Since this is the 5th edition, CPhI Worldwide has decided to look back at previous Annual Reports to see how accurate the predictions were. These included the expanded use of PAT, QbD, serialization, green chemistry and R&D improvements, as well as the rise of strategic relationships between pharma and CMOs (or CDMOs as they are now called). However, a potential hindrance to the industry was the predicted rise in the number of FDA warning letters.
The 2013 Annual Report forewarned of the rapid increase of FDA warning letters as a result of a tightening regulation environment and a lagging industry. This prediction proved entirely accurate with FDA warning letters tripling over the past few years, from 4882 in 2012 to 14,590 in 2016. Another bold prediction from the first report was an expected boom in pharmaceutical R&D and improvements in development cycles. Interestingly, this was true in 2014 and 2015, stellar years for NME (New Molecular Entities) and BLA (Biologics License Applications), with 41 and 45 FDA approvals respectively. However, this increased productivity dropped off significantly in the following years, with 22 in 2016 and a similar number anticipated for 2017.
As predicted PAT, QbD, and serialization have now become industry wide practices that further ensure quality and efficiency. Another trend identified, is the implementation of continuous processing in both Big Pharma and CDMOs for APIs and finished products, and the use of these technologies is now increasing.
CMOs were anticipated to grow in prominence across the industry, with strategic pharma partnerships proliferating. In the past two years, mega-mergers were expected to become more frequent amid the aggressive competition to become leading and full service providers. This is perhaps best highlighted by the recent deals struck between a number of CDMOs and pharma companies, as well as the purchase of Patheon by Thermo Fisher.
This year’s CPhI Annual Report features twelve experts that provide valuable insight on the current and future state of our industry, including manufacturing, R&D, regulations, biologics, PAT/QbD, and innovation, among many others.
The CPhI Expert Panel members for 2017 are:
Gil Roth, President at the PBOA
Alan Sheppard, Principal, Global Generics at IMS Health
Vivek Sharma, CEO at Piramal Enterprises Ltd.
Ajaz Hussain, Founder CEO at Insight Advice & Solutions LLC
Dr Minzhang Chen, CEO at STA Pharmaceutical
Dilip Shah, CEO at Vision Consulting Group
Prabir Basu, Pharma Manufacturing and Regulations Consultant
Brian Carlin, Global Excipients Expert
Emil Cuirczak, President at Doramaxx Consulting
Bikash Chatterjee, President and CSO at PharmTech Associates
Girish Malhotra, President at EPCOT International
B.S.V. Prasad, Senior Vice-President and Head of Small Molecules Business Unit at Biocon Ltd
