By Fran DeGrazio, executive editor
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2024 was certainly an active year for the pharmaceutical and biopharmaceutical industry. It was especially so around activities driven by industry growth and by the associated challenges of delivering safer and more effective drugs – and more of them – to patients. As I watched and reflected on advances in drug and therapy delivery throughout 2024, five familiar challenges continually appeared as topics of focus and conversation at industry conferences, in peer interactions, and during industry group collaborations.
Those five top drug delivery challenges from 2024 are the following:
- Qualifying device suppliers for combination products
- Applying a ‘systems’ approach to combination product development
- Leveraging platform devices to achieve speed to market
- Keeping pace with increasing demands and higher doses in self-administration
- Achieving regulatory approvals for combination products
Drug Delivery Challenge #1: Qualifying Device Suppliers
In early 2024, the FDA issued a final rule amending the medical device current good manufacturing practice (CGMP) requirements under 21 CFR 820 to align more closely with the ISO 13485:2016 international consensus standard for medical device quality management systems. This change also applies to combination products. (Later in the year, we here at Drug Delivery Leader, hosted an online panel discussion of the implications of this new Quality Management System Regulation, or QMSR, and I followed up with an article on the topic.)
This regulation has raised the importance of various aspects of CGMP especially for those biopharma companies that historically were more familiar with drug GMPs but are now working to develop and market a combination product. One of the key areas where industry is seeing gaps that must be closed is in purchasing /supplier controls. Suppliers in this space must understand what their obligations are. Their obligations go beyond the foundational requirement of delivering high quality products to encompass collaborating with sponsor companies. That means providing knowledge and documentation such as risk management files and control strategies, and to do so openly and without hesitation. It is the pharma company/market authorization holder’s responsibility to demonstrate that a supplier meets the needs for the device being acquired. Frankly, If the supplier is not open to exchanging risk and controls information, then perhaps it should not be identified or qualified as a supplier of a device intended for a combination product. (Later in the year, I returned to the topic in an article on supplier controls.)
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2024 was certainly an active year for the pharmaceutical and biopharmaceutical industry. It was especially so around activities driven by industry growth and by the associated challenges of delivering safer and more effective drugs – and more of them – to patients. As I watched and reflected on advances in drug and therapy delivery throughout 2024, five familiar challenges continually appeared as topics of focus and conversation at industry conferences, in peer interactions, and during industry group collaborations.