1. 11th Annual
Biosimilars UK
Strategic planning to maximize benefits in a complex
regulatory and legal environment
29th – 31st October 2012, Visiongain Conference Centre, London UK
KEY SPEAKERS
• im Roach, SVP, Development and Chief Medical Officer, Momenta
J
• Peter Pitts, President, CMPI
• Cyrus Chowdhury, CEO & Managing Director, CB Partners
• Fredrik Sundberg, Strategic Market Development Director GE Healthcare
• Anjan Selz, CEO, Finox
• Judith MacDonald, EU Regulatory lead for Biosimilars, Pfizer
• Brian Healey, Associate Director, Global Product Development, PPD
• James Harris, CEO, Healthcare Economics LLC
GOLD SPONSOR SILVER SPONSOR
Media Partners Organised By
To Book Call: +44 (0) 20 7336 6100 www.visiongain.com/biosim

2. 11th Annual Biosimilars UK GOLD SPONSOR
Merck Millipore is the Life Science division of Merck KGaA of
Conference Introduction
Germany and offers a broad range of innovative, performance
products, services and business relationships that enable our
customers’ success in research, development and production of
biotech and pharmaceutical drug therapies. Merck Millipore serves as a strategic
partner to customers and helps advance the promise of life science. Headquartered
in Billerica, Massachusetts, the division has around 10,000 employees, operations
in 64 countries and pro forma 2009 revenues of $2.9 billion. Merck Millipore
Dear Colleague, operates as EMD Millipore in the U.S. and Canada.
With a patent cliff looming in the future, the market for biological therapeutics is looking to undergo radical For further information, please visit www.merckmillipore.com
changes. Both producers of branded drugs and upstarts looking to meet the demand for cost-effective healthcare
will be looking to find the best strategies and solutions to compete in this dynamic environment. It is more
critical than ever to make sure your company’s plan to tackle the issues of litigation, pricing and reimbursement, SILVER SPONSOR
regulatory approval and risk management meet the benchmarks set by industry leaders. United BioSource Corporation (UBC) is a global
biopharmaceutical and medical device services
organization of over 1200 staff members internationally
Following the huge success of our events in Boston and London, we plan to continue with an agenda that will that combines deep scientific knowledge with broad
bring together big pharma, regulatory bodies, CROs, CMOs and law firms to discuss and develop strategies for a execution expertise across the product lifecycle. Our focus is strategizing to
challenging market. identify, analyze and present real-world evidence to support the development and
commercialization of medical products for emerging and established life science
companies. We partner with our clients to meet their needs with experts to provide
Visiongain’s 11th Annual Biosimilars event will provide a unique networking event to boost your understanding strategic planning; scientific leadership; extensive experience in peri- and post-
of how to: approval research; clinical and strategic development services; data integrity and
technology services; investigator and patient programs; and medical education,
• Review the latest regulatory guidelines and understand how it will affect you and your competitors communication and market access programs.
• Assess the financial viability of manufacturing biosimilars and explore alternative pathways for approval For further information, please visit www.unitedbiosource.com
• Learn how to incorporate a patent portfolio strategy to prepare for the changing landscape
• Explore strategies to overcome legal issues to gain marketing approval MEDIA PARTNERS
• Analyse preclinical and clinical challenges in proving interchangeability and patient safety
PharmiWeb.com is the leading industry-sponsored
• Gain insight into the role the US and European market will have in developing biosimilars portal for the pharmaceutical sector. Supported by
• Investigate pricing and re-imbursement plans especially for meeting government healthcare demands most of the leading pharmaceutical corporations, PharmiWeb.com provides
dynamic real-time news, features, events listings and international jobs to
• Plan a pharmacovigilance framework to monitor patient safety industry professionals across Europe and the US.
• Utilise a great networking opportunity with key players in the market For further information please email: corporate@pharmiweb.com
BIOTECHNOLOGY EUROPE is owned by
I look forward to meeting you at the conference. BIOTECHNOLOGY WORLD. It is based and located in
Best regards, Warsaw, Poland. Biotechnology World was founded in 2007 to provide the
world’s biotech and pharma information and market to make it universally
accessible and useful for scientific and business processes. Its first step
to fulfilling that mission was building the BIOTECHNOLOGY EUROPE
platform that will allow a quick spread of information in different channels.
Shahidul Islam BIOTECHNOLOGY EUROPE offers companies completed internet public
relations, publication and marketing solutions. One of the mains goals of
Conference Producer BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in
Europe to global biotechnology, pharmaceutical and life science activities.
For further information please visit: www.biotechnology-europe.com
Future Pharmaceuticals has forged powerful relationships
with key industry leaders to provide a platform for
Who should attend this conference? successful brand recognition, and for senior decision-makers to have the
means to procure and plan implementation strategies based on the topics
Presidents, Chief Executives, Chief Scientific Officers, Chief Operating covered. Positioned to be an authoritative resource within top pharma
Officers, Senior Vice Presidents, Vice Presidents, Heads, Senior Directors, companies as well as small, specialty, and biotech, Future Pharmaceuticals
Directors, Clinicians, Principal Scientists, Principal Investigators, Managers, magazine is geared to create a deep penetration into a highly targeted and
Project/Team Leaders in: responsive audience, bridging the gap between the industries’ top issues and
• Biosimilars/Follow-on Biologics/ • Patent Law the solutions top-tier vendors can provide.
Follow-on Proteins For further information please visit: www.futurepharmaus.com
• Regulatory Compliance
• Biologics/Biopharmaceuticals/ • Health Economics InPharm is the online platform for exclusive
Biogenerics/Biotechnology pharmaceutical news, comment, contracts,
• Pricing and Reimbursement
• Clinical Immunology services, jobs and events and is home to InPharmjobs.com, Pharmafile and
• Marketing and Sales Pharmafocus.
• Drug Safety
• Branded and Generic For further information please visit: www.inpharm.com
• Patient Safety
Pharmaceutical Companies
• Regulatory Affairs
• Quality Assurance/Quality
• Contract Research Organisations/
Contract Manufacturing
Sponsorship and exhibition
Control
• Scientific Affairs
Organisations opportunities
• Drug Regulators This event offers a unique opportunity to meet and do business with some
• Pharmacovigilance
• Academics of the key players in the pharmaceutical and biotech industries. If you have a
• Research and Development
• Government service or product to promote, you can do so at this event by:
• Process Science & Manufacturing
• Contract management • Hosting a networking drinks reception
• Analytical Characterization • Taking an exhibition space at the conference
• Business Development • Process development
• Advertising in the delegate documentation pack
• New Product Development • Business development
• Providing branded bags, pens, gifts, etc.
• Commercial Affairs • Drug discovery & delivery If you would like more information on the range of sponsorship or exhibition
• Legal Affairs • Patent law possibilities for visiongain's 2nd Vaccine Research and Innovation Conference,
• Intellectual Property • Investment and venture capital please contact us:
Damian Gorman, +44 (0)20 7549 9934
damian.gorman@visiongainglobal.com

3. 11th Annual Biosimilars UK
Day 1 / Thursday 30th October 2012
09:00 Registration and refreshments 13:40 Managing the complexities in biosimilar
development
• Overcoming hurdles from inception to submission
09:30 Opening address from the Chair
• Managing the evolving regulatory landscape
• Assessing the IP challenges
09:40 Clinical challenges with development of biologics
• Considering sourcing and partnering issues
• Biologics are complex molecules and challenges with manufacturing
will be highlighted Anjan Selz
CEO
• Clinical trial design and complexity will be discussed Finoz AG
• Issues with extrapolation and interchangeability will discussed with
regard to biosimilar drug development
14:20 Immunogenicity issues with biosimilars
• The importance of immunogenicity issues
10:20 How to operationalize biosimilar product
development • Strategies and methods for detection of immunogenicity
• Addressing regulatory hurdles • Update
• Efficient study designs to reduce patient enrollment requirements
• Managing the specific clinical development environment for biosimilars 15:00 Afternoon Refreshments
• Developing practical strategies for conducting clinical trials with
biosimilars
15:20 The challenge of discovering and developing
Brian Healey biobetters – they had better be better!
Associate Director, Global Product Development
• The challenge of discovering and developing “biobetters” is to translate
PPD
modifications made in discovery to real clinical benefit
• Potential modifications engineered into a MAb or Fc fusion protein
11:00 Morning refreshments preclinically that may have potential impact on efficacy, safety,
convenience, manufacturing, supply chain, cost, and/or patient
compliance include modifications of Fc immune function activity, half-
11:20 Biosimilars in the Age of Post-Patent Medicine life, potency, formulation, stability, and route of administration
• How will the thorny issues of safety, efficacy and cost (and in that
order) impact the role of biosimilars in 21st century healthcare
16:00 The Momenta Approach to Developing Biosimilars
• What are the top 10 issues for regulators? and Potentially Interchangeable Biologics
Peter Pitts Jim Roach
President SVP, Development and Chief Medical Officer
CMPI Momenta
12:00 Using Innovative Protein Analytics to Characterize 16:40 Closing remarks from the Chair
Biosimilars
Fredrik Sundberg
16:50 Networking Drinks
Strategic Market Development Director
GE Healthcare T
ake your discussions further and build new
relationships in a relaxed and informal setting
12:40 Networking lunch
Biosimilars and Follow-On Biologics: World Market 2012-2022
REPORT
What are the commercial prospects for biosimilar drugs? Visiongain’s report shows you potential revenues and trends
to 2022, discussing data, opportunities and prospects. This study investigates biosimilars (follow-on biologics). It lets
you assess forecasted sales at world market, therapeutic submarket and national level to 2022. The new report gives
you coverage of regulatory affairs too - FDA, EMA and others - assessing trends and outlooks for biosimilar drugs.
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers © Copyright visiongain Ltd, 2012

4. 11th Annual Biosimilars UK
Day 2 / Friday 31st October 2012
09:00 Registration and refreshments 12:40 Networking Lunch
09:30 Opening address from the chair 13:40 Biosimilar IP issues in Europe
• Freedom to operate issues and confronting patents with broad
09:40 Biosimilar Regulatory Policy: Current Issues and protection-pitfalls and tips
thinking
• Supplementary Protection Certificates and biosimilars – unresolved
Judith MacDonald issues
EU Regulatory lead for Biosimilars
Pfizer
14:20 Licensing of biosimilars
10:20 Biosimilars - beyond the injection • Experience to date in the EU
• The existing “Biologic Experience”
• Regulatory requirements and guidance
• What Biosimilar manufacturers will likely need to do in order to provide
• Scientific advice
a optimal patient experience
• Future biosimilar products
11:00 Morning refreshments
15:00 Afternoon refreshments
11:20 Biosimilars: delivering on global commercial
potential in the emerging markets
15:20 New developments in the regulation of biosimilars
• Which biologic therapies carry the greatest competitive pressures and
in the US and EU
why?
• How are some of these competitive pressures relieved by environmental • Basic framework
opportunities unique to the emerging markets? • Regulatory standards
• Which emerging markets represent the greatest commercial opportunity
• Latest developments in the US, EU and ROW
for biosimilars and why?
• What are the funding opportunities for biosimilars within the emerging
markets? 16:00 Uptake of biosimilars in clinical practice
• What are the pricing and market access challenges associated with
• What do doctors know about biosimilars?
biosimilars within these markets?
Cyrus Chowdhury • What are the obstacles to increased use?
CEO Managing Director • What do we know about prices on biosimilars?
CB Partners
• Who shall decide which drug to use?
12:00 Opportunities and challenges for biosimilars in the
global market 16:40 Chair’s closing remarks
• Assessing the promise and potential for biosimilars
• Latest progress in biosimilars development
16:50 End of Conference
• Regulatory update on bioequivalence, interchangeability and
substitution for biosimilars
• Provider perspectives and acceptance of biosimilars
• Payer perspectives and formulary acceptance
• Examining the viability of biosimilars ROI considerations
James Harris
CEO
Healthcare Economics LLC
Pharma Business Daily
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Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers © Copyright visiongain Ltd, 2012

5. 11th Annual Biosimilars UK
Registration Form
For multiple bookings
Photocopy this form Conf. code VG 11th Annual
Biosimilars UK
Standard Prices 29th – 31st October 2012
Conference and workshop Fee: £1699
Location: Visiongain Conference Centre
Conference only Fee: £1299
Address:
Workshop only Fee: £599 230 City Road
London
EC1V 2TT
UK
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Fax: +44 (0) 20 7549 9932
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