BIO-Europe^® 2013 Program Overview

In this session, we will explore how new technologies and novel therapeutic approaches impact advances in cancer drug development and help us deliver on the promise of personalized medicine.

• The role of next generation sequencing on the identification of new disease modifying drug targets
• The role of next generation sequencing in oncology drug development, molecular diagnostics and the advent of personalized medicine
• New immunotherapeutic approaches to cancer treatment and what is required for success
• New antibody drug conjugates and recent clinical success stories

Finally, our panel of experts will discuss the multitude of opportunities for partnering by small and large companies alike in the brave new world of personalized oncology and next generation drug development.

Moderator:
John Freshley – CBO, Compendia Bioscience

• Kim Caple – VP and General Manager, Molecular Diagnostics Business Unit, Life Technologies
• Susan Galbraith – VP and Global Head of Oncology iMed, AstraZeneca
• Joseph Monforte – Executive VP and CSO, AltheaDx, Inc.

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By 2019, a large number of biopharmaceutical blockbuster patents will have expired. Therefore, it is expected that Biosimilars, i.e., follow-on products of biopharmaceuticals after their patent expiration, will become of paramount importance for the cost-efficient treatment of severe diseases. Biosimilars offer an attractive risk-reward profile for pharmaceutical companies. The savings potential for the national health care system in the EU under favorable conditions is estimated to amount to more than EUR 30 billion by 2020. It is anticipated that Biosimilars will become at least as important for the supply of pharmaceuticals as the classic generics since their market introduction more than 30 years ago. During this workshop, panelists will discuss the latest developments regarding Biosimilars and their impact on the market at present and in future.

Moderator:
Peter Homberg – Partner, Salans

• Joseph Damond – Senior VP, International Affairs, Biotechnology Industry Organization (BIO)
• Paul Greenland – Head, Biosimilars Business Unit, EMEA Region, Hospira
• Tom Moore – Director, Value, Access, and Policy, Amgen GmbH
• Peter Stenico – Head Commercial Operations, Western Europe, Sandoz International

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Companies often do not think about the long term effects of the decisions they make and the impact those decisions will have on the ability of the company to strategically position itself and its assets within the marketplace. The failure to think about long term impact can affect not only the best development course for the asset but may also have negative effects on the company's ability to monetize assets, evaluate the best deal partner, better position the asset's clinical development and the right indication for the asset where multiple avenues are available, not to mention affecting the company's legal position. These decisions can affect how attractive the company is to a potential investor or deal partner. In this workshop experienced business development and legal executives discuss how to make the best long range decisions when developing your asset, focusing on these key issues:

• Why to develop a specific indication vs. looking at multiple indications.
• What the market will look like in five years.
• How to identify the correct party for future partnership.
• How to position a clinical development plan that not only moves the asset forward in development but makes it more attractive for a partner.

Moderator:
Dr. Christofer Eggers – Partner, WilmerHale

• Carlos de Sousa – VP, Head of Commercial Licensing, GLBD, Takeda Pharmaceuticals
• Mercedes Diz – Department Head, Licensing and Corporate Development, Almirall
• Leif Helth Jensen – Investment Manager, Life Science, CAT Science
• James O'Mara – VP, Corporate Development, Ironwood Pharmaceuticals

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Win a one-to-one meeting with senior executives from big pharma. Each member of the audience will have 30 seconds to present their company or technology to a star-studded panel of pharma BD executives. The top picks will be selected for a second round that includes an additional two to three minutes of presentation and/or Q&A time with the panel. The first place winner will receive a full 30-minute private follow-up meeting with the panelist of their choice. Audience preparation notes:

• Participants will have only 30 seconds to pitch their company, product, technology or service to the panel.
• Participants will be judged on the quality and effectiveness of the overall pitch.
• Remember, the primary goal of an elevator pitch is to spark interest for a follow-up meeting.
• Pre-workshop coaching is available from the moderator (contact: doug@macbiocom.com).
• Practice, practice, practice!

Moderator:
Douglas MacDougall – President, MacDougall Biomedical Communications

• Vered Bisker-Leib – Bristol-Myers Squibb
• Begoña Carreño – Novartis Pharma
• Rick Cousins – CEEDD, GlaxoSmithKline
• Mark Dennish – Daiichi Sankyo
• Claudia Karnbach – Bayer HealthCare
• Patrick Tricoli – Sanofi

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Sticking to the critical timeline is crucial for the success of small biotech companies. The panel will discuss realistic timelines and success factors for the process from request for proposal to final contract signature, including the importance of addressing slots reservation, IP, etc., at the right time-usually earlier than anticipated. Having the right pace and including the stakeholders in the process early on is necessary to meet ambitious goals. The panel will share best practices and provide detailed information about a smooth process towards contract signature.

Moderator:
Klaus Binder – Managing Director and Founder, Binder Associates

• Uwe Bücheler – Senior VP, Global Biopharma Operations, Boehringer Ingelheim Pharma
• Dagmar Cirkel – Director Legal, Vetter Pharma Fertigung GmbH & Co. KG
• Ulf Grawunder – CEO, NBE Therapeutics
• Fritjof Linz – Senior Director, Marketing and Sales, DSM Biologics
• Klaus B. Schoepe – Senior VP, Client Relations, Rentschler Biotechnologie

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• Carola Schropp – President, EBD Group
• Dr. Horst-Michael Pelikahn – State Secretary, Hamburg Ministry of Science and Research
• Ralph Müller-Beck – State Secretary, Ministry of Economic Affairs, Employment, Transport and Technology Schleswig-Holstein
• Joseph Dillon – Managing Director, Investor Relations and Business Development, Biotechnology Industry Organization (BIO)

Moderator:
Chris Morrison – Editor-in-Chief, Biopharma and Consumer Products, Elsevier Business Intelligence

• Hubert Birner – Managing Partner, TVM Capital Life Science
• Stephen Evans-Freke – Co-Founder and Managing General Partner, Celtic Therapeutics
• Gilles Nobecourt – Partner, Edmond de Rothschild Investment Partners
• Roger J. Pomerantz, MD, FACP – Senior VP, World Wide Head of Licensing & Acquisitions and Knowledge Management, MSD/Merck

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Increasing pressure to heighten productivity and lower cost has led many pharma companies to completely rethink their R&D and commercialization strategies. The blueprint is changing—be it by innovative internal structures or through external resources such as M&A or collaborations with VCs, academic institutions, or biotechs. External resources promise new sources of innovation, but also create new challenges for the R&D and commercial teams tasked with delivering approvable, reimbursable and differentiated products at the end of the development process. Join this session as we review both early successes and lessons learned from the implementation of novel R&D and commercialization blueprints, and discuss what they could mean for the industry as a whole.

Moderator:
George Schmidt – Practice Area Leader, Campbell Alliance

• Anders Ekblom – Head Global Science & Technology Integration, AstraZeneca
• Philippe Lopes-Fernandes – Corporate VP, Head of Licensing, Business Development & Alliance Management, Merck Serono
• Dirk Moritz – VP, Global Strategic Marketing, Shire HGT
• Garry Neil – Interim CEO, TransCelerate BioPharma; Partner, Apple Tree Partners and Head, R&D, Apple Tree Pharmaceuticals

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How effective are the corporate venture arms of big pharma today in selecting early stage programs that could eventually be pulled in-house? Or is this even their role? The panel will explore in detail how corporate venture funds are positioned and structured in order to manage their dual role: investors and consortial partners together with VC players on the one hand, as well as dealmakers to capture innovation for their parent companies on the other hand. Experienced corporate venture capitalists as well as traditional VC investors lay out how to work with both to build a roadmap to successful funding.

Moderator:
Ruediger Herrmann – Partner, WilmerHale

• Roel Bulthuis – Head, Merck Serono Ventures, Merck Serono SA
• Stuart Collinson – CEO, Tioga Pharmaceuticals; Partner, Forward Ventures
• Yuji Iizawa – Senior Investment Director, Takeda Ventures, Inc.
• Anja Koenig – Managing Director, Novartis Venture Fund
• Jimmy Wei – Venture Partner, KPCB China

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The burgeoning number of early stage collaborations is well known, whether they be among consortia or between a corporate player and a research institution. But the dividing line between pre-competitive space and the competitive arena is less obvious. This panel will examine the different corporate perspectives on open innovation and how pre-competitive deals are being structured to meet each company's ultimate need to compete downstream.

Moderator:
David Flores – Co-Founder, President and CEO, BioCentury

• Siegfried Bialojan – Executive Director, Head European Life Science Center, Ernst & Young
• Frank Borriello, MD, PhD – Senior Director, Global Business Development Search and Evaluation, Takeda Pharmaceuticals
• Anders Ekblom – Head Global Science & Technology Integration, AstraZeneca
• Thomas Hanke – Director, Biopharmaceuticals Innovation Sourcing, Biopharm, Research Unit, Novo Nordisk
• Ron Newbold – VP, Strategic Research Partnerships, External R&D Innovation, Pfizer

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Moderator:
Joseph Dillon – Managing Director, Investor Relations and Business Development, Biotechnology Industry Organization (BIO)

• Scott Clarke – VP, Business Development and Scientific Licensing, BioMarin Pharmaceutical
• Gregory S. Robinson – Senior Director, Scientific Licensing Assessment, Shire HGT
• Henk Schuring – Group VP, Regulatory Affairs, Genzyme Europe BV
• Jeremy P. Springhorn – VP, Corporate Strategy and Business Development, Alexion Pharmaceuticals

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This panel will examine the outlook for regenerative medicine and cell-based immunotherpies for the rest of the decade. Panelists will discuss the major clinical developments and therapeutic areas where we are likely to see the most immediate results. The panel will also discuss the role of the major stakeholders in this sector and the types of partnerships necessary to sustain progress.

Moderator:
Wilfried Dalemans – Chief Technology Officer, TiGenix

• Anne Altmeyer – VP, Business Development and Licensing, Novartis Oncology
• Rudolf Berger – CEO, Tissue Med Biosciences
• Eric Halioua – CEO, Promethera Biosciences
• Shosh Merchav – Director, Cell Therapy, Teva Global R&D
• Brian Strem – Associate Director, Business Development, Shire Pharmaceuticals

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While risk-sharing arrangements among drug development firms and their partners, whether they be CROs or firms with other complementary expertise, have been in vogue for some time, there is still a question whether they are working and truly enabling more productivity from biopharma drug discovery and development. This panel will examine the relationships between the top CROs in the world and their changing and evolving customer base. It will consider the fact that some of the new venture and pharma-funded drug development models are looking earlier to CRO partners that can become even more engaged in the development process and shoulder more of the long-term risk. The session will also examine the extent to which the global reach of these firms can be leveraged effectively.

Moderator:
Dennis J. Purcell – Senior Managing Director, Aisling Capital

• Chip G. Gillooly – Global VP, Corporate Development, Quintiles
• Andre Hoekema – Senior VP, Corporate Development, Galapagos
• Richard Soll – Senior VP, Integrated Services and Head, Corporate Alliances, WuXi AppTec

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Countries throughout Europe, and increasingly in the rest of the world, are using comparative effectiveness systems to guide decisions about which new products to reimburse, as well as the terms (indications and prices) of reimbursement. While many countries, including the US, are just developing the process, other countries, such as Germany and Great Britain, have systems in place. The biotech industry is just beginning to feel the consequences of these government decisions. Are comparative effectiveness systems making health systems more efficient and effective in delivering the best treatments, or are they impeding market access for promising new medicines? What are the regional and global trends? How will these government actions influence the price for a new product? This panel will explore these questions, with a view toward determining the impact on returns for new medicines, and the potential impact on future research and development.

Moderator:
Skip Irving – Partner and Managing Director, Health Advances

• Joseph Damond – Senior VP, International Affairs, Biotechnology Industry Organization (BIO)
• Alexander Natz – Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
• Koen Torfs – VP, Health Economics, Reimbursement and Market Access, Europe, Middle East and Africa, Janssen

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Companion diagnostics and subsequent targeted therapies are highly touted to inevitably revolutionize traditional patient treatment paradigms. A great deal of uncertainty, however, has plagued the evolution of newly formed relationships between the two key stakeholders essential to the realization of personalized medicine, namely drug companies and diagnostic developers.

Key topics:

• To what extent can pharma offset lower volume sales through increased value pricing with CDx?
• Where will value/risk be captured/shared between Rx and Dx?
• What business models are acceptable?
• How will diagnostics companies be rewarded/compensated given that payers have very different approaches to recognizing value and reimbursing pharmaceutical products compared to diagnostics/lab testing services?
• Outside of oncology, where will CDx play a significant role?
• What is the ideal regulatory roadmap?
How can misalignment in global regulatory strategies be corrected?
How can clinical trials be optimally conducted?
• Rx/Dx track record: What has worked, what hasn't?

Moderator:
Toby Zaleski – Director, Base Pair Group

• David de Graaf – CEO, Selventa
• David L. Dolinger, PhD – Executive VP, Seegene
• Guy Greiveldinger – Director, BD&L and M&A, Novartis
• Bruce Jordan – Senior International Product Manager, Roche Diagnostics

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Catalonia: Building a competitive hub

Catalonia's biocluster is one the most dynamic in Spain, which overall happens to be one of the most active areas in Southern Europe in this field. During the last five years, the rate of new biotech company creation in Catalonia has ranged between 30% and 15% average, gathering 481 companies in 2012, which, given the current economic downturn, shows the potential of the life sciences sector.

The seminar, moderated by Montserrat Vendrell, CEO of Biocat (the organization that coordinates biotechnology and biomedicine in the region) will feature four examples of outstanding companies that will provide an overview of their best business practices that are contributing to the competitiveness and innovation of the sector.

Moderator:
Montserrat Vendrell – CEO, Biocat

• 13:30 – Welcome and presentation: Overview of the main figures and assets of the BioRegion of Catalonia and introduction to the speakers.

• 13:35 – Miquel Àngel Bonachera – CEO-CFO, AB-Biotics
• 13:45 – Carles Estévez – Scientific Director and VP of Research, IUCT (Science and Technology Institute)
• 13:55 – Mercedes Diz – Associate Director, Licensing and Corporate Development, Almirall
• 14:05 – Joël Jean-Mairet – Managing Partner, Ysios Capital Partners
• 14:15 – Discussion with audience

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The Italian Biotech Sector
Alessandro Sidoli – President, Assobiotech

The Role of Science andTechnology Parks and Clustering Activities in the Italian Life Science Sector
Francesco Maria Senatore – Business Development Communication & Projects, Toscana Life Sciences Foundation

bioPmed: Supporting Life Sciences in Piemonte: A Shared Services Approach
Gianni Garotta – bioPmed

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Innovative clusters and networks from four countries joined forces to showcase the R&D strength and partnering opportunities from Northern Europe. Nordic countries offer unique biobanks, strong translational R&D centers in oncology, diabetes, neurosciences and other disease areas and dynamic biotech milieus as illustrated by recent success stories such as Algeta and Symphogen. The speakers represent the Oslo Cancer Cluster, the Lund University Diabetes Centre, the Danish Biopeople and BioTurku from Finland. The seminar will update the audience on selected initiatives and developing pipelines and is an invitation to connect for more information on collaborative opportunities.

• Martin Bonde – CEO, Epitherapeutics and Chairman of Dansk Biotek – Denmark
• Sylvie Bove – Innovation Officer EXODIAB, Lund University Diabetes Centre – Sweden
• Tom Pike – Chairman and Director of the Board for several Nordic Biotech companies (Vaccibody, Epitarget, Europharma Nordic, Clanotech, Diagenic, ACD Pharmaceuticals) – Norway
• Per Walday – CEO, PCI Biotec – Norway
• Tarja Laitinen – Professor, University of Turku and The Hospital District of Southwest Finland; Coordinator of Clinical Biobanking Network – Finland

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Regenerative Medicine in Austria

Speakers:

• Johannes Sarx – Head Life Science Austria, Austria Wirtschaftsservice GmbH
Welcome and Chair

• Rudolf Berger – CEO, Tissue Med Biosciences
New strategies for the treatment of chronic diseases

• Johannes Grillari – CSO, Evercyte GmbH
Human urine derived cells as model systems

• Rainer Henning – CEO, Aposcience AG
From cells to secretomes: A novel approach for functional organ recovery

• Roman Schenk – CEO, RECARDIO GmbH
Regenerative cardiac therapy: The new option

• Ekkehart Steinhuber – CEO, Innovacell Biotechnologie AG
Highlights and news: Study results using cell therapy for treatment of stress urinary and fecal incontinence

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• Dr. Claude Gimmi – Global Head, Oncology Business Development and Licensing, Boehringer Ingelheim

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• Thorsten Umland – Head, Business Development Consumer Care, Bayer HealthCare

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• Begoña Carreño – Global BD&L, Head Search and Evaluation Primary Care, Novartis Pharma AG

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• Dr. Tim Herpin – VP SPBD Oncology and Science and Technology Licensing, Strategic Partnering and Business Development (SPBD), AstraZeneca

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• Tanja Weber – Strategy and Business Development, Corporate Licenses, VP Oncology, Sanofi

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• Tibor Papp – Director, Scientific Licensing, Shire Pharmaceuticals

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• Dr. Susan Jane Herbert – Executive VP, Global Business Development; Strategy Member, Merck Serono Pharmaceutical Executive Committee

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• Dr. Manfred Horst, MD, PhD, MBA – Director, Business Development, Worldwide Licensing and Acquisitions, MSD/Merck

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• Bettina Hamelin – Interim Medical Director, Primary Care Business Unit, Pfizer

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• Jørn R. Müller – CVP, Biopharmaceuticals Innovation Sourcing, Novo Nordisk

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• Dr. Markus Werner – Director Commercial Licensing, Global Business Development, Takeda

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• Nicki Thompson – Director, Business Development; Alternative Discovery and Development, GlaxoSmithKline

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• Joseph McCracken, DVM – Global Head, Business Development and Licensing, Roche Partnering

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• Alexander Schuth, MD, PhD – Associate Director, Business Development, Genentech Partnering

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Moderators:
Evonne Sepsis – Managing Director, ESC Advisors
David Stubbs – Founding Partner and Managing Director, Inverness Advisors

• Cord Dohrmann – CSO, Evotec
• Lubor Gaal – Head of Europe, Search and Evaluation, Strategic Transaction Group, Bristol-Myers Squibb
• Shaun Grady – VP, Strategic Partnering and Business Development, AstraZeneca
• Barbara Yanni – VP and Chief Licensing Officer, MSD/Merck

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