Case Study: Mining of Existing Research Databases

NERI's Role

To remain competitive, pharmaceutical companies need to constantly enhance their understanding of diseases related to their product pipeline. Knowing the strong publication record of NERI Epidemiology in key therapeutic areas, two top-20 pharmaceutical companies approached NERI for assistance in meeting this objective. NERI Epidemiology staff developed custom-fit solutions specific to the needs of the company. Outlined below are two representative case studies.

Results

Scenario A:

Company A had a marketed product and had numerous clinical trial databases that were submitted in support of their New Drug Application (NDA). NERI Epidemiology staff identified additional data analyses based on these databases and developed an analysis strategy to provide additional information regarding the disease indication for the product.

Scenario B:

Company B had a promising product early in their pipeline, and therefore did not yet have clinical trial data. NERI Epidemiology staff developed an approach involving the development of a series of papers relevant to the indication using existing NERI databases. A total of 10 papers were published in peer-reviewed medical journals as a result of this collaboration.

These case studies highlight several important facets of NERI Epidemiology:

• We seek to understand the needs of clients and tailor our approach to specific client needs
• We “think outside the box” to meet client objectives
• We focus on scientific publication and making contributions to clinical care and public health knowledge
• We have unparalleled experience in statistical analysis, whether using in-house or external databases