CPhI

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Generics companies, responding to tough times, steer towards higher-risk portfolio strategies

These are tough times financially and strategically for many generics companies, particularly in the U.S., the world’s largest pharmaceutical market. Manufacturers are experiencing falling net prices driven by customer consolidation and increasing competition, coupled with a lack of operational flexibility and a landscape of new product opportunities significantly different from those of the past. Additionally, […]

Regulatory considerations, strategy and best practices for choosing a quality CMO

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and […]

Changing product mix, shifting geography drive sourcing and manufacturing outlook

Manufacturing (supply) and sourcing (demand) are very much intertwined. In an industry where scaling up manufacturing or getting approvals to use a new supplier can take several months, if not years, it is critical to anticipate future needs. It is clear that one area to watch in biopharma sourcing and manufacturing is the changing product […]