The Value of Small Scale Studies

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BioProduction recently caught up with Brij Patel, Deputy Manager and Assessor, MHRA to find out more about his upcoming talk at this year’s event and what attendees can take away from his session

BioProduction (BP): Could you give us a brief overview of your key research interestes?

Brij Patel (Brij): Originally, my research experience stems from work with vaccines and drug delivery technology. I still remain interested in vaccines and biotech products, but now from a regulatory perspective (where I have had considerable experience as a regulatory evaluator for biological products on both MHRA and EMA applications).

BP: What can industry gain from this?

Brij: The ultimate aim is to attain regulatory approval – as fast and as efficiently as possible. My previous regulatory experience would provide an insight into how regulators assess risks and solutions.

BP: And what work will you be presenting at BioProduction this year?

Brij: EU regulators have now come across a number of QbD applications for biological products. There is obviously a “disconnect” between industry and regulators. I would like to present a reflection on regulatory experience with biological QbD

BP: What will our delegates gain by attending your presentation and session? What is the message you would like them to leave with?

Brij: Some of the key issues include agreement on risk assessments, the value of small scale studies, and regulatory flexibility. Communication (appropriate detail, at the right times, FTF meetings) is critical in order to persuade the regulator when deviating from the usual

BP: How will the industry look in 2-3 years? What challenges will still remain/would have been overcome?

Brij: QbD principles will be built into most programmes. The issue will be how to get ROI

BP: What did you want to be when you were young?

Brij: Useful

For more information about Brij’s talk and all of our other presentations, please visit our website or download the brochure


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