2days

30expert casestudies

35+exhibitors

100+meetings

www.terrapinn.com/biosimilar2014

Part ofCo-located with

3rd annual

11-12 November 2014

Starling Geneva Hotel & Convention Center

Geneva, Switzerland

It’s all about engagement

The World Biosimilar Congress is the region’s most interactive and thought-provoking event for next generation biosimilar medicines. R&D, production,

regulation and market considerations; all discussed in a brand new format which allows you to come away with tangible ideas for your business.

For more information about the event, contact Megan Rumford on +44 (0) 207 092 1186 oremail megan.rumford@terrapinn.com

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SHOWCASE NETWORKING KNOWLEDGE

Product Roundtables

Case Studies

Exhibition Keynotes

Expert Panels

Party

Posters

1-2-1 Partnering

Discuss and share ideas with your peers

Understand how new players are tackling the market

Explore upcoming research and gain new ideas

Grab a drink and kick back with your peers

Shop around for new, innovative technologies

Make new connections with other industry leaders

Opening keynotes from global regulators and big pharma

Industry experts debate and strategise live, onstage

Your congress, your way

Hear the latest developments across all aspects of the biosimilar space.

As the pharmaceutical industry as a whole takes an ever-increasing look at the advent and implications of biosimilar medicines, now is an important time to ensure you are at the forefront of knowledge in the biosimilar space. Make sure you understand the full scope of considerations in developing biosimilars, and that you are aware of and engaged with the progress of your peers - as the race to market is well and truly underway.

The earlier you book - the more you save.

Hear from big pharma…

KEY SPEAKERS

Dr Martin UllmannHead of Bioanalytics, BiosimilarsMerck Serono

Martin Ullmann is Head of Bioanalytics, Biosimilars at Merck-Serono in Switzerland since 2013. He received his Ph.D. in Biochemistry at the University

of Hamburg, Germany. Since 2001 Dr. Ullmann is member of the AAPS and later joined the Steering Committee of the Ligand Binding Assay Bioanalytical Focus Group and more recently the Biosimilars Focus Group Subcommittee on Non-clinical and Clinical Assays. He joins the congress to discuss how the new draft guidelines impact bioanalytics for biosimilars.

Dr Ira JacobsOncology Portfolio Global Medical Lead-BiosimilarsPfizer

Doctor Ira Jacobs is a fellowship trained surgical oncologist who started Pfizer in November 2012 as the oncology biosimilars global medical lead.

Prior to Pfizer, Doctor Jacobs worked as a medical director in oncology global development at Amgen for four years. He led clinical development programs in breast, lung, prostate, and bone cancers. He is the author of more than 25 publications and has received numerous awards and honors.

Hear updates on global regulation…

Dr Elena Wolff-HolzMember of the Biosimilar Working Party, CHMP, EMA; Senior Medical Assessor, Paul Ehrlich Institut

Dr Elena Wolff-Holz is currently working as senior medical assessor at the Paul-Ehrlich-Institut and is a member of the Biosimilar Working Party (BMWP) of

the CHMP and a national expert to the Oncology Working Party (OWP) of the CHMP. She will be giving an overview on EMA biosimilar regulations at the congress.

Dr Teruyo AratoProfessor, Department of Regulatory Science, Hokkaido University Graduate School of Medicine, Japan

Teruyo Arato joined the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences (Japan) in 1999,

and from 2005 - 2011,she was a Review Director, Office of Biologics I, PMDA. She served as the Division Director of Human Resources Development Division, Office of Regulatory Science, PMDA from 2011-2012. She is currently working as a Professor of Hokkaido University Graduate School of Medicine.

Dr Pekka KurkiDirector, Research ProfessorFimea - Finnish Medicines Agency

Dr. Pekka Kurki, M.D, Ph.D, joined the Finnish Medicines Agency (Fimea) in 1997, where he now works as a research professor. He has had

several scientific positions at the European Medicines Agency (EMA) over the last 14 years. Currently, he is an alternate member of the EMA management board and an expert in the CHMP biosimilar working party (BMWP).

Dr Marjorie ShapiroChief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal AntibodiesCDER/FDA

Dr. Marjorie Shapiro’s current research continues towards understanding antibody repertoire development in natural and artificial systems and

potential implications for therapeutic monoclonal antibodies. She joined the Division of Monoclonal Antibodies (DMA) in 1993 and is currently Chief of the Laboratory for Molecular and Developmental Immunology in DMA where she supervises regulation of novel and biosimilar monoclonal antibodies and Fc fusion proteins. She will be giving an update on FDA regulations via weblink to the congress.

Dr Mark McCamishGlobal Head Biopharm & Oncology Injectables DevelopmentSandoz

Dr. McCamish is the Global Head of Biopharmaceutical and Oncology Injectable Development for Sandoz International, a Division of

Novartis. He leads research and development of all biologics at Sandoz Biopharmaceuticals, which is the world leader in development and commercialization of biosimilars. His responsibilities include selection of the target, cloning, technical development, scale-up, pre-clinical and clinical development of biologics and development of oncology injectable medications including interfaces with regulatory authorities worldwide.

Dr Richard MarkusExecutive Medical DirectorAmgen

Richard joined Amgen in February 2006 as Clinical Research Medical Director and then Medical Affairs Lead for denosumab (XGEVA®) for patients with

bone metastases from prostate cancer, breast cancer and other solid tumors. Richard then went on to be Global Development Leader for Aranesp Oncology until joining the Biosimilars Division as their head of development, taking on the responsibility for all nonclinical and clinical development. He joins the congress to discuss Amgen’s biosimilar programs.

Close of Day One

Taste of Geneva Party

Tuesday 11th NovemberDAY 1Registration and Morning Refreshments08:00

The Global R&D and Regulatory Landscape09:10

17:50

18:30

09:0

0

Chairman’s opening remarks

Paul Chamberlain, Advisory Board Member and Immunogenicity Expert, NDA Group

09:1

0

Harmonizing global biosimilar development plans with multiple regulatory authorities

Dr Mark McCamish, Global Head Biopharm.& Oncology Injectables Development, Sandoz

14:5

0

Update on the WHO INN program and inclusion of 4 letter biological qualifier code

Dr Raffaella Balocco-Mattavelli, INN Program Director, World Health Organisation

15:1

5

Extrapolation and interchangeability - what data do we have, what are the issues about extrapolation and interchangeability?

Dr Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global Medical Affairs, AbbVie

Afternoon Break15:40

16:2

5

A member state’s approach to tackling the worries of extrapolation and interchangeability; case Finland

Dr Pekka Kurki, Director, Research Professor, Fimea - Finnish Medicines Agency

Hosted by Paul Chamberlain, Advisory Board Member and Immunogenicity Expert, NDA Group

Dr Pekka Kurki, Director, Research Professor, Fimea - Finnish Medicines Agency

Dr Mark McCamish, Global Head Biopharm.& Oncology Injectables Development, Sandoz

Dr Jaap Venema, Therapeutic Area Lead Biotherapeutics, Global Medical Affairs, AbbVie

Morning Break10:25

Lunch12:55

Interchangability: extended panel discussion16:50

09:3

5

EMA – regulatory overview, including reworked guidelines on mAbs and use of global reference product

Dr Elena Wolff-Holz, Member of the Biosimilar Working Party, CHMP, EMA; Senior Medical Assessor, Paul Ehrlich Institut

10:0

0

Japan – regulatory overview on approvals for biosimilar therapeutics

Dr Teruyo Arato, Professor, Department of Regulatory Science, Hokkaido University Graduate School of Medicine, Japan

11:1

5

Case Study: Amgen – Designing meaningful biosimilar development programs – structure, function and the science of biosimilarity

Dr Richard Markus, Executive Medical Director, Amgen

14:2

5

Commercial Partner Opportunity

To take part in this session please contact Derek Cavanagh on +44 (0) 207 092 1297 or email derek.cavanagh@terrapinn.com

12:3

0

Development of RPH-001 and RPH-002 biosimilars of bevacizumab and cetuximab, respectively, for emerging markets

Dr Yan Lavrovsky, CEO and CSO R-Pharm Overseas, R-Pharm

11:4

0

How do the new draft guidelines impact bioanalytics for biosimilars: non-clinical and clinical case study of a mAb biosimilar

Dr Martin Ullmann, Head of Bioanalytics, Biosimilars, Merck Serono

12:0

5

Opportunities and challenges with the development of biosimilars: the Pfizer perspective

Dr Ira Jacobs, Oncology Portfolio Global Medical Lead-Biosimilars, Pfizer

Extrapolation and Interchangeability14:50

Panellists

Professor Tore Kvien, Department of Rheumatology, Diakonhjemmet Hospital/University of Oslo

Dr Anita O’Connor, Consultant, Anita O’Connor Consulting

Morning Break

Registration and Morning Refreshments Lunch

Biosimilar Uptake and Market Considerations

Roundtable Discussion Session

Non-clinical Concerns

Wednesday 12th NovemberDAY 209

:00

09:1

009

:35

10:0

0

10:25

08:00 12:15

09:10

11.10

13:35Chairman’s opening remarks

Dr Alain Beck, Senior Director, Antibody Physico-Chemistry, Centre d’Immunologie Pierre Fabre; Associate Editor, mAbs

The clinician’s point of view: thoughts on understanding and uptake of biosimilar medicinal products and design and implementation of switching studies

Professor Tore Kvien, Department of Rheumatology, Diakonhjemmet Hospital/University of Oslo

Market access – facing the challenges

Dr Steffen Thirstrup, Director NDA Regulatory Advisory Board, NDA Group

13:3

5

Fc receptor binding assays for biosimilar antibody testing

Christian Demmler, Head of Bioassays at the Cell and Tissue Services Department, Department Head of Quality Control, ProBioGen

The market dynamic, innovation and economic impact of biosimilars

Fereshteh Barei, Laboratory of Health Economics and Management of Health Related Organisations, LEGOS Paris Dauphine University

Attendees will choose from a variety of topics for a 1 hour small group discussion, and sign up in advance to attend a the session of their choice. Attendance will be capped at 15 persons per table.

Afternoon Break

Close of Congress

14:0

014

:25

14:5

015

:50

16:1

5

15:15

16:45

Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies

Dr Alain Beck, Senior Director, Antibody Physico-Chemistry, Centre d’Immunologie Pierre Fabre; Associate Editor, mAbs

Non-clinical aspects of biosimilar development

Dr Tanja Ficko Trcek, Scientist, Technical Development, Sandoz Biopharmaceuticals

Efficiency in the upstream process

Senior Representative, FeF Chemicals

Intellectual Property considerations in developing antibody and next generation therapeutics

Candi Soames, Partner, Maschio and Soames

Closing Keynote: FDA update on the regulation of antibody therapeutics and biosimilars/biosimilar mAbs (via weblink)

Dr Marjorie Shapiro, Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, CDER/FDA

1Overcoming concerns with naming, safely and traceability of biosimilar medicines

2 days that will changeyour next 12 months.

The earlier you book - the more you save

Book online now

www.terrapinn.com/biosimilar2014

2Methods for characterising and comparing biosimilars to originator products

3Beyond the planning – the practicalities of undertaking biosimilar clinical trials

4 Optimising process development of biosimilar medicines

5 Experiences in sourcing innovator reference product

6How to increase clinician understanding, uptake and trust in biosimilar medicines

To present a poster at the event please contact Megan Rumford on+44 (0) 207 092 1186 or email megan.rumford@terrapinn.com or book

online at www.terrapinn.com/biosimilar2014

POSTERSAt this year’s congress up to sixty posters will be on display.

Posters provide an opportunity for an informal presentation of informationto conference attendees. Presenting a poster is a great way to

discuss and receive feedback on a work in progress that has not beenfully developed into a paper.

Presenting a poster at the World Biosimilar Congressallows you to:

Discuss and receive feedback

Source information on original or early-stage R&D

Collect business cards from interested peers

Build a name for yourself in the scientific community

Table 6How to increase clinician understanding, uptake and trust in biosimilar

medicines

Table 1Overcoming concerns with naming, safely and traceability of biosimilar

medicines

Table 4Optimising process

development of biosimilar medicines

Table 2Methods for

characterising and comparing biosimilars to

originator products

Table 5Experiences in sourcing

innovator reference product

Table 3Beyond the planning – the practicalities of

undertaking biosimilar clinical trials

If you would like to host one of our roundtables please contact Derek Cavanagh on+44 (0) 207 0921 297 or email derek.cavanagh@terrapinn.com

ROUNDTABLESRoundtable Discussion Sessions...

How do you tackle the differing stages of the biosimilar development process? What is the current 'best practice' in biosimilar characterisation, clinical trials and process development? How do we increase clinician understanding and uptake of biosimilars? Which new research has the ability to

disrupt current industry thinking?

The Roundtable Discussion Sessions offer you the chance to exchange ideas with the brightest minds in the biosimilar space.

How does it work?Each table will open with introductions between attendees. This will be followed by group

discussion around key topics directly related to the table topic. It's a great way to make new connections and exchange ideas with the other world-leading peers.

The 10th annual European Antibody Congress is the region’s most exciting congress for antibody and antibody-like molecule development - bringing together decision makers, influencers and end users from across industry and academia. The congress delivers

specific content on immunoconjugates, antibody immunotherapies, mAbs, bispecifics, fusion proteins, CMC/developability issues and more. Explore the intersection of science

and business in the antibody space.

The HPAPI World Congress is dedicated to process enhancement, technical innovation and business development in the high-potency API market. Co-located with the European Antibody Congress and World Biosimilar Congress, it’s a chance to introduce pharma and

biotech to key HPAPI players.

But wait, there’s more…

Not only is the World Biosimilar Congress taking place, this fantastic event is also co-located with the European Antibody Congress and the HPAPI World Congress. Network with a wide range of key opinion leaders, broaden your

knowledge, increase the scope of your contacts and gain exposure across all three of these fantastic events.

The global HPAPI Market is

expected to reach 113bn by 2018 at a CAGR of 9.9%.

Join us at a top secret Geneva-based location for one stunning evening. Celebrate the last 12 months of

milestones and achievements of the global biosimilar sector and look forward to what

the next year may bring!

The World Biosimilar Congress presents...

6.30pm Tuesday 11th November

Geneva...shhhh, it's a secret

Taste of

Your Networking ManagerTake advantage of this dedicated and personalised meeting service. Hold meetings with pre-qualified partners arranged by your Networking Manager in your private on-site meeting area.

Keep all your messages, appointments and favourites at your fingertips and continue networking whilst you’re there. You can still use the networking tool within the app for a full year after the event so you can follow up with anybody you’ve missed months down the line.Gina Geldenhuys

It’s a networking event

We recognise the importance of networking and offer an experience which allows you to do just that. With the bespoke Total BioPharma mobile app, dedicated Networking Managers and peer-

to-peer partnering, we ensure that you get the most from your time on site.

Plus, with the co-located European Antibody Congress and HPAPI World Congress, increase your connections by meeting with delegates across all events.

Download our networking appDownload our networking app to get organised and get in touch with all attendees before the event.

Use the Total BioPharma portal to:• Plan your sessions• Build a personalised agenda• Identify exhibitors to visit• Set up onsite meetings with key executives.• Network with other attendees

Why exhibit• Make sales

• Debut new products

• Profile your brand

• Meet new business partners and suppliers

• Develop key relationships

• Educate pharma and biotech companies

Pursue and partner• Hundreds of partnering meetings in 2 days

• 100+ companies in the Total BioPharma

Partnering system

• 2 engaging networking lunches

• 1 social evening function

Who will you meetBiosimilar decision makers, influencers and end

users from large and mid cap pharma, large and

SME biotech, CMOs, academic and research

institutes, government bodies and regulators

plus select industry solution providers.

Who should sponsor• Contract Research Organisations • Contract

Manufacturing Organisations • Fill / Finish

• Finished Dosage • Platform Technology

Providers • Drug Delivery / Drug Diagnostic

Providers • API Suppliers • Medical Device

Manufacturers • OEM / Equipment Providers

• Consultants • Law Firms

The Exhibition at World Biosimilar Congress 2014

Sponsors & exhibitor logos

35

1

REFRESHMENTS REFRESHMENTS

29

3

Registration

Sponsor Networking Zone

27

5 8

31 26

6

30

2

28

4 7

323334

www.terrapinn.com/biosimilar2014

Company Name Stand

ISOTOP4LIFE 1

AVAILABLE 2

AVAILABLE 3

RESERVED 4

Stemgent Asterand 5

FeF Chemicals 6

Quality Assistance 7

LFB Biomanufacturing 8

RESERVED 9

Retrogenix 10

Agilent Technologies 11

RESERVED 12-21

PALL Life Sciences 22

KBI Biopharma 23

Catalent 24

Clean Cells 25

ModiQuest Research 26

Molecular Devices 27

Genovis 28

Myoderm 29

AbD Serotec, a Bio-RAD Company 30

Fujifilm Diosynth Biotechnologies 31

IBIS Technologies 32

AVAILABLE 33

AVAILABLE 34

Aldevron 35

The Exhibition at World Biosimilar Congress 2014

25

10

18

15

17

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REFRESHMENTS REFRESHMENTS

Sponsor Networking Zone

22

118

20

13

2426

9

19

14

23 21

12

SOLD

RESERVED

AVAILABLE

reasons to attend1 Evaluate the leading players in the biosimilar space – presentations from

Sandoz, Amgen, Merck Serono, Pfizer, AbbVie, R-Pharm and more

3 Network with the leaders, the influencers and the key R&D scientists working in the biosimilar space

5 Learn how to overcome challenges in biosimilar clinical and non-clinical development

7 Peruse the exhibition hall and meet with solution providers that cater to your needs

2 See the latest strategies for characterisation and comparability of biosimilars

4 Listen to updates from the EMA on biosimilar regulatory approval, and the WHO on biosimilar naming and use of INNs

6Attend the breakout roundtable discussion and clinic sessions for more opportunities to learn, and the co-located European Antibody Congress and HPAPI World Congress giving more opportunities to network

8 Discuss – where to from here? What will be the next quantum leap in biosimilar development and approval?

The earlier you book the more you’ll save.

It’s really easy to register online.

And our online calculator will ensure you take advantage of the best deal.

Go to and registerwww.terrapinn.com/biosimilar2014 now.

BRING YOUR TEAMThere’s so much great content, you can’t possibly cover it all alone! Bring your team and get an extra discount.

There are special group packages available call +44(0) 207 242 2324 for more details or go towww.terrapinn.com/biosimilar2014

BOOK NOW

Go towww.terrapinn.com/biosimilar2014and register with a special discount

code BD03

Or call +44 (0) 207 242 2324

Reserve your place today

Register now and get the offer price - on your phone

Scan this QR pattern with the camera on your smartphone and register with a discount code BD03 at the special offer price.

Don’t have a QR reader app? You can download one for free from App Store.Don’t have a smartphone? You can also register and get the offer on our website www.terrapinn.com/biosimilar2014

Booking code BD03

Package

2 day conference

Academic price

Poster Session

Before 3 Oct 2014

€1880SAVE €240

€1050SAVE €105

Full Price

€2,120

€1,155

€50*

* For registered attendees only

Contact us today for a tailored sponsorship package to meet your business objectives.www.terrapinn.com/biosimilar2014

2014 SPONSORS

EXHIBITORS

SPONSORS

MEDIA PARTNERS

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