Combination Product Industry News & Guidance
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INDUSTRY NEWS BRIEF: When patient access to important therapy is delayed…
If you’ve got a new combination product drug/device that will likely have high demand, it’s imperative that you plan ahead for launch to ensure a stable supply is available. Delays in getting your product to market will affect your ability to capitalize on market demand, reducing profit and giving the competition time to grab early-entry market share.
Beyond business interests, patient safety is also a factor. When a highly desired drug is approved and the drug company has difficulty getting it quickly out to market, patient safety can become a concern in severe cases. Take this recent article by statnews.com, which warns of the extreme measures taken by some patients to get their hands on life-changing drugs, no matter the risk.
In our consulting work, we have seen launches limited by GMP issues at their fill/finish CMO and others delayed by constraints due to drug product & device component manufacturing, just to name a couple of challenges to plan against. We are happy to talk through the risks of your launch anytime, while also discussing possible preparations, mitigations, and contingency measures to head off or address such scenarios. One thing no stakeholder wants is for a company’s preparedness (especially related to device components!) to stand in the way of patient access to important therapy. If you are interested in starting a conversation, simply fill out our online contact form HERE.
Jonathan Amaya-Hodges, Senior Principal Consultant, Regulatory & Quality, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.