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
Asthma Atherosclerosis Diabetes Hepatitis C HIV Rheumatoid Arthritis Innovation in Therapeutic Areas • Alzheimer disease • Oncology • Thrombosys • Hypertension • Vaccines
Les essais cliniques internationaux et leur monitoring :Quels sont les facteurs clés de succès ?
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
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
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…..)
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
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
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
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.
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
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.
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.
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.
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.
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