«CMC Program Health» Assessment

Category: CMC Development and Manufacturing Consulting
Through a board member recommendation, Cilatus was asked by the CEO of a late-stage, US West Coast based, publicly listed Biopharmaceutical Company to assess the «CMC program health» of their phase III, small molecule development candidate. Within one month, the Cilatus team was able to assess all CMC areas of the late-stage program: the drug substance development and drug substance CMO, the drug product development work, CMO and future plans, the clinical supply situation, the state and quality of the regulatory filings, and the entire quality system. All finding were presented to the executive team of the client and summaries were provided to the board of directors. Then, the Cilatus team developed new strategies, action plans, and timelines together with the client leadership and led or supported the execution of the developed strategies and plans. Based on client feedback, the Cilatus assessment, leadership, and support during phase III were instrumental in the successful completion and later approval of the new chemical entity by the FDA. References for this work and case study are available on request.