CPhI expert industry panel members highlight future implications for
pharma in final part of CPhI industry report
FRANKFURT, Germany, Oct. 23, 2013 /CNW/ -
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
Alternatives for APIs include modular technologies in place of
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
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
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 and CPhIPharma Evolution, 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
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
"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
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 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
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.
SOURCE: UBM Live
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