A client developing a neoantigen-targeted therapy sought insights on emerging best practices in potency assay development to support a successful BLA submission.
Task
Elucidate historical trends in potency assay strategies for similar therapies already approved, then deduce current characterization trends and most likely FDA guidance for similar therapies in development.
Action
Combed through FDA and EMA filings to infer patterns in regulatory requirements for potency assays of similar therapies approved to date.
Developed an umbrella framework for similar therapies in development, customized according to attributes and characterization techniques most relevant to the client’s technology.
Integrated disparate data streams to fully articulate characterization assays for the most relevant competitors.
Distilled findings into a concise narrative.
Addressed knowledge gaps for specific therapies in development by tracing the publication trail from founding scientific labs.
Validated our hypotheses using patents and primary intelligence from our network of scientists.
Results
Based on our insights, the client was able to align internal stakeholders around a robust, phase-dependent, matrixed potency assay strategy. This enabled them to avoid unnecessary regulatory setbacks and move their BLA filing forward in a timely fashion.
Learned from analogues in the field
Expedited BLA filing
Aligned internal stakeholders
Avoided a
Regulatory Setback
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Please note: images are for illustrative purposes only.
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