Dr. Theuer is Chief Medical Officer at Halozyme where he is responsible for providing leadership and guidance to Halozyme and its partners/collaborators in subcutaneous drug development with ENHANZE® technology and auto-injectors.
A new European Union regulatory framework known as MIDBA may streamline auto-injector approvals for biologics by reducing the need for repetitive pharmacokinetic (PK) bridging studies. Charles Theuer discussed how the model-based approach could accelerate drug-device combination development and potentially influence future FDA policy.
At AAPS NPC 2026, Charles Theuer discussed how converting biologics from intravenous (IV) infusion to subcutaneous (sub-q) administration is reshaping patient experience, safety profiles, and regulatory development strategies. The shift toward pharmacokinetic (PK)-based approvals and label extrapolation is enabling faster development of subcutaneous oncology and biologic therapies.
Emerging sequential treatment study designs may simplify and accelerate IV-to-subcutaneous biologic conversions by reducing variability and shrinking clinical trial sizes. Charles Theuer discussed how streamlined pharmacokinetic (PK)-driven regulatory pathways and evolving EU initiatives are reshaping subcutaneous biologic development.
