De-risk transition from primary packaging to combination product
West can help you mitigate risk, reduce timelines and deliver a great patient experience
The clock is ticking once patents are filed, and you need to cope with rising development costs, concerns about quality, and more stringent regulatory requirements—it all adds up to more pressure and more risk.
To navigate the uncertainty around combination products, pharmaceutical companies will often focus on drug development and speed to market with simple, known containment systems and delay focusing on drug – device combination products until later phases. But thinking about your long-term lifecycle management (LCM) strategy early on could offer many benefits, including helping to solidify your market position.
When you work with West, you can Simplify the Journey™ by considering combination product development and regulatory strategies throughout drug-device development.
This makes it easier to plan for every phase of your product’s life cycle, and you’ll find it easier to avoid surprises, shorten timelines, improve operational efficiencies, and increase the probability of regulatory success.
Challenge - Complex development processes and stringent regulatory requirements
Both drug and product development are challenging in their own right. Add the complexity of developing a combination product and the stringent and evolving regulatory landscape, it is no wonder drug developers often make errors in their development path.
Make data-driven decisions earlier in development
With West, you can confidently plan each and every phase. West offers support services from concept and development, through to analytical testing, assembly, and regulatory filing, to help streamline the commercialization of drug delivery systems while mitigating risk.
With West’s extensive knowledge of material science and experience in helping customers bring combination products to market, the burden to plan for every eventuality—even those you can’t predict—is reduced.
Custom roadmaps mean that you have a clear line of sight to avoid pitfalls that might otherwise have been revealed too late. With this confidence in execution and by not having to constantly re-evaluate work, you can reduce development risk and accelerate time to market.
Challenge - Selecting the Ideal Presentation
As therapies become more complex and shift towards self-administration, you’re pressed to bring more intricate devices to market that are also easy to use. Against this backdrop, evolving regulations require you to prove your drug, containment and delivery system are reliable and safe.
Design with the patient in mind
When working with West, you will have the benefit of West’s extensive expertise to help you in selecting the right product for delivering an improved patient experience and in gathering the information you need to meet regulatory requirements.
Having the ability to understand each unique combination product application and build the data to support product development is critical. With proper documentation of the containment and the delivery system, you can select the ideal presentation from the beginning. You’ll be able to navigate regulatory guidelines for combination devices, plus take advantage of user-centered design and testing to deliver a truly patient-centric product.
When you do this, you mitigate the safety and usability risks that usually come with a new drug-delivery system, including meeting the increasing expectations of regulatory agencies.
Challenge - Supply chain complexity
Developing combination products requires industry know-how from concept through commercialization. To fill in the gaps, you may rely on multiple suppliers, which could leave you with an overabundance of vendors to track and manage as you commercialize your drug, along with several service and quality agreements that you must constantly monitor.
Because the dynamics and nature of the relationship are different, you need on-going collaboration and transparency. This calls for a partner who understand the unique challenges of building the components and the constituent parts of a drug-device delivery system.
Simplify the supply chain without limiting options
West’s vertical integration means that you can build visibility and accountability across the entire development, industrialization, and commercial phases.
And with West’s breadth of components and presentations, you can access materials that have already been found to be suitable for combination devices, reducing the risk of complex life-cycle management and de-risking incompatibilities.