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

Frankfurt, Germany (ots/PRNewswire) -

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 ; 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 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.

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