2015’s Pharma Trends Highlights:
- 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.
“New technologies like continuous manufacturing, QbD and PAT continue to expand in importance within the pharma industry, yet age-old issues regarding the supply chain and working with the right partners are also seen as essential in 2015- demonstrating the integral role CPhI will continue to play. Strategic partnering has been a theme for some time in the industry and CPhI provides the necessary tools to establish more pharma contacts and make improved business decisions.” Chris Kilbee, Group Director Pharma at UBM.