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

AsiaNet 54733

FRANKFURT, Germany, Oct. 23 /PRN=KYODO JBN/ --

    - CPhI expert industry panel members highlight future implications for

pharma in final part of CPhI industry report

    - Industry to encounter drug shortages and threat of adulterated products,

with pharma shifting focus to orphan drug development, low cost products and

continuous processing

    Report's expert highlights

    Girish Malhotra, President at EPCOT International:

    - Pharma to switch to low-cost drugs that have a larger customer base

    - Industry is at risk from possible drug shortages as weaker players in

developing countries fail to meet regulatory requirements

    - Minimizing process inefficiencies through PAT and QbD will lead to 20-25%

savings of global revenues

    - Continuous processing is forecast to revolutionise manufacturing with

reduced costs, increased sustainability and consistently higher product quality

    - Alternatives for APIs include modular technologies in place of continuous

processing

    Prabir Basu, Independent Consultant and a former Director of NIPTE:

    - Regulatory environment needs to change to offer incentives for achieving

excellence- presently pharma is focussed on non-compliance

    - FDA should focus resources on regions with a likelihood of failure

    - FDA could learn from 'trust and verify'-style OHSA Voluntary Protection

Program

    - Biggest threat to industry is that most companies get ingredients that

are not being inspected

    - cGMP needs to be extending to excipient manufacture.

    Emil Ciurczak, Principal at Doramax Consulting:

    - Speed of development from lab scale to small scale manufacturing is

dramatically accelerating

    - Batch processing may now be a thing of the past

    - In 10-15 years it will be impossible to tell if one is in a generics or

branded pharmaceutical facility

    - Generics race will lead to smaller number of larger generics companies

    - Increased collaboration between FDA and EMA, with QbR adoption ensuring

generics manufacturers improve process knowledge-base

    Hedley Rees, Principal at PharmaFlow:

    - Regulation with such a prescriptive approach is not actively targeting

mal-intent within the supply chain

    - Regulators should raise the bar for CMC filing at the IND/CTA stage to

ensure only the most promising molecules enter the clinic

    - Improvements in in silico and in vitro testing will help to improve

predictive capabilities

    - Track and trace under FDASIA to support supply chain improvements but a

change in behaviour is needed to truly ensure safety

    - Contract research and manufacturing sector needs to take an active role

in innovation and share some of the costs and risks

    CPhI Worldwide [http://www.cphi.com ] and CPhIPharma Evolution

[http://www.pharmaevolution.com ], part of UBM Live's Pharmaceutical Portfolio,

announce the release of the remaining findings of its annual report- with

contributions from expert industry panel members Prabir Basu, Independent

Consultant and former Director of NIPTE, Girish Malhotra, President at EPCOT

International, Emil Ciurczak, Principal at Doramax Consulting and Hedley Rees,

Principal at PharmaFlow.

    (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a )

    The remaining four articles of the annual report highlight the effects that

increased regulation and new practices, including QbD, are likely to have on

the global marketplace, alongside continuous processing and risks in the supply

chain.

    Girish Malhotra's analysis suggests that alongside these quality and

process issues, pharma is likely to change its business model towards

developing lower-cost drugs that have a larger customer base, with big pharma

revenues increasingly coming from orphan drugs.

    However, he also sees risks of an increasingly stringent regulatory

environment, with drug shortages envisaged as consolidation occurs amongst

weaker players in developing countries.

    Prabir Basu, in contrast, sees the greatest threat to the industry coming

from uninspected ingredients and argues that it is essential that cGMP be

extended to excipient manufacture.

    Hedley Rees echoes these thoughts and believes that the current

prescriptive approach is not adequately targeting 'mal-intent in the supply

chain'.

    One solution, Basu believes, to the regulatory minefield would be for the

FDA to implement a 'trust and verify'-style OHSA Voluntary Protection Program,

which would provide flexibility for cGMP sites to make modifications whilst

accelerating the implementation of Operational Excellence (OpEx) without fear

of shutdown. The FDA should also focus its resources on regions with the

greatest likelihood of failure.

    "Track and trace under FDASIA will also help to drive supply chain

improvements but a change in behaviour is also needed to ensure safety.

Industry is far too reliant on regulation as an excuse for not taking the

initiative," Hedley Rees notes.

    Another major problem, Prabir Basu identifies, is that the current

regulatory environment does not incentivise achieving excellence and is rather

more focused on non-compliance. Girish identified a solution to this and

believes that the implementation of PAT and QbD will not only lead to higher

standards, but will help remove process inefficiencies- leading to global

revenue savings of 20-25%.

    Emil Ciurczak also sees the benefits of these new methodologies and states

that in 10-15 years' time, it will be impossible to tell if a site is generic

or a branded pharmaceutical facility.

    These improvements in standards will inevitably come at the cost of market

consolidation, with a generics race underway ultimately leading to a smaller

number of larger generics companies. An essential element to improve standards

across generics manufacturing will be the adoption of QbR and ever-closer

collaboration between the FDA and EMA.

    Another benefit of QbD/PAT is the ability to vary experimental conditions,

which should allow development work to progress from laboratory scale to small

scale manufacturing more quickly. Hedley Rees supported this, adding that

supply chain quality should be brought into the equation at the early

development stage, with poorly characterized molecules becoming redundant

before development work. He also suggests regulators should raise the bar for

CMC filing at the IND/CTA stage to help ensure that only the promising

molecules enter the clinic.

    The final area highlighted by several of the panel members, including

Girish Malhotra and Emil Ciurczak, is the potential for continuous processing

to revolutionise manufacturing with reduced costs, increased sustainability and

constantly higher product quality, with the advent of QbD and PAT producing an

enabling environment so that batch processing may be a thing of the past.

    Chris Kilbee- Group Director, Pharma, commented: "The remaining findings

from our CPhIPharma Evolution annual report show that over the next few years

stringent regulations and practices such as QbD are prominently shaping the

global marketplace. A large number of our experts emphasise QbD in playing an

increasingly large role to ensure products are manufactured to consistently

high standards of quality that align with all regulatory bodies. But with

increased standards does come short-term risks of product shortages, however,

in the longer term we can expect huge revenues savings from these techniques,

and in as little as 10-years' time standards at generics and branded sites will

be indistinguishable."

    For full copies of the submission and overall reports please visit:

http://www.cphi.com

    Notes to editors

    About CPhIPharma 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 CPhIPharma Evolution

    CPhIPharma 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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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