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The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.
CPhI Worldwide, organized by UBM, has announced the 2017 expert panel for the fifth edition of the CPhI Annual Report. The report will be released in two parts, one before the show and the other during CPhI Worldwide (October 24–26, 2017 in Frankfurt).
Five years on from the release of its first annual report, CPhI Worldwide decided to review the accuracy of the predictions made in past reports. Experts have previously predicted the expanded use of process analytical technology (PAT), quality by design (QbD), serialization, green chemistry, R&D improvements, and the rise of strategic partnerships between pharma and contract development and manufacturing organizations (CDMOs). A potential hindrance to the industry, however, was the predicted rise in the number of FDA warning letters.
The 2013 Annual Report, which was the very first, predicted that the number of FDA warning letters would increase as a result of tightening regulations and a lagging industry. Based on information on FDA’s website, the past few years have seen FDA warning letters for pharma development and manufacturing activities increase from 23 in 2012 to 58 in 2016, confirming the accuracy of this prediction.
In the first report, experts also predicted a boom in pharmaceutical R&D and improvements in development cycles. Interestingly, 2014 and 2015 were the stellar years for new molecular entities (NMEs) and biologics license applications (BLAs), with 41 and 45 FDA approvals respectively. This figure, however, dropped significantly in the following year, with 22 in 2016. A similar number is anticipated for 2017.
PAT, QbD, and serialization have now become industry-wide practices for ensuring product quality, safety, and efficiency. Big Pharma and CDMOs are implementing continuous processing for their APIs and finished products, and the use of these technologies continues to increase. Previous reports also predicted a shift to green chemistry, route scouting, and process improvements to reduce the amount of waste produced. This trend is taking shape across the industry.
Experts also foresaw the proliferations of strategic partnerships between pharmaceutical companies and CDMOs. Mega-mergers are becoming more frequent, driven by competition to become leading and full-service providers. Examples include Lonza’s acquisition of Capsugel and the announcement of Thermo Fischer Scientific’s plan to purchase Patheon in May 2017. In addition, Big Pharma has also set-up co-development deals with a number of companies, particularly to develop and commercialise biologics and biosimilars.
This year’s CPhI Annual Report features twelve experts that provide valuable insight on the current and future state of the pharmaceutical industry, including manufacturing, R&D, regulations, biologics, PAT/QbD, and innovation, among many others.
The CPhI Expert Panel members for 2017 are:
Source: CPhI Worldwide