First-in-Human Clinical Trials

First-in-Human Clinical Trials
April 13, 2021 Amy

The Challenge:

TherapeutAix was contacted by an innovative biotech company that was undertaking final preparations for First-in-Human clinical trials. It was known that their biologic has a complex metabolic pathway in vivo. One of the bioanalytical methods needed a major overhaul to be on the same technical level as the rest of the analytical toolbox. We were requested to interrogate the existing methodology to identify problem areas and potential options for an improved method for deployment in initial clinical studies.

The Action:

Our initial free of charge review identified significant gaps which formed the basis for a formal proposal. We then conducted a “deep dive” into existing method development and validation to identify specific areas to address.

Tapping-in to our networked R&D model, we selected, engaged, and coordinated a team of specialist CROs, including Alderley Analytical  and Peak Proteins, to confirm methodological issues and provide solutions via an integrated package of experiments.  

The Result:

TherapeutAix’ coordination of teamwork between the client and 3 CROs provided the client with 2 options for an improved bioanalytical method, the preferred option now being validated to support clinical Phase I. The package of work also provided an enhanced understanding of the clearance process for the biologic enabling clarity of messaging in key documentation. 

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