1. KEY SPEAKERS:WHY ATTEND THIS EVENT:
• Discover guidelines issued by regulatory bodies
and how they impact your business model
• Understand market access pathways and see
case studies on successful products
• Hear development processes from preclinical
focussed research from big pharma companies
• Learn from expert legal opinions on intellectual
property and patent protection programmes
• Evaluate global research co-operation
producing blockbuster Biosimilars
• Develop clinical plan for Biosimilar and
Biobetters drug design for your clinical trial -
When is the right time to proceed?
SMi presents their fourth annual...
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Thursday 3rd October 2013, Marriott Regents Park Hotel London, UK
Linking Performance to Strategy in the Pharmaceutical
Market: Developing your Marketing Plan
Workshop Leader: Edward Ghabour, Head of Strategic Planning, Novartis
8.30am - 12.30pm
1ST - 2ND
OCTOBER
2013Marriott Regents Park Hotel London
Biosimilars &Biobetters
• Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
• Edward Ghabour, Head of Strategic Planning, Novartis
• Josh Adelson, Director, Commercial Development, Business
Development Biosimilars, Pfizer
• Haiyan Jing, Senior Director, Biogen Idec
• Malcolm Mitchell, Senior Medical Fellow, Eli Lilly & Co
• Thomas Klein, IP Specialist, Roche
• Jennifer Campbell, Director Worldwide Biosimilars Programme,
Merck
• Steinar Madsen, Medical Director, Norwegian Medicines Agency
• Meenu Wadhwa, Section Leader, Cytokines & Growth factor
Section, Health Protection Agency (NIBSC)
• Gary Walsh, Professor Industrial Biochemistry, University of
Limerick
www.biosimilars-biobetters.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Biosimilars, the
commercial reality
Workshop Leader: Peter Whittner, Founder, Findacure
1.30pm - 5.00pm
BO
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BY
31STM
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SAVE
£300
BO
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BY
28TH
JUN
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SAVE
£100

2. SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding
packages, uniquely tailored to complement your
company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your
client base within the context of an independent discussion
specific to your industry. Should you wish to join the
increasing number of companies benefiting from
sponsoring our conferences please call:
Alia Malick on +44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
Want to know how you can get involved? Interested
in promoting your services to this market?
Contact Margaret Mugema, SMi Marketing
on +44 (0) 207 827 6072,
or email: mmugema@smi-online.co.uk
Register online at: www.biosimilars-biobetters.co.uk • Alternatively fa
Biosimilars & Biobetters
Day One | Tuesday 1st October 2013 www.biosimilars-
• Analytics
• Business Development
• Business Strategy
• Corporate Development
Strategy
• Commercial Affairs
• Intellectual Property
• Marketing & Sales
• Medical Affairs
• New Product Development
• Legal Affairs
• CMC
• Preclinical and Clinical
Development
• Product Development
• Regulatory Affairs
• Pricing and Reimbursement
• Research and Development
• Biologic Production
• Quality Assurance
• Scientific Affairs
• Strategic Planning
• Strategic Sourcing
WHO SHOULD ATTEND THIS CONFERENCE?
You should attend this event if you are a Director, Area Head, CSO, or VP from within the
Pharmaceutical or Healthcare industry with responsibilities in the following areas:
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Recent developments and introductions to Biosimilars & Biobetters
9.10 A clinical pharmacologist's view of Biosimilars
•PK and/or PD
•Population to Study
•Design of Study
•3-way comparison-a need too far
Malcolm Mitchell, Director, BioPharmaceuticals, Eli Lilly & Co
9.50 Biosimilar guidelines in the USA: Why industry has not yet
filed a 351k
•Summary of the USA Law
•FDA’s non-legal barriers for filing a 351k
•Deficiencies of the FDA Published Guidelines
•FDA’s Scientific Advice
•Best strategies to avoid the pathway and still be reimbursed by
payers with physician and patients’ acceptance
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
10.30 Morning Coffee
11.00 Potential partnering in Biosimilar development
•Where has partnering been successful in biosimilar
development
•Where Pfizer has succeeded and failed
•Case studies of future pipelines
Josh Adelson, Director, Commercial Development, Business
Development Biosimilars, Pfizer
Market access and biosimilar use
11.40 Market Access issues for Biosimilars
•Pricing and Reimbursement
•Health Technology Assessment
•Guidelines Listing
•Prescriber Preference
Brian Lovatt, Managing Director & Chief Executive, Vision
Healthcare Consultancy Ltd
12.20 Networking Lunch
1.20 Linking performance to strategy in the pharmaceutical
emerging markets
•Measuring tangible or intangible assets
•Limitations of relying only on financial measures
•Characteristics of a good PMS
•The emergence of the BSC
•Linking multiple scorecard measures to a single strategy
•Experience with BSC implementation
•Key success factors for the BSC implementation
Edward Ghabour, Head of Strategic Planning, Business
Development and Licensing, Novartis
2.00 How to encourage physicians and patients to use biosimilars
•Physicians and patients views on biosimilars
•Which information is needed?
•Who will decide?
Steinar Madsen, Medical Director, Norwegian Medicines Agency
Biosimilar litigation
2.40 Biotech patenting and litigation
•Patenting strategies for biotech molecules
•Litigation strategies, in particular in emerging markets
•Case study
Thomas Klein, European and Swiss Patent Attorney, Roche
3.20 Afternoon Tea
3.40 Avoiding injunctions in biologics patent litigation
•Compulsory licences?
•Ethical or public health imperatives?
•Competition law?
•Strategic litigation
Christopher Stothers, Counsel, Arnold and Porter
4.20 UK patent litigation on biologics
•An overview of recent cases, including MedImmune v Novartis
and Lilly v HGS
•The litigation pitfalls of broad claim drafting
•Issues surrounding SPCs
•Predictions for litigation involving biosimilars
Dominic Adair, Associate, Bristows
5.00 Chairman's Closing Remarks and Close of Day One

3. ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Day Two | Wednesday 2nd October 2013-biobetters.co.uk
Supported by
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Clinical updates on biosimilar research: Case studies
9.10 Preclinical and clinical development of recombinant FIX Fc
and FVIII Fc fusion proteins for severe hemophilia
•Processes if biologics licence applications
•Ideas moving forwards
•Case studies on recombinant factor VIII / IX Fc
Haiyan Jing, Senior Director, Preclinical and Clinical Research,
Biogen Idec
9.50 Biosimilars: an analysis of EU product approvals
•Sourced primarily from regulatory documentation, this work
analyzes in detail the regulatory data that underpinned the
approval of authorized biosimilars in the EU
•The data is contextualized in terms of biosimilar guidelines
•The duration of regulatory consideration of biosimilar
applications to those of additional biopharmaceutical
applications received within the same timeframe is compared.
•Likely further developments in EU biosimilar regulatory policy is
considered
Gary Walsh, Professor Industrial Biochemistry, University of
Limerick
10.30 Morning Coffee
11.00 Risk Management of a First-in-Class oncological product
•Generation and continuous adaptation of the RMP of a
complex biological product
•Lessons learned during pre-submission meeting with EMA,
validation phase and phase around d120/d180
•Link of RMP to other pivotal documents such as SmPC,
EPAR, PSUR
•Impact of new legislation, Directive 2010/84/EU on RMP
•What biosimilars can learn from this case
Alexander Kainz, Vice President, Head Regulatory Affairs &
Quality, Fresenius Biotech GmbH
11.40 Speeding map to clinic: A predeterminded map process
template for your biosililar
•Predefined process parameters in a map template
•Minimising process design
•Ensuring process robustness
•Case study: Down stream process development
Jennifer Campbell, Director World Wide Biosimilars Program,
Merck
12.20 Networking Lunch
Regulatory perspectives
1.40 Registering biosimilars “globally”: a regulatory perspective
•Biosimilar development and registration rules in different zones
(EU/US/WHO/INDIA): main features and main differences
•Focus on the Reference Medicinal Product: points to consider
(considering the new EMA overarching guideline)
•Other (nonclinical and clinical) considerations
David Uguen, Project Director, Drugs & Biologics, Voisin
Consulting
2.20 Assessing the needs of biosimilars and biobetters from a
regulatory perspective
•The differences in regulatory pathways for biosimilars and
biobetters
•How similar is similar? Do minor product modifications negate
the biosimilar paradigm?
•Can reduced development programs support the approval of
biobetters?
•What options exist for biobetters, and what are the likely
regulatory implications?
Alex Bloom, Consultant, PAREXEL
3.00 Afternoon Tea
3.30 Key factors in the generating of anti-drug antibody responses
including the importance of T cell help
•Data showing the benefits of assessing drug immunogenicity by
measuring induction of CD4+ T cell responses
•Comparison of innovator and biosimilar products for the
capacity to induce T cell responses in vitro
•CMC related factors that can modulate T cell activation
Matthew Baker, CEO & CSO, Antitope
4.10 EU Legal developments and strategies for Biosimilars
•EU legislation framework and case law
•Key questions and strategic issues
•Looking into the future: upcoming developments, revision of
the guidelines and next steps
Marc Martens, Senior Associate, Bird & Bird
4.50 Chairman's Closing Remarks and Close of Day Two

4. HALF-DAY POST-CONFERENCE WORKSHOP
Thursday 3rd October 2013
8.30am - 12.30pm
Marriott Regents Park Hotel London, UK
Linking performance to strategy in the
pharmaceutical market:
Developing your marketing plan
Workshop Leader:
Edward Ghabour, Head of Strategic Planning,
Novartis
Overview of workshop:
In this workshop, you’ll be provided with a case
study about company’s products in specific
environment/market. Within such context, you’ll
work in teams (and then to present as a team)
on 6 main pillars:
• SWOT analysis
• Objective setting
• Segmentation, targeting and positioning
strategy
• Customer value proposition
• Promotion mix elements
• Annual plan of action
Why you should attend:
Engagement in such workshop represents a
significant opportunity to share your experience,
gain insights from other experienced colleagues,
and enrich your skills in the area of
strategic/marketing planning. Once back at your
company, we believe a lot of experience would
be gained to help enhancing the development of
strategic/marketing plans for your products.
Programme
8.30 Registration & Coffee
9.00 Welcome & Introductions
9.10 Lecture: Linking performance to strategy
in emerging markets
10.30 Morning Refreshments
11.00 Workshop: Case study
11.40 Group presentation & Discussion
12.30 Close of Workshop
About the workshop host
Edward has more
than 25 years’
experience in sales,
marketing, business development and strategic
planning positions at Novartis.
He has both academic background and
practical interventions. He holds DBA degree
(Doctorate of Business Administration) from SMC
University, Switzerland. His degree is accredited in
Europe by ECBE [European Council of Business
Education] & in the US by ACBSP [Accreditation
Council for Business Schools and Programs]. His
dissertation was on “Linking Performance
Management and Measurement to Strategy in a
Pharmaceutical Company, using the Balanced
Scorecard framework”
Being a head of strategic planning, he used to do
portfolio analysis and to prepare strategic plans
for Novartis. He also used to lead and work closely
with cross-functional teams to implement the
agreed plans.
Being a head of BD&L, he prepares business cases
to increase both top line and bottom line for
Novartis and follow the implementation of the
approved deals. He is also managing the mature
products and outsourcing business at Novartis.

5. HALF-DAY POST-CONFERENCE WORKSHOP
Thursday 3rd October 2013
1.30pm - 5.00pm
Marriott Regents Park Hotel London, UK
Biosimilars, the
commercial reality
Workshop Leader:
Peter Whittner, Founder, Findacure
Overview of workshop:
The higher regulatory barriers in Europe and
issues of interchangeability have resulted in a
limited number of product launches so far and
slow progress for those that are already in the
market. Across the Atlantic, the situation is
changing with the long awaited legislation now
in place to simplify biosimilars registration. By
contrast, in less regulated markets lower
regulatory barriers have allowed a biosimilars
market to take off, but there are questions about
whether these “biocopies” are indeed truly
biosimilar.
The workshop will examine all these issues and
take a look into what the future may bring.
• A good overview of the Biosimilars picture
across the world
• Insight into the varying regulatory approaches
prevailing in different regions
• An understanding of the commercial situation
as it is now and likely to develop in the future
• Enough background to determine whether
entering the biosimilars market is an
appropriate strategy for their company
Programme
1.30 Welcome & Introductions
1.40 Overview - Biosimilars? Biogenerics?
Follow-on Biologicals?
2.10 Biosimilars - the commercial reality
3.10 Afternoon Tea
4.45 The Future
5.00 Close of Workshop
About the workshop host
Peter Wittner, B.Sc., is an independent consultant
specialising in the commercial aspects of generics with
more than 30 years’ pharmaceutical experience. In
one of his industry roles, he joined the Indian generic
leader Ranbaxy as Managing Director to help set up its
UK business before returning to consultancy work
www.interpharm-consultancy.co.uk.

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Workshop A □ Workshop B □
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BIOSIMILARS & BIOBETTERS
Conference: Tuesday 1st and Wednesday 2nd October 2013, Marriott Regents Park Hotel, London, UK Workshop: Thursday 3rd October 2013, London
4 WAYS TO REGISTER
www.biosimilars-biobetters.co.uk