CPhI Announces Founding Members of Expert Industry Panel

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 
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 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 
in October.

"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."

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 

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 MalhotraBiography

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
        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 includeSupply 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 


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.