BIO-Europe^® 2011 Program Overview

This session will principally explore the much-ventilated but poorly understood concept of virtual drug development (which is NOT simply "hire a CRO"). The participants are all seasoned drug developers with first-hand experience in the whole range of development tactics: large pharma in-house development, use of CROs, and truly virtual drug development. All have their place. Indeed, there is even a difference between a small CRO and a large one in terms of approach, while virtual drug development goes a step further.
Small biotech needs to understand the whens, whiches, and whys about all these. When should each be deployed?

Moderator:
Tony Fox – President, EBD Consulting, Inc.

Panelists:

• Grahaem Brown – Director, Competitive Drug Development International
• Carsten Dehning – CEO, Aspireo Pharmaceuticals Ltd.
• Edgar Fenzl – Managing Director, FGK Clinical Research
• Axel Polack – General Partner, TVM Capital

BIO-Europe^® 2011

Optimizing drug substance and drug product development and manufacturing is a key factor in product quality and value in the preclinical development of biopharmaceuticals. The two processes go hand in hand, and most biotech companies rely on external partners. In its fourth year, this panel discussion focuses on critical issues such as when to start, how to reduce the risk, and how to keep costs low before POC. The panel of leaders from international CMOs will provide models and solutions for early stage product development and will answer questions on how to leverage a CMO’s core competences.

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

Panelists:

• Dorothee Ambrosius – Senior VP, Global Process Science, Boehringer Ingelheim Pharma
• Dirk T. Lange – VP, Global Strategic Alliances, KBI Biopharma
• Fritjof Linz – Senior Director, Business Development & Marketing, DSM Biologics
• Klaus B. Schoepe – Senior VP, Client Relations, Rentschler Biotechnologie
• Joerg Zimmermann – Director, Process Development and Implementation, Vetter Pharma-Fertigung GmbH & Co.
• Robert E. Zoubek – Head, Protein Characterization and Preformulation, formycon a division of Scil Technology

BIO-Europe^® 2011

Looking back on your last deal, what would you have done differently? During this interactive workshop, experienced business development executives will draw from their dealmaking experience and dive into some of the common and not so common pitfalls in partnering. The panelists will give examples of mistakes made in negotiations and around deal structures. They will discuss the correct use of arbitration clauses, how to prioritize deal points and how to recognize and acknowledge both parties' needs to create a mutually beneficial partnership.

Moderator:
Diane Romza-Kutz – Partner, Troutman Sanders

Panelists:

• Steve Damon – CEO, 4P Therapeutics
• Berthold Hinzen – Head, Global Business Development and Licensing General Medicine, Bayer Pharma
• Juergen Lasowski – Executive VP, Corporate Development and Strategy, Onyx Pharmaceuticals
• Linda Pullan – President, Pullan Consulting

BIO-Europe^® 2011

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

Judges:

• Roel Bulthuis – Merck Serono Ventures
• Begoña Carreño – Novartis Pharma
• Paola Casarosa – Boehringer Ingelheim
• Lubor Gaal – Bristol-Myers Squibb
• Thomas Hanke – Novo Nordisk
• Claudia Karnbach – Bayer HealthCare
• Gwen Melincoff – Shire
• Alex Schuth – Genentech

BIO-Europe^® 2011

This workshop will discuss recent developments in IP law, with special reference to personalized medicine and biomarker-assisted methods of treatment. The ways patents are procured, challenged or defended, and enforced are facing different changes on both sides of the Atlantic and, with large pharmas pushed over patent cliffs, the new IP framework and current market conditions will have far reaching effects not only on how deals are structured but also who those deals are with. What are the key changes to IP law in Europe and in the USA? How do they differ and what do they hope to achieve? What new deal models will result and between which market players? Do the changes give a competitive edge to one geography? This in-depth workshop on how IP developments can impact your company will include time for audience questions.

Moderator:
Peter Homberg – Partner, Raupach & Wollert-Elmendorff

Panelists:

• Alexander Bucka – Examiner, European Patent Office
• Robert Cobuzzi, PhD – Senior VP, Corporate Development, Endo Pharmaceuticals Inc.
• Marc Markus – Head, Patents, Biotherapeutics East, Pfizer
• Peter Nolan – Senior VP, Commercial Development, Oxford BioMedica
• Hans Sauer – Deputy General Counsel, Intellectual Property, Biotechnology Industry Organization (BIO)

BIO-Europe^® 2011

Major advances in medical research and information technology (e.g., e-health, m-health, social media) are broadening treatment options for many diseases. Focusing on the individual patient in a more holistic approach to improve health outcomes, the pressure is building for non-traditional partnering among diverse groups of players. In order to shift their drug discovery programs from conventional models based on costly, long haul clinical trials to a better predictive model based on the information gathered from genomics, there is a tremendous need for collaboration with companies with data management and analytics expertise. Every indicator is pointing toward a scenario where future health outcomes will depend on non-traditional partnerships and alliances.

Moderator:
Patrick Flochel – Partner, EMEIA Life Sciences Leader, Ernst & Young

Panelists:

• Joerg Moeller – Senior VP, Head, Global Clinical Development, Bayer Pharma AG
• Peer M. Schatz – CEO, QIAGEN
• Dan Zabrowski – Head, Partnering; Member, Corporate Executive Committee, Roche

BIO-Europe^® 2011

Few people would say it's a seller's market for biotech assets. However, in certain therapeutic areas, an interesting trend has emerged. There is a rising interest in assets in some of the most sought-after therapeutic areas: those where access is all but assured, patients are more easily identified, and the commercial call-point is narrow. These market characteristics are usually associated with niche indications which, ironically, have been the primary area of focus for growth-oriented biotech companies.

At the same time, traditional R&D-focused biotechs see the opportunity to enter these markets as commercial players. If large pharma companies continue to trend toward the same niche areas, can they continue to demonstrate the relevance of their traditional in-licensing model? Rather than picking and choosing from among biotech assets that have successfully overcome proof-of-concept hurdles, should pharma companies consider taking the same early-stage bets that biotech is taking?

These questions and others will be explored as the team takes a look at trends revealed through Campbell Alliance's Dealmakers' Intentions Survey and examines the implications for the year ahead.

Moderator:
Ben Bonifant – Practice Area Leader, Campbell Alliance

Panelists:

• Brent Bankosky – VP, Business Development, Tranzyme Pharma
• Scott Clarke – VP, Business Development and Scientific Licensing, BioMarin Pharmaceutical
• Gary J. Clements – Senior Director, Business Development, Shire
• Lubor Gaal – Head, Europe Strategic Transactions Group, Bristol-Myers Squibb

BIO-Europe^® 2011

With IPOs and acquisitions available to only a select few biotech companies there is an increasing interest in new business models that provide investors faster paths to liquidity. A few nimble VCs and entrepreneurs are developing funds and corporate structures that may once again make private biotech companies attractive investments. Whether constructing licensing deals where VCs receive cash dividends or rethinking the corporate structure, companies changing the game have one common theme: they focus on the drug, not the company. This panel will explore these nascent deal and company structures as well as innovative approaches to rethinking the drug development model.

Moderator:
Ruediger Herrmann – Partner, WilmerHale

Panelists:

• David J. Collier, MD – CEO, Velocity Pharmaceutical Development; Managing Director, CMEA Capital
• Regina Hodits – General Partner, Wellington Partners
• Olivier Litzka – Partner, Edmond de Rothschild Investment Partners
• Willem "Pim" Stemmer – CEO and Founder, Amunix

BIO-Europe^® 2011

Biotech/pharma licensing deals face many challenges, not the least of which is the possibility of deal termination due to lack of efficacy, safety or due diligence concerns. Between the 38% of deals terminated due to reprioritization and the 7% of terminations due to M&A activities, almost half of all deals come to an end for reasons that are completely outside the control of the biotech partner. This panel will tell the stories of companies that have faced such scenarios and have managed to move their compound forward nonetheless.

Moderator:
Denise Pollard-Knight – Managing Partner, Phase4 Ventures

Panelists:

• Beth Fordham-Meier – VP, Licensing and Intellectual Property, Targacept
• Michael French – President and CEO, Marina Biotech
• Johan Inborr – Head, Business Development (Pharma Products), Medivir
• Onno van de Stolpe – CEO, Galapagos

BIO-Europe^® 2011

That things will go wrong in negotiations and partnerships is not surprising. It can be a function of inexperience, not understanding the motivations of the other side, changes that occur during negotiations or changes that occur after the deal is done. Deal experts will discuss cases where they ran into difficult problems and how they came up with creative solutions.

Moderator:
Karen Bernstein – Co-Founder, Chairman and Editor-in-Chief, BioCentury

Panelists:

• Ronald A. Pepin, PhD – Senior VP and CBO, Celldex Therapeutics
• James Sabry – VP, Genentech Partnering, Genentech
• Robert Wills – VP, Alliance Management, Janssen Global Services
• Barbara Yanni – VP and Chief Licensing Officer, Merck

BIO-Europe^® 2011

Increasingly, pharma companies are turning to academic institutions to foster early stage partnerships. So why now? For pharma these collaborations can be a way to access technologies and engage with talent already at university level. Within the academic institutions, the more commercially minded see these partnerships as a way to move their programs and technologies from the bench into the clinic more efficiently. Mutually aligned interests aside however, how do pharma and academia overcome conflicting core values, rights to IP, and co-mingling of funds to successfully manage the alliance? Is there a new drug development business model evolving that reduces the need for venture capital? This panel will explore academia's increasing role in the drug development ecosystem.

Moderator:
John Carroll – Editor-in-Chief, FierceBiotech

Panelists:

• Maina Bhaman – Director, Healthcare Investments, Imperial Innovations
• Matthias Gottwald – VP, Research Policy and Collaborations, Bayer Pharma
• Kristian T. Hansen – Director, Strategy and Sourcing, Diabetes Research Unit, Novo Nordisk
• Tom McCarthy – CEO, Spinifex Pharmaceuticals

BIO-Europe^® 2011

Radical collaboration, partnerships with nontraditional players that co-create value for each other and the healthcare system, is one of the core components of the emerging Pharma 3.0 trend. With innovation no longer focusing solely on new drugs or devices but on products and business models that will improve patient outcomes, pharma companies are turning to new players to implement these changes in the marketplace. But who are these new players and what is their agenda in the new health outcomes ecosystem? What core competencies do they bring to the table? What new approaches to sharing will be necessitated by their involvement in product development? Mostly importantly, how can these new deals be monitored for success? This panel will explore the changing dynamics that these new players and the deals established with them are creating in today’s industry.

Moderator:
Siegfried Bialojan – Executive Director, Head European Life Science Center Mannheim, Ernst & Young

Panelists:

• Frank Kumli – Lead Analyst, Life Sciences, Ernst & Young
• Lee McCracken – Former Corporate Head, Business Development, Prometheus Laboratories (acquired by Nestle Health Science)
• Ruediger Weseloh – Senior Director, Head Strategic Transactions, Merck Serono

BIO-Europe^® 2011

In this session, experienced dealmakers, pharma leaders and diagnostic development experts will explore:

• If pharma and biotech are now embracing a personalized approach to oncology drug development, what capabilities are now required for them to succeed?
• Recent applications of personalized medicine strategies to advance clinical and market development of novel therapeutics.
• Predicting a changing regulatory environment and its impact on translating biomarkers to the clinic and into the marketplace.
• Identifying the new players emerging within the personalized medicine space (i.e., emerging companies, re-modeled companies, institutes, patient-centered social media).
• What will dealmaking look like with these new players?
• What role will small and midsize companies play in this rapidly developing space?

Moderator:
John Freshley – CBO, Compendia Bioscience

Panelists:

• Peter Collins – VP, Diagnostics, GlaxoSmithKline
• Joseph Monforte – Executive VP and CSO, AltheaDx
• Graeme Smith – Senior Project Director, Oncology Innovative Medicines Unit (iMed), AstraZeneca

BIO-Europe^® 2011

Nanotechnology is best known as a drug delivery method, but an increasing number of companies are using nanomedicine to apply its special characteristics to therapeutic drug development. This panel will explore the definitions, differences, and respective benefits of the therapeutic uses of nanotechnology, using examples currently in use and under development. The panel will also explore the role nanomedicine can play in the development of personalized medicine and how new methods of collaboration might be necessary for this unique therapeutic approach to flourish.

Moderator:
Laurent Levy – CEO, Nanobiotix

Panelists:

• Dr Alain Herrera – Alain Oncology Consulting
• Christoph Huels – VP, Head, Early Stage Licensing, Portfolio Development, Merck Serono
• Bertrand Loubaton – Director, Pharmaceutical & Academic Collaboration Europe, GE Healthcare

BIO-Europe^® 2011

Australia Unlimited: Unrivaled Biotech Opportunities Down Under

With its thriving network of 470 biotechnology companies, Australia has a well-established reputation for biotechnology and is now the world's fifth largest biotech center.

Australia is an attractive market for pharmaceutical investment in the Asia-Pacific region due to its growing population, excellent access to medicines, strong and resilient economy, world-class science, strong government funding for public research and development, great capacity for international partnerships, cost effectiveness, and a robust, transparent and efficient regulatory system, in particular surrounding IP protection. By the end of March 2011, the sector achieved its highest ever total market capitalization of AUD 25.8 billion. This positive trend is a reflection of the ongoing efforts of the Australian Government in fostering innovation and international competiveness through programs like Commercialisation Australia which has supported more than 30 biotech-related projects through grants worth AUD 13 million. The Australian Research Council Linkages Projects for Australian and international partnerships between universities and industry delivered over AUD 33 million to biotechnology and biological sciences projects in 2011. The Australian Government's new R&D Tax Credit provides a tax offset of up to 45 cents on the dollar designed to encourage more companies to engage in R&D in Australia. The Country Seminar will showcase Australia's wealth of untapped opportunities and competitive edge in the biotech and pharmaceutical sector, providing a unique overview of the industry and resources available for international companies and research institutes looking for an Australian product or service or to grow their business in Australia.

Speakers:

• Dr Juergen Michaelis – CEO, BioInnovation SA; Chairman of the Investment Committee, Terra Rossa Capital Pty Ltd., Adelaide, Australia
• Nicola Watkinson – Senior Trade & Investment Commissioner West Europe, Australian Trade Commission, Frankfurt, Germany

BIO-Europe^® 2011

Innovative Transformation of the Russian Pharmaceutical and Healthcare Industries: Pharma2020 and MedProm2020 programs

Speakers from Russian government agencies will emphasize the progress made in government initiatives, and discuss major milestones in federal and regional programs and recent developments in Russian healthcare reform implementation. Seminar participants will learn about:

• underlying factors contributing to the growth of the healthcare market in Russia
• prospective areas for investment in pharmaceutical development in the Russian Federation
• governmental initiatives to support R&D programs of foreign companies in the Russian Federation (including federal co-financing of R&D projects for up to USD 4 billion)
• regional initiatives to support innovations
• road map of applied scientific research in the field of medical technologies development in Russia

Governmental Program "Pharma 2020": Regional Aspects

• Sergey Tsyb – Director, Department of Chemical Engineering and Bioengineering Technologies Complex of the Ministry of Industry and Trade of the Russian Federation (Minpromtorg of Russia)

Pharmaceutical and Medical Clusters in the Russian Federation

• Oleg Korzinov – President, Biopharmaceutical Cluster "Northern"

Successful Investments into Russia's Emerging BioTech and Pharma Industry

• Henrik Konarkowski – Director, ChemRar Venture

Integrated R&D to Proof of Concept Engine with Russian CRO

• Irina Tyrnova – Director, Business Development, ChemRar High Tech Center

Representatives of the regional pharmaceutical (St. Petersburg, Yaroslavl, Kaluga) and medical clusters in Russia, established to implement the strategies of Pharma2020 and MedProm2020

BIO-Europe^® 2011

Personalized Medicine: A Stronghold of Danish Biotech

Denmark has especially strong competencies within interdisciplinary and cross-sectional collaboration between researchers in the biotech sector. This makes it only natural that Denmark has an evolving discipline of personalized medicine and personalized prognostics.

Speakers:

• Dr Rasmus Beedholm–Ebsen – Project Manager, Invest in Denmark
• Dr Henrik Winther – VP, Corporate Business Development, DAKO

BIO-Europe^® 2011

The Future's Orange: Dutch Best Practices To Speed Up Innovation in Life Sciences

One of the main challenges in life sciences is to accelerate the development of drugs, devices and diagnostics while reducing costs. In other words, how do we decrease the time between bench and bedside? The Dutch life sciences and health sector presents a number of its best practices to accomplish this goal.

1. Cooperation is in our genes
   Building a strong and open life sciences and health cluster
   Annemiek Verkamman – Program Director, Life Sciences Health (welcome and chair)
2. Technology is our backbone
   Optimizing biopharmaceutical development and production
   Remko Clasen – Business Development Manager, BAC BV
3. Science shapes our minds
   A solid scientific foundation is key to fight priority diseases
   Guus Scheefhals – CEO, CrossBeta BioSciences
4. We have a nose for business
   The fast track from university to enterprise
   Ada Kruisbeek – CEO, DC Prime
5. Prosensa: We are all ears
   Patient oriented innovation
   Luc Dochez – Chief Business Officer and Senior VP Business Development, Prosensa Therapeutics

BIO-Europe^® 2011

Austrian Influenza Pipeline

The highly contagious viral disease influenza is on the radar of Austrian life science companies and the potential is vast. According to the World Health Organization (WHO), 15 percent of the world's population suffers from an influenza infection each year, leading to between 250,000 and 500,000 deaths. At least four Austrian companies are trying to find innovative ways to combat this viral infection and to prepare for possible pandemics to come.

Moderator:

• Johannes Sarx, MBA, BSc – Manager Life Science Austria, Austria Wirtschaftsservice

Speakers:

• Dr Roger Beerli – Head Human mAb Discovery, Intercell AG
• Dr Angelika Bodenteich – Head Development, Marinomed Biotechnology
• Dr Oliver Szolar – CEO, Savira Pharmaceuticals

BIO-Europe^® 2011

Speaker:

• Paola Casarosa – Head, Respiratory Licensing, Boehringer Ingelheim

BIO-Europe^® 2011

Speaker:

• Michael Petersen – Senior Director, BD/KAM Contract Manufacturing Business Biopharmaceuticals Europe, Boehringer Ingelheim

BIO-Europe^® 2011

Speaker:

• Michael Schultz – VP, Global Business Development & Licensing; Head, New Business Ventures, Bayer HealthCare AG

BIO-Europe^® 2011

Speaker:

• Carlos de Sousa – VP Corporate Licensing , Nycomed: a Takeda Company

BIO-Europe^® 2011

Speaker:

• Thomas Hanke – Director Biopharmaceuticals Sourcing, Novo Nordisk

BIO-Europe^® 2011

Speaker:

• Manfred Horst – Director, Scientific Liaison, Licensing & External Research Europe, MSD

BIO-Europe^® 2011

Speaker:

• Stewart Kay – Director, Transactions, GlaxoSmithKline

BIO-Europe^® 2011

Speakers:

• Michael Crowley – Director, Business Development, Genentech
• Shafique Virani – Global Head, CNS Business Development & Licensing, F. Hoffmann-La Roche, Basel

BIO-Europe^® 2011

Speaker:

• Begoña Carreño – Head, Search and Evaluation Respiratory, Global Business Development & Licensing, Novartis Pharma AG

BIO-Europe^® 2011

Speaker:

• Jane Buus Laursen – Business Development Director, Respiratory & Inflammation, AstraZeneca

BIO-Europe^® 2011

Speaker:

• Christoph Huels – VP, Head, Early Stage Licensing, Portfolio Development, Merck Serono

BIO-Europe^® 2011

Speaker:

• Christian Lerche – Associate VP Diabetes and Metabolism Strategy and Business Development, Sanofi

BIO-Europe^® 2011

Speaker:

• John Poulos – Group VP, Global Pharmaceutical Licensing and Acquisitions, Abbott

BIO-Europe^® 2011

Speaker:

• Philip Oliver – Executive Director, Global External R&D, Europe and MENA, Eli Lilly and Company

BIO-Europe^® 2011

Now in its ninth consecutive year, this provocative session is a true panel debate of strategic dealmaking issues by dealmakers from major companies. This year senior executives on the panel will focus on major transformational deals that have changed the competitive landscape and their companies’ position in the industry.

Moderator:
Anton Gueth – Managing Director, Burrill & Company

Panelists:

• Mercedes Diz – Associate Director, Licensing and Corporate Development, Almirall
• Gunnar Gårdemyr – Senior VP, Corporate Development/M&A, Nycomed: a Takeda Company
• James O'Mara – VP, Corporate Development, Ironwood Pharmaceuticals
• Catherine A. Sazdanoff – VP, Business Development, Takeda Pharmaceuticals
• Jack Tupman – VP, Corporate Business Development, Eli Lilly

BIO-Europe^® 2011