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

Pipeline Merck as of Nov11

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

New Model

Les essais internationnaux multicentriques

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

Summary

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 ?

Set up phase is more complex

Logistics and Management are more complicated

More and better possibilities for back up plans.

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

LocalGlobal

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

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 :

PerformanceInitiative

CommunicationCommitment