Challenge
A pharmaceutical company faced a critical situation when they reported a serious
adverse event (SAE) for a patient enrolled in their clinical trial. Swift action was needed
to respond to the FDA’s questions, safeguard patients, and prevent disruptions to the
trial. However, addressing FDA’s questions presented a formidable challenge because it
required extensive, non-standard genomic analyses to establish that the SAE was not
the result of the investigational treatment. The internal team, already stretched thin, not
only lacked the capacity but also the relevant expertise in genomic data analysis
required to promptly handle this crisis.
Action
At this critical juncture, the company trusted Diamond Age (DA) to help them navigate
through the crisis. DA swiftly intervened, deploying a senior bioinformatics consultant
with extensive genomics expertise to lead the effort on behalf of the client. As the
sequencing data were being generated, DA developed a customized solution for the
genomic analysis, guided the internal team through the plan, managed expectations,
and installed the necessary analysis tools for a swift response once the data were
ready.
Upon availability of the sequencing data, DA delivered preliminary results to the client
within days, including raw data, a comparative analysis across different tools, and
interpretation of the findings. Collaboratively, DA and the client crafted the final report,
which was then submitted to the FDA.
Result
By leveraging DA’s expertise, the client was able to rapidly respond to the FDA with a
robust, customized analysis, while maintaining the integrity of their internal operations.
The analysis successfully assured FDA that the investigational treatment did not cause
the patients’ SAE. DA is now collaborating with the client to address various biological
questions arising from the ongoing clinical trial.