CPhI Annual Expert Industry Report (Part II): Live from CPhI Worldwide

Frankfurt, Germany (ots/PRNewswire) -

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: 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
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 ; CPhI and
P-MEC India (3-5 December, 2013 at the Bombay Exhibition Centre in
Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan ; 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,
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Through premier brands such as TFM&A, Internet World, IFSEC, MD&M,
CPhI, Cruise Shipping Miami, the Concrete Show, and many others, UBM
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sectors.

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