CPhI Announces Founding Members of Expert Industry Panel
CPhI Announces Founding Members of Expert Industry Panel
AsiaNet 53301
AMSTERDAM, June 7, 2013 /PRN=KYODO JBN/ --
- Panel to leverage their collective expertise to create monthly and
annual reports to explore future contingencies affecting the global
pharma industry
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
[http://www.pharmaevolution.com/bloggers.asp#Girish_Malhotra ]
- Hedley Rees, Managing Director at PharmaFlow Ltd
- Ajaz Hussain, CSO & President Biotechnology at Wockhardt
CPhI Worldwide [http://www.cphi.com ], 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 [http://www.pharmaevolution.com ] 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."
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: 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 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).
For more information, please contact: cphi@ubm.com
For media enquiries, please contact:
Alex Heeley or Tristan Jervis
De Facto Communications
T: +44(0)207-203-6745 / 6740
E: a.heeley@defacto.com / t.jervis@defacto.com
SOURCE: UBM Live
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