Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.
The key challenge areas within the drug delivery product industry include:
Product positioning and regulatory strategy
Determining the primary mode of action
Preclinical development, animal models, and proof-of-principle study designs
Clinical development plan and study designs, including human factor studies
Biological and clinical evaluation, including literature analysis
Complex international registration pathways requiring expertise in both drugs and medical devices
Bridge device and drug vigilances
Life cycle and change management.
MediPhorum addresses the operational challenges associated with drug delivery product development. It brings together senior business leaders and subject matter experts across multiple disciplines, including combination product and packaging development, device engineering, regulatory, and quality. It will also work on issues such as regulatory compliance, drug-device co-development, device design, digital healthcare, and the supply chain.
The MediPhorum work program is developed by our members, who work together to identify priority topics for collaboration.
Four teams are currently addressing the following priorities:
Essential performance requirements (EPRs) for device specification setting
This team will develop a standardized approach for interpreting and applying EPRs during development and manufacture
EU Medical Devices Regulation implementation
This team will develop an industry consensus approach for incorporating Article 117 into device development processes
Post-launch change requirements
This team will focus on best practice approaches for managing variations in regional change requirements on post-launch changes
This new team will facilitate knowledge exchange and explore opportunities for best practice approaches across various topics, including regulatory guidance implementation, study design, and participant training.