spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

CPhI Annual Reports - how accurate were they 5 years on?

CPhI Worldwide

The CPhI predictions foresaw advancement in QbD, continuous processing, and a dramatic rise in FDA warning letters

Amsterdam, 27 July 2017: CPhI Worldwide, organized by UBM announces the 2017 expert panel for the highly anticipated CPhI Worldwide Annual Industry Report (5th edition) – to be released in two parts; part one in late summer and part two during CPhI Worldwide (October 24-26, 2017 in Frankfurt). The report is a comprehensive and critically important publication that analyses key trends and innovations forecast by a panel of world class experts.

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. Additionally, both pharma and outsourcing providers were correctly anticipated by the reports to begin looking at green chemistry, route scouting and process improvements earlier in development to make less wasteful products and this has already begun taking shape across the industry.

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. In addition, Big Pharma has also set-up co-development deals with a number of companies, particularly to develop and commercialise biologics and biosimilars.

However, some of the first Annual Reports missed the pulse of the industry, expecting tighter regulations to have a consequential effect of decreasing the number of biotechs and small companies entering the market. In contrast, the biotech environment has significantly heated up in last couple of years, with the traditional hot spots in the USA seeing growth as well as a rapid emergence of newer biotech hubs – particularly in China.

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

“This year’s Annual Report features some of the industry’s most stellar names and pharmaceutical industry experts and we are extremely grateful for all their efforts. It is a testament to their work and industry acumen that so many of their foresights five years on are beginning to take shape across industry. It also adds to the growing weight of evidence that the CPhI Annual Report is an essential document for anyone looking to stay ahead of market trends, explore new partnerships, opportunities and technologies, and to ultimately help advance the industry more quickly”, commented Orhan Caglayan, Brand Director – Europe, UBM.
email customerservice@ubm.com
web www.cphi.com
 
Print this page
Send to a friend
   
spacer
News and Press Releases

CPhI Annual Reports - how accurate were they 5 years on?


More info >>


White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models

DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
More info >>

Industry Events

7th American Drug Delivery & Formulation Summit

28-29 August 2017, The Westin Copley Place Boston Hotel

Innovative solutions to the greatest challenges in pharmaceutical development
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement