CPhI Announces Founding Members of Expert Industry Panel
Amsterdam, 03 June 2013: CPhI Worldwide, organised by UBM Live, announces 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 cumulatively over 155 years of 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 Mr 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 welcomes 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.
“Our vision, was to harness the power of CPhI’s independent position within the industry so that we could produce an unbiased analysis of the global pharma sector and help bring different perspectives together. For the report’s content, we had to ensure we had the right mix of appropriate experts that could holistically – and this cannot be stressed enough, independently – examine the next five plus years’ worth of developments. The panel we realised was the crucial element in making the reports and platforms robust enough to offer advice that was globally relevant and practical in its implications”, commented Andrew Pert, Brand Director, Pharma at CPhI.
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.
Andrew Pert, added: “I am delighted that we have been able to source so many leading figures from within the industry to take part in the panel, as collectively they bring a huge amount of experience and insight. Already the panel’s knowledge spans pharmaceutical ingredients, manufacturing processes, global supply chain issues and regulatory frameworks. One thing they all have in common is a wealth of experience across international markets and a practical approach to problem solving, which will be invaluable in postulating future market dynamics.”
For more information, please contact: cphi@ubm.com
Ali Afnan Biography
An expert in compliance and quality, Dr. Ali Afnan was one of the first to establish a pharmaceutical process analytical technology (PAT) program at AstraZeneca in Europe. He is currently the head of Step Change Pharma, which recently entered into a partnership with Tunnell Consulting.
Dr. Afnan was recruited in 2003 by the FDA’s Center for Drug Evaluation and Research (CDER) to join the agency’s Process Analytical Technology (PAT) and Drug Product Quality initiatives. As a member of the PAT steering team and as the science policy advisor to the Office of Pharmaceutical Science, he co-authored the agency’s PAT Guidance and helped draft its most recent guidance on process validation.
The recipient of several FDA and CDER awards, Dr. Afnan left the agency in 2010 and founded Step Change. He was awarded the 2012 IPS Medal for contributions to Industrial Pharmacy from the International Pharmaceutical Federation.
Ajaz Hussein Biography
Dr. Hussain is Chief Scientific Officer and President for Biotechnology at Wockhardt Ltd., an Indian multinational pharmaceutical and biotechnology company. He is based in the USA.
Prior to this appointment in 2012, Dr. Hussain worked as Vice President at Philip Morris International (PMI), where he worked on developing a platform for manufacturing vaccines in tobacco plants, and also worked on developing modified risk tobacco products.
At Sandoz, he helped develop and register several biosimilar products, and also helped to establish a ‘quality by design’ framework for biosimilar development.
Prior to his industrial experience Dr. Hussain worked at the U.S. FDA for ten years, and prior to FDA he was focused on academic teaching and research (University of Cincinnati and the Ohio Northern University).
He is a Fellow of the American Association of Pharmaceutical Scientist and the Swiss Society for Pharmaceutical Sciences and has received several awards such as the FIP’s Industrial Pharmacy Medal, Scientific Achievement Award of AAPS and numerous FDA Awards.
Brian Carlin Biography
Brian Carlin is Director of Open Innovation (Pharma) at FMC BioPolymer. He was previously the Global Manager Pharmaceutical R&D, and has been with FMC for 17 years. He chairs the IPEC Americas Quality by Design and Excipient Composition Committees, and also serves on the USP Excipient Committee. Prior to joining FMC, he worked at SmithKline and Richardson Vicks in new product development. He obtained his doctorate in Interfacial Rheology from the School of Pharmacy, University of London, and an Honours degree in Pharmacy from the University of Aston in Birmingham. Brian serves on the distance learning MSc course at De Montfort University, UK, where he is an Honorary Visiting Professor. He is the recipient of the 2012 IPEC Foundation Industry Research Achievement in Excipient Technology award.
Bikash Chatterjee Biography
Bikash Chatterjee is President and Chief Technology Officer of Pharmatech Associates. With over 30 years' experience in the pharmaceutical, biosciences, medical device/diagnostic, and nutraceutical/dietary supplement industries, he has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA-regulated development process to market. Throughout his career, he has been responsible for product development, technology and process transfer and technology, and established global supply chain processes in over 40 different countries around the world and been responsible for the commercialization of more than a dozen products.
Mr. Chatterjee sits on several scientific advisory boards for pharmaceutical and medical device companies. He is a standing member of several prominent editorial advisory boards and contributes columns for key publications on industry trends and challenges. He has published over 60 articles and editorials throughout his career in peer reviewed journals. He is a Certified Lead Assessor and a Lean Six Sigma Master Black Belt. He holds a BA in biochemistry and a BS in chemical engineering from the University of California at San Diego.
Girish Malhotra Biography
Girish Malhotra, President and founder of Epcot International, has over 43 years of industrial experience in pharmaceuticals; specialty, custom, and fine chemicals; as well as coatings, resins and polymers, and additives. His expertise ranges from manufacturing to process and technology development and business development. The author of Chemical Process Simplification: Improving Productivity and Sustainability (Wiley 2011), Mr. Malhotra specializes in enhancing profitability by simplifying technology and manufacturing practices using engineering and science principles resulting in technology leadership. He accomplishes these goals through a combination of the following:
• Process technology development
• Manufacturing process simplification and product quality improvement
• Lower manufacturing costs: batch process improvements or continuous processes
• Waste reduction, due diligence/training, environmental, safety and health
• Competitive intellectual property review
Mr. Malhotra also contributed a Chapter on Simplified Process Development and Commercialization, in Quality by Design – Putting Theory into Practice, which was published by the Parenteral Drug Association and DHL Publishing in 2011. He also wrote the research report, "Strategies to Enhance API Manufacturing Processes," published by Business Insights in 2011.
Hedley Rees Biography
Hedley Rees is Managing Consultant at PharmaFlow. A practicing consultant, coach, and trainer in pharmaceutical operations and supply chain management, his clients include pharmaceutical companies, ranging from large Top 10 firms to emerging biotech, private equity, a global strategic consultancy, contract manufactures, facility design and build specialists, and third/fourth-party logistics service providers. Assignments span early-stage clinical trial supply chains up to complex multi-product supply networks covering global territories. Prior to this, Hedley held senior positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of competencies from strategic procurement, production and inventory control, and distribution logistics, to information systems and improvement. His early career was spent as an industrial engineer in the automotive, consumer durables, and FMCG sectors.
As an expert in lean thinking and production systems, Mr. Rees is a zealous advocate of the regulatory modernization frameworks of the FDA's 21st Century Modernization and ICH Q8 – Q11. He graduated from the University of Wales as a production engineer and holds an Executive MBA from Cranfield University School of Management. He is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS), a former member of the UK BioIndustry Association's Manufacturing Advisory Committee, and on the Advisory Boards of the International Institute for Advanced Purchasing & Supply (IIAPS) and Marken, the only supply chain service provider dedicated 100 percent to the pharmaceutical and life science industries.
Mr. Rees regularly delivers podcasts and webinars and speaks at international conferences and is co-chair of the highly regarded FDA/Xavier University sponsored PharmaLink Conference held in Cincinnati annually. In collaboration with Xavier Health, he works closely with industry, the FDA, patient advocacy, and other key stakeholders in finding solutions to today's supply chain integrity issues. His publications include Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics (John Wiley & Sons).
About CPhI
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, China, India, Japan, Southeast Asia, Russia and South America and co-locates with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com and hosts a global community with news and analysis at PharmaEvolution.com, produced by UBM Live and partners.
For more information visit: www.cphi.com
About UBM Live
UBM Live connects people and creates opportunities for companies across five continents to develop new business, meet customers, launch new products, promote their brands, and expand their market. Through premier brands such as TFM&A, Internet World, IFSEC, MD&M, CPhI, Cruise Shipping Miami, the Concrete Show, and many others, UBM Live exhibitions, conferences, awards programs, publications, Websites, and training and certification programs are an integral part of the marketing plans of companies across more than 20 industry sectors.
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