Director AstraZeneca, Biologics Pharmaceutical Development, Dosage Form Design Gaithersburg, Maryland
Advancement in novel combination products and drug-device combined use provide unique opportunities for the development of HCP and patients empowering medicine. This presentation provides a CMC roadmap for both technical and regulatory considerations of developing drugs and devices combined use to target specific patient classes, for example, pediatric medicine. Specifically, we want to also take into clinical considerations on drug delivery directly to the organ target to minimize systemic adverse effects as well as potentially maximizing drug-target exposure. While all patient classes will be reviewed, the case study for this presentation will focus on non-intravenous and organ-specific route of administration of hazardous ADCs to geriatric patients. The formulation and dosage form design will focus on how to develop their combined use with devices, following international regulations. (Theme 3: Formulation and Delivery for Patient Centric Product Development).
Learning Objectives:
Understand the complex landscapes of clinical development strategies regulations (dosing) to CMC and Device challenges for patient-focused and organ specific delivery
Talk to clinical team as well as device / drug product development teams to ensure patient centricity and develop strategies to overcome regulatary challenges.
Understand how challenges can be multifaceted beyond drug/device technicalities but also clinical and regulatory uncertainty.