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

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    Alex Heeley or Tristan Jervis

    De Facto Communications

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    SOURCE: UBM Live