Contents
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POLICY & REGULATION EMERGING MARKETS
60 92
US grapples with paying for pricey drugs Latin America: ripe for clinical research?
What’s ruffling US seniors’ feathers? As the high-growth economies of Latin America
become increasingly attractive, its largest markets
63
are looking to align their regulatory systems with
those of the west
Biosimilars regulation finds its feet
Europe remains the only major market with a
biosimilars regulatory pathway, but the US might
94
soon catch up Ranbaxy buyout heats up Indian M&A
65
Daiichi Sankyo plunges headlong into the Indian
market, buying up domestic champion Ranbaxy,
The view from Canary Wharf
but who will follow?
Thomas Lönngren, head of the EMEA, muses on
improving the efficiency of drug development, as
98
well as that of his own organisation Enter the ‘pharmerging’ markets
As expansion in the world’s major markets slows,
Will China live up to its 68
pharma already has its eye on a handful of new
growth drivers
innovative potential?
Japan’s PMDA puts its house in order
The Japanese regulator squares up to one of its
Not content with its status as a generics and
OUTSOURCING
biggest challenges: the country’s ‘drug lag’ problem
antibiotics manufacturer, China is hoping to
transform its domestic pharma industry into a
70
101
powerhouse of innovative R&D
Exit task in-sourcing, enter comprehensive
The expert third party
outsourcing
A group of scientists who decided that working for
The key to optimising clinical trials management:
the regulators wasn’t a job for life
outsourcing larger, more comprehensive pieces of
CLINICAL TRIALS
work
73
106
Safety issues to the fore
Joined up thinking
Scrip 100
Why clinical supplies and supply chain management
The US FDA flexes its newfound drug safety muscle
are rising up pharma’s agenda
through the FDAAA, while risk management
A supplement to Scrip World
initiatives gather pace in the EU
Pharmaceutical News
109
77
The CRO turns transaction trendsetter
Editor: Pete Chan
Europe’s watershed year for paediatric
What’s whetting clinical outsourcing providers’
Managing Editor:
medicines
appetite for M&A deals?
John Davis
The EU now has its first drug developed specifically
Sales Managers:
for children, with the prospect of many more to
112
Fergus Gregory,
come On the crest of the middle tier
Jennifer Cheng
80
These are high times for CROs driven by pharma’s
Designers: push for cost-containment
Paul Pancham,
Trial starts signal industry’s best bets
Myriam Lengliné,
Analysis of recently initiated clinical trials points to
115
Nathan Bentley,
the future direction of pharmaceutical R&D Risk: assessment, aversion and denial
Paul Wilkinson
Front cover image:
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How globalisation has become a bugbear for the
fine chemicals community
Mark Frost
Cognition mission
Head of Production: Lee Spencer
Production Editor: Zoë Dann
How assessment of cognitive processes can support
118
safety and efficacy testing in clinical research Chemistry class
Advertising Production: Tony Dixon
Companies might consolidate to deliver larger, more
Publisher: Phil Jarvis
sophisticated contracts, but not at the expense of
Head office: Informa Pharma, Telephone House,
their reactive edge
69-77 Paul Street, London, EC2A 4LQ, UK
Tel: +44 (0)20 7017 5000 CAREERS & PEOPLE
© Informa UK Ltd 2008
All rights reserved. Full terms and conditions
121
available on request.
Knowing your unknowns
The views expressed in this supplement are the views
of the authors but not necessarily those of Scrip. While
Neglecting to ensure employees fully understand
information is compiled with all due care, Informa UK
their jobs is setting pharma up for considerable risk
Ltd will not be liable for the consequences of anyone
acting or refraining from acting in reliance on any
information.
Printed by Newman Thomson, Burgess Hill,
West Sussex, RH15 9TL, UK Yes Obama can, but what
www.scripnews.com/supplements
57
change for pharma?
Is the new US President a friend
of innovators?
Published December 2008
4
www.scripnews.com/supplements Scrip 100
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