A few years ago, Cilatus was asked to perform CMC due diligence for two private equity investment companies who wanted to invest in a novel biologic for an unmet medical need that was being developed by a small European biopharmaceutical company. Cilatus initiated the due diligence effort with a visit to the biotech company and meeting with the management team. After establishing initial understanding, alignment, and reviewing the high-level status and plans for further clinical development, Cilatus reviewed current and past regulatory filings, all agency communications, all development reports, the manufacturing history, specifications, and release data, the current clinical inventory, and all already planned CMC development, CMO manufacturing, and clinical development plans. During the assessment, Cilatus kept the investment companies and the management of the biotech company informed of any questions and on progress of the review. Within three weeks Cilatus issued a draft CMC assessment report for all parties for review. The report included a “Cilatus CMC Risk Score” which evaluated the CMC, Supply, and Regulatory on a relative basis to enhance understanding and creating transparency for the investors. After review and discussions with the biotech’s management and both investors, Cilatus issued the final CMC due diligence assessment report. The CEO of the biotech company later informed Cilatus, that the Cilatus CMC due diligence assessment was instrumental in receiving funding for further clinical and CMC development from both private equity investment companies.
