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
FRANKFURT, Germany, Oct. 22, 2013 /CNW/ -
Report's expert highlights
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers:
Big pharma to develop niche medicines and associated companion
Technical advances in design and development to reduce costs - with a
more collaborative model between partners and increased outsourcing in
Academic partnerships with pharma and CMOs to increase innovation
William Botha, Sensei, Interlean:
Increased outsourcing to lower risk processes such as packaging and
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
Bikash Chatterjee, President and CTO, Pharmatech Associates:
Pharma to focus on improving drug discovery and development
CMOs need to develop larger service development offerings
Understanding of foreign regulatory requirements, beyond FDA, to become
FDAs enforcement of QbR in generics to reduce GMP transgressions
Ajaz Hussain, Independent Consultant:
Continuous manufacturing processes to continue to grow, encouraged by
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 and CPhI Pharma Evolution, 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
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
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: http://www.cphi.com
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
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
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
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