1.
“Uniting industry leaders to analyse advanced commercial developments & to identify successful
management strategies of Biosimilars”
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
Key Speakers Include
Uwe Gudat,
Kenneth Walsh,
Paul Greenland,
Edward Ghabour,
Atakan Yesil,
Laurent Rebier,
Cecil Nick,
Carsten Brockmeyer,
Omar Ali,
Alex Kudrin,
Steinar Madsen,
Alan Sheppard,
Bernd Liedert,
Malcolm I Mitchell,
Merck,
Head of Safety, Biosimilars
Head Emerging Markets Pricing
Vice President – Biologics
Head of Marketing & Sales Operations (MSO) and Strategic Planning
Market Development & Reimbursement Manager
Sr.Clinical Program Leader Biosimilars
Senior Medical Fellow, Clinical Pharmacology
Director Business Development
Vice President, Biotechnology
CEO
Pharmacy Consultant
VP and Head of Global Development
Medical Director
Principal, Global Generics, Thought Leadership
GSK,
Hospira,
Novartis (Egypt),
Abbott (Turkey),
Merck Biosimilars,
PAREXEL,
Formycon AG,
QIPP Adviser Payer Network
ERG panel
Celltrion (Korea),
Norwegian Medicines Agency,
IMS Health,
Boehringer Ingelheim,
Eli Lilly,
& (Former member
NICE cost modeling )
Francis P. Crawley,
Karsten Roth,
Duncan Emerton,
Sandy Eisen,
Mikhail Samsonov,
Christopher Holloway,
Dominic Adair,
Maarten Meulenbelt,
Anna Harrington - Morozova,
Good Clinical Practice Alliance – Europe
(GCPA) European Academy
of Paediatrics (EAP),
& Member, Ethics Working Group,
Executive Director
Director Clinical Operations
Senior Director, Syndicated Insights & Analysis
Chief Medical Office
Chief Medical Officer
Group Director of Regulatory Affairs
Partner
Partner
Scientific & Regulatory Director
Cinfa Biotech,
FirstWord,
Frontline Pharma Consulting,
R-PHARM,
ERA Consulting,
Bristows,
Sidley Austin,
Regem Consulting,
Plus Many More..

2.
8th Biosimilars Congregation 2016
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
Dear Colleagues,
Biosimilars market is going to heat up considerably in the next
three years. Biosimilar versions of a number of major biologic
drugs used in the treatment of cancers and rheumatic diseases
are expected to complete their development and potentially
come on to the market. In order to ensure the sustainability of
public healthcare systems, in the context of ageing populations
and growing incidence of chronic diseases, it will be essential to
harness to potential of biosimilars to deliver savings, so that
greater numbers of patients can be treated with these medicines.
The development of the Biosimilars market is growing
exponentially with the industry forecast to be worth $25 billion
by 2020.
This conference will bring together top pharmaceutical,
biotechnology and regulatory representatives under one roof
that will address the key issues of the industry. Hence, this 4th
Biosimilars Congregation 2014 will look at the multiple facets of
biosimilars, ranging from the evolving regulatory landscape and
challenges in clinical development, to the legal and economic
aspects. This Biosimilars conference will focus on multiple
aspects of biosimilar product development to successfully
deliver safe, biosimilar products to the market place. By
attending this conference you will gain a comprehensive outlook
on the key issues surrounding biosimilars. This event will
provide an important platform for Biosimilars stakeholders to
discuss and share best practices in expediting Biosimilars
development.
It gives me great pleasure in welcoming all of you to the Virtue
Insight’s 8th Biosimilars Congregation 2016.
Regards,
Fen Castro
Head Productions
Virtue Insight
ORGANIZED BYORGANIZED BY
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and the world class leaders as speakers attract delegates to
attend from around the world. We aim for our attendees to be
equipped with knowledge of latest developments & enable
them to network with the industry key personnel.
Delegate Registration - sponsor.uk@virtueinsight.com
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3.
8th Biosimilars Congregation 2016
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
SPECIAL REASONS TO ATTEND
• Current market trends and future challenges for biosimilar
success
• Biosimilar development in emerging markets
• Payer Perspectives on Biosimilars - Current & future
landscape with key drivers for NHS payers
• Redesigning the biosimilar business model: What is the
optimum business model for biosimilars?
• Commercial challenges and opportunities - strategies to
develop Biosimilars
• Leading Biosimilars companies share their views and
strategies on successful market penetration and learn to
implement best practices through recent successful
strategies and business models – real time case studies
• How do payers see biosimilars and where the market is
going?
• Developing successful business models and dealing with
every ambiguity in biosimilar product development
• Advances in biosimilar clinical development and resulting
regulatory challenges and opportunities
• Non-Clinical Studies in biosimilars development
• Biosimilars development and impact on clinical practice
• Capturing the mAb biosimilar opportunity
• Research-based industry biosimilar strategies
• Gain in-depth knowledge on role of technology transfer - How
does this effect market access?
• Considerations for the analytical similarity assessments when
designing a biosimilar development program
• Determining the right investments & potential returns from
Biosimilars
• Understanding the current regulatory approval standards for
Biosimilars in Europe, US and ROI including for monoclonal
antibodies
• Be part of a major networking opportunity
AN EVENT TO VOW
Get more from the event, with a broader scope bringing the whole
communications value chain together. Enjoy and make the best
out of our dedicated networking drinks time, meet the leading
international vendors showcasing the products of tomorrow in the
co-located exhibition. Expand your knowledge of the latest
business models and strategies in the high-level conference.
Whether you are on the branded or generic side, you cannot afford
to miss this opportunity to benchmark your tactics and strategies
against the industry leaders who will be the first to traverse the
pathway. Devise an immediate action plan for your biosimilar
prosecution and litigation strategies in light of the barriers to
entry, research and development costs, and regulatory hurdles,
which are balanced against an enormous potential for increased
profit margins.
WHY EXHIBIT?
Make Sales
Debut new products
Profile your brand
Meet new business partners
Develop key relationships
Educate pharma and biotech companies
WHO WILL YOU MEET
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:
Biopharmaceuticals/ Biotherapeutics, Follow on Biologics/Follow on Proteins/Biosimilars, Biologics/Biotechnology/ Biogenerics
Legal Affairs, Intellectual Property, Health Economics, Pricing and Reimbursement, Clinical Immunology, Principal Scientist
Chief Scientific Officer, Process Control and Analytical Technologies, Analytical Characterisation, Regulatory Compliance
Pharmacovigilance, Drug Safety & Risk Management, Quality Affairs/ Quality Control, New Product Development, Process Science
Portfolio Management, Research & Development, Business Development, Business Operations, Scientific Affairs, Commercial Affairs
Marketing

4.
08:30 – Coffee and registration –
09:30 – Chairperson opening remarks
FirstWord
09:40 – Market access in the EU market and the way forward
IMS Health
10:20 – Just Biosimilar or even interchangeable ?
Boehringer Ingelheim
11:00 – Morning Coffee/Tea & Discussion
An opportunity to meet and to
network with your conference colleagues.
Senior Director, Syndicated Insights &
Analysis,
• Biosimilars – Market strategies and techniques to overcome the
hurdles
• Considerations for successful market of biosimilars
• Market access experiences with initial biosimilars
• Payer perception of antibody biosimilars
• Surveying the battlefield: how are the key players lining up?
• The way forward
Principal, Global Generics, Thought
Leadership,
• Impact of comparability and compatibility issues on anti-drug
antibody formation
• New formulations and immunogenicity
• Clinical design: Eligible population and study duration
• Dealing with improved immunogenicity profiles
• Methodical challenges for post-authorization studies
Sr.Clinical Program Leader Biosimilars,
DUNCAN EMERTON,
ALAN SHEPPARD,
BERND LIEDERT,
12:00 – “Education a key component in securing stakeholder
confidence and enabling market success”
Merck
12:40 - Networking luncheon
13:50 – Topic TBC
Formycon AG
Head of Safety, Biosimilars,
CEO,
UWE GUDAT,
CARSTEN BROCKMEYER,
CECIL NICK,
STEINAR MADSEN,
14:20 – Navigating the mAb biosimilar regulatory maze
PAREXEL
15:00 – Afternoon Tea/Coffee
15:20 – Biosimilar infliximab – lessons for future biosimilar
monoclonals
Norwegian Medicines
Agency
16:00 – Solution Provider Presentation
• Ensuring quality before embarking on clinical Development
• Ranking the importance of critical quality attributes
• Analysing the monoclonal antibody
• Guidelines: How to get regulatory approval of your mAb
• Developing Biosimilar Mabs for EU vs. US vs RoW
• The challenge of indication extrapolation for mAb Biosimilars
• Drivers and barriers for mAb uptake:aligning the players
Vice President, Biotechnology,
Medical Director,
For sponsorship opportunities please contact
info.uk@virtueinsight.com
DAY ONE 08th MARCH 2016–
11:20 – Keynote Panel Discussion: Market Challenges and
Opportunities
• Market opportunities for biosimilars – How about biosimilars
coming through the R&D pipeline?
• How to overcome some of the common developmental
stumbling blocks that are being faced within the biosimilar
sector?
• What characteristics of biosimilar partnerships are critical in
developing commercially successful biosimilars?
• What is expected from the pricing strategy for this biosimilar?
• How can payers and industry work together to ensure that
innovative and valuable treatments make it to the market?
• How do payers see biosimilars and where the market is going?
8th Biosimilars Congregation 2016
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
CHALLENGES & OPPORTUNITIES
MARKET OVERVIEW & ANALYSIS
Moderator:
FirstWord
Panellists:
GSK
Hospira
Eli Lilly
Celltrion (Korea)
Senior Director, Syndicated Insights &
Analysis,
Head Emerging Markets Pricing,
Vice President – Biologics,
Senior Medical Fellow, Clinical
Pharmacology,
VP and Head of Global Development,
DUNCAN EMERTON,
KENNETH WALSH,
PAUL GREENLAND,
MALCOLM I MITCHELL,
ALEX KUDRIN,
BUSINESS MODELS

5.
17:10 Chairperson’s closing remarks and end of conference–
08:30 – Coffee and registration –
09:30 – Chairperson opening remarks
FirstWord
09:40 – Understanding and reviewing current data regarding
the hurdles in commercialisation of biosimilars
10:20 – Forming strategic partnerships and alliances to access
new opportunities in emerging markets
Novartis (Egypt)
11:00 – Morning Coffee/Tea & Discussion
11:20 – Payer Perspectives on Biosimilars Current & future
landscape with key drivers for NHS payers
An opportunity to meet and to
network with your conference colleagues.
Senior Director, Syndicated Insights &
Analysis,
• Getting a correct balance between cutting costs and treating
more patients?
• Payer perceptions of biosimilars, and key areas of focus
• How influential are payers in the speed in which biosimilars
are taken up in healthcare systems?
• Enabling patentability of biosimilars to facilitate commercial
profitability
• What are the pricing and market access challenges associated
with biosimilars within these markets?
• Determining the right investments & potential returns from
Biosimilars
• Pricing of biosimilars in the future
• Various partnership models
• Partner’s selection criteria, and
• Key success factors in general
• Specific examples from Egypt’s experience
Head of Marketing & Sales Operations
(MSO) and Strategic Planning,
• NHS Fiscal Landscape & Funding streams for medicines
• National Guidance on Biosimilars from NICE and key issues
for translational to Regional Uptake
• Models for aggressive reimbursement from NHS
Commissioners, inter-relationship with NHS providers and
Clinical engagement models
• Phased Introduction of Biosimilars within RA, Dermatology &
GI/IBD within current NHS Commissioning Models, PbR
issues & innovation trade-offs
• Payer's perspectives on applicability of evidence and
licensing, EMEA & regulatory issues
• Payer's perspectives on the concept of "biosuperiors" and
perceptions on biosimilar marketed by 'Big Pharma'
–
DUNCAN EMERTON,
EDWARD GHABOUR,
8th Biosimilars Congregation 2016
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
17:20 - 18:10 - Networking Drinks - Take your
discussions further & build new
relationships in a relaxed & informal setting
DAY TWO 09th MARCH 2016–16:30 Panel Discussion: Developing successful business
models and dealing with every ambiguity in biosimilar
product development
Moderator:
FirstWord
Panellists:
Merck
Biosimilars
Frontline Pharma
Consulting
R-PHARM
–
• What is the optimum business model for biosimilars?
• Which are the emerging markets that represent the greatest
commercial opportunity for biosimilars and why?
• What are the funding opportunities for biosimilars within the
emerging markets?
• Global commercialisation strategies: How to strategically
build a global biosimilar portfolio
• Project management strategies for long-term biosimilar
development projects
Senior Director, Syndicated Insights &
Analysis,
Director Business Development,
Chief Medical Officer,
Chief Medical Officer,
DUNCAN EMERTON,
LAURENT REBIER,
SANDY EISEN,
MIKHAIL SAMSONOV,
COMMERCIALISATION & MARKET ACCESS

6.
15:50 – Biosimilar litigation is born
Bristows
17:00 Chairperson’s closing remarks and end of conference
FirstWord
17:10 – End of the 8th Biosimilars Congregation 2016
• A look at the recent Herceptin cases from the UK
• Comparing to the Neupogen litigation in the US
• Reasons why the litigation started
• Future predictions as to what’s next
Partner,
Senior Director, Syndicated Insights &
Analysis,
–
DOMINIC ADAIR,
DUNCAN EMERTON,
OMAR ALI,
KARSTEN ROTH,
CHRISTOPHER HOLLOWAY,
ATAKAN YESIL,
QIPP Adviser Payer Network
ERG panel
–
Pharmacy Consultant,
& (Former member NICE cost modeling )
12:00 – Biosimilars development and impact on clinical practice
12:40 Networking luncheon
13:50 – Clinical development strategies; a mid size pharma
perspective
Cinfa Biotech
14:30 – What constitutes a successful biosimilarity package for a
biosimilar monoclonal antibody
ERA Consulting
15:00 – Afternoon Tea/Coffee
15:20 – Health policy environment in Turkey and impact on
Biosimilar R&D and production
Abbott (Turkey)
• Will biosimilars increase access to biologic therapies in chronic
debilitating conditions?
• How are Biosimilars developed?
• What are the regulatory challenges and expectations currently
in the EU and what can we expect in the US?
• What does an ideal legal/regulatory framework looks like for a
successful Biosimilar model?
• What impacts will we see in prescribers, payers and patients
and what does this mean for drug developers?
• Analysis on the current situation in terms of biosimilar
infliximab
• Recent regulatory guideline updates, impact for preclinical and
clinical development programs
• Clinical trial models to test for bioequivalence
• Pk, PD and immunogenicity testing in clinical trials
Director Clinical Operations,
Group Director of Regulatory
Affairs,
• Macro Political & Economic Environment
• Health Policy Environment
• Incentives for Biotech products’ R&D and Production
• Pricing & Reimbursement of Biosimilars
• Interchangibility / Substitution of Biosimilars in Pharmacy
Level
Market Development & Reimbursement
Manager,
8th Biosimilars Congregation 2016
08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK
16:20 – Panel Discussion: The developing regulatory framework
in advanced and developing markets – for Today &
Tomorrow
Moderator:
FirstWord
Panellists:
Good Clinical
Practice Alliance – Europe (GCPA)
European Academy of Paediatrics (EAP)
Sidley Austin
Regem Consulting
ERA Consulting
• The latest in regulatory thinking - Update and current trends
for EU and US biosimilar approvals, new and future
guidelines. What has changed? – Get yourself updated.
• What is the best way for industry to present data to the
regulatory authorities?
• Regulatory changes necessary to maximize biosimilars
potential
• How similar is similar? What is likely not to be accepted by
the regulator?
• What types of additional risk minimisation measures may be
necessary?
• IP and regulatory rights
Senior Director, Syndicated Insights &
Analysis,
Executive Director,
& Member, Ethics Working
Group,
Partner,
Scientific & Regulatory
Director,
Group Director of Regulatory
Affairs,
DUNCAN EMERTON,
FRANCIS P. CRAWLEY,
MAARTEN MEULENBELT,
ANNA HARRINGTON – MOROZOVA,
CHRISTOPHER HOLLOWAY,
PRECLINICAL & CLINICAL DEVELOPMENT
REGULATION OVERVIEW & UPDATE

7.
8th Biosimilars Congregation 2016
FLOOR PLAN - Book your stalls now before they run out !!!
CONFERENCEHALL
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3 x 2 m
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3 x 2 m
S1
REGISTRATION
DESK
3 x 2 m

8.
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