Laura Mendieta is a scientific and regulatory advisor at Asphalion, a regulatory consultancy firm with 25 years of experience. Asphalion specializes in guiding academia, biotech firms, and pharmaceutical companies through every stage of drug and medical device development, from early research to post-marketing stages. Here are a few questions to get to know her and Asphalion better:
Can you tell us about your role in the MISTRAL project?
In MISTRAL, my main role is to provide regulatory advice and support to all technology partners. It is crucial to integrate regulatory perspectives from the very beginning to ensure that scientific discoveries align with industry requirements and can move forward effectively. My contributions focus on three key areas: guiding scientific breakthroughs with regulatory insights, engaging with relevant regulatory authorities, and helping all consortium members navigate regulatory challenges.
What are some of the latest contributions you have made to the project?
Recently, we have been involved in drafting an Innovation Task Force briefing and preparing a report on the role of IT in drug development.
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