This document provides an agenda and details for the "5th Pharmaceutical Product Lifecycle Management" conference taking place on January 24-25, 2012 in London. The conference will focus on strategies for optimizing pharmaceutical product lifecycle management and will feature presentations from industry leaders on topics such as innovative portfolio strategies, benefit-risk evaluation, patent protection, drug safety, submissions and regulation, brand management, and portfolio management. The document outlines the schedule, speaker biographies, sponsorship opportunities, and reasons for attendees from pharmaceutical and biotechnology companies to register.

1. 5th Pharmaceutical Product
Lifecycle Management
An integrated advance towards pharmaceutical product lifecycle management optimisation
24th - 25th January 2012, Visiongain Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Jonathan Deutsch, Safety Science Leader, Roche
Dr Beverley Forsythe, Principal Safety Physician, AstraZeneca
Christiano Silva, Global Product Manager, Boehringer-Ingelheim
Dr Denise Oleske, Director of Pharmacoepidemiology & Global Surveillance, Abbott
Oliver Mitchell, Head of Customer Excellence, Abbott
Bill Griffiths, DVP, Regulatory Affairs, Abbott
Dr Enrica Alteri, Head Risk Management & Epidemiology, Merck Serono
Dr Miri Halperin, Global Head of Business Affairs, Actelion Pharmaceuticals
Hans Hoogkamer, Global Business Affairs, Actelion Pharmaceuticals
Garreth Duncan, Associate, D Young & Co
Professor Johanna Gibson, Intellectual Property Law, Queen Mary, University of London
Dr Afzal Mohammed, Lecturer in Pharmaceutics, Aston University
Professor Howard Stevens, Professor of Exploratory Drug Delivery, University of Strathclyde
John Bennett, Consultant, Harpum Consulting
Paul Fitzgerald, Director, Syntropy Medica
Driving the Industry Forward | www.futurepharmaus.com
Media Partners Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/plm

2. Conference Introduction
5th Pharmaceutical Product Lifecycle Management
24th - 25th January 2012, London, UK
Dear Colleague, Media Partners:
esearch shows that pharmaceutical companies spend approximately 19% of their total
R PharmiWeb.com is the leading industry-sponsored portal for
revenue on activities that fall under the heading of pharmaceutical lifecycle management the pharmaceutical sector. Supported by most of the leading
(PLM)1. With many blockbuster drugs drawing closer to the end of their patents, R&D new pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
chemical entity output declining and the current economic climate; the utilisation of product features, events listings and international jobs to industry professionals across Europe
lifecycle management is set to increase as pharmaceutical companies look for ways to and the US.
optimise revenue. For further information please email: corporate@pharmiweb.com
oin us at Visiongain’s 5th Pharmaceutical Product Lifecycle Management Conference
J BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
where you will obtain up-to-date practical knowledge on PLM encompassing an array of WORLD. It is based and located in Warsaw, Poland.
issues ranging from drug portfolio management, patent protection, regulation, submission Biotechnology World was founded in 2007 to provide the world’s biotech and pharma
and drug safety. In a period when PLM is increasing in popularity and importance, we aim information and market to make it universally accessible and useful for scientific
to provide applicable case studies as well as a focus on topical PLM strategies such as and business processes. Its first step to fulfilling that mission was building the
Reformulation and Brand Optimisation. BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in
o not miss this exciting opportunity to further your knowledge in an interactive learning
D different channels. BIOTECHNOLOGY EUROPE offers companies completed internet
environment while networking with diverse leaders in the PLM sector! public relations, publication and marketing solutions. One of the mains goals of
BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
Reasons to register today: global biotechnology, pharmaceutical and life science activities.
For further information please visit: www.biotechnology-europe.com
• Gain integrated insight of the entire process of PLM. Driving the Industry Forward | www.futurepharmaus.com
Future Pharmaceuticals has forged powerful relationships
• Learn about patent protection strategies. with key industry leaders to provide a platform for successful
• Investigate improving the selection of drug candidates brand recognition, and for senior decision-makers to have the means to procure and
plan implementation strategies based on the topics covered. Positioned to be an
• Analyse challenges involved with increasingly complex regulation and submissions authoritative resource within top pharma companies as well as small, specialty, and
• Evaluate drug safety throughout PLM biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
a highly targeted and responsive audience, bridging the gap between the industries’
• Optimise introduction, growth and maturity phases in PLM. top issues and the solutions top-tier vendors can provide.
• Focus on brand optimising as a PLM strategy For further information please visit: www.futurepharmaus.com
• Analyse the reformulation strategy of PLM InPharm is the online platform for exclusive pharmaceutical
news, comment, contracts, services, jobs and events and is
• Network with key leaders in the industry and take advantage of the learning platform home to InPharmjobs.com, Pharmafile and Pharmafocus.
I look forward to meeting you at the conference For further information please visit: www.In-Pharm.com
Best regards
Poster Presentation
At a busy conference it is hard to make sure everyone who shares your interests
knows what you are doing. Maximise your time at Visiongain’s 5th Annual
Pranita Nangia
Pharmaceutical Product Lifecycle Management meeting by sharing your results in a
Head of Conferences poster presentation. With a plethora of key decision makers, take advantage of this
senior networking opportunity.
Please send your 200 word abstract, in English, to: info@visiongainglobal.com for
approval. The deadline for submissions is Tuesday 17th January, 2012. Please include
contact details for the corresponding author(s).
Who should attend? Academic institutions will not be charged a fee if booked as full-price delegates.
Posters submitted by pharmaceutical and biotechnology firms will be charged a fee
Presidents, CEOs, Vice-Presidents, CSOs, Directors, Senior Business Developers,
of £199.
Researchers, Consultants and Professors in: Posters submitted by service providers / vendors are welcome and will be subject
• Product Lifecycle Management
to evaluation. Upon approval a fee of £500 will apply. Two delegates from your
organisation must be booked at full price to present a poster.
• Portfolio Management Please note that all posters will be displayed at the discretion of Visiongain Ltd and
• Research & development are subject to approval. Due to limited space, please register your interest early.
• Business Development
• Strategic Planning
• Licensing Sponsorship and exhibition opportunities
• Mergers & Acquisitions
This event offers a unique opportunity to meet and do business with some
of the key players in the pharmaceutical and biotech industries. If you have
• Process Chemistry a service or product to promote, you can do so at this event by:
• Formulation • Hosting a networking drinks reception
• Brand Management
• Taking an exhibition space at the conference
• Advertising in the delegate documentation pack
• Clinical Research • Providing branded bags, pens, gifts, etc.
• Patent Law If you would like more information on the range of sponsorship or
• Patent Counsel
exhibition possibilities for visiongain's 5th Annual Pharmaceutical Product
Lifecycle Management Conference, please contact us:
• Regulatory Affairs
Piyush Patel, +44 (0)20 7549 9961
• Drug Development
piyush.patel@visiongainglobal.com
Visiongain Pharmaceutical Product Lifecycle Management 2010-2020
1

3. Day 1
5th Pharmaceutical Product Lifecycle Management
Tuesday 24th January 2012
09:00 Registration and refreshments 12:40 Networking lunch
13.40 Drug safety in early development
09:30 Opening address from the Chair
 • mportance of understanding mechanism of a new drug
I
 • voiding drug recall
A
09:40 Innovative lifecycle and portfolio management  • xamples
E
strategies: create value for patients and pharma Dr Jonathan Deutsch
Safety Science Leader
 • ifecycle and portfolio management: how do they really create value?
L
Roche
 • hy science is an important driver of corporate strategy
W
 • ow can innovation in science and corporate strategy be linked?
H 14:20 Managing drug safety throughout product pipeline
 • fficient portfolio planning in a resource constrained environment
E and lifecycle
Dr Miri Halperin Wernli & Hans Hoogkamer • Integrating signal detection using totality of information
Global Business and Science Affairs • Implementing proactive safety risk management
Actelion Pharmaceuticals
• Understanding benefit-risk assessment and decision making
• est practices for developing transparency with safety
B
governance committees
10:20 Benefit-risk evaluation throughout a drug’s lifecycle:
a paradigm shift Dr Beverley Forsythe
Principal Safety Physician
 • mpact of the new pharma legislation: is the industry ready?
I
AstraZeneca
 • he technical challenges: an overview of methodologies
T
 • ighlights of the PROTECT project
H 15:00 Afternoon refreshments
 • ow proactively managing safety during a product’s life cycle could be a
H
competitive advantage
Dr Enrica Alteri 15:20 Sponsor Spotlight Session
Head Risk Management & Epidemiology
 T
ake this unique opportunity to be a part of the conference theme, network,
Merck Serono
share ideas and provide an overview of your product/services to the audience.
For more information please contact piyush.patel@visiongainglobal.com
11:00 Morning refreshments
16:00 Epidemiology for Maximizing Drug Safety
throughout the Product Life Cycle
11:20 Strategies for maximising IP protection • Why is epidemiology essential throughout a drug’s life cycle?
 • econdary patent strategies
S
• Electronic health databases and drug safety assessment
 • atent term extension strategies
P
• ase study: Pharmacoepidemiological Safety Assessment of an
C
 • ata exclusivity and other regulatory protection
D Anti-Obesity Drug
Garreth Duncan • The future of epidemiology in drug safety assessment
Associate
Dr Denise Oleske
D Young & Co
Director of Pharmacoepidemiology & Global Surveillance
Abbott
12:00 Presentation to be announced 16:40 Closing remarks from the Chair
Professor Johanna Gibson
Professor of Intellectual Property Law
Queen Mary, University of London
16:50 Networking drinks
Take your discussions further and build new
relationships in a relaxed and informal setting
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

4. Day 2
5th Pharmaceutical Product Lifecycle Management
Wednesday 25th January 2012
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair
13:40 Electronic submissions: regulatory perpspective
 • pdate on electronic submissions
U
09:40 Maximising introduction, growth, and maturity
phases to increase revenue  • se of eCTD
U
 • mportance of an early engagement with opinion leaders
I  • ase study
C
 • roduct uniqueness as trigger to revenue maximization throughout LCM
P Remco Munnik
RPN Regulatory
 • linical development plan to support LCM: importance of choices
C
Pharma Net
 • aking market access and reimbursement strategies into consideration
T
Dr Christiano Pereira Silva
14:20 Brand extension into Emerging Markets
Global Marketing
Boehringer Ingelheim  • merging Markets – strategic opportunity but a crowded market
E
 • ross functional organisational considerations
C
10:20 Portfolio Management: crucial areas
 • oordinated regulatory, commercial, development & manufacturing
C
 • he varying requirements for industry
T strategies
 • rug discovery and development phases
D  • ld products for new markets
O
 • arket access and commercial route of new drugs
M Bill Griffiths
DVP, Regulatory Affairs
 • ffective resource optimisation.
E
Abbott
John Bennett
Consultant
Harpum consulting 15:00 Afternoon refreshments
11:00 Morning refreshments
15:20 Reformulation: the drug delivery perspective
 • verview of reformulation
O
11:20 Brand optimisation
 • mproving therapeutic effect with a change in drug delivery
I
 • ist things first – portfolio optimisation
F
 • rug delivery options
D
 • nderstanding the patient flow
U
 • xamples of cases of reformulation
E
 • inking the strategy to the investment
L
Dr Afzal Mohammed
 • hy competitive analysis is so important
W
Lecturer in Pharmaceutics
 • ow to create good marketing objectives
H Aston University
 • ow to look at ROI
H
Ollie Mitchell 16:00 The contribution to PLM through academic
Head of Customer Excellence spin-out activities
Abbott
 • TC field
O
 • eneric pharmaceutical field
G
12:00 Brand leverage methodologies
 • P protected drug delivery systems
I
 • verview
O
Professor Howard Stevens
 • reparing the product
P
Professor of Exploratory Drug Delivery
 • efining the brand
D University of Strathclyde
 • esources
R
 • xamples
E 16:40 Chair’s closing remarks
Paul Fitzgerald
Director
Syntropy Medica 16:50 End of Conference

5. Registration Form
5th Pharmaceutical Product Lifecycle Management
24th - 25th January 2012, London, UK
Angel
Conf. code PP Pentonville Road
5th Pharmaceutical Product
Ci
Standard Prices
ty
Lifecycle Management
Ro
ad
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
24th - 25th January 2012
Old Street
Number of bookings: Total cost: Location: Visiongain Conference Centre Old Street
Address:
230 City Road
Promotional Literature Distribution
City Road
London
Distribution of your company’s promotional literature to all conference attendees EC1V 2TT
UK
Fee: £999 VAT: £199.80 Total: £1198.80
Details How to book
Forename: Surname: Email: piyush.patel@visiongain.com
Web: http://www.visiongain.com/plm
Job Title: Company: UK Office:
Tel: +44(0) 20 7549 9961
Fax: +44(0) 20 7549 9932
Main Switchboard Number:
Visiongain Ltd
BSG House
Address: 226-236 City Road
London
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UK
Country: Postcode: General information
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Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line).
Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376
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