samples - Laura Darling

e
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“ WGSN helps minimise
risk in range planning”
Taking the risk out of product decisions reaching two years hence is a difficult task, but for Sara Laor,
Head of Market Intelligence at Nickelodeon, WGSN provides the ultimate support and reassurance.
Minimising risk
Engaging with customers
Risk in business planning is a fact of life, but WGSN’s
authoritative guidance allows Sara to plan ahead,
reassured that she has the best possible support in her
business decision-making. ‘WGSN helps me predict
the performance of a product line next season, and
know how to correct it mid course if necessary. I need
to know which risks are measured, and which are
unsupportable.’
‘Knowing what our core customers want is crucial to our
continued growth over the next few years,’ explains Sara,
‘I use WGSN to uncover what trends and themes each of
our market sectors, from toddlers through to teens, will
most engage with, how to present an inspiring story to
retailers and in turn, how that will drive our growth.
Commercialising design
Part of Sara’s remit involves ensuring that a cohesive
look and feel across a huge range of merchandise
translates to the bottom line. ‘Keeping abreast of each
and every one of our products and ranges means I need
to have that information at my fingertips,’ says Sara.
She finds WGSN invaluable in this regard, as its rapid
and intuitive reporting gives her the answers she needs
in real time, whilst allowing her an eye as to how each
product range will develop every season.
‘It’s visually stunning’
‘It’s like no other source,’ says Sara, ‘It’s like sticking one’s
head into a candy shop.’ The rich visuals WGSN offers
play an important role in the quality of information that
Sara is able to download, and she enjoys her interaction
with WGSN, whilst knowing it saves her time verifying
sources and validating business perspectives.
Without WGSN, Sara would require a large team of
people in order to get the same research done. ‘I know
I’m getting the best of the best,’ she says.
6 reasons why Nickelodeon
subscribe to WGSN:
• To minimise risk in range and strategy planning
• To save time researching and editing
• To identify and validate global trends
• To engage with customers from various market segments
• For a cohesive view of upcoming themes and trends
• To interact with an exciting and intuitive source of intelligence which is unquestionably reliable
To find out how WGSN can help your business,
give us a call on +44 (0) 20 7728 5000
or email us at [email protected]
12
financial talk
Firm foundations
Forty three years in banking, three recessions, and a wealth of local business
knowledge; Alan Trace, Senior Manager at Lloyds TSB explains why his
experience and Lloyds’ commitment to nurturing relationships makes for a
strong foundation in the Gatwick Diamond.
Alan is in a good position to judge a recession. “I’ve witnessed these economic
conditions before, but I’m a realistic optimist,” he says. “The Gatwick Diamond has
a strong economy and is well placed to weather the storm.”
Alan’s new role sees him heading up a team of 21 relationship managers and
advisers in the area who advise companies with turnover of up to £5 million.
This network of managers in branches was set up by Lloyds TSB two years ago
and Alan sees it very much as playing to the bank’s strengths. ”It’s a return to
the old days of bank managers who know the local area and have one-to-one
relationships with their clients,” he explains. “I’ve learnt from the previous
recession that it’s crucial to remain close to our customers and know their
current business, their history and their future direction. Then, whilst offering
expert financial advice, we can also act as a GP on other matters and point our
clients in the right direction. I am very aware that without their business, we have
no business.”
Does he have any advice for business leaders facing challenging times?
“Absolutely. Firstly, don’t bury your head in the sand and do ask for help early
on. If you have a business plan, act upon it, if you don’t, write one! And get it
critiqued and reviewed – Business Link can help here (see page 14). And I’d
always advise to people to set a stop/loss level, i.e, how much you’ll put in and
how much you’re prepared to risk, and stick to it.”
Alan’s help to MDs is crucial and draws upon his own experience. “Make sure you
have a disciplined and structured approach to your own role, so you know exactly
what you should be doing and aren’t constantly fire-fighting. It can be a lonely
job, so finding a mentor is a good idea; someone who’s not immediately involved
that you can share your concerns and ideas with.”
As well as the financial advice you’d expect from your bank, Lloyds has also
launched a small business Charter, which includes pledges to pass on reductions
in the base rate, not change the terms of overdrafts and to agree to any
reasonable request for short term finance, amongst other measures. Alan is also
taking part in two of the 120 seminars rolled out nationwide. Billed as ‘Your
Business, the Economy and your Bank’, he will speak about the local business
community and economy whilst introducing other areas of the bank. Customers
will also be invited to talk about their experiences with Lloyds TSB.
Alan’s drive in his role is obvious: he loves his job and takes great personal
satisfaction from helping clients achieve their goals. “A while ago, I encouraged
a customer to review his prices as he had no room to increase sales and no idea of
his supplier’s budget. He did just that, his supplier didn’t protest, and as a result
he increased his turnover. It was a simple solution that had huge benefits, and it
made me extremely satisfied to be doing what I’m doing.”
Alan’s team network is repeated through Sussex, and other senior managers are
based in Brighton, Chichester and East Sussex. For larger businesses of £5-15
million turnover, a similar structure is in place. “Lloyds has reacted in a very positive
way to the economic situation,” Alan says. “With managers at the coalface, as it
were, l know we’ll be able to offer the best possible support to our customers.”
For more information please contact Alan Trace, Senior Manager, Lloyds TSB
Commercial, Gatwick Diamond Group.
Tel: 07747 627 983
E-mail: [email protected]
www.businesstalkmagazine.co.uk
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“ WGSN helps us create the
right fashion at the right time”
Express is a fashion retailer with a successful formula, and the ability to deliver faster and closer to
season relies upon rapidly-executed runway edits, and the help of WGSN.
Making the impossible possible
Tried and tested
Juliette Benn, Design Director of Accessories, manages
twice-yearly runway edits as part of her special project
remit, and she says the amount of work and scope of the
edits would be impossible without WGSN.
Much of Juliette’s time is spent travelling between the
four major US cities in which the shows take place, and
she finds using WGSN before and during trips helps
save Express time and money.
“ The presentation that I give as a result of the review
is huge; we focus on the well-known collections as
well as upcoming designers; those we call the new
guard. I cover shows from four cities, and each
review takes two weeks. Each presentation consists
of around 700 slides. I simply couldn’t pull it all
together without WGSN.”
“ We know our four major US cities well, but WGSN is
invaluable for new destinations. It also supports our
global travel, helping us to hone our research and
travel the destinations well.”
The perfect starting block
WGSN’s trade shows, retail shop guides and trend reviews are part of Juliette’s initial research that helps her
interpret the wider trend directions to fit with Express’s
own story and seasonal emphasis. “I use the Top 10 and
reports, then tailor them to my business,” she says.
Tried and tested
In Juliette’s daily business as Design Director of
Accessories, she and her team rely heavily upon the
depth and breadth of WGSN’s reporting, and she is
reassured in her decision-making that what WGSN
says, goes.
“ Over the years of using the service, we know that
WGSN’s forecasts and reports come to fruition. It
is tried and tested and we love the frequency of its
updates and the broad categories it covers. It is easy
and a pleasure to use.”
6 reasons why Express
subscribes to WGSN:
• To enable the compilation of runway reviews
• To help analyse vast amounts of trend information
• To save time and money on travel trips
• To ensure Express’ seasonal directions fit with global trends
• For ease of use and quick access to vital reports
• For reassurance that WGSN’s view is unquestionably reliable
To find out how WGSN can help your business,
give us a call on +44 (0) 20 7728 5000
or email us at [email protected]
EXPRESS
4
business talk
“I’ll save you money –
or your money back”
Quite a promise, but Brian Blunden of Managing Carbon is so convinced
he’ll save clients money on their energy bills that this is the guarantee
he’s offering.
We heard from Brian in the last issue of Business Talk and we’ve caught up with
him this month to put some searching questions to him about exactly how your
business can save money by stepping up your environmental awareness.
“Firstly,” says Brian, “I’m delighted that businesses in the Gatwick Diamond have
responded so positively since the last issue and are prepared to lead the way
for other areas of the country. This can only set us in good stead for when the
recession has abated and businesses are hoping to enter a refreshed market one
step ahead of their competitors.”
Business Talk: Ah yes, the recession. Why not wait until it’s over before
worrying about green issues?
Brian Blunden: Well, recessions come and go, but the environmental reality is
upon us whether we like it or not. By facing up to the inevitable now, we can turn
what may be seen as yet another concern into a way to keep costs down. Many
businesses are already looking out of the recession and at ways of stealing a march
on their competitors, and this is one of them. You only need to run a google search
on companies that have initiated a carbon management programme to see what
I mean.
BT: Can embarking on carbon management really have a commercial
benefit as well as the feelgood factor about going green?
BB: The companies that already have this in place are getting a lot of good PR, and
are splashing it over their marketing and recruitment programmes. I mentioned
in the last article about Marks and Spencer being an example of a company that
expects its supply chain to have a carbon management programme, and this is
becoming more widespread. Stakeholders, potential employees, the public are
starting to expect this too.
BT: But what about the cold, hard financials? Isn’t this what most
business leaders are concerned about?
BB: The fundamental part of carbon management is energy efficiency which
makes sense for so many reasons, and I agree; in the current climate, the chance to
save money is the priority of most businesses. I expect many people reading this
www.businesstalkmagazine.co.uk
Brian Blunden
are currently paying a climate change levy on their electricity bill that they’re not
even aware of. This is where I come in: I’ll look at all aspects of the business and
its energy consumption, and, unlike the council and government agencies, I’ll be
a long term partner, saving money and looking out for the best alternatives along
the way.
BT: And what is your answer to people who say that their money is better
spent elsewhere at the moment?
BB: I want to demonstrate the ‘spend a little, save a lot’ maxim, and this is why
I’m offering my clients this guarantee. Simply put, if a client is not happy
with the costs I’ve saved them, then I’ll waive my fee completely. I am
effectively putting my money where my mouth is because I believe 100% that
energy efficiency and greening the workplace makes good business and
ecological sense.
To find out the areas where you can save money, Brian offers a free, no-obligation
assessment of your business. To contact him, call:
T: 07792 871666
E: [email protected]
W: www.managing-carbon.co.uk
business talk
19
Lightening the Load
Picture the scene from a 1970s office sitcom: The harrassed manager in the
brown suit is panicking, surrounded by piles and piles of paper that grow to
such mountainous heights they threaten to overcome him…
over the years, and which
enables them to work with
companies of all sizes and
needs; from small local
businesses to some of the
largest multinationals in
the world. Simple archiving
is no longer enough; so Document
Options controls and manages
business information
throughout its lifecycle,
making it fully searchable
and instantly available anywhere
in the world, 24 hours a day.
“It’s a big relief for our clients to know
that they can free up staff from the rigours
of document admin to do the jobs that they’re
employed for. And now, it’s equally important for them to
know they have us in place, so when the economic upturn arrives, they can hit the
ground running.”
Paul explains how Document Options recently started working with Close
Brothers, one of the City’s most respected and enterprising merchant banks.
Within weeks, thousands of critical documents had been scanned and were
uploaded onto a secure site, accessible to Close employees anywhere in the world,
instantly. Since the success of this first stage, Close has extended their solution to
encompass more document types and more employees, thus transforming the
way they communicate internally.
Paul Guyer, Sales Manager
By 2009 it should all be different, shouldn’t it? We thought that our computers
would negate the need for filing cabinet chaos, but the paper-less office
revolution never quite took place. And it would appear that the pressure for
compliance with regulatory matters means we’re churning out more of the stuff
than ever before.
Document Options are keen to help their customers realise the advantages of
efficient document management, and understand how much time, energy and
money they can save by outsourcing to the right company.
“We’re always trying to pre-empt the market’s needs,” explains Paul. “And our
advantage is that we’ve been in the business long enough to know exactly what
makes an efficient system for each individual business or department, and, of
course, how to take the headache out of all that paperwork…” he smiles.
This is a scenario that Paul Guyer, Sales Manager at Document Options,
understands well. “Organisations need to maintain access to more information
and for longer periods, but how can you do it cost-effectively and efficiently?”
Having been in the business of capturing, storing and managing all manner of
documentation for thirty years, Document Options is particularly well-placed to
provide a completely bespoke service to their clients.
“It’s easy to talk about good customer service, as though it is a given that every
company offers it.” Paul notes. “However, we’re really proud of the team here;
they’ve been servicing some of our customers for decades. Working with us is just
like working with a department in your own company, except we’re always happy
to help! You get direct access to people who understand your needs and they will
bend over backwards to help you.”
Paul’s also proud of the technical competency Document Options has built up
To find out more about how Document Options can help your business, please
contact Paul on:
Tel: 01293 426677
Fax: 01293 403453
Email: [email protected]
Web: www.document-options.co.uk
IMS Chemical Portfolio
ESSENTIAL INTELLIGENCE FOR THE PHARMA-CHEMICAL SECTOR
Essential insights into the
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ASSESS FUTURE GENERICS OPPORTUNITIES
IDENTIFY OPPORTUNITIES AND MARKET POTENTIAL IN
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If you are operating in the generics or specialist
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When a pharmaceutical product loses patent protection,
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With unique global coverage on sales, kilogram and unit
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Presents an overview of the world’s actives market (top 1500 by values in US$ and volume in KG).
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Compiles over 115,000 patent records for drugs in Phase III and above with a global coverage of
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IMS HEALTH®
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7 Harewood Avenue
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NW1 6JB UK
Tel: +44 (0)20 7393 5888
Fax: +44 (0)20 7393 5999
THE AMERICAS
IMS Health
660 West Germantown Pike
Plymouth Meeting
PA 19462-0905
USA
Tel: +1 800 523 5388
Fax: +1 610 832 5438
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Aobadai Hills
4-7-7 AobadaiMeguro-ku
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Tel: +81-(0)3-3481-3586
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www.imshealth.com
CHEMBRO0806
“Pharmaceutical manufacturing is in a state of flux”
Manufacturing in the Global
Pharmaceuticals Industry
Key Drivers, Company Strategies and Regulations
3rd edition
The new edition of this essential report covers:
• Planning a global manufacturing strategy
• Regulations and quality assurance issues
• The 'New Paradigm' in manufacturing
• Making the right investment decision
• The key drivers and changes in today's
manufacturing environment
• The inclusion of APIs in GMP compliance
This report will benefit:
• Pharmaceutical investors
• QA professionals
• Development managers in emerging markets
• Operations and logistics professionals
• Biotech start-ups
• API and excipient suppliers
• Non-technical decision-makers
See all our market reports at www.urchpublishing.com
Manufacturing in the Global Pharmaceuticals Industry
Key Drivers, Company Strategies and Regulations
By Dr Kate McCormick
The new edition of this best-selling report offers insight into the manufacturing process,
strategy, issues and drivers from an expert author.
This is the only report available that covers this
crucial area of the pharmaceutical industry in
such depth. The concentration in recent years on
creating organisations that are market or
customer-led, or research-driven has taken the focus
away from the manufacturing process, although it is
clear that the most successful organisations integrate
all these activities to remain market leaders.
Global pharmaceutical manufacturing is in a state of flux.
There is excess capacity in manufacturing facilities for
finished dosage forms and a shortfall for biotechnology
manufacturing. The situation in APIs is not so clear cut,
and the trend for multinationals to grow through M & A
has led to the need to rationalise facilities. Meanwhile,
local companies from emerging markets wishing to
expand into new markets and exporting must be able to
satisfy ever more stringent quality standards.
This report tackles the challenges of manufacturing in a
global marketplace by providing unique insight into the
strategies a successful company will adopt. By using
examples, case studies and scenarios to aid clarification
of the more technical aspects of the manufacturing
process, you can be assured your desisions are made
with full understanding of the key issues.
This timely third edition will enable you to:
• Assess the pros and cons of outsourcing manufacturing
functions and develop key strategies to effectively
measure supplier and contractor performance
• Interpret and prepare for the latest regulations
applicable to manufacturing and their global variations
• Develop strategies to effectively manage contractor
relationships
• Understand the definitions used in validation, and how
extra investment in validation will improve
performance
• Build competencies for manufacturing that meet the
objectives of:
speed of delivery, reduction in product cost, overall
quality, optimisation of capital spend, maintenance of
customer inventory, minimisation of regulatory impact,
optimisation in the number of manufacturing sites,
maintenance of strategic sourcing for disaster
management planning
• Understand the 'New Paradigm' in international
manufacturing and how it relates to the pharmaceutical
industry.
This report covers finished dose forms, APIs and biotech
products.
Who should invest in this report?
• Manufacturing
• Regulatory affairs
• Material management
• Operations
• Compliance
• Quality management
• Logistics
• Suppliers
About the author
Dr Kate McCormick, of Heathside Information Services
Ltd, UK, is a manufacturing consultant with extensive
strategic and operational management experience in the
international pharmaceutical industry. Kate has 10 years’
of line management and 20 years’ of internal and external
consulting experience, and has worked with multinationals,
SMEs, non-governmental organisations and national drug
regulatory authorities in more than 50 countries.
Kate is a published author, editor of GMP Review, European
Education Advisor for ISPE and a regular speaker at
international conferences. She gained a degree in
biochemistry and a doctorate in microbiology, both at
London University, together with a Masters in Business
Administration from Cranfield University. She is registered as
a senior GMP expert within the EU and is eligible to act as a
QP under the terms of the EU directive.
Contents of the Report
KEY ISSUES FACING THE
PHARMACEUTICAL INDUSTRY
Structure of the industry
Global product portfolio
Pressures
The need to change the way the industry works
Historical development of manufacturing
PHARMACEUTICAL MANUFACTURING
VERSUS SALES WORLDWIDE, EUROPE
AND JAPAN
World market
Western Europe: Covering Austria, Belgium,
Czech Republic, Denmark, Finland, France,
Germany, Greece, Ireland, Italy,The Netherlands,
Norway, Poland, Portugal, Slovenia, Spain, Sweden,
Switzerland, UK
Japan
Partnerships
Contracting out
Outsourcing
Licensing out
Selling off the product
Selling off the company
Acquisitions
Strategic options for companies in emerging markets
Facility for rent
THE IMPACT OF E-COMMERCE ON THE
PHARMACEUTICAL INDUSTRY
Product registration
Manufacturing information sources
Purchasing
Documentation control
Sales and marketing
Electronic communities
GMP guidelines and enforcement around the world
The role of the World Health Organisation
GMP and the multinationals
Harmonisation of standards
CERTIFICATION OF FACTORIES TO GMP
COMPLIANCE
Determining the appropriate standard
Factory inspection – the Food and Drug Administration
(FDA) approach
WHO certification scheme
ISO 9000
Quality Systems Inspection Technique
DESIGNING AND BUILDING A
MANUFACTURING FACILITY
Obtaining the correct environmental standards
Classification systems
Product types, dosage forms and related technologies
Environmental requirements
Manufacture and filling
Environmental requirements
Environmental requirements
Packaging
Types of packaging
Other dosage forms and technologies
API manufacturing
Trends in facility design
Greenfield site development versus refurbishment
Getting the design right from the start
VALIDATION IN MANUFACTURING
PHARMACEUTICAL MANUFACTURING
VERSUS SALES IN CENTRAL AND EASTERN
EUROPE
Covering: Armenia,Georgia, Kazakhstan, Russia,
Turkey, Ukraine
PHARMACEUTICAL MANUFACTURING
VERSUS SALES IN THE AMERICAS
North America
Latin America; covering Argentina,Brazil, Central
America and the Dominican Republic, Chile,
Colombia, Mexico, Peru, Puerto Rico, Venezuela
PHARMACEUTICAL MANUFACTURING
VERSUS SALES IN THE REST OF THE WORLD
Africa; covering Morocco, Nigeria, South Africa,
Zimbabwe
Australasia
Far East; covering China and Singapore
India
Middle East; covering Saudi Arabia, Egypt, Jordan
STRATEGIC OPTIONS FOR
PHARMACEUTICAL MANUFACTURE
In-house manufacture
OUTSOURCING PHARMACEUTICAL
MANUFACTURING
Why outsource?
Outsourcing providers (the contract takers)
Prerequisites for successful outsourcing
Researching the outsourcing market
KEY ISSUES FACING MANUFACTURING
Drivers for manufacturing strategy
Current manufacturing base
Internal factors
Economic factors
Political factors
Geographical factors
Disaster management
Biotechnology manufacturing
Definitions
Design qualification
Installation qualification
Operational qualification
Performance qualification
Process validation
Retrospective validation
Cleaning validation
Analytical validation
Validation – a cost–benefit analysis
THE NEW PARADIGM
Twenty-first-century pharmaceutical manufacturing
New terminology
Quality risk management (QRM)
ICH and the ‘New Paradigm’
Mandatory versus optional activities
THE FUTURE FOR PHARMACEUTICAL
MANUFACTURING
Trends
The shape of the manufacturing industry
QUALITY MANAGEMENT IN
PHARMACEUTICAL MANUFACTURING
Quality assurance
Good manufacturing practice
Quality control
Electronic records and electronic signatures
GMP for starting materials
Price:
Pages:
ISBN:
PDF £1250 / print £1160
135 (approx)
978-1-905751-09-9
OTHER ESSENTIAL REPORTS FROM URCH PUBLISHING
Pharmaceutical Distribution in Europe
The Emergence of Direct-to-Pharmacy Supply
This report comprehensively reviews the business
of medicines distribution in Europe. Using case
studies, detailed analysis and market forecasts, it
will help you identify key areas that will change
in the pharmaceutical market structure over the
next five years, support your internal planning
and decision-making and enable understanding
of how the regulatory environment could change
to reflect new business models.
Key features of the report include:
• Contains 20 case studies including these
companies, Bayer, DocMorris, Galencia, IBS,
Novartis, Phoenix and Pfizer,
• Unbiased synopsis of the UK’s Office of Fair
Trading’s (OFT) report into the medicines’
supply chain
• Overview of the European pharmaceutical
supply chain and the stakeholders involved in
medicines distribution
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Pharma, Physicians and Social Media: Engaging Opportunities and Challenges - a FirstWord Dossier report
September 2009
Pharma, Physicians and Social Media:
Engaging Opportunities and Challenges
The inexorable rise of social media is resulting in more and more business
communities taking notice of its huge global potential, and the pharmaceutical
industry is no exception.
Whilst patients have been the early adopters of social media channels,
physicians and other healthcare professionals (HCPS) have somewhat lagged
behind. But things are changing fast, with recent studies revealing that
physicians are increasingly turning to the Internet for product and treatment
information. Indeed, Twitter’s adoption by many healthcare professionals
demonstrates how it is evolving from a purely social medium to one
promoting serious content. With its global reach, the potential for an exciting
new way to connect with a more diverse audience is proving compelling.
So, if HCPs and their patients are increasingly using social media platforms,
how are pharma companies tapping into this new medium to target and
engage with them? And, with the internet becoming the most prevalent
source of healthcare information for both HCPs and their patients, can pharma
companies afford not to get more involved?
Publication date:
Product code:
Format:
Pages:
Price:
£2,495 Global License
Content Highlights
●
●
The report maps the experiences and activities of leading pharmaceutical
companies to establish:
Who in the healthcare profession is using social media and how
pharmaceutical companies are tapping into their 'influence points'
How pharma companies can benefit from using social media and
remain within the spirit and letter of regulation
●
The report:
●
●
●
●
Examines how physicians and other HCPs are currently using social
media
Investigates what pharma companies are doing to tap into this space
Compares and contrasts social media channels with the more
traditional internet marketing methods employed by pharma
Analyses the benefits and challenges facing those pharma companies
who actively engage this community
Executive Summary
Physicians Current Use of Social Media
> Are Healthcare Professionals (HCPs)
using social media?
> Key attractions
> Use of social media
> Professional usage
> Personal usage
> What are they using?
> Twitter
> Healthcare Professionals
> Hospitals and clinics
> Facebook
> YouTube
> Blogs
> Physician-only sites
> Case Study
> Mayo Clinic
> Key Concerns
> Privacy and Professionalism
This 50-page report -- the second in FirstWord’s best-selling Pharma and
Social Media series -- brings the issues into sharp focus using a wealth of
examples, opinions and case studies. It investigates how pharma companies
are using social media as a new channel for reaching out to physicians and
the digital HCP community.
●
£295 Single User License
£795 Site License
Key insights from expert sources
●
September, 2009
FWD0080909
PDF
50
How are Pharma companies currently
engaging with HCPs?
> So what are pharma companies
currently doing?
> Traditional
> Live video detailing & e-sampling
> Physician customer service
portals
> Enhanced Product Websites
> Search Engine Marketing
> Engaging through Social Media
> Boehringer-Ingelheim (BI)
> Johnson & Johnson (J&J)
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Pharma, Physicians and Social Media: Engaging Opportunities and Challenges - a FirstWord Dossier report
> Pfizer
> Sanofi-aventis
> Novartis
> Through physician only websites
> Engaging HCPs through social
media - benefits for pharma
companies
> Get to know outcomes and
receive opinion data from doctors
> Gain first hand knowledge of
how particular drugs are working
in the real world
> Dissemination of useful
information
> Online physicians write more
prescriptions?
> So how can pharma companies
engage with physicians?
> Challenges of engaging with
healthcare professionals via social
media
Networks covered by the report:
●
●
●
●
Facebook
Twitter
YouTube
Physician-only networks
Pharma, Physicians and Social Media: Engaging Opportunities
and Challenges costs £295 a copy.
Click here to order
For multi-user access, click here to contact us.
●
●
●
APPENDIX – ALL FEATURED WEBSITES
ACKNOWLEDGEMENTS
INDEX
Privacy Policy | Contact
All Contents Copyright © 2009 Doctor's Guide Publishing Limited. All Rights Reserved
For written advertising and subscription enquiries, contact:
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World Pharmaceutical Market Summary
You have subscribed to the latest update on the world pharmaceutical
market from IMS Health.
This month we bring you a bumper edition, complete with the welcome
return of Company News. Also, the second in our three part series which
studies the potential and promise of the Chinese pharmaceutical market,
focusing on paving the way for a blockbuster launch.
Finally, from Biopharmaceutiques, we have an interesting interview with
Michèle Ollier, partner at venture capital company Index Ventures, who
discusses the evolution of the biotech investment model.
Next month IMS will release the definitive global market data for 2009.
Look out for this important market indicator in the next issue of The
World Pharmaceutical Market Summary.
Regards,
Paul Jenner - Editor
IMS Health
Sales Through Retail Pharmacies (Twelve months to November 2009*)
NORTH AMERICA $232.5 billion up 5%
U.S.A. $216.1 billion up 5%
CANADA $16.3 billion up 7%
EUROPE (TOP 5) $108.5 billion up 3%
GERMANY $34.5 billion up 5%
FRANCE $29.1 billion up 1%
UK $13.4 billion up 3%
ITALY $16.4 billion up 2%
SPAIN $14.9 billion up 4%
JAPAN (including hospitals) $79.5 billion up 6%
CHINA (hospital) $24.7 billion up 27%
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LATIN AMERICA (TOP 3) $22.9 billion up 11%
BRAZIL $12.5 billion up 14%
MEXICO $7.04 billion up 1%
ARGENTINA $3.3 billion up 22%
VENEZUELA $5.6 billion up 32%
AUSTRALIA/NZ $7.6 billion up 7%
The top 5 therapy classes at ATC3 level in the 12 months to November 2009 were:
1.
2.
3.
4.
5.
C10A – Cholesterol & trigly. regulators
A2B - Antiulcerants
N6A – Antidepressants & mood stabilisers
N5A - Antipsychotics
C9C – Angioten-II Antag, Plain
The top 5 products in the 12 months to November 2009 were:
1.
2.
3.
4.
5.
Lipitor
Plavix
Nexium
Seretide
Crestor
The top 5 corporations in the 12 months to November 2009 were:
1.
2.
3.
4.
5.
Pfizer
AstraZeneca
Novartis
GlaxoSmithKline
Sanofi-Aventis
MAIN NEWS
IMS Health's experts share the second in a three part series investigating the promise
of China: "Sowing the Seeds of a Blockbuster Launch in China."
In China, however promising a new drug product is, being first-to-market is no
guarantee of its success. The launch of any new drug should be studied and planned
way in advance, and creating the category and the market must be built from the
ground up…
Click here to read the full report.
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COMPANY NEWS IN BRIEF
Mergers & Acquisitions
SIGMA-TAU completed the acquisition of ENZON's US specialty pharmaceutical business,
but the main development in the month was NOVARTIS' decision to exercise its option to
purchase another 55% of eye care company ALCON from NESTLE, for $180 per share,
taking its ownership to 77%. It will then offer to buy the final 23% from public
shareholders, but was only prepared to pay them $153 per share – which was not well
received: Alcon's independent director committee said the proposal was "grossly
inadequate". PFIZER, TEVA and ACTAVIS were reported to be the front-runners in the
bids for German generics manufacturer RATIOPHARM.
Licensing
Pfizer continued its expansion in the generics arena via a collaboration with India's
STRIDES ARCOLAB: Pfizer will distribute the latter's sterile injectable and oral products
in the US. The US giant also signed a co-development agreement with DEBIOPHARM,
which will run a new Phase III trial of its melanoma candidate, tremelimumab. Alcon
acquired two topical eye care products, Durezol and Zirgan, from SIRION: both are
already marketed in the US, and Alcon also acquired global rights (excluding Latin
America), to Zyclorin, in development for dry eye. BIOCRYST licensed its intravenous
influenza drug peramivir to MERCK KGaA for Europe, Russia, Canada and Singapore, and
to HIKMA for the Middle East (excluding Israel) and North Africa.
BRISTOL-MYERS SQUIBB and LILLY settled their dispute over rights to the former
ImClone's follow-up to Erbitux, necitumumab: the two will co-develop the Phase III
product in the US, Canada and Japan, with Lilly retaining exclusive rights elsewhere.
GLAXOSMITHKLINE exercised its option to develop CHEMOCENTRYX's Traficet-EN, for
inflammatory bowel diseases, while SANOFI-AVENTIS licensed KALOBIOS' KB001, for
the prevention or therapy of Pseudomonas aeruginosa infections. ASTRAZENECA formed
an antibacterial collaboration with CRYSTAL GENOMICS, and is to develop companion
diagnostics for its cancer treatments with DAKO.
KYOWA HAKKO KIRIN licensed REATA's lead compound, bardoxolone, for chronic kidney
disease, in Japan and certain other Asian markets, and also began an RNAi oncology
collaboration with DICERNA. IPSEN formed a haemophilia alliance with INSPIRATION,
while Novartis will collaborate with GENVEC on hearing loss treatments. BIOGEN IDEC
signed a licensing agreement with immune-based biologics specialist TRILLIUM.
Novartis licensed out Proleukin, marketed for metastatic melanoma and kidney cancer,
in the US to PROMETHEUS, while JOHNSON & JOHNSON licensed CNTO-530 to EDISON
for clinical evaluation in rare mitochondrial and other neglected diseases.
Regulatory activity
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In the US, Novartis launched Fanapt, developed by VANDA for the acute treatment of
schizophrenia in adults, while ASTELLAS and ZOGENIX introduced Sumavel DosePro for
acute migraine and cluster headaches. In Japan, SHIONOGI launched flu drug peramivir,
licensed from BioCryst, as Rapiacta.
The FDA granted extra indications to GSK's Lamictal XR (add-on epilepsy therapy for
patients aged 13+ with primary generalised tonic-clonic seizures) and Tykerb (first-line
treatment, in combination with letrozole (Novartis' Femara), for post-menopausal
women with HER2+ metastatic breast cancer). The EC cleared BMS' Orencia for use in
combination with methotrexate in children aged 6+ with moderate-to-severe
polyarticular juvenile idiopathic arthritis who have not responded sufficiently to DMARDs.
New drugs approved by the FDA included NOVO NORDISK's Victoza, for Type II diabetes
in adults; it was also cleared in Japan. ROCHE's Actemra was given the green light for
the treatment of moderately-to-severely active rheumatoid arthritis in adult patients
who have had an inadequate response to a TNF-inhibitor. ACORDA's Ampyra, which will
be manufactured by ELAN and marketed outside the US by Biogen Idec, was approved
for use in improving walking in patients with multiple sclerosis.
The EC cleared MERCK & CO's Elonva infertility treatment. Japan approved ABBOTT's
Xience V drug-eluting stent, which will also be marketed by BOSTON SCIENTIFIC as
Promus, plus Novartis' Equa (Galvus) for diabetes, antihypertensive Exforge, and
Afinitor, for kidney cancer.
Product issues
Abbott suspended sales of obesity drug Reductil/Meridia in the EU after the EMA said its
risks outweighed its benefits; the FDA asked the company to add a stronger warning to
the product's label, noting that it increased the chances of a heart attack or stroke in
people with cardiovascular disease. The moves followed the release of data from a
10,000-patient, six-year trial: sibutramine was associated with an 11.4% risk of a
cardiovascular event, compared with 10% for placebo.
J&J withdrew a number of over-the-counter products, led by Tylenol, mainly in the
Americas, following reports of a "musty" odour that was, in a small number of cases,
associated with gastrointestinal adverse effects. The problem was linked to trace
amounts of a chemical sometimes applied to wood pallets. The FDA chastised the
company for not acting sooner.
The EMA recommended an update to the label of Biogen Idec and Elan's MS therapy
Tysabri regarding management of the risks of PML, while the FDA said it would be
reviewing the risk of AMGEN and J&J's erythropoietins with regard to strokes. Pfizer is
facing personal injury lawsuits alleging attempted suicides and deaths linked to its
smoking cessation drug Chantix, and said it was abandoning plans to seek FDA approval
for Lyrica as an add-on treatment for anxiety.
Merck & Co said it wouldn't be filing HIV drug vicriviroc for FDA approval in the nearterm after it failed to meet the primary goal in two Phase III studies, while INSPIRE
and ALLERGAN's Prolacria failed a Phase III trial for dry eye.
Corporate developments
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Novartis CEO Daniel Vasella is standing down, and will be replaced by head of the
pharmaceutical business Joe Jimenez, while Biogen Idec President and CEO James
Mullen will retire in June.
AstraZeneca said it would be cutting 10,400 jobs over the next few years, including
3,500 associated with a reduction in the number of therapeutic areas it conducts R&D
on. Pfizer is laying off 1,200 employees and cut 100 projects from its R&D pipeline; it
now has 133 compounds in clinical trials. Merck & Co is shedding more than 500 US sales
reps. UCB is exiting the US primary care market as it transitions to being a specialtyfocused company.
The US Department of Justice accused J&J of paying kickbacks to Omnicare to ensure
that its antipsychotic Risperdal was used in nursing homes. Novartis agreed to plead
guilty to violation of the US Food, Drug and Cosmetic Act and pay a $185m fine
concerning off-label promotion of its epilepsy drug Trileptal. A US judge approved a
$165m settlement from Merck & Co regarding alleged fraudulent statements about the
former Schering-Plough's antihistamine Clarinex, while Abbott (and SOLVAY) will pay
$22.5m to a number of US states to settle claims that it tried to block generic
competition for cardiovascular drug TriCor.
The EC stepped up its antitrust investigation into patent settlements between
pharmaceutical firms and generics manufacturers. Companies involved in the probe
include BOEHRINGER INGELHEIM, Pfizer, AstraZeneca, GSK, sanofi-aventis, Novartis and
Roche. LUNDBECK is also being formally investigated for blocking generic competition
for its antidepressant Cipramil.
Pricing and Reimbursement News
France: ASMR ratings up in 2009
The Transparency Commission (Commission de la Transparence) granted a total of 42
improvements in medical benefit (Amélioration du Service Médical Rendu , ASMR)
ratings of I-IV in 2009, up from 31 in 2008, according to the pharmaceutical industry
association, LEEM.
UK: Consultation launched on generic substitution proposals
The Department of Health (DoH) has launched a consultation on plans for the
introduction of generic substitution. The proposals were due to take effect in January
2010 under the terms of the 2009 Pharmaceutical Price Regulation Scheme (PPRS),
but have been delayed until stakeholders have had a chance to comment on the three
options now under consideration.
UK: AstraZeneca renews distribution deal with wholesalers
AstraZeneca will continue to distribute its products exclusively through AAH and
Alliance Healthcare (formerly Unichem) over the next four years under a renewed
deal.
USA: GAO reports on ‘extraordinary’ drug price increases
"Extraordinary price increases" for certain brand name drugs have been driven by a
"lack of therapeutically equivalent drugs" and "limited competition", says a new
report from the Government Accountability Office (GAO).
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For further information on our Pricing & Reimbursement offerings including IMS
Pharmaquery click here.
News from Biopharmaceutiques
This month we bring you an enlighteneing interview with Michèle Ollier, Partner,
Index Ventures, discussing "The biotech investment model must continue to evolve."
BioPharmaceutiques: The current economic crisis has deepened the funding problems
facing biotechnology firms. How do you see 2009 for biotech companies generally
speaking and for European biotech companies in particular?
Michèle Ollier: The results are clear and my answer will be fairly standard in the
sense that we have seen biotech companies encountering major difficulties in
financing or refinancing. It has also been difficult to achieve exits. The reason for this
is that investors are now far less confident in biotechnology. This may seem a fairly
banal observation, but a very concrete example was seen in 2009. Now, agreements
for significant sums have been signed by investors and by those ultimately
purchasing the technology and here there is clearly no problem about pricing
regarding high-value products and technologies. This continues to be the case and
companies developing projects with potentially high added value and providing
quality solutions that meet real needs will have no problems raising money or finding
buyers.
BioPharmaceutiques: Has there not been an increase in the time needed to process
financing dossiers in 2009?
Michèle Ollier: Yes, from a psychological standpoint, there is currently much less
willingness to lay out money. Even if funds are available, subconsciously, there is
much more reticence because of fear of investing. Throughout this period, the key
priority for venture capital companies has been to support companies already in our
portfolios. By definition, we invest in companies that we feel are potential winners
and we therefore feel our energy and money is best spent in this field. We then look
at those companies about whom we have some doubts and finally, new investments
take third place.
BioPharmaceutiques: Which are the most difficult stages to fund?
Michèle Ollier: It is certain that early-phase projects are becoming increasingly less
attractive for venture capitalists. A number of parameters are at play here. First of
all, there is the risk element in an environment in which everyone is speaking
incessantly about the crisis and wants to take as little risk as possible. Regardless of
the development stage of a project, evaluating the potential risk associated with the
investment is extremely important. The more advanced the project, the more data we
have to work with and consequently the more comfortable we feel. At Index
Ventures, we are concentrating more on company creation and early-phase
development. There has been no change in this regard since one key parameter we
look at is the amount of money already used up by a company. We are not interested
in companies that have already raised a great deal of money and we prefer to
become involved in projects at a much earlier stage. In our view, such projects must
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be of high quality, with a real chance of reaching maturity and providing an
innovative solution to a major existing need. The quality of the entrepreneurs and
scientists involved in the project is also a critical issue for us. The other essential
point is the cash consumption required to ensure that the project reaches maturity,
at which point a transaction may effectively come about. And there must be a
reasonable margin between investment costs and the price of this transaction and
our model does not accommodate companies raising EUR 50 to 100 million.
BioPharmaceutiques: What do you see as promising scientific and technological
directions in the coming years?
Michèle Ollier: For the last two years, we have been following the stem cell sector,
but we have yet to identify the technology or project in which we would like to
invest. This is not to say that no excellent technologies exist; our approach is more
opportunistic and when we are interested in a developing technology, we do not
attempt at all costs to find a company active in the domain. Acting in this fashion
naturally introduces a certain bias into one's choices. The development of products
and technologies involves such a high degree of complexity and risk and that our
model attempts to introduce as little bias as possible. The best way of achieving this
is to look openly at everything without prejudice. When a technology or product
presents itself to us, our first reflex is to ask whether we are capable of managing
the associated risk and determining the cost of the development programme. Finally,
it is essential to establish if the product holds any real potential interest. We do not
concern ourselves with whether or not a project is fashionable. Stem cells are of
course a very interesting area and we are extremely attracted by a number of
sectors, but we will not necessarily invest in them if we do not find an interesting
project. Our approach is highly opportunistic and open-minded.
BioPharmaceutiques: If you were involved in the funding of biotechnology companies
this year, what were your main reasons for doing so? Did you deliberately choose
between biotech companies and firms in other domains (medical devices,
diagnostics, cleantech, TIC)?
Michèle Ollier: Our investment in 2009 was not significant. We invested in NovoCure,
a biotech company in the USA, and we are currently finalising another agreement
over there. However, we are not ruling anything out specifically since our goal
involves finding the most concrete scientific and technological projects of the best
possible quality. We have no geographical limitations and we favour the highest
quality products available to us. However, we make relatively few investments,
generally two or three a year, since we are extremely involved in working closely
with those companies in which we have chosen to invest.
BioPharmaceutiques: What do you see as necessary changes or developments to
enable biotechnology companies to gain access to funding? What role could venture
capital play here? Is this a job for venture capital companies?
Michèle Ollier: This is a tricky question since it depends on the investment strategy
of the individual venture capital companies. At Index Ventures, we rarely get
involved in companies that have already been created. The key consideration is the
quality of the project and of the management team. Companies that have trouble
finding funds are those that clearly have not managed to bring together all the
necessary skills. There are many companies with an extremely high quality scientific
team, but this on its own is not enough. Developing a product or technology requires
many skills: scientific, regulatory, clinical and manufacturing skills and vision. If less
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weight or professionalism is attached to any of these individual areas, you are bound
to have problems at some point developing your product. Unfortunately, many small
companies fail to grasp the vital need for each and every one of these parameters
and skills.
BioPharmaceutiques: So the ideal configuration of a top-level scientist and a
manager aware of business constraints within the sector still holds?
Michèle Ollier: Quite. I don't see how it could be any other way. It is a necessary
prerequisite of product development and there are no other ways to develop a
product properly. Scientists that are also good managers do exist, but they are a rare
breed, and such people are able to forget that they are scientists and to put on their
managers' hats. One very good example is Jean Paul Clozel at Actelion in
Switzerland, who was able to make the transition towards this new responsibility
and outlook, but such cases are few and far between.
BioPharmaceutiques: Do you feel optimistic or pessimistic for European biotech
companies that will attempt to raise funds in 2010? Why?
Michèle Ollier: I do not feel that things will change drastically for the good over the
next year. It is no coincidence that biotech currently finds itself in a tricky position.
You can hear investors in biotech funds saying that the biotech investment model
needs to evolve in order to provide more attractive performance. You must remember
that it is far easier to obtain feedback on extensive investment in areas such as IT for
instance than it is in the life sciences. The main reason for less promising
performance in biotech concerns the large sums invested in companies attempting to
develop product portfolios. A handful of shining examples such as Actelion have lured
some into thinking that many prosperous companies may easily be created, but as
time goes on, it becomes clear that such examples are in fact the exceptions to the
rule and that it is unrealistic to plan the creation of prosperous companies from the
venture capital stage. The biotech sector and the venture capital sector have begun
to reflect in earnest on how the model should evolve and this reflection will continue
in 2010. I feel that this is a key issue for the future funding of biotech and it is
certainly one of the major challenges for 2010.
For more information on BioPharmaceutiques, click here.
*Source: IMS HEALTH. Growth rates are calculated at a constant exchange rate, (i.e. at the local
currency level).
The unique system in Japan reduces the importance of the retail pharmacy in the distribution chain so
sales for Japan include hospital data. For the USA, retail, foodstore and mail order pharmacy channels
are included. In other countries sales monitored are limited to retail pharmacies only.
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