pharmacist or Biologist who have a master‘s in monitoring clinical trials.

  16. International Monitoring • Roles and Future Development • Junior and Senior CRAs • Usually Responsible for sites in the country where he is based. • Mobility is difficult due to language, costs, culture, etc… • Senior CRA – In Europe 4-6 years experience while in China only 2 years is needed. • Clinical Team Lead or Coordinator. • Responsible for CRAs in regional/global studies. • Usually travel in the region for co-monitoring visits. • In Europe >5 years experience while in China only 3 years is needed. • Clinical Research Manager • Line Manager of the CRAs. • Local / International Project Manager. • Main point of contact to the client and responsible for the project.

  17. International Monitoring Key Success Factors • Organized and assuring everything is well documented. • Good Communication and social skills • English skills • Flexible making sure the work is done properly. • Ability to deliver according to the timelines. • Ability to understand the key points of the study. • Team work engagement.

  18. International Monitoring CRA in 2011: Sponsor’s Expectations CRA core tasks and responsibilities knowledge is only a baseline, it’s all about : Performance Initiative Communication Commitment