Leading in the Combination Product Space: Insights for Improving External Engagement

STUDY OVERVIEW

The successful development and launch of new combination products in a timely manner can provide a significant competitive advantage to biopharmaceutical organizations. However, stringent regulatory guidelines and manufacturing complexities are few of the major challenges in launching these new products.

Consequently, it is important to develop a strategic approach to external engagement to effectively navigate these challenges. In this study, “external engagement” refers to the activities and collaborations undertaken to help shape future combination-product standards and regulations.

Best Practices, LLC undertook this benchmarking research to inform product and leadership teams about key external engagement approaches, staffing and investment needed to successfully develop and launch combination product assets. This study also identifies companies that are considered to be industry leaders in shaping combination product regulatory requirements and the reasons for the same. The top post-marketing safety reporting challenges are also highlighted in this study.

KEY TOPICS

• Group Organization
• Strategy and Tactics
• Staffing and Budget
• Industry Leaders – and Why
• Post-marketing Safety Reporting

SAMPLE KEY METRICS

• What is the name of group or internal function to which external engagement employees belong?
• How many full-time staff members do you currently allocate to all external engagement policy activities?
• In the last fiscal year, what was the approximate total budget allocation to your external engagement program for the combination product space?

SAMPLE KEY FINDINGS

• Firms more likely to locate external engagement personnel in a small, standalone group rather than within any single larger function: About half of companies (47%) have created an independent group to assess and drive external engagement within the combination product space. Some companies install their external engagement employees within Regulatory Affairs (13%), R&D (7%), Clinical Program Development (7%), Lifecycle Management (7%) or elsewhere.

METHODOLOGY

Best Practices, LLC engaged 17 executives from 14 leading pharma, biotechnology and other healthcare companies in this research through a benchmarking survey.

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