CPhI Worldwide has announced the founding members of its expert industry panel who are set to collectively assess the changes taking place across the industry in a series of monthly and annual reports – with the first monthly report on ‘formulation and ingredients’ out in mid-June.
The panel has already confirmed six full members including some of the world’s leading experts on APIs and excipients (Girish Malhorta and Brian Carlin respectively). In addition, the panel features regulatory heavyweights, Ajaz Hussain and Ali Afnan, the latter formally of the FDA’s PAT team and an expert on development processes.
Ajaz Hussain, now of Wockhardt, who is renowned for coining the term PAT, will lend his expertise in establishing and improving drug regulation. Across supply chain issues, the panel will leverage the knowledge of Hedley Rees, whilst on quality systems and the Asian market, Bikash Chatterjee brings a wealth of experience to the table. The expert panel provides diverse perspectives with high level pharma experience.
Each panel member has been individually chosen following an exhaustive selection process involving industry peers and journalists to ensure that the panel has the appropriate expertise to independently and holistically examine global trends. In total, CPhI envisages harnessing the collective knowledge of between 12 and 15 world renowned experts, covering the entire pharmaceutical supply chain from R&D through to finished products. In addition to the founding members, a further five global experts - including C level executives and R&D specialists from some of the industry’s largest and most innovative names - are set to join the panel imminently over the next couple of weeks. The members of the panel will collaborate and draw upon their combined expertise to provide foresights into the global pharma industry.
Featured on the founding panel is Brian Carlin who chairs the IPEC Americas Quality by Design and Excipient Composition Committees. He also serves on the USP Excipient Committee and is the recipient of the 2012 IPEC Foundation Industry Research Achievement in Excipient Technology award.
Joining Carlin is Bikash Chatterjee, who brings an in-depth knowledge of pharmaceutical process development, including process and technology transfer across the entire supply chain, having commercialised more than a dozen products in 40 countries.
Synonymous with the term PAT, Dr Ajaz Hussain is an acknowledged leader within pharmaceutical and regulatory science and drug development. Having previously worked with the FDA, Dr Hussain displayed outstanding leadership within review, research and international harmonisation, having served as the FDAs ICH lead and expediting the progress and implementation of ICH Q8, Q9 and Q10.
The winner of several FDA Commissioner Awards, Dr. Ali Afnan is another well-respected industry influencer and was a key contributor to the drafting and finalising of the current FDA Process Validation Guidance.
CPhI also welcomed Hedley Rees, a supporter of lean thinking and production systems, and a zealous advocate of the regulatory modernization frameworks of the FDA’s 21st Century Modernization and ICH Q8 – Q11, who will be providing his expertise on global supply chain dynamics. Finally, Girish Malhotra is world renowned for his expertise within pharmaceuticals, with knowledge across coatings, resins and polymers. In particular, he is widely regarded as an API production guru, and his experiences in significantly lowering manufacturing costs using continuous processing and batch process improvements are keenly sought.
For the duration of 2013 members of the panel will take part in CPhI short monthly reports – entitled ‘CPhI Pharma insight series’ - examining topical issues across a total of eight broad themes: Drug Delivery; Formulation & Ingredients; R&D; Manufacturing; Packaging & Distribution; Regulatory Compliance; Contract Services & Supply Chain Management; and QA/QC. The monthly reports will also feature raw data, which will be compiled from the wider industry via the CPhI Pharma Evolution site.
However, the ultimate goal of the panel’s inception is to utilise their respective areas of expertise to scrutinize how the industry will change across the coming 5-10 years in an annual report to be produced ahead of CPhI in October.
The annual report will feature a mixture of primary industry data (industry surveys) and the collection of in depth essays from each panel member - with experts given carte blanche to prophesize how the industry will look and operate in the future from both an economic and practical perspective. CPhI believes this approach will give the report an unrivalled picture of how the industry is predicted to change, with the survey results providing an overall indication of the sentiments of the wider community.
CPhI is now in the later stages of assembling the panel’s full line-up and plans to announce all participants before the end of this year.