Launching a Novel Drug with a Contracted Sales Force

Background and Challenge

A privately held pharmaceutical company was preparing for the commercial launch of their first prescription drug. The Executive Management team brought their commercial leaders on board just prior to the product being approved by the FDA. The decision was made to utilize a Contract Sales Organization (CSO) to promote the new product.

It was vitally important for the organization to achieve commercial success with their first brand given that their pipeline was built around additional formulations of the same active ingredient. The company recognized the importance of entering the market with a reputation for conducting compliant promotional activities while also maximizing sales effectiveness with their CSO.

WLH was sought out to help develop the organization’s compliance function and create a field observation and monitoring process. WLH helped the organization to define how they would work with their CSO to create accountability and to leverage the limited scale of their internal commercial team to establish oversight.

Approach and Deliverables

WLH worked closely with the organization’s Chief Compliance Officer to accomplish the following:

• Define the mission, goals, and unmet needs of the compliance department
• Create processes to identify and mitigate key areas of risk in the commercial function
• Engage the Marketing, Medical, and Sales leads to define desired promotional behaviors
• Establish a process for collaboration between the company’s commercial leaders and the leaders of the CSO
• Create organizational standards for compliant promotional activities, field coaching, and sales effectiveness
• Provide behavioral-based training to reinforce expectations for compliance and accountability with CSO leadership
• Implement the I GLASS™ Field Based Monitoring process with their CSO, Field Medical, and Promotional Speaker Program teams
• Generate real-time reports (to inform field coaching) following observations
• Develop group reporting tools to show trends and validate compliance efforts

Results Achieved

WLH helped the client to operationalize their compliance function, clarify their promotional strategies, and effectively engage with their CSO. The Contract Sales Organization successfully met the initial performance expectations specified by the company. A defensible process to support appropriate promotional activities was implemented and has been consistently maintained by the company with ongoing support from WLH.