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Insight

Our client, a medium sized pharmaceutical company, was seeking acquisition of new products, and reached out to the current Market Authorization Holder (MAH) for product information. The MAH sent them a tremendous amount of information in what could best be described as a “data dump.” Our client did not have enough resources to adequately sift through this mountain of material, and also felt it beneficial to have a third party review to ensure a more neutral look at the data.

Idea

Ashfield Pharmacovigilance’s Vice President of Pharmacovigilance Sciences met with the client, and presented them with a cost effective alternative to traditional consultancy services. Ashfield Pharmacovigilance proposed an in-depth review by one of our expert pharmacovigilance physicians. Our physician sifted through masses of raw data in past emails;, confidential information provided to the buyer; as well as all information already provided to the FDA to ensure discovery of all pertinent information related to the potential acquisition. Discovered information included the original NDA filing; annual safety reports and supplemental applications; all data from all phases of clinical studies; as well as post marketing data; In addition to past periodic reports and past Risk Evaluation Mitigation Strategies (REMS). This data was carefully reviewed and analyzed by our physician.
In conducting their review and analysis, our physician searched through databases, ran a FAERS search, created a benefit / risk analysis, and performed various literature searches. All the events and findings identified were populated into spreadsheets for further review and System Organ Class (SOC) table evaluation.

Impact

Once all the data was thoroughly evaluated, our physician utilized her strong medical background and expertise in drug development and pharmacovigilance and proposed a list of questions that would be important for our client to consider asking the current MAH. After all outstanding questions were answered, the findings were compiled, summarized and presented to the client as a twenty 20-page “Due Diligence Report.”
Following the in depth and expert look at all of this data by Ashfield Pharmacovigilance and the thorough consultation with our client, our client successfully acquired the product. The client was so pleased with the timeliness, accuracy and the comprehensive work performed that they recently contracted for more due diligence work which also resulted in an additional product acquisition.

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