Getting to know Ciara Airey, Head of Regulatory Affairs

Ciara Airey recently joined #TeamInivata as our new Head of Regulatory in our Medical Affairs Department. Here Ciara talks about her experience in Medical Affairs and why she decided to join Inivata.

  1. Tell us about your work experience prior to joining Inivata.

After completing my PhD, I moved straight into industry developing PCR-based assays for QIAGEN. While there, I developed an interest in regulatory affairs and joined their RA team to lead regulatory strategy, submission, and registration projects for companion diagnostic tests. Following that I spent some time with the CRO, NAMSA, where I provided regulatory support to many global IVD and companion diagnostic manufacturers. I’ve also had the opportunity to work on the pharma side of precision medicine at GSK, and now I feel I’ve found my home at Inivata.

    2. What has been your biggest achievement(s) and your biggest challenge of your career so far?

    The biggest achievement of my career so far has to be the approval of a companion diagnostic test for which I was the regulatory lead, but that was also my biggest challenge! Quite often, these tests are intended for use in patients with very rare cancers and clinical samples are difficult to obtain for assay validation, requiring lengthy discussions with regulators to find the best route forward. The long hours are always worth the effort when a diagnostic is approved that will provide patients (who may have previously had very limited treatment options) access to a new and innovative targeted therapy that may potentially be life changing for them.

    3. There are a number of companies operating within the biotechnology industry globally. What made you want to join Inivata?

    What initially drew me to Inivata was our innovative technology, particularly RaDaR™, which has the potential to revolutionize the liquid biopsy space.  Since joining I have been really inspired by the passion, commitment and collaborative culture among the Inivata team to make new clinical applications for liquid biopsy happen.  

    4. It has been a challenging year navigating the pandemic. Are there any key learnings or reflections that you can share with us?

    Over these past couple of years, I’ve learned to not sweat the small stuff and to be grateful for every small thing in life. 

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