Dear Ladies & Gentlemen, Hope all is well, Glad to share details with you of our upcoming conference “6th Biosimilars 2015” taking place on 10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK. Please find attached the updated agenda for the same with this email. In case you and your colleagues would like to book as delegate there is a discounted price now :- Introductory Offer (3 delegate places for the price of 2):- A huge saving of £ 600 Super Early Discount (Till 26th December 2014):- Conference Delegate Pass (£ 600 + VAT per delegate) We can also offer some other sponsorship packages which include speaking opportunities/ branding etc. For some sample packages on the same please email me and I can call you to discuss the options further. For any further assistance please feel free to contact me anytime. I look forward to a positive response from your end. Best Regards, Deepak Raj Delegate and Sponsorship Sales Virtue Insight Gsm - + 91 9171350244;

1. KEY SPEAKERS:-
Chetak Buaria, Director - Alliance Management (Biosimilars),
Ira Jacobs, Oncology Portfolio Global Medical Lead-Biosimilars,
Malcolm I Mitchell, Director - BioPharmaceuticals,
Patrick Liu, Senior Director and Global Head of Bioassays,
Sumit Munjal, Medical Director,
Juan Vergez, Global Brand Manager & Global Biosimilars Business Intelligence,
Cecil Nick, Vice President, Biotechnology,
Carsten Brockmeyer, Managing Director,
Paul Greenland, Vice President – Biologics,
Steinar Madsen, Medical Director,
Duncan Emerton, Senior Director, Syndicated Insights & Analysis,
Martin Bluggel, CEO,
Peter Wittner, Senior Consultant, Former Managing Director R
Kristie C. Kuhl, Senior Vice President,
Michael Tovey, Director of Research, Laboratory of Biotechnology and Applied Pharmacology,
Sandy Eisen, Chief Medical Officer,
Lincoln Tsang, Partner,
Gopalan Narayanan, Biologics and Advanced Therapies Expert,
Anna Harrington-Morozova, Scientific & Regulatory Director,
Ash Patel, Director of Regulatory Affairs (Biologics),
Marie Manley, Partner & Head of the Regulatory Practice,
Liz Fuller, Partner,
Merck Serono
Pfizer (USA)
Eli Lilly
Teva Pharmaceutical
Takeda Pharmaceuticals
Merck Serono
Parexel
Brockmeyer Biopharma
Hospira
Norwegian Medicines Agency
FirstWord
Protagen Protein Services
Interpharm Consultancy ( anbaxy UK)
Makovsky & Co (USA)
INSERM
Frontline Pharma Consulting
Arnold & Porter LLP
NDA
Regem Consulting
ERA Consulting
Bristows
Bird & Bird
Plus Many More.....
Conference Hashtag - #VI_Pharma

2. ORGANIZED BY
6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK
SUPPORTED BY
ASSOCIATE SPONSORBRONZE SPONSOR

3. CONFERENCE INTRODUCTION:-
Studies after research predicts the world market for biosimilars and related follow-on biologics will reach $9.2bn in 2018, and multiply in size to
2024. By 2020, some $55 Billion worth of biologic patents are due to expire. Key factors driving market growth include patent expiries of key
biological drugs, cost containment measures from governments, aging population, and supporting legislations. The recent establishment of
regulatory guidelines for biosimilars in the US is expected to add further momentum to the growth of the global biosimilars market. Increasing
pressure from governments and insurers for greater biologic competition, there exists an incredible opportunity for biosimilar producers to
capitalise on what is set to become the fastest growing sector of the pharmaceutical industry. Advice from experts was clear; biosimilar
companies need to focus on products that see IP [intellectual property] begin to expire beyond 2020, the so-called third wave of biosimilar
opportunity
It is also predicted that the world biosimilar monoclonal antibody (mAbs) market will generate $3,229m in 2018. That drug industry earned
$61.88m in 2012
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 6th Biosimilars Congregation 2015
WHY SHOULD YOU ATTEND:-
dedicated networking drinks time, meet the leading international vendors
Expand your knowledge
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our
showcasing the products of tomorrow in the co-located
exhibition. 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.
KEY THEMES DISCUSSED AT THIS SUMMIT:-
• Gain access to the latest developments and expert views on future trends across a range of topics, from competitive strategy, clinical
development, IP, policy and pricing
• How to approach the rapidly emerging and developing biosimilar market?
• Next generation monoclonal antibody development and clinical challenges with biosimilar drug development
• Understand the key issues, such as country-level policy changes in relation to biosimilar naming, interchangeability and automatic
substitution
• Biosimilars Infliximab – Experiences and Expectations
• Upcoming EU Clinical Trials regulation (2016); where are we heading in terms of biosimilars development?
• Scientific and clinical considerations for biologics and biosimilars
• Biosimilars development and impact on clinical practice
• Research-based industry biosimilar strategies
• Technical case studies for analytical and clinical comparability strategies
• Role of technology transfer - How does this effect market access?
• 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
• Biosimilarity concept: a paradigm shift for many key stakeholders
• Manufacturing changes for the upcoming biosimilars era
• Determining the right investments & potential returns from Biosimilars
• Biobetters & biosimilars
• Safeness – Patients and their data
• Regulations - EU, US, ROW and WHO guidelines
• Be part of a major networking opportunity
WHO SHOULD ATTEND:-
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
6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK

4. An opportunity to meet and to
network with your conference colleagues.
• Understand the key issues, such as country-level policy changes in
relation to biosimilar naming, interchangeability and automatic
substitution
• Current regulatory guidelines
• Open issues for FDA
• FDA guidelines
• Driving on global commercial potential through the emerging
markets
• Biosimilars: Less than a Decade and where are we heading with it?
08:30 – Coffee and registration –
09:30 – Chairperson opening remarks
09:40 – Topic TBC
10:20 – Biosimilars in USA
11:00 – Morning Coffee/Tea & Discussion
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis,
Carsten Brockmeyer, Managing Director,
Kristie C. Kuhl, Senior Vice President,
FirstWord
Brockmeyer
Biopharma
Makovsky & Co (USA)
(https://www.linkedin.com/in/duncanemerton)
(https://www.linkedin.com/pub/carsten-brockmeyer/1a/881/182/en)
Morning Keynote Address 1:
Morning Keynote Address 2:
12:00 – Reaching and demonstrating Biosimilarity by state of
the art analytics
13:50 –
14:30 – Capturing the mAb biosimilar opportunity
15:10 – Afternoon Tea/Coffee
• Regulatory demand for demonstrating biosimilarity
• Monitoring reference molecule
• Matching critical quality attributes during development
• Comparability exercise
• Analysing the Monoclonal Antibody Guidelines: How to get
regulatory approval of your mAb
• Historic uptake of generics and biosimilars -key learnings
• Drivers and bariers form mAb uptake: aligning the players
• mAb opportunity in autoimmune disease: stakeholders and entry
strategy
• Ensuring Quality CMC in place before embarking on mab production
Approval of first biosimilar insulin
• What was done
• How the rules changed
• Clinical pharmacology aspects
• The result
Martin Bluggel, CEO,
Malcolm I Mitchell, Director - BioPharmaceuticals,
Protagen Protein Services
Eli Lilly
(https://www.linkedin.com/pub/martin-bl%C3%BCggel/2/891/89a)
6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK
12:40 - Networking - Take your discussions
further & build new relationships in a relaxed
& informal setting...
luncheon
DAY ONE - 10TH MARCH 2015
MARKET OVERVIEW & ANALYSIS
CHALLENGES & OPPORTUNITIES
11:20 – Keynote Panel Discussion: Challenges and
Opportunities
Moderator:
Panellists:
• Global development of biosimilars – vision or reality?
• Current commercial trends in biosimilars
• Opportunities to drive your longer term biosimilars strategy –
Possible strategies to enter in emerging markets
• Developing commercially successful biosimilars?
• Will generic companies continue to dominate, or can Big Pharma
gain control with its huge marketing muscle?
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis,
Sandy Eisen, Chief Medical Officer,
Malcolm I Mitchell, Director - BioPharmaceuticals,
Chetak Buaria, Director - Alliance Management (Biosimilars),
FirstWord
Frontline Pharma
Consulting
Eli Lilly
Merck Serono
(https://www.linkedin.com/in/duncanemerton)
(https://www.linkedin.com/in/sandyeisen)
BUSINESS MODELS
15:30 – Afternoon Keynote Panel Discussion: Biosimilars:
Global commercial potential in the upcoming markets
Moderator:
• Evaluating the barriers to market entry and uptake for biosimilars
Cost of development and technology demands
• 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?
• Customer perceptions on biosimilars in today’s market
• Are payors pushing for more utilization of biosimilars?
• What are the pricing and market access challenges associated with
biosimilars within these markets?
• Understand what needs to be done, according to a consensus of
experts, to drive biosimilar use, particularly in Europe
• Key trends in biosimilars and biobetters
Panellists:
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis,
Juan Vergez, Global Brand Manager & Global Biosimilars
Business Intelligence,
Paul Greenland, Vice President – Biologics,
FirstWord
Merck Serono
Hospira
(https://www.linkedin.com/in/duncanemerton)
(https://www.linkedin.com/pub/juan-vergez/15/900/916/en)
(https://www.linkedin.com/pub/paul-greenland/3/26a/198)

5. 16:10 – Manufacturing changes for the upcoming biosimilars
era
16:50 - Chairperson’s closing remarks and end of conference
• Matching critical quality attributes during development
• Will experience in marketing, manufacturing skills and industry
knowledge give them a competitive advantage over those already
in the market?
• Reflecting the limitations of conventional biological assays that may
be inadequate to detect differences resulting from a change in the
manufacturing process
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis, FirstWord (https://www.linkedin.com/in/duncanemerton)
08:30 – Coffee and registration –
09:30 –
09:40 – – Biosimilars: Providing on
global commercial potential in the upcoming markets
12:00 – Afternoon Keynote Address – Scientific and clinical
considerations for biologics and biosimilars
An opportunity to meet and to
network with your conference colleagues.
Chairperson opening remarks
• Find out on which of the biologic therapies that carry the greatest
competitive pressures and why?
• How are some of these competitive pressures relieved by
environmental opportunities unique to the emerging markets?
• 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?
• What are the pricing and market access challenges associated with
biosimilars within these markets?
• Regulatory & clinical development considerations for biosimilars
• Striking a balance between requiring larger and more sophisticated
trials and facilitating market entry for biogenerics
• Managing to ensure patient safety
• Educating patients
• Extrapolating data obtained in clinical trials for a reference product
to support biosimilar applications
10:20 – – Immunogenicity matters
of biosimilars: Industry perspective
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis,
Ira Jacobs, Oncology Portfolio Global Medical Lead-Biosimilars,
Patrick Liu, Senior Director and Global Head of Bioassays,
Cecil Nick, Vice President, Biotechnology,
FirstWord
Pfizer (USA)
Teva
Pharmaceutical
Parexel
(https://www.linkedin.com/in/duncanemerton)
(https://www.linkedin.com/pub/cecil-nick/10/984/573)
Morning Keynote Address 1
Morning Keynote Address 2
11:00 – Morning Coffee/Tea & Discussion
11:20 – Achieving regulatory approval of monoclonal
biosimilars in the EU and US
• What challenges do monoclonal biosimilars present?
• Are there differences in CHMP and FDA approaches?
• Can extensive physico-chemical and biological testing reduce clinical
data requirements?
• What is the value of clinical data?
• How can extrapolation across indications be justified?
• What are the pitfalls?
17:00 - 18:00 Networking Drinks - Take your discussions
further & build new relationships in a relaxed
& informal setting...
Sumit Munjal, Medical Director,
Peter Wittner, Senior Consultant,
Former Managing Director
Michael Tovey, Director of Research, Laboratory of
Biotechnology and Applied Pharmacology,
Takeda Pharmaceuticals
Interpharm Consultancy
( Ranbaxy UK)
INSERM
(https://www.linkedin.com/pub/sumit-munjal/17/400/410)
(https://www.linkedin.com/in/interpharmconsultancy)
6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK
BIOMANUFACTURING & PRODUCTION
DAY TWO - 11TH MARCH 2015
COMMERCIALISATION & MARKET ACCESS
CLINICAL STUDIES FOR BIOSIMILARS
12:40 - Networking - Take your discussions
further & build new relationships in a relaxed
& informal setting...
luncheon

6. 6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK
13.50 – Biosimilar infliximab – Norwegian experiences and
European expectations
14:30 – Updates on Russia and comparison with EU on what to
be learnt
15:10 – Afternoon Tea/Coffee
15:30 – Biosimilars perpective: Maximisation of IP regulatory
rights
• Market uptake and prices
• What are the attitudes of physicians?
• Switching study – what is the status?
• Lessons for future biosimilar drugs
• Update on progression of Biosimilars in Russia
• Differences in clinical trial designs accepted for registration of
biosimilar in EU and Russia
• Requirements, opportunities and challenges of technology transfer
for localisation of manufacturing in Russia
• Interplay between various IP regulatory rights in the EU
• How to maximise IP regulatory rights & relevant jurisprudence
o RDP
o Market exclusivity
o SPC
o Paediatric rewards
• Interaction of regulatory & competition – hints & tips
Steinar Madsen, Medical Director,
Anna Harrington-Morozova, Scientific & Regulatory Director,
Marie Manley, Partner & Head of the Regulatory Practice,
Norwegian Medicines Agency
Regem Consulting
Bristows
(https://www.linkedin.com/pub/steinar-madsen/a1/448/6aa)
.linkedin.com/pub/anna-harrington-morozova/12/451/546)
(https://www.linkedin.com/pub/marie-manley/12/41/834)
(https://www
16:50 - Chairperson’s closing remarks and end of conference
17:00 – End of the 6th Biosimilars Congregation 2015
Duncan Emerton, Senior Director, Syndicated Insights &
Analysis, FirstWord (https://www.linkedin.com/in/duncanemerton)
16:10 - Panel Discussion: The developing regulatory
framework in advanced and developing markets – for Today &
Tomorrow
Moderator:
Panellists:
• Upcoming EU Clinical Trials regulation (2016); where are we
heading in terms of biosimilars development?
• EU, US, ROW positions
• WHO guidelines
• Discussing how to get regulatory approval for your mAb
• What are the regulatory frameworks to consider when preparing a
marketing authorization application?
• Implications for 2014 and beyond
Ash Patel, Director of Regulatory Affairs (Biologics),
Lincoln Tsang, Partner,
Gopalan Narayanan, Biologics and Advanced Therapies Expert,
Anna Harrington-Morozova, Scientific & Regulatory Director,
ERA
Consulting
Arnold & Porter LLP
NDA
Regem Consulting
(https://www.linkedin.com/pub/ash-patel/6/6aa/975)
(https://www.linkedin.com/pub/lincoln-tsang/0/74b/aaa)
(https://www.linkedin.com/in/narayananbiologicalsexpert)
(https://www.linkedin.com/pub/anna-harrington-morozova/12/451/546)
REGULATION OVERVIEW & UPDATE
Liz Fuller, Partner, Bird & Bird

7. 6th Biosimilars Congregation 2015
FLOOR PLAN - Book your stalls now before they run out !!!
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AREA
CONFERENCEHALL
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REGISTRATION
DESK
TEA/COFFEE/LUNCH

8. REGISTRATION:-
6th Biosimilars Congregation 2015
10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK
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be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to
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Virtue Insight's preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.
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Early Discount (27th December 2014 - 30th January 2015) - £800 + VAT (Per Delegate)
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