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West’s Tibor Hlobik and Chris Evans will present at the 2015 Drug Delivery Partnership conference, January 28-30 in Boca Raton, FL.
Tibor Hlobik, Global Director of PFS Technologies, will present “Minimizing Drug Development Risks With a Robust Component Strategy,” on Wednesday, January 28, 2015 at 11:00AM.
Presentation Overview: Commercializing drug products has become more challenging, particularly when launching complex biologics in a prefilled syringe and auto-injector delivery system format. Component design and material selection during development must take into account the drug stability during storage, robustness of the container closure system and intended user requirements to ensure safety and effectiveness of the medicine. Regulatory bodies also may request evidence of acceptable container closure selection and supporting design history elements during premarket application or final submission. In this talk, we will review component selection strategies applied by leading companies to mitigate risks associated with defect attributes, extractables and leachables, particles including sub-visible, poor reliability and inadequate functional performance. It is essential that components used to store and deliver drug products be of the highest quality and are designed to support combination product needs.
In addition, West’s Chris Evans, Director of Innovation, and Katrina Firlik, MD, Chief Medical Officer and Co-Founder of HealthPrize Technologies, will present “Enhancing Patient Adherence to Drug Delivery: The New Imperative” on Friday, January 30, 2015 at 8:45AM.
Presentation Overview: Future gains in patient outcomes are likely to come less from advances in drug development or drug delivery, and more from improvements in patient behavior. Medication adherence is a key driver of outcomes in addition to the other “healthy behaviors” of exercise, diet, and abstinence from smoking. Improving medication adherence is a win-win for all constituencies in healthcare, given its ability to improve outcomes, lower healthcare costs, and increase pharma revenues. Poor medication adherence is estimated to cost the healthcare system $290 billion in “otherwise avoidable medical spending” and an estimated $188 billion in lost pharma revenue per year in the US. Strategies to improve adherence, from education to cost reductions to digital engagement programs are now a key imperative for pharmaceutical companies. Services “wrapped around the pill” will extend to services linked directly to drug delivery devices in order to enhance patient motivation by improving the immediate experience of adhering to chronic medication therapy. This presentation reviews the status of medication adherence initiatives within the pharmaceutical industry, with a particular focus on more recent and innovative efforts. The basic tactics fall into the following overarching themes: (1) reminders (2) cost-reductions (3) education (4) rewards (5) gamification.
Chris will also serve as a panel member during the “Patient Adherence Trends, Engagement Strategies and Innovative Solutions to Enhance Patient Compliance and Deliver Customer Value” session on at 9:30 AM.
For more information or to register to attend, visit http://www.iirusa.com/ddp/welcome.xml
When selecting parenteral packaging components, the vial and stopper are typically discussed, but the seal is often an afterthought. Seals do not have direct product contact and are considered secondary packaging. However, the selection of an appropriate seal is critical to assure proper container closure integrity as well as determine how the product will function for the end user.
Join our subject matter experts at the new West headquarters building for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”
On June 15, 2016, West’s contract manufacturing division—formerly known as The Tech Group—attended Medical Design & Manufacturing (MD&M) East in New York City. This annual event is especially insightful, as it offers access to six additional industry expos–EastPack, ATX (Automation Technology) East, Atlantic Design & Manufacturing, PLASTEC East, HBA Global, and Quality Expo. Show attendees discovered the latest innovations, new materials, and state-of-the-art manufacturing processes from among 900 suppliers.
<span style="color: #000000;">West has completed a preliminary study of its SmartDose® technology platform, which incorporates a Daikyo Crystal Zenith® (CZ) cartridge. The study evaluated multiple attributes of the technology and subjects’ experience with the self-application process. </span>
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
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