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Practical Pointers

Published • Jan 1, 2026
Authors:
Gerald Klein
,
Freddy Byrth
,
Michael Fath

Abstract

This practical pointer synthesizes three upstream development priorities: Oncology, rare disease, and complex immunology dose-finding studies, Medical-device human factors, and Translational Medical Affairs (TMA) evidence planning. This is incorporated into a single, actionable framework for sponsor...

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