MIDD to Support New Drug Applications

MIDD to Support New Drug Applications

Overview of the 2024 MIDD Webinar Series

The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.

Martin Bergstrand

Principal Consultant and MIDD Platform Science Lead

Pharmetheus

Principal Consultant and MIDD platform science lead at Pharmetheus.

PhD in Pharmacometrics from Uppsala University.

Twenty years of drug development experience in areas such as metabolic disorders, autoimmune disease, infectious disease, hematological disorders etc.

Co-founded the consulting company Pharmetheus AB in 2012. Engaged as a strategic advisor on behalf of multiple clients and acted as the main responsible consultant for 50+ pharmacometric data analysis projects on behalf of more than 20 different clients. The projects have ranged from pre-clinical translational projects to submission ready large-scale phase III PKPD analysis. These analyses have among other things contributed to 5+ successful NDA filings.

First-hand experience with pharmacometric analysis of a wide variety of endpoints including time-to-event analysis, Markov-models, mechanism-based models for multiple linked endpoints and characterization of complex pharmacokinetics. Authored 30+ peer-reviewed articles.

Special interest in the development of methods for efficient communication regarding MIDD.

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MIDD to Support New Drug Applications
Select the "View On-Demand Recording" button to begin.  |  60 minutes
Select the "View On-Demand Recording" button to begin.  |  60 minutes