Regulatory Insights for the EU-Funded MISTRAL Project

March 31, 2025

The MISTRAL Project is an EU-funded initiative exploring the link between the gut microbiome and HIV/AIDS, specifically HIV-1. Since the microbiome plays a crucial role in immune function, its disturbance may contribute to immune disorders and chronic inflammation—key factors in HIV infection. MISTRAL aims to identify biomarkers to support new interventions that mitigate HIV infection and enhance vaccine and therapy responses. The project will also develop an open-access database for patient screening and a cloud-based tool for microbiome interpretation in research and clinical settings. 

How does regulatory expertise fit in?
Laura Mendieta, scientific and regulatory advisor at Asphalion, is ensuring that scientific breakthroughs in MISTRAL align with regulatory standards. With 25 years of experience, Asphalion helps academia, biotech, and pharma navigate the complexities of drug and medical device development. 

Laura’s role in MISTRAL:
Providing regulatory guidance to technology partners
Engaging with regulatory authorities
Addressing regulatory challenges to accelerate progress 

Asphalion’s latest contributions:
Drafting an Innovation Task Force briefing
Preparing a report on IT’s role in drug development 

Watch the full interview to learn more! 🎥 

Insights from Laura Mendieta: Regulatory Guidance for the MISTRAL Project – Mistral 

Need help in your EU-funded project or in Regulatory Affairs? Contact us! [email protected] 

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