Pharma predictions for 2015: From CPhi Worldwide

Highlights from 2015’s Pharma Trends include:

The Good

·         Big growth in use of QbD, continuous manufacturing and Quality Metrics with contract manufacturers and generic companies also starting to implement

·         Shift in USFDA’s role from just being an “investigator” of products to an “enabler” of better quality processes and cultures within pharma manufacturing

·         Breakthrough treatments for infectious diseases and growth across NCEs and biopharmaceuticals

The Bad

·         Shortages of popular drugs in Western markets due to marginal pressures and reduced stockpiling

·         Fears for pharma not ‘walking the talk’- QbD and continuous manufacturing and other quality changes are being implemented in finished dosage, but in API, not enough necessary manufacturing changes have occurred

·         Challenging year for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages

The Ugly truth

·         It’s crucial for pharma to take greater control over ingredients

·         Outsourcing and related quality issues are unlikely to be reduced in the near future. Big Pharma may even, in some cases, repatriate key elements of the drug development chain

·         Battle between IP protection and patient access set to hot up in 2015

Source: http://www.europeanpharmaceuticalreview.com/29188/news/industry-news/experts-make-pharma-predictions-2015-good-bad-ugly/#.VNBbEdpDHIU