Regulatory Pathways for Codevelopment

MolecularMD is a Trusted Advisor to Biopharma Clients Throughout the Codevelopment of a Diagnostic Assay

Most biopharma companies seek a partner with knowledge and expertise in the refinement and development of a biomarker for use as a clinical trial assay or a companion diagnostic. Clinical trial assay optimization and validation are two important early stage activities that MolecularMD provides to their clients.

Several of our Biopharma clients refer to Phase II as “The New Phase III” and this means the clinical trial assay/diagnostic must be optimized and validated earlier in the drug program. Therefore, it is important to have a codevelopment partner with capabilities and experience in compressing/optimizing the diagnostic development timeline to mesh with the therapeutic timeline requirements. Early involvement is a critical success factor for drug–diagnostic codevelopment programs to ensure assay robustness for the clinical trial. Key considerations such as sample type, sample collection protocols and collection kits, appropriate testing platform and application need to be defined and put implemented. Having a codevelopment partner who has experience with assay development, validation, bridging and migration studies are vital to the success of the therapeutic program.