Panel to leverage their collective expertise to create monthly and
annual reports to explore future contingencies affecting the global pharma industry
AMSTERDAM, June 6, 2013 /CNW/ -
Founding panel members:
Ali Afnan, President at Step Change Pharma (formally of the FDA's PAT team)
Brian Carlin, Director Open Innovation at FMC
Bikash Chatterjee, President and CTO at Pharmatech Associates
Girish Malhotra, President & Founder, Epcot International
Hedley Rees, Managing Director at PharmaFlow Ltd
Ajaz Hussain, CSO & President Biotechnology at Wockhardt
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
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
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."
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: http://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.
Notes to the editor
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
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
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
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
Waste reduction, due diligence/training, environmental, safety and
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
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).
SOURCE: UBM Live
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