We all know that bringing a novel drug to market is, to put it simply, difficult. Success in today’s biopharmaceutical marketplace requires the advancement of increasing complex drugs, sometimes in combination with delivery devices. Disruptive technologies are reshaping healthcare through real-world data and patient engagement mobile apps, further raising the bar on market success, but adding a new dimension of complexity to a market application.

Navigating the ever-changing industry standards and regulatory requirements propels the journey from molecule to market to a new and challenging level. At the same time, organizations are under pressure to advance development and ultimately gain regulatory approval as quickly as possible. Many find themselves resource constrained – making the journey more difficult and complex.

West has witnessed our role evolve from merely a supplier of goods and services to an advisor along every step of the product development journey and beyond. Biopharma companies increasingly need expert advice beyond a packaging or device recommendation – they need and expect suppliers to intimately understand current regulatory expectations that impact their container closure selections, while also providing the services to generate the data required to gain regulatory approval and satisfy post-approval reporting.

The first step in the journey starts with packaging and/or device selection. Organizations are evaluating options earlier in the drug development process than ever before. Biopharma companies have a strong understanding of the sensitivities of their molecules along with a vision for how they will be commercially supplied and administered in the market. The demand for drug device combination products is increasing as organizations look to deliver drugs more effectively, as well as provide differentiation and increased intellectual property protection. 

Selection of a package or device is only the tip of the iceberg. They seek unprecedented levels of guidance on regulations and standards. Staying up-to-date on ISO, USP, FDA guidances, MDR article 117, EU Annex 1 and the nuances that relate to our products requires a tremendous amount of resources.

Once an organization understands the regulation and standards, they are now left with the burden to prove that their system is suitable for its intended use and establish critical quality attributes. Mid-to-small pharmaceutical companies have resource constraints, especially with access to staff and other internal resources that bring challenges to timely drug development. Larger customers may have many resources, but typically want to outsource areas not core to them. Outsourcing addresses common barriers such as workload fluctuations and the need for specialized scientific know-how, equipment and instrumentation to meet complicated regulatory expectations. 

West recently launched an Integrated Solutions Program to provide the industry with a comprehensive approach to drug containment and delivery system development. The new offering combines West’s drug packaging and delivery products with its testing and support services to help meet the unique needs of the drug product and its delivery system at any stage of development, across all injectable formats.

Through the program, West provides testing and support services for unique drug product and delivery systems. Importantly, a dedicated Program Manager provides a single point of contact to help reduce development and supply risk, reduce total cost of ownership, and accelerate the path to market.

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Stacey Vaughan is Senior Director, Strategic Marketing at West Pharmaceutical Services. Her professional experience spans the entire healthcare value chain culminating from roles in Quality, R&D, Technical Operations, Business Development, Alliance Management, Supply Chain & Commercial Operations. Stacey has held management roles at Cardinal Health, Catalent, Putney and Mylan Pharmaceuticals.