Clarkston recently partnered with a a pharmaceutical company on a due diligence for therapy acquisition. The client was in the process of acquiring a portfolio of therapies and engaged Clarkston to conduct a supply chain, quality, and regulatory due diligence on the portfolio, which consisted mostly of IP therapies that were commercialized as well as therapies in the pipeline. The client wanted to ensure that all risks involved in supply chain, quality, and regulatory aspects were detected, which would ultimately not only ensure the therapies were worth acquiring but also ensure they would be acquired at a fair price.
Given that the supply chain was the acquirer’s priority, Clarkston began by examining each level of the supply chain – from the active pharmaceutical ingredients (API) manufacturers and contract development and manufacturing organizations (CDMOs) to the third-party logistics (3PLs)– identifying risks at each level (e.g., capacity, lead times, etc.) with a proposal of high-level solutions necessary to address any gaps as well as various ways in which the acquirer could add efficiency.
Clarkston then focused on the quality assessment, reviewing a wide range of documents, including audit reports of API manufacturers and of CDMOs, as well as batch-related documents and contracts between various parties. The emphasis was on quality elements (e.g., ensuring good documentation practices) and evaluating risk and potential impact on operations.
Finally, Clarkston conducted a thorough regulatory analysis on therapies that were still in the pipeline (i.e., not commercialized yet) to validate the requirements needed for approval and proposed alternative ways to get therapies into market. Ultimately, Clarkston was able to identify the main risks involved with each of the therapies in the pipeline, validating the regulatory pathway and estimating timings for launch as well as documenting gaps with proposals for remediation.
The overall project allowed the pharmaceutical company to better understand various components related to the target company and ensure that the main risks related to supply chain, quality, and regulatory aspects were detected and that the right steps were taken to mitigate these risks.
If your organization is looking for guidance in the areas of due diligence, supply chain, or quality and compliance, Clarkston can help.
Download the Due Diligence for Therapy Acquisition case study here. Learn more about our Due Diligence, Supply Chain, or Quality and Compliance services by contacting us below.
Contributions from Ramy Accad