Panel to leverage their collective expertise to create monthly and annual
reports to explore futurecontingencies 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 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 21(st) 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
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
"Our visionwas 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 nextfive-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
andpractical 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
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
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 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
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
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, President and founder of EpcotInternational, 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
-- Lower manufacturing costs: batch process improvements or
-- Waste reduction, due diligence/training, environmental, safety
-- 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 includeSupply Chain Management in the
Drug Industry: Delivering Patient Value for Pharmaceuticals and
Biologics(John Wiley & Sons).
For more information, please contact:firstname.lastname@example.org
For media enquiries, please contact: Alex Heeley or Tristan Jervis De Facto
Communications T: +44(0)207-203-6745 / 6740 E:email@example.com
SOURCE: UBM Live
To view this news release in HTML formatting, please use the following URL:
CO: UBM Live
NI: 2575 WNEWS
-0- Jun/06/2013 17:03 GMT
Press spacebar to pause and continue. Press esc to stop.