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In the biologics space, there are clear trends toward higher delivery volumes, less frequent dosing, and the conversion from intravenous to subcutaneous delivery. This is driving demand for wearable technologies. Read more below about the FDA’s Patient-Focused Drug Development (PFDD) Initiative and how these findings can enable more insightful patient offerings.
Under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), the FDA has conducted 24 disease-specific PFDD meetings to systematically gather patients’ perspectives on their condition and the available therapies for treatment. The FDA recognizes the value of gathering patient input through PFDD meetings and continues to host disease specific PFDD meetings. The information gathered is subsequently summarized in a Voice of the Patient report¹.
When designing a drug development program, Voice of the Patient reports can offer valuable insights into the user experience, which can help to ensure the final medicine is effective, tolerable and in a format that enhances the patient’s administration experience. As we know, no medicine is effective at treating disease if the patient refuses to take it.
Patient user experience is at the heart of West’s wearable solution, the SmartDose® delivery platform. West has commercialized the SmartDose 3.5 injector and will soon bring its higher volume SmartDose 10 injector to market. The SmartDose 10 injector incorporates technical and human factor improvements to enable delivery up to 10mL.
West’s SmartDose 3.5 injector is currently used with Amgen’s Pushtronex® device, providing patients with a single, monthly dose of Amgen’s Repatha® drug.
In January 2019, scPharmaceuticals Inc. announced its intent to incorporate West’s SmartDose 10 injector into its FUROSCIX® On Body Infuser for delivery of its FUROSCIX drug which provides treatment for edema in patients with congestive heart failure. FUROSCIX is formulated for subcutaneous delivery, and West’s SmartDose wearable injector provides an outpatient alternative for treatment². Alexion has also announced its adoption of the SmartDose 3.5 injector for delivery of its ULTOMIRIS® drug, which provides treatment for blood disorders. Use of the SmartDose 3.5 injector may help to reduce or eliminate hospital visits for treatment. West’s SmartDose delivery platform offers options for drug administration across a number of acute and chronic therapy areas, from oncology and autoimmune to CNS. The SmartDose platform can allow patients to treat themselves in a clinic or in the comfort of their own home as opposed to a hospital setting, with fewer injections than a multiple autoinjector alternative.
For support with bringing your drug to market with West’s SmartDose delivery platform, please contact us today.
SmartDose® and logo, and the external product configuration of West’s SmartDose® drug delivery platform are the intellectual property of West Pharmaceutical Services, Inc. or one of its subsidiaries, in the United States and other countries.
Pushtronex® and Repatha® are registered trademarks of Amgen Inc.FUROSCIX® is a registered trademark of scPharmaceuticals Inc.ULTOMIRIS® is a registered trademark of Alexion Pharmaceuticals, Inc.
West and Dublin City University (DCU) in Ireland have formed a 4-year educational partnership that will provide 180 students from socio-economically disadvantaged backgrounds with scholarships and educational opportunities. The partnership with the DCU Access programme features the creation of a new annual €45,000 scholarship fund by West to run for four years.
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?
<span style="color: #000000;">Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity.</span>
West has announced a new online resource center to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labeling for cap overseals and ferrules on injection vials, United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010).
<p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director</em><em>, Xavier University.</em></p><p>Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe. But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?</p>
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