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

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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:

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 (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

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    SOURCE: UBM Live