BIO-Europe Spring^® 2012 Program Overview

Traditional drug discovery models focused on target identification, validation, and screening as well as early methods for developing and testing immunotherapies are giving way to much more sophisticated, specific, and ultimately more efficient ways of developing therapeutics. This session will examine some of the newest drug discovery models that are attracting investment in this difficult financial environment and accelerating the path to clinical proof of concept.

Moderator:
Joe Dillon – President, Dillon Capital Strategies

Panelists:

• Ada Kruisbeek – CEO and CSO, DCPrime
• Chris Varma – CEO, Blueprint Medicines

BIO-Europe Spring^® 2012

Today's dealmakers are facing new challenges in ever-changing times. Although investments in emerging technology are happening more frequently now than two years ago, competition among companies for investment dollars is fierce. Recent deals have shown that young companies are not only learning to assess the marketplace, but are becoming more sophisticated in their approach to investors. However, there is still a great deal to learn about how to better position the asset in order to attract investors or deal partners. Development of an asset has to be done with an understanding of the goals, both short term (attracting investors) and long term (partnering, M&A or taking the product to market). In today's environment, positioning the asset is as important as positioning the company. This workshop will discuss how to assess and manage the asset, how to develop a plan to correctly position the asset for a deal, and how such a plan can lead to a successful partnership.

Moderator:
Diane Romza-Kutz – Partner, Troutman Sanders

Panelists:

• Martin Buckland – CBO, Astex Pharmaceuticals
• Steve Damon – CEO, 4P Therapeutics
• Beth Fordham-Meier – VP, Licensing and Intellectual Property, Targacept
• Horacio Moreno – Head, Licensing and Corporate Development, Almirall

BIO-Europe Spring^® 2012

Those coming to BIO-Europe Spring in Amsterdam have dealmaking on their minds. This session will feature several recent deals with Dutch companies. Whether it is an early investment, a joint lead development deal including milestone payments, or a licensing deal between a biosimilar and a formulation technology company, this session will provide insight from both sides of the deal. Executives will discuss how the parties met, what the dealmaking hurdles were and what they learned from the process. They will also look at how the alliance has been managed since the deal was put into place, and discuss future plans. With a special emphasis on Dutch biotech deals, this session is sure to be enlightening!

Moderator:
Roel Bulthuis – Head, Merck Serono Ventures

Panelists:

• Mikael Brönnegård – CEO, NeuroVive Pharmaceutical
• Willem van Weperen – CEO, to-BBB technologies

BIO-Europe Spring^® 2012

Life science executives, venture capitalists and researchers are adopting Twitter in greater numbers, making it (even) more valuable to all of us. Find out what the fuss is about in this interactive session. Veteran Twitterer Steve Dickman of CBT Advisors will show you how to set up a (free) Twitter account, populate it with experts and increase the value of your information flow right away. Our fellow life science Twitter maven Maude Tessier recently described Twitter as all of the following:

• An ideal source for real time data/news to inform business strategies
• A helpful forum to poll the community on a subject
• A platform to comment on the state of the life science industry
• A way to better understand how people think
• A tool to make new connections with companies and patient groups

not to mention

• A medium to build credibility for you and your organization.

We agree with all of that. Adoption and improvement of Twitter by life science dealmakers and executives is just beginning—come with your laptop or tablet and find out what it's all about.
Please note that seating for this session will be limited to 50 people on a first come, first served basis on site.

Instructors:
Steve Dickman – CEO, CBT Advisors (@cbtadvisors)
@Michael_Gilman – CEO, Stromedix

BIO-Europe Spring^® 2012

With quite a few assets currently in late stage development, this panel takes a look at how these deals strive to overcome the inevitable challenges in late stage drug development. While it is sometimes argued that late stage deals face less science risk, other factors can be equally as challenging. The high costs of large clinical trials, risks associated with regulatory hurdles, and the preparation for market access must be taken into account. Therefore the decision whether to go it alone or how to partner strategically is critical. Join this panel to learn how major companies are mitigating this risk and betting on later stage assets.

Moderator:
Michael Steiner, PhD – Managing Partner, JSB Partners

Panelists:

• Philippe Lopes-Fernande – VP, Head of Global Business Development, Merck Serono
• Gunnar Olsson – VP, Head of CVGI Innovative Medicines, AstraZeneca
• Barbara Yanni – VP and Chief Licensing Officer, Merck

BIO-Europe Spring^® 2012

The panelists in this session examine some of the significant deals of the last 12 months, including transactions they have been involved in, and what these deals reveal about pharma's priorities, strategy and the options available to drug development companies in need of a corporate partner. Join dealmakers from these major companies for a strategic look inside the deal.

Moderator:
Ben Bonifant – Practice Area Leader, Campbell Alliance

Panelists:

• Frank Borriello – Director, Corporate Development, Millennium: The Takeda Oncology Company
• Young Kwon – VP, Business Development, Momenta Pharmaceuticals
• Sander Slootweg – Managing Partner, Forbion Capital Partners

BIO-Europe Spring^® 2012

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 explores these nascent deal and company structures as well as innovative approaches to rethinking the drug development model.

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

Panelists:

• David J. Collier, MD – CEO, Velocity Pharmaceutical Development; Managing Director, CMEA Capital
• Dennis J. Purcell – Senior Managing Director, Aisling Capital
• Thomas Zioncheck – Senior Director, Business Development, Genentech

BIO-Europe Spring^® 2012

After years of chasing blockbuster opportunities in the US and established European markets, life science companies are shifting focus. The commercial strategies of large as well as mid-tier companies are gearing up to take advantage of specialty indications and regional markets, such as China, the Middle East, Russia and South America. Whether it is by building up a presence in these markets or by entering into commercialization deals with regional players who already have a distribution/sales network in place, this panel will examine different strategies related to commercialization in specific territories.

Moderator:
Ian Wisenberg – Managing Director, ChinaBio^® Capital Partners

Panelists:

• Carlos de Sousa – VP, Head of Commercial Licensing, GLBD, Takeda Pharmaceuticals
• James O'Mara – VP, Corporate Development, Ironwood Pharmaceuticals
• Håkan Wickholm – Director, Regional Business Development, Central & Eastern Europe - Middle East & Africa, AstraZeneca

BIO-Europe Spring^® 2012

Investing in life science companies has always presented special challenges to venture capitalists. And the math is only getting worse, as timelines, costs and regulatory hurdles increase while exit opportunities have nearly vanished. How are current VCs, especially those who became life science investors because they love the science, coping with these new realities? Is there a recipe for successful investing in early stage science? Will recent initiatives from both government and industry designed to husband early stage science out of academic institutions help or hurt the venture industry? Join the panel as they discuss these and other questions facing the industry.

Moderator:
Wendy Johnson – Venture Partner, ProQuest Investments

Panelists:

• Stuart Collinson – Key Voting Member, Forward Ventures; CEO, Tioga Pharmaceuticals
• Anja Koenig – Managing Director, Novartis Venture Fund
• Carsten Schou – General Partner, SEED Capital Denmark
• Dinko Valerio – General Partner, Aescap

BIO-Europe Spring^® 2012

This panel will examine the major clinical and commercial developments among companies using stem cells and regenerative medicine as therapies and drug discovery platforms. It will also consider progress in the development of immunotherapies and therapeutic vaccines to treat cancer and other diseases. As these products continue to progress through the clinic and stem cells continue to evolve as important tools in the drug discovery arsenal, what role will big pharma play in supporting these new therapies? Will mid-tier pharma and established biotech companies be willing to step in sooner? This panel will discuss these and other key questions in the evolution of this important sector.

Moderator:
Morrie Ruffin – Managing Partner, Adjuvant Global Advisors

Panelists:

• Douglas W. Losordo – VP, New Therapeutic Development, Baxter Healthcare
• Gil Van Bokkelen – Chairman and CEO, Athersys

BIO-Europe Spring^® 2012

Around the world, the new realities of the healthcare landscape have caused investors and companies (including non-life science entities) to rethink their strategies for dealmaking. In this session, we will explore multifaceted examples of powerful strategies and non-traditional deals. Panelists will describe how and where they fit along the continuum of "unconventional deals to herculean strategies."

Moderator:
Lee McCracken – Former Corporate Head of Business Development, Prometheus Laboratories (acquired by Nestle Health Science)

Panelists:

• Harry Glorikian – Managing Partner, Scientia Advisors
• Ted Snelgrove – Chief Commercial Officer, Crescendo Bioscience

BIO-Europe Spring^® 2012

The past few years have seen dramatic changes in biomarker driven drug development due to the evolution of our understanding of cancer biology.

The rapid improvements in multiplex diagnostic platforms and sequencing technologies open up seemingly endless possibilities for personalized oncology, but also raise challenging questions:

• Will personalized medicine enable or disrupt our ability to develop cancer drugs more effectively?
• Will the endless possibilities lead to no end for drug developers?
• How can we ensure that novel cancer drugs reach the patients who need them, while providing sufficient funding and incentive for the companies to embark on the journey?

In recent meetings, the concept of community drug development as a partnership between academic institutions, diagnostics companies, technology providers and multiple bio/pharma companies has been suggested as a new model for cancer drug development. Will this new approach help to realize the opportunity of personalized oncology?

In this session, we will discuss the potential opportunities and challenges of this novel method.

Moderator:
John Freshley – CBO, Compendia Bioscience

BIO-Europe Spring^® 2012

The final and most dramatic phase of the patent cliff coupled with the wreckage from attrition have left the pharma industry grappling with something more difficult than protecting the balance sheet. In a world so thoroughly dominated by generic medicines, pharma is now struggling just to stay relevant. Biotechs seeking to partner based on early stage data also need to focus hard on proving the unquestioned relevance of any proposed new therapy—even if data do not yet exist to support proof of concept for the program. Just as importantly, due to today's shortened capital runways, these companies will need to address the challenge of de-risking on early data in small numbers of patients, which means their knowledge of relevant biomarkers must be at least equal to that for the mechanism/target. This presentation will highlight some strategies for successfully navigating the rough waters ahead.

Speaker:

• Ed Saltzman – President, Defined Health

BIO-Europe Spring^® 2012

The antimicrobial marketplace is heating up, with renewed interest in antibiotics from companies of all sizes. The ever present threat from Gram positive pathogens like Staphylococcus aureus is being overshadowed by the increasingly problematic issue of treating multidrug resistant Gram negative pathogens like Pseudomonas spp. and Acinetobacter spp. In addition, Clostridium difficile continues to increase in terms of both prevalence and severity across the USA and EU.

As a result, big and specialty pharma now see a potential opportunity to return to this space, but, unfortunately, few have the pipelines at hand to realize their ambition. Many companies are thus looking outside for well differentiated, novel agents to address these growing unmet needs—good news for all biotechs with innovative programs, whether they are traditional small molecule approaches, immunological therapy or host defense peptides.

Join us for this session where Tim Joslin will convene a panel to discuss the key issues for originators and their future partners as the antimicrobial market space comes back to life.

Moderator:
Timothy Joslin – Managing Director, Europe, Defined Health

Panelists:

• Simon Dew – VP, Business Development and Early Phase Commercial Development, Astellas Pharma Europe
• Peter Hammann – Head, External Opportunities and Innovation, R&D TSU Infectious Disease, Sanofi
• Mark Leuchtenberger – President and CEO, Rib-X Pharmaceuticals

BIO-Europe Spring^® 2012

This panel will explore the intersection of clinical development of anticancer therapies with the commercial realities of cancer drug development, and how Proof of Relevance is becoming even more relevant in an increasingly competitive oncology market. Using development of novel immunotherapies and next generation biologics for cancer as the context, we will examine how potential utility of a platform at an early stage of development looks to address the unmet needs within a given tumor type, and then how the details of the treatment space must shape the clinical development path and product characteristics: practical aspects of disease management, evolving standard of care, and competitive dynamics. For example, in the instance of Provenge, a novel product was introduced into the market after many years of development only to face logistical, reimbursement, and perhaps most critically, competitive pressures. Questions to be addressed include how the logistics of the technology affect the Target Product Profile (e.g., does the efficacy bar need to be higher for more logistically difficult approaches?), how can one learn from the unmet needs and market to modify the approach to make it more "user-friendly", what are the levels of hurdles to focus on for achieving meaningful outcomes for all parties (physicians, patients, payers), the impact of generics and biosimilars, and how much does one need to keep an eye on the competition (not just other vaccines but more broadly)?

Moderator:
Jeffrey M. Bockman – VP, Defined Health

Panelists:

• Paul G. Higham – CEO, immatics biotechnologies
• Matthew McCourt – Director of Biology, Oncology, MedImmune
• Wolfgang Wein – Executive VP, Global Business Unit Oncology, Merck Serono
• Christian Zahnd – CEO, Molecular Partners

BIO-Europe Spring^® 2012

Pain stands out—not in a good way—as a therapeutic area with one of the largest or even the largest patient population. While there is a good understanding of the underlying biology of pain as a therapeutic category, there are only a few very old therapeutic targets (e.g., opioid receptors and prostaglandins). This leaves clinicians with a limited tool box to address the needs of a wide range of patients and pain conditions, and the "one size fits all" approach has resulted in "one size fits some"—leaving a large number of patients with significant unmet need.

Historically, the industry has relied on novel delivery methods to overcome some of the issues associated with existing therapeutic approaches, but the ability to make meaningful improvements on the standard of care via delivery tweaks is harder and harder to do. In addition, the clinical trial requirements to prove superiority in terms of side effects and/or safety (e.g., number of patients and length of studies) are nearly insurmountable. To make a meaningful impact on unmet need, novel targets and mechanisms are necessary.

Various new small molecule approaches targeting a range of potential pain mediators (e.g., cannabinoid receptors, purinergic approaches, such as P2X7, chemokines, cytokines, and ion channels) have been, and are being researched with varying degrees of success. Pharma is also looking at biological therapies to address targets that are not amenable to small molecule approaches (e.g., nerve growth factor, IL–6, TNF) as a potential way to get over the wall of inadequate pain relief provided by traditional therapies. While the requirement for some biologics to reach a CNS-based target (i.e., cross the blood brain barrier) is not easily accomplished, novel technologies to facilitate penetration of the CNS is an active and emerging field of research.

This panel will discuss novel approaches to pain management in late, mid- and early stages of development.

Moderator:
Ginger S. Johnson – VP, Defined Health

Panelists:

• Iain Chessell – VP and Head, Neuroscience Centre of Excellence, MedImmune
• Juergen Haeussler – Head, Development Pain, Janssen R&D US
• Daniele Piomelli – Director, Drug Discovery and Development, Italian Institute of Technology

BIO-Europe Spring^® 2012

Speaker:

• Christoph Pittius – VP Strategic Partnering & Business Development, Bayer HealthCare Pharmaceuticals

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Speaker:

• Jennifer King – Senior Director, Scientific Licensing, Business Development, Shire

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