Case #1 - Globalizing Drug Safety

Situation — The client company had separate drug safety organizations in Europe and the United States and had difficulty implementing global approaches. Systems and procedures to evaluate drug safety were incompatible. New acquisitions brought separate drug safety organizations and safety issues that required integration and global direction.

Externally, the past five years had seen a rapid evolution in drug risk management on a global basis. Both the European EMEA and the American FDA had issued new reporting requirements to ensure that drugs will be used as safely as possible. Most safety executives in the industry focused on writing safety reports, rather than leading a proactive safety function.

What We Did—Blair and Company was retained initially to recruit an experienced safety physician for Europe and to work with the Senior Vice President to identify functional gaps that needed to be filled in order to be successful in the current regulatory environment. Gaps identified included clinical epidemiology, statistics, and outcomes research. Blair also identified the characteristics of executives who would be successful in leading or working on the drug safety team and then recruited candidates for each position. Key steps in our search process included:

• Conducting informal phone surveys with regulatory agencies in the U.S. and Europe, to understand key issues that the successful candidate would address.
• Contacting professional societies and organizations to identify sources of safety specialists.
• Establishing a dedicated international team, consisting of a physician consultant, a sourcing specialist, candidate development specialists in Europe and the US.
• Visiting facilities in the US and Europe, to understand cultural issues.
• Identifying the personal, professional and leadership characteristics that would be required for the successful candidate to work on a multi-functional global safety team.
• Developing a series of questions for academics to determine the extent of their clinical trial experience and to answer their concerns about transferring into industry.
• Identifying physicians working on safety and efficacy clinical trials, contacting them, and making the case to transfer to the safety function.
• Setting up candidate interviews in conjunction with meetings of professional societies - a convenient venue for busy professionals.

Results — Over a 4-year period, 7 senior safety executives were recruited. This team led the following accomplishments:

• Creation of a truly global drug safety function.
• Successful management of complex drug safety issues regarding a product that was eventually withdrawn from the market and another with annual sales of more than $1 billion.
• Creation of an effective safety sciences organization accountable for safety-related risk assessment.