Πηγή: PharmExec Staff
An expert CPhI Worldwide panel has identified "the good, the bad, and the ugly" in its forecast for the pharmaceutical industry for 2015.
Among the "good" developments are the shift in FDA’s role from
“investigator” of products to “enabler” of better quality processes and
cultures within pharma manufacturing; breakthrough treatments for infectious
diseases; and growth across NCEs and biopharmaceuticals.
The bad will continue to be defined by shortages of popular drugs in western markets due to marginal pressures and reduced stockpiling; fears for pharma not ‘walking the talk'; and the challenging year ahead for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages.
The "ugly truths" pointed out by the panel include predictions that
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), and that the battle between IP protection and patient
access is set to further heat up.
Details of the panelists and some of their individual predictions are
further outlined below.
Prabir Basu, Consultant at Pharma Manufacturing
- Outsourcing will continue to increase, especially to India and China. Outsourcing and related quality issues are not likely to be reduced in the near future.
- Industry and FDA will continue to emphasize Quality Metrics though nothing substantial is expected.
Hendrik Baumann, CEO of Arevipharma GmbH.
- Biopharmaceuticals will grow continuously and NCE’s (new chemical entities) will develop moderately. We might see a breakthrough in HIV treatment, Malaria treatment, and therapy of Hepatitis C or similar viral infections.
- Individualized medicine will become more and more popular. Either via individual dosages, mixtures of different API’s or new biopharmaceutical treatments. The pharmacist will lose influence; compounding pharmacies will become more important.
- Government influence over health systems will increase. More and more generic API’s will be sold through so called “tender businesses”. Margins will continuously decrease and popular medicines will be less attractive to produce. Pharmaceutical producers and wholesalers will decrease warehouse capacities and stockpiling. Consequently, there will be shortages of popular drugs.
Brian Carlin, Director, Open Innovation, FMC
- Greater focus on impact of raw material variability on the quality of finished pharmaceutical products.
Emil W Ciurczak, President Doramaxx Consulting
- The "movable" process line (Pfizer announced it was doing this) may be brought to a remote site to ensure consistency of products, no matter where produced. This is possible by performing a mini-DoE, using locally available raw materials (we all know excipients vary from country to country). This allows a proprietary company to produce "home-style" products at any contract site.
Girish
Malhotra, President EPCOT International
- The industry will continue with a “regulation-centric” approach despite the benefits of the “process-centric” methodology.
Hedley Rees, Managing Consultant at PharmaFlow
- Big Pharma will begin to repatriate certain drug development value chain activities to regain control over quality, lead times and cost.
- FDA’s launch of the new Office of Pharmaceutical Quality will provide much needed focus and integration in the US regulatory process, which will drive drug developers and manufacturers to design quality into their products at a much earlier stage.
- Virtual drug developers will be challenged to meet their ever-increasing commitments to GMP/GDP and also to meet expectations of prospective big Pharma partners with respect to the robustness of their CMC packages.
Dilip Shah, CEO, Vision Consulting Group
- The role of theFDA may change from that of mere an "investigator" to that of an "enabler" bringing in attitudinal and culture change and transform product quality oversight from a qualitative (subjective) to a quantitative (objective) and expertise-based process to ensure adequate supply of safe, effective and quality medicines to the U.S. citizens.
- The drug regulators will face societal pressures to facilitate entry of follow-on innovative drugs to promote competition in the patented segment.
- The developed economies may move towards balancing the interests of the innovators and the patients in the field of pharmaceuticals.
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