SMi Group's 5th annual Biosimilars & Biobetters 2014 conference returns to London this September

1. Benefits of attending:
• The must attend event discussing strategies for accelerating biosimilar
drug development to market
• Explore the latest thinking and techniques in this growing area
• Book now and join us for exciting interactive discussions about the
current and potential offerings for biosimilar production
• Hear from knowledgeable presenters – our expert panel of speakers
are handpicked!
• The ideal platform for networking and learning from your industry peers
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 1st October 2014, Holiday Inn Regents Park Hotel, London
A: Biosimilars - A Regulatory Update
Workshop Leader: Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President,
Global regulatory - Governmental Relations, Fresenius Kabi Headquarters
8.30am - 12.30pm
B: Biosimilars - ‘The Holy Grail?’
Workshop Leader: Ineke Braat, Chief Executive Officer, PanGenrika
1.30pm – 5.30pm
Chairperson:
Richard Dicicco,
Chairman, Harvest Moon Pharmaceuticals
Key Speakers Include:
• Dr Uwe Gudat, Head of Safety Biosimilars, Merck
• Catherine Akers, Regulatory Affairs Manager, Amgen
• Steiner Madsen, Medical Director, Department of Drug
Information, Norwegian Medicines Agency
• Dr Alok Sharma, Principal Scientist & Head Analytical
Development, Lupin Limited
• Alan Sheppard, Principal Global Head Generics, Thought
Leadership, IMS Health, UK
• Victoria Fine, Founder, Psoriasense
…Look inside for further details!
SMi present the 5th annual…
29th - 30th
SEPT
2014Holiday Inn Regents Park Hotel, London
The biosimilars opportunity: creating and
commercialising a quality product
Biosimilars & Biobetters
BOOK BY 30TH MAY AND SAVE £300 • BOOK BY 30TH JUNE AND SAVE £100
www.biosimilars-biobetters.co.uk
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
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2. Register online at: www.biosimilars-biobetters.co.uk • Alternatively fa
Biosimilars & Biobetters Conference
Day One I Monday 29th September 2014
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
MARKET OUTLOOK - PART I
OPENING ADDRESS
9.10 What is on the horizon? ... reviewing the opportunities and
challenges for the biopharmaceutical industry
• Reviewing the sustainability of the biosimilars market, will it be
saturated in the future?
• The big question…who will be most successful, those who are:
- the fastest to market
- generates the most similar biosimilar
• Evaluating the barriers to market entry and uptake for
biosimilars
• Where are we heading and what needs to happen?
Alan Sheppard, Principal Global Head Generics, Thought
Leadership, IMS Health, UK
9.50 The gloves are off! Measuring the viability of biosimilars vs.
biobetters
• What is the point of a biosimilar, why not go for a biobetter?
• Where are biobetters being used and are they indeed better?
• What is a biobetter anyway, and what is the relevant regulatory
framework?
Paul Ashton, President & Chief Executive Officer, pSivida
10.30 Morning Coffee
10.50 The big guns are coming! ...how will the entry of originator
companies impact the biosimilars industry
• Understanding how this will shape the competitive, dynamic
and commercially lucrative biosimilars market segment
• Reviewing why big pharma companies are considering
entering the market with monoclonal antibody biosimilars
• Will their experience in marketing, manufacturing skills and
industry knowledge give them a competitive advantage over
those already in the market?
• What are their weaknesses?
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
11.30 Biosimilars, biobetters - the patients perspective
• A patients understanding of biologics, biobetters & biosimilars
• What biosimilars and biobetters actually mean to patients
• The true impact of biosimilars and biobetters
Victoria Fine, Founder, Psoriasense
12.10 Networking lunch
REGULATORY UPDATES
1.10 Biosimilars/ Biobetters in the USA
• US PTO regulations extending the impact of the Myriad decision
• Strategy and hurdles for patenting your biosimilar in the US
• Update on evolving FDA regulations for biosimilars: why are
there no approvals in the US?
Albin (Jim) Nelson, Partner, Schwegman,
Lundberg, Woessner IP, P.A
Robin Chadwick, Partner, Schwegman,
Lundberg, Woessner IP, P.A
1.50 Christening day…but what shall we call you! Discussing the
ongoing debate on naming biosimilars
• Taking an in-depth look at the discussion regarding the WHOs
initiative for a unique identifier for biologics – what will this
mean?
• The use of identical INNs for biosimilars could lead to
inadvertent switching at the pharmacy - true or false?
• What is the view at home and abroad?
• USA - GphA and originator citizen petitions to the FDA
Peter Wittner, Senior Consultant, Interpharm Consultancy
2.30 You can’t injunct me - I’m a biosimilar!
• Review of the principles governing interim injunctions in patent
litigation
• Application of those principles to pharma cases
• Why biosimilar cases may not necessarily be a good fit – will the
injunctions stick?
Dominic Adair, Associate, Bristows
3.10 Afternoon Tea
3.30 European update - the latest in regulatory thinking
• Understanding current regulatory approval standards for
biosimilars in Europe, reviewing the regulatory pathways in other
jurisdictions
• What are the regulatory requirements for non-clinical studies in
developing biosimilars
• Other aspects of the regulatory framework to consider when
preparing a marketing authorisation application
Sarah Faircliffe, Legal Director, Bird & Bird
Liz Fuller, Partner, Bird & Bird
4.10 The case for biosimilars - a payer’s perspective
• Why are payers interested in utilizing biosimilars?
• Switching or not switching in pharmacies?
• Switching or not switching for economical reasons after
treatment initiation/during treatment?
• What will happen in Norway onwards?
Erik A. Stene, Senior Advisor/MPhil Econ, Department for
pharmacoeconomics/reimbursement/value assessment,
Norwegian Medicines Agency
4.50 Same, similar, equivalent, this is a serious game! Proving that
a biosimilar is ‘similar’ to the originator is not trivial pursuit!
• Defining biosimilarity
• How similar is the biosimilar to the innovator…measuring
how much work this entails at the early stage
• Evaluating what metrics and analytical similarity
assessments should be employed when designing
a biosimilar development program
• Determining type and volume of clinical data
required for establishing biosimilarity
• Establishing validated standardized assays that
allow direct comparisons of the relative potency
and immunogenicity of the biosimilar and the
innovator product
• Considering the limitations of conventional biological
assays that may be inadequate to detect differences
resulting from a change in the manufacturing process
• Conducting a non-clinical or a clinical study
Michael Tovey, INSERM Director of Research, Laboratory of
Biotechnology and Applied Pharmacology, Ecole Normale
Supérieure de Cachan
5.30 Chairman’s Closing Remarks and Close of Day One
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3. ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Biosimilars & Biobetters Conference
Day Two I Tuesday 30th September 2014
8.30 Registration & Coffee
9.00 Chairman’s Opening Remarks
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
MARKET OUTLOOK - PART II
OPENING ADDRESS
9.10 Biosimilars - hurdles to patients’ access
• Development of biosimilars: A case study
• Patent protection
• INN issue
• Switching: interchangeability and substitution
Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice
President, Global regulatory - Governmental Relations, Fresenius
Kabi Headquarters
9.50 What do they really think...reviewing customer perceptions of
biosimilars in Europe
• Discussing what doctors think of biosimilars and how willing are
they to prescribe them
• Monitoring how patients react when their doctor prescribes a
biosimilar
• Are payors pushing for more utilization of biosimilars in Europe?
Ineke Braat, Chief Executive Officer, PanGenerika
10.30 Morning Coffee
10.50 Innovations in creating best in class biosuperior biologics:
meeting the challenges of biosimilars
• Innovations in improving the existing biologics therapies to
create best in class molecules for diseases with unmet medical
needs
• Making biosuperiors successful and cost effective through
advances in protein engineering and pioneering technologies
- Case studies of biosuperior vs. biosimilars
• Identifying which class of biologics have the best potential for
‘biosuperior’ development
• Challenges in development of biosuperior biologics
• Accelerated preclinical and clinical development of biosuperior
biologics
Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety
Assessment, Medimmune (AstraZeneca Biologics)
BIOSIMILAR DEVELOPMENTS
11.30 Pharmacovigilance considerations for biologics and biosimilars
• Unique characteristics for biologics which influence their safety
profile
• Importance for accurate traceability to allow effective
pharmacovigilance
• How biologics have been recognised in the new EU
pharmacovigilance legislation and what implementation looks
like across Europe.
Catherine Akers, Regulatory Affairs Manager, Amgen
12.10 Networking lunch
1.10 Tracking the introduction of biosimilar infliximab in Norway
• What are the attitudes of physicians?
• Switching study – what is the status?
• Monitoring prices and sales
Steinar Madsen, Medical Director, Norwegian Medicines Agency
1.50 Designing and executing comparability studies…an important
‘key’ in the development of products
• Conducting meaningful preclinical and clinical comparability
studies, to establish analytical and bioanalytical equivalency
between biosimilars and originators
• Ensuring a comparability exercise is followed with the innovator
product at all levels of product development, including:
- physicochemical attributes
- biological activity
- preclinical in vivo comparability
- Phase I PK and safety
- Phase III efficacy and safety
• Demonstrating equivalence to materials used in toxicology
and early phase clinical trials to avoid bridging studies which
increase timescales and costs
• Guidance on how to practically carry out comparability studies
and prove comparability to regulators
Dr Alok Sharma, Principal Scientist & Head Analytical
Development, Lupin Limited
2.30 Afternoon Tea
2.50 A clinical perspective on biosimilars: development and beyond
• The challenge - creating strategies to overcome the obstacles
we face
• The means - utilizing the tools at our disposal
• The scenarios - a collection of possible outcomes
Dr Uwe Gudat, Head of Safety Biosimilars, Merck
3.30 A new dawn… biosimilar monoclonal antibodies (mAbs), a new
milestone for the biosimilar market!
• Reviewing how approval of the first biosimilar monoclonal
antibody therapy will impact the industry, what are the
implications for 2014 and beyond
• Evaluating if this will spearhead the start of a new era of mAbs
in the pharma industry
• Discussing how to get regulatory approval for your mAb
• Will this bring greater commercial rewards
• Will generic companies continue to dominate, or can Big
Pharma gain control with its huge marketing muscle?
Carsten Brockmeyer, Chief Executive Officer, Formycon AG
4.10 Chairman’s Closing Remarks and Close of Day Two
Supported by

4. Overview of workshop:
Europe is by far the most advanced region with a
regulatory pathway for biosimilars for the last decade.
This workshop will give a regulatory overview of the
biosimilars rules & guidelines in the EU, US and India. This
will address the differences between regulatory agencies’
approaches, helping participants build adequate
regulatory strategies.
Why you should attend:
This Workshop will give a detailed overview of the current
regulatory situation, current regulatory requirements and
address the differences. It will help you to build adequate
regulatory strategies to respond to the needs of early
access to biosimilars.
Programme:
8.30 Registration and coffee
9.00 Opening remarks
9.10 Session 1: Regulatory Overview EU and
US: An update on the EU and US regulatory
requirements for biosimilars
9.50 Session 2: EU and US Regulatory pathways:
A refreshment of the current regulatory
pathways for biosimilars in the EU and USA
10.30 Coffee break
11.00 Session 3: Biosimilars Regulatory Overview in
India: A description of the regulatory
requirement in India and the published
biosimilars guidelines
11.40 Session 4: Biosimilars Wrap-up. Questions and
answers, allowing the workshop participants to
interact and exchange experiences
12.20 Closing remarks
12.30 End of workshop
About the workshop host:
Dr. Michel Mikhail has more than 25 years
pharmaceutical industry experience and
a track record of achievement in R &
D and International Regulatory Affairs
in large multinational research-based
pharmaceutical companies, as well
as in the generic industry. Dr Mikhail is
a chartered expert in pharmacology -toxicology, a
chartered clinical expert as well as a chartered analytical
expert. Dr Mikhail served on the Safety Working Group
and Efficacy Working Group of the European Federation
of Pharmaceutical Industry Associations (EFPIA) also as
a topic leader. He served on the regulatory group of
the European branch of the Pharmaceutical Research
and Manufacturers of America (PhRMA Europe), on
the Regulatory and Scientific Affairs Group of the
European Generic Medicines Association (EGA), as well
as Pharmacovigilance Working Group, Market Access
Advisory Committee, among others and on different
associations and organisations. Dr Mikhail is member of
the EGA’s European Biosmilars Group (EBG). Dr Mikhail
is a Board Member of The European Generic Medicines
Association (EGA) as well as member of the Executive
Committee of the EGA. He is a member of the British
Institute of Regulatory Affairs (BIRA), the European
Society of Regulatory Affairs (ESRA), both now known
as The Organisation for Professionals in Regulatory Affairs
(TOPRA). Dr Mikhail is member of the Expert Committee
for Toxicology of the United States Pharmacopea (USP).
Dr. Mikhail has been recently nominated as a Member
of the Expert Committee of the German Federal Institute
of Risk Assessment (Bundesinstitut für Risikobewertung).
Currently Dr. Mikhail is Chief Regulatory Officer
& Executive Vice President Global Regulatory –
Governmental Relations at Fresenius Kabi, a multinational
pharmaceutical company.
Biosimilars - A Regulatory Update
Workshop Leader:
Dr Michel Mikhail, Chief Regulatory Officer, Executive
Vice President, Global regulatory - Governmental
Relations, Fresenius Kabi Headquarters
HALF-DAY POST-CONFERENCE WORKSHOP A
Wednesday 1st October 2014 I 8.30am – 12.30pm
Holiday Inn Regents Park Hotel, London

5. Overview of workshop:
Are biosimilars something that companies should
want to introduce in their product portfolio or should
we look at other opportunities and leave the bios to
companies that have money to burn? That is the big
question!
Why you should attend:
If you want to gain some insight into the costs and
profitabiity of biosimilars and and biobetters. Also, if
you want to know whether or not you are missing the
boat if you don’t get into these products then join this
workshop to find out what is happening in this area.
Programme:
1.30 Registration and coffee
2.00 Opening remarks
2.10 Session 1: Question you should ask within
your organisation before starting to produce
biosimilars
2.50 Session 2: Biosimilars what is the ROI for
working with them?
3.30 Coffee break
4.00 Session 3: Why and more important;
how do you introduce biosimilars
4.40 Session 4: Is there a yellow brick road?
5.20 Closing remarks
5.30 End of workshop
About the workshop host:
Ineke Braat, CEO of PanGenerika has
been working in the pharmaceutical
industry for over 30 years and is
founder and owner of PanGenerika
B.V., B-Medical B.V. and Sanare B.V,
with all companies working within
the pharmaceutical and or personal
care industry. Ineke has worked in the ‘innovating’
pharmaceutical industry (Abott; Yamanouchi e.a.)
before starting her own companies. Ineke’s main
focus in all companies is the question: will it benefit
the patient/consumer?’
About PanGenerika:
PanGenerika began as an alliance of small/medium
sized European pharmaceutical companies, but
is expanding to all countries that accept e-CTD
formatted dossiers. There is only one exclusive
member per country. For information please visit
www.pangenerika.eu
Biosimilars - ‘The Holy Grail?’
Workshop Leader:
Ineke Braat, Chief Executive Officer, PanGenrika
HALF-DAY POST-CONFERENCE WORKSHOP B
Wednesday 1st October 2014 I 1.30pm – 5.30pm
Holiday Inn Regents Park Hotel, London, UK
Want to know how you can get involved?
Interested in promoting your services to this
market? Contact Julia Rotar, SMi Marketing
on +44 20 7827 6088, or email:
jrotar@smi-online.co.uk
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and branding packages, uniquely tailored
to complement your company’s marketing
strategy. Should you wish to join the increasing
number of companies benefiting from sponsoring
our conferences please call: Alia Malick, Director
on +44 (0) 20 7827 6168 or email:
amalick@smi-online.co.uk

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BIOSIMILARS & BIOBETTERS CONFERENCE
Conference: Monday 29th – Tuesday 30th September 2014, Holiday Inn Regents Park Hotel, London I Workshops: Wednesday 1st October 2014
4 WAYS TO REGISTER
ONLINE www.biosimilars-biobetters.co.uk
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