BIO-Europe Spring^® 2010 Program

The commercial strategies of mid-cap companies are shifting to take advantage of more accessible regional markets and specialty indications that are not always a good fit for the larger firms. The smaller companies also have the advantage of being able to build dominant market positions in niche indications and leverage this dominance into adjacent markets both regionally and in terms of specific product opportunities. This panel will examine variations of this strategy related to specific territories and disease areas that lend themselves to specialization and smaller more nimble marketing and drug development operations.

Moderator: Jeff Conroy – Managing Partner, Adjuvant Global Advisors

• Helmut Kessmann – CBO, Santhera Pharmaceuticals
• Jukka Muhonen – Director, Global Business Development and Alliance Management, Orion Corporation
• Carlos de Sousa – VP, In-licensing, Business Development, Nycomed

With big pharmas shrinking in number, with reorganizations underway at all of them and with pipeline rationalization a reality, the myth endures that biotech will be the salvation of the drug industry by supplying novel drug opportunities. Yet we find that doing deals today is even more challenging than ever. Can it possibly be that the biotech universe can no longer support every drug concept and the company behind it? How do we better match supply and demand? Or do we simply let Darwinian laws prevail? Five industry veterans, buy side and sell side, square off to try and bring clarity to a very fuzzy future.

Moderator: Jack M. Anthony – CEO, Osprey Pharmaceuticals USA

• Anton Gueth – Managing Director, Burrill LLC
• Wendy Johnson – President, Palkion, Inc.
• Dennis Purcell – Senior Managing Director, Aisling Capital
• Robert Wills – VP, Alliance Management, Johnson & Johnson

Many battle-lines have been drawn by large pharmaceutical companies and investors in the tight financing environment over the past year. Assets with definitive value stories in “hot” therapeutic areas such as oncology, CNS, and metabolics floated to the top. Many of these programs benefited during the surprisingly strong increase in licensing activity during the fourth quarter of 2009. So, in what areas do the next wave of partnering and financing opportunities exist? Over the past year, large pharmaceutical companies and investors have gravitated toward licensing and funding assets in a fairly narrow group of categories. This may be leaving some valuable opportunities for companies willing to partner with or invest in assets in other areas.

We have identified three areas that were not the focus of recent dealmaking, but with a moderate level of investment could yield a disproportionate increase in value:

• Early stage programs outside of the “hot” therapeutic areas
• Promising assets that require additional investment before embarking on an expensive phase 3 program
• And, pre-launch products about to enter challenging or highly competitive specialty or primary care markets

Join our panel of experts as they look more closely at the types of assets that fall into these areas and discuss what alternative partnering and financing options are available for the emerging companies hoping to commercialize them.

Moderator: Ben Bonifant – VP, Business Development Practice, Campbell Alliance

• Christoph Hüls – VP, Early Stage Licensing, Merck Serono
• Tom Needham – Partner, Advent Healthcare Ventures
• Michael J. Nowak, PhD – Managing Director, Yorkville Advisors, LLC
• James O’Mara – VP, Business Development, Ironwood

How effective are the corporate venture arms of big pharma today in selecting early stage programs that could eventually be pulled in-house?
Do they offer different insight into novel platforms or therapeutic opportunities that might not otherwise surface through traditional BD?
What are the benefits/challenges for early stage companies that are capitalized largely by corporate venture?
Does this limit their partnering options downstream?

Given the growing importance of corporate venture in financing early stage programs, these are all questions that must be addressed on both sides of the table. This panel will feature experienced investors from the corporate venture world, traditional BD groups and companies that have received significant investments from corporate venture groups.

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

• Roel Bulthuis – Head of Merck Serono Ventures
• Anja König – Managing Director, Novartis Venture Fund
• Patrick Krol – Partner, Aescap Venture
• Malcom Weir – CEO, Heptares Therapeutics

Spain is the EU country with the highest growth in biotech results in the past years and the BioRegion of Catalonia is the fastest growing biocluster in Spain. The international sector sees Barcelona as one of the key cities in the European biotech panorama in the next years. This panel, with the main actors in the Spanish and Catalan sectors, will provide insights in the organizations and initiatives behind this growth as well as in the common issues that all European regions must overcome to keep improving and raise their performance.

Moderator: Montserrat Vendrell – CEO, Biocat

• Rafael Camacho – Director, Genoma España
• Albert Castellanos – Director, Talència (CATALUNYA RECERCA)
• Joan Marca – Secretary General, Catalonia BIO (Catalan Association of Biotech Companies)
• Jordi Martí-Pifigueras – General Director, Amgen SA

With the globalization of the life science industry over the past decade, China has emerged as one of the key markets for the next decade. From the start, providing valuable preclinical services to the industry at the turn of the century, China has now established itself as a fully integrated drug development country with large commercial opportunities for big pharma, and several companies deploying large sales forces there. Our panel of experts will address, from their personal and company perspectives, various aspects of how and why China has evolved so rapidly and what other transformations they see over the next three to five years. This will include information about how they got started in China, regulatory challenges or hurdles they faced, funding opportunities and commercialization strategies.

Moderator: Ian Wisenberg – Senior VP, Strategic Development, ChinaBio LLC

• Michael Heerde – Director, Business Development, Bayer Healthcare Company, China
• Yuwen Liu – General Manager, bioBAY, and VP, Suzhou Ventures Group
• Richard Soll – Senior VP, Integrated Services, WuXi AppTec, Inc

In the past, management teams of development-stage companies have focused on the purity, safety and efficacy of a pipeline product. Commonly, a reimbursement strategy wasn’t considered until a product reached Phase III or was submitted for approval. With rising worldwide healthcare costs, the debate around US healthcare reform, and active Health Technology Assessment bodies throughout Europe, reimbursement is now being linked to cost-effectiveness, as opposed to only product efficacy. With this backdrop, biotech executives must consider reimbursement strategies earlier in product development as potential partners and investors now take a closer look at how reimbursement and cost- effectiveness influence a product’s commercial opportunities. Is cost-effectiveness the increasingly important factor in determining whether and at what level a drug will be reimbursed? If so, what are the current factors and parameters? The session will look at reimbursement trends with an emphasis on the NICE system—how decisions are made and the implications this system may have on the UK, Europe, and potentially the USA.

The panel will explore how this 4^th hurdle—reimbursement and cost-effectiveness—impacts product development, internal and external R&D at big pharma, and consequently partnering with biotech companies.

Moderator: Ted Buckley – Director, Economic Policy, Biotechnology Industry Organization (BIO)

• Kees Been – President and CEO, EnVivo Pharmaceuticals
• Meindert Boysen – Programme Director, Technology Appraisals, NICE
• Adrian Griffin – VP, HTA and International Policy, Johnson & Johnson
• Gordon McCauley – CEO, Allon Therapeutics

With pharma increasingly looking outside for strategic R&D capabilities, companies with valuable discovery technologies or cost-effective integrated preclinical services are now in a good position to find R&D partners. This session will examine what types of collaborative deal structures actually work, how IP issues are addressed, and how the parties remain interested and equally incentivized to see them through to a successful result. The panelists will also examine which groups within big pharma are driving R&D collaboration today. Are the TAs getting more involved or does the responsibility remain with the R&D and enabling technologies groups?

Moderator: Mike Ward – Senior Editor, BioCentury Publications

• Pamela Demain – Executive Director, Corporate Licensing, Merck & Co., Inc.
• Harren Jhoti – CEO, Astex Therapeutics Ltd.
• Manni Kantipudi – President, GVK Biosciences
• James S. J. Manuso, PhD – Chairman, President and CEO, SuperGen, Inc.

With the IPO window shut and VCs turning tail and hiding, the good news for biotechs is that pharma remains desperate for assets. While a strong sellers’ market persists for a winnowed population of late stage programs, the early stage deal space has become a very tough place for sellers. Pharma, while continuing to browse, seems not to like what it finds for sale, despite what might look to be attractive valuations on high quality programs. Pharma’s longstanding risk aversion is only one contributing factor to sluggish early stage deal activity—diversion of focus to address mega-restructurings and post-merger integrations, the perpetual need to manage quarterly earnings, numerous and nebulous environmental shifts such as regulatory uncertainty, healthcare reform, comparative effectiveness studies, pharmacogenomics / personalized medicine, and even changes in restrictions on marketing practices are also at play. Finally, pharma has its own early pipelines to manage. The early pipelines of the Top 10 pharmaceutical companies alone contain over 800 preclinical/P1 agents, and pharma is contributing to the crowded conditions for early stage sellers by stepping up their own out-licensing efforts.

Success for early stage companies and their investors moving forward will depend on something more vital than accomplishing proof of concept; that is, achieving Proof of Relevance (PoR). This entails making smart, calculated development decisions to prioritize those compounds capable of crystallizing for potential buyers their indisputable value without having to advance them to prohibitively expensive later stage development.

This session will discuss and provide examples of how thinking about PoR can inform platform development, lead candidate selection, target product profile creation, selection of clinical endpoints and/or biomarkers and early use of comparative outcomes studies.

Moderator: Ed Saltzman – President, Defined Health

• Jeffrey M. Bockman, PhD – VP, Defined Health
• Ginger S. Johnson, PhD – VP, Defined Health
• Timothy Joslin – Managing Director, Europe, Defined Health

The WHO predicts that by 2030 there will be 12 million deaths per annum worldwide due to cancer, and that at least 30–40% of these could be preventable. At present, however, only around 2% of the total budget of the National Cancer Institute (NCI) in the United States is directed towards cancer prevention and early detection.

Given the historical success of the industry in primary prevention in the anti-hypertensive and anti-hyperlipidemic spaces, the question arises as to whether oncology could ever support a risk-prevention market. If so, where and when will there be a place for pharmacological interventions, assuming that, at a minimum, preventing cancer will probably require a multimodality approach that incorporates early detection through screening, the avoidance of environmental carcinogens, and lifestyle choices with respect to exercise and diet?

Ultimately, perhaps the most challenging aspect of developing an agent for chemoprevention will be clinical development and regulatory pathway. Development of cancer vaccines, for example, has been stymied by the need to develop these within the advanced stage, usually refractory setting, while experimental model data suggests that earlier usage would probably be more beneficial.

This panel will explore the current and projected level of activity in the chemoprevention space, likely tumor prospects, promising MOAs and agents and developments with regard to endpoints, surrogates, biomarkers and clinical trial design.

Moderator: Jeffrey M. Bockman, PhD – VP, Defined Health

• Saverio Bettuzzi – Professor of Biochemistry, Department of Experimental Medicine, University of Parma
• Craig Eagle – VP, Strategic Alliances, Pfizer Oncology
• Douglas F. Hager – VP, Business Development and Licensing, Global Oncology, Novartis Pharmaceuticals

Thanks to the slow but steady advancement in the understanding of Alzheimer’s basic biology in the public sector, believers in the beta amyloid theory of AD (so called ‘BAptists’) are perhaps beginning to doubt their faith, and companies are spreading their bets onto other mechanisms. Targets are plentiful, and the next wave of big pharma deals is likely to be focused on approaches targeting the other side of the historical AD divide, tau, and its role in the formation of neurofibrially tangles (the doctrine of the ‘TAUists’).

The potential rewards from this still elusive market come with considerable risk, evidenced by late stage failures in the clinic (e.g., Flurizan, Myriad Pharmaceuticals and Alzhemed, Bellus, formerly Neurochem). In fact, the risk may be too big for even the biggest of the big pharma to face alone—that of bapineuzumab one of the most advanced and most controversial disease modifying AD therapies will of late be shared by a constellation of Elan, Wyeth/Pfizer and J & J.

Meanwhile, controversy remains around trial design and the optimal point of intervention in the progression of the disease and the development of biomarkers. A major concern is that treatment is being introduced too late in the course of the disease—at a point when the damage (to the brain) has been done. However, identifying patients at the very earliest stages of the disease requires biochemical markers or imaging techniques that correlate with clinical response. To date there is no clinically accepted surrogate marker of efficacy for AD.

This panel will discuss the current state of Alzheimer’s R&D as well as what’s next in terms of novel targets, trial design and the use of biomarkers.

Moderator: Ginger S. Johnson, PhD – VP, Defined Health

• Andrea Cavalli – Drug Discovery and Development, Italian Institute of Technology
• Sarah Holland – Global Head, CNS Partnering, Roche
• Manuel Lopez-Figueroa – VP, Bay City Capital
• Dale Schenk, PhD – Executive VP and CSO, Elan Corporation

There has been a renewed interest in antibiotics after a period of merger/change of ownership-induced torpor over the last three years, with a number of products finally reaching clinical stage development. Most of these agents are focused on Gram positive pathogens like MRSA and are advances on established classes as opposed to novel approaches. Gram negative pathogens look to be the major danger in the coming years, and currently there is a limited choice of marketed and developmental agents able to deal with the ESBL and carbapenemase producing pathogens, with clinicians resorting to decades old approaches like polymixin B. Extreme and multidrug resistant TB, and the continuing increase in problems caused by Clostridium difficile add to the maelstrom of unmet need in this space. Publicly available information on the current development pipeline and presentations/posters at major conferences like ICAAC do not show a wealth of novel and imminent answers to these problems.

Given the level of unmet need, is this market an attractive prospect for new entrants? If so, where might a new company want to place its bets?

This panel will discuss the future evolution of the battle against pathogens and give some insight into opportunities for all sizes of companies in this longstanding and potentially lucrative market.

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

• Georg Buchner – VP, Business Development, Novacta Bioscience
• Stefan Fischer – CEO, FAB Pharma
• Peter Hammann – Co-leader, Global Infectious Disease Initiative, sanofi-aventis