Chris Bray, Director of Regulatory Affairs, Manchester
Why is the seemingly boring topic of Regulatory Affairs so important?
We enable QIAGEN to sell its products. It’s as simple as that!
How did you get into Regulatory Affairs?
While working for a start-up supporting the clinical trials of pharma companies, we began developing companion diagnostic tests to help them obtain regulatory approval for their products in the U.S.
What exactly are companion diagnostics?
A companion diagnostic test provides information to a health care professional that is essential for the safe and effective use of a corresponding drug.
What does your job involve?
I’m responsible for a team that spends around 80 % of its time supporting projects that are developing companion diagnostics. The regulatory requirements vary from country to country and are always changing. We need to prove to regulatory authorities that our products are safe and effective. Up to now, only the U.S. and Japan required co-approval of a companion diagnostic to register a corresponding drug. But in 2017, the new EU IVD regulation will contain specific companion diagnostic requirements. Registration in the big markets can be complex, expensive and take a long time.
What do you see as one of your biggest successes?
In 2012, the FDA approved our therascreen KRAS test for detecting seven KRAS mutations in colorectal cancer samples. Back in 2008, the FDA had little experience with the regulatory requirements for companion diagnostics but we worked collaboratively with them and found creative ways of dealing with certain issues. Subsequently, the FDA has published two guidelines related to companion diagnostics. We played our part in this success story, which is ultimately about helping cancer patients live longer.
What kind of challenges do you face?
One big challenge is sample availability for development studies. For example, the FDA wants us to test 1,000 samples, but we only have 100 available. That’s when creative thinking is needed.
What’s next on your pioneering horizon?
NGS plays a key role in personalized healthcare, and we want to enable any lab to take advantage of this powerful technology. The GeneReader NGS System was the first, but by far not the last milestone in this journey. We want to change the paradigm of NGS-based biomarker testing and not only make the entire workflow even simpler while ensuring the highest quality standards, but also develop new test panels that add further testing options in addition to the current ‘one test – one drug’ approaches. There are several alignment and regulatory challenges that we need to address on the way, but overcoming these hurdles is what makes being a pioneer so rewarding.