CMO Selection and Management

The selection of a CMO is one of the critical decisions a sponsor - engaged in the development of candidate medicinal products - will take. The success of CMC development, the drug development program and ultimately the financial success of the sponsor relies heavily on this selection.

It is a decision which is made early in CMC development and early in the drug development program. The associated request for proposal (RFP) process and contract negotiations (including quality and price) require significant resources, skills and experience.

CMO selection is often binding beyond the direct contractual and financial details e.g. in the case of biologicals, it may not be technically feasible to move manufacturing during development without negating non-clinical and clinical study data or necessitating bridging studies. Regardless of the compound, it is costly to change CMOs. Therefore a first-time-right approach is crucial.

The CMC consultants at Kinesis Pharma leverage experience with an extensive network of CMOs to identify potential CMOs which can deliver the required technical know-how, technology and quality, and evaluate proposals independently and objectively on a case-by-case basis.

Once a CMO is selected, Kinesis Pharma can carefully manage all aspects of the relationship, this may include contract negotiation, (technical) support, and relevant quality documentation (e.g. batch production records (BPRs)) and reporting to agreed timelines.