CPhI Annual Expert Industry Report (Part II): Live from CPhI Worldwide
CPhI Annual Expert Industry Report (Part II): Live from CPhI Worldwide
AsiaNet 54729
FRANKFURT, Germany, Oct. 22, 2013/PRN=KYODO JBN/--
CPhI Expert Industry Panel Members Comment on Future Contingencies for
Pharma in Part II of CPhI Industry Report
Pharma to change business model to include increased academic partnerships,
CMO development work, more niched products, industry-wide QbD and regulation of
suppliers
Report's expert highlights
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers:
- Big pharma to develop niche medicines and associated companion diagnostics
- Technical advances in design and development to reduce costs- with a more
collaborative model between partners and increased outsourcing in
development processes
- Academic partnerships with pharma and CMOs to increase innovation
William Botha, Sensei, Interlean:
- Increased outsourcing to lower risk processes such as packaging and
logistics
- Increased vertical integration when risks are higher (e.g. APIs)
- Changing pharma business model towards niche products or commodity-based
low margin products
- Regulators to pay increased attention to human factors and staff turnover
Bikash Chatterjee, President and CTO, Pharmatech Associates:
- Pharma to focus on improving drug discovery and development effectiveness
- CMOs need to develop larger service development offerings
- Understanding of foreign regulatory requirements, beyond FDA, to
become increasingly common
- FDAs enforcement of QbR in generics to reduce GMP transgressions
Ajaz Hussain, Independent Consultant:
- Continuous manufacturing processes to continue to grow, encouraged by the
FDA
- CDER manufacturing metrics to help regulators identify data that is too
good to be true and potential compliance issues
- Industry to witness more frequent inspections of foreign facilities
CPhI Worldwide [http://www.cphi.com ] and CPhI Pharma Evolution
[http://www.pharmaevolution.com ], part of UBM Live's Pharmaceutical Portfolio,
announce the release of the second edition of its annual report - with its
expert industry panel identifying the market trends set to affect growth and
innovation across the industry.
(Logo: http://photos.prnewswire.com/prnh/20130723/629764-a )
Part i of the report was launched prior to CPhI Worldwide, with a further
eight industry expert panel submissions being released in part ii of the
report, over two days at the show (Tuesday 22nd and Wednesday 23rd October).
The first four articles for part ii of the report indicate that over the
next few years, big pharma's business model is shifting from its traditional
markets and moving towards the development of niche medicines, companion
diagnostics, and perhaps most significantly, towards increased partnerships,
both with CMOs and academia. The implication of this is that innovations and IP
processes will be coming from outsourced partners, big pharma and academia. QbD
is seen as being essential to the process of harmonizing product and process
development, which will accelerate standards, enabling more developed
partnerships and strategic uses of outsourcing.
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers forecasts in
his submission that big pharma will move towards the development of niche
medicines, alongside companion diagnostics for patients with specific genotypes.
Echoing these sentiments, William Botha, Sensei at Interlean, says that as
well as a move towards niche medicines, pharma will increasingly diversify
towards commodity-based, low margin products- meaning we will see an increased
specialisation, particularly amongst small and medium pharma. To achieve this
goal, he argues that there will need to be increased connection between product
development and manufacturing so that products can move more seamlessly through
the development process.
Bikash Chattejee, President and CTO at Pharmatech Associates, argues that
two essential developments that will be universally adopted over the next five
years are the concepts of Quality by Design (QbD) and Quality by Review (QbR).
If we are to move towards the harmonization of product and process development
cycles, QbD will be essential not only in safeguarding quality but also in
reducing the cost of development. However, one area that is forecast for
particular change is the application of QbR within the generics drugs industry.
For instance, FDA enforcement approaches, it is forecast, will start to look
more at baseline characterisation activity, which will reduce the number of GMP
transgressions in the medium-term future.
One longer-term change that all experts across the industry panel agree on
is the increased collaboration with strategic outsourcing partners and
particularly the commercial development of innovations coming out of academia.
Ajaz Hussain, an independent consultant and formerly of the FDAs PAT team,
continued: "Academic partnerships such as that between Novartis and MIT will
also be increasingly important over the coming years and academia will play
significant roles in both technology and policy. This partnership concept will
also expand to relationships with suppliers and manufacturers where there is a
need for knowledge-based relationships, particularly in the areas of QbD and
FDASIA."
Hussain also believes that manufacturing metrics from CDER will allow
regulators to identify data 'too good to be true' and decrease non-compliance
over the coming years.
Another growing trend is the increased outsourcing across the supply chain
and development cycle with industry building symbiotic relationships, commented
Bikash Chatterjee. He highlighted that a CMOs ability to provide product
development services will be essential to companies moving into emerging
markets and smaller start-ups looking to tap into the global marketplace.
Botha however, sees significant risks in too much outsourcing and predicts
that lower risk downstream processes such as packaging and logistics will grow,
alongside upstream vertical integration of high-risk areas such as APIs:
"Outsourcing isn't always the answer. In some cases it is just abdicating or
abrogating responsibility."
Venugopal expands on these ideas in his contribution, and believes that the
ability to handle increasing volumes of data will facilitate partnerships with
reduced risks and enable the global implementation of QbD: "Our ability to
increase collaboration and knowledge has increased with our ability to manage
data. We can now gather and analyse knowledge to an unprecedented degree." His
view is that whilst contracting will increase, this will be more strategic in
nature across the global supply chain.
Chris Kilbee - Group Director, Pharma, commented: "The CPhI Pharma
Evolution annual report highlights the main industry trends over the next five
years, with tighter regulatory controls and processes (e.g. QbD) and
diversification of ingredient suppliers featuring prominently in all
submissions. Harmonising product and development process partnerships are going
to be critical to the success or failure of this - which proves the importance
of making strategic partnerships at events such as CPhI."
For full copies of the submission and overall reports please visit:
Notes to editors
About CPhI Pharma Evolution annual report and expert industry panel
Earlier this year, CPhI launched a major new initiative with the
introduction of its annual report published in cooperation with Pharma
Evolution - written by a panel of world-leading experts across the
pharmaceutical supply chain.
The vision was to harness the power of CPhI's independent position within
the industry so that it could produce unbiased analysis of the global
pharmaceutical industry and help bring different perspectives together.
The annual report utilises expert in-depth essays, looking at future
contingencies. Experts were given carte blanche to evaluate current industry
practices and examine the future implications for the industry.
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 co-located 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.
For more information visit: http://www.cphi.com
The UBM Live annual schedule of Pharmaceutical events also includes CPhI
Worldwide, ICSE, P-MEC Europe and InnoPack (22-24 October, 2013 at Messe
Frankfurt, Germany); CPhI and P-MEC India (3-5 December, 2013 at the Bombay
Exhibition Centre in Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan
(9-11 April, 2014 in Tokyo); CPhI Russia and IPhEB (16-17 April, 2014 in St
Petersburg, Russia); CPhI, P-MEC and Innopack South East Asia (20-22 May, 2014
in Jakarta, Indonesia); CPhI Istanbul (4-6 June, 2014, Turkey) and CPhI,
Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (26-28 June, 2014 at SNIEC,
Shanghai, China). CPhI South America (5-7 August 2014 at Expo Centre Norte, Sao
Paulo- Brazil)
About CPhI Pharma Evolution
CPhI Pharma Evolution (http://www.pharmaevolution.com) launched in February
2013 as a global online community where professionals from across the
pharmaceutical manufacturing sector can talk with their peers and share
best-practices and regulatory updates across the pharmaceutical ingredient and
contract manufacturing space. Pharma Evolution is the new go-to community for
industry professionals to exchange thoughts and network on key areas including:
formulation, APIs, excipients, drug delivery, R&D, manufacturing and quality,
packaging and anti-counterfeiting, regulatory compliance, and outsourcing and
supply chain management. Pharma Evolution was created as an extension of
CPhI's global events business as a forum and resource for pharmaceutical
executives to employ 365 days a year. Pharma Evolution is published by CPhI and
UBM DeusM (http://www.deusm.com), the marketing services division of UBM
specializing in building and operating highly engaged communities of qualified
users within specialist B2B markets, using a strategy of best-practices focused
on content and technology.
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.
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SOURCE: UBM Live
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