Monday, November 2, 2009
09:00–10:30

For the past several years, advocates of personalized medicine approaches have been reliant on the same case studies to make their argument—Herceptin and Gleevec—and skeptics have been quick to claim that these cases were the rare exception rather the rule. After the 2009 ASCO (American Society of Clinical Oncology) meeting in Orlando, perhaps the tide has turned and the exception is now the rule. Several breakthrough clinical trial results were announced, with objective response rates as high as 50%, in clinical trials targeted at specific subsets of patients identified using molecular or genomic markers. A panel of experienced biologists, dealmakers and biotechnology executives will explore:

• Recent advances in the clinical development of novel targeted cancer therapies
• The opportunities and challenges of replicating these advances into clinical results
• The effect on oncology dealmaking now and how it will affect dealmaking tomorrow

This session will be structured with multiple Q&A breaks to ensure an informative and dynamic exchange.

Monday, November 2, 2009
09:00–10:30

In these uncertain times, many companies are faced with unexpected challenges and obstacles. These changes do not always only affect one company but can have an impact on partnerships with other entities. How can a partnership survive or even thrive under such circumstances? This panel will discuss internal business structures which allow a company to grow, change and adapt to become more sophisticated in its approach to partners, investors and regulators. The panelists will discuss the economics of renegotiation and specific case studies.

CMO-Biotech Partnerships: Ways to Successful Collaboration

CMOs, drug delivery companies and fill-and-finish experts are key partners for biotech as well as pharmaceutical companies when it comes to costly, timely and successful biopharmaceutical product development. How can biotech/pharma companies identify these partners to optimize their own resources and accelerate timelines?

In this workshop, experts from five international service providers will explain the key success factors for securing and optimizing pharmaceutical outsourcing. Only a common understanding about the processes and needs can ensure timely and successful product development. From valid proposals, interactive project management to timely well balanced formulation and final drug product development all aspects will be discussed. Short presentations will be addressing the following topics:

• Making outsourcing a success—collaborations in biopharmaceutical manufacturing and product development
• From contact to contract
• Successful process development and clinical material supply based on risk-oriented strategies
• Communication and project management—watch out for the pitfalls
• Customer orientation in drug delivery—identify success factors along the process chain
• Optimizing efficiency and harmonization in outsourcing of fill-and-finish

Monday, November 2, 2009
09:00–10:30

The art of generating partnering interest in your technology or programs is in communicating your value proposition clearly and succinctly. Join our panel of BD executives and communications experts for a very interactive workshop that will help you open doors and accelerate the course to a successful partnership.

How can this year's important regulatory trends charm or harm your clinical development program? Three central areas of regulations, and how to leverage them into your plans will be discussed: Pediatric Investigation Plans (PIPs), biomarkers, and Good Clinical Practice inspections.

What these are, what they are not, and where is the payback? Some practical examples will be presented, together with time for discussion and questions.

Comprehensive information on the development of national biotechnology industries in the newest EU member states and candidate countries is finally available with the publication of the 14allbio Biotechnology Report, which offers an in depth look at the development of national biotechnology industries within these 14 countries. Critically examining the existing framework, available supports and to-date progress made in each individual country, this report provides a solid base on which future policy, business development activity and investor action can be based.

This workshop will review the findings of the 14allbio Biotechnology Report and current opportunities in Eastern Europe, and offer recommendations on how the biotechnology industry can be further developed. In addition, four companies from the newest EU members will give presentations in this specially featured workshop.

Monday, November 2, 2009
11:15–12:30

Over the last year, the biotech sector has gone through dramatic changes. The business models that have driven the industry since its beginnings were strongly based on venture funding and have become unsustainable through the financial crisis. With big pharma companies relying heavily on the biotech industry to fill their empty pipelines, biotech needs to re-invent itself to continue driving drug discovery and thus bringing novel drugs and therapies to patients.

Are there new and more sustainable ways of funding drug development on the horizon? What type of new business models will determine the future of biotech? In this plenary session, leaders from big pharma, biotech and the finance sector will share their insights on the metamorphosis of the life science industry and the impact these developments will have on their business strategies.

Monday, November 2, 2009
13:30–14:30

With the recent stall—and arguably collapse—of the financial markets, the past year has been a trying one for both large pharmaceutical companies and emerging biotechs alike. Is there indeed a silver lining on every cloud? This panel of industry executives will reflect on dealmaking intentions data collected earlier this year to discuss whether 2009 was a boom or bust. They will also share their initial thoughts on the direction of dealmaking in the year to come. Are there still clouds on the horizon or will 2010 be smooth sailing?

Monday, November 2, 2009
14:45–18:15

Monday, November 2, 2009
13:30–14:30

Has market volatility shifted the way pharmaceutical and biotech companies enter into agreements? An increased prevalence in inking option deals has emerged as a mechanism for pharmaceutical companies to mitigate risk and biotech companies to secure funding. Will the trend towards option deals and other back-ended deal structures prevail over time or even replace traditional M&A activity? This panel will address the viability of option deals in a changing economic climate.

Monday, November 2, 2009
14:45–15:45

M&A or partnering agreement, product or technology—in order to get the deal done, a biotech company has to be prepared to open its doors, books and labs to a potential partner. Especially for large deals, due diligence is a complex commercial, legal and financial analysis that involves almost everyone within the biotech company and needs to be well orchestrated. This panel will give guidance on what needs to be taken into consideration to conduct due diligence. How can a biotech company prepare for this process? Who needs to be involved? How can you get the timing just right? What does the pharma side expect to see and what do they not want to see? Panelists from both biotech and pharma will draw from their due diligence experience and discuss what worked and what did not work so well.

Monday, November 2, 2009
16:00–17:00

The pharma/biotech industry faces unprecedented challenges to its long term sustainability with the loss of blockbuster products, thin pipelines, public scrutiny of marketing practices, soaring R&D costs and increasing price competition in a global environment.The creation of a truly integrated portfolio management which includes the constant evaluation of all in-house R&D and product portfolios in comparison to existing in-licensing and M&A opportunities will become key. Predictably the willingness of companies to sell or out-license programs and products which have fallen outside the focus of a given company will distinguish out performers from under performers in the decade to come.

This panel will discuss the challenges and best practice solutions of an integrated portfolio management in big pharma and biotech companies. It will address structural questions and potential redesign of overall business models, the implementation of effective decision making processes, financial and managerial aspects of portfolio management and the interaction with outside parties such as VC funds and other companies who play an increasingly important role in optimizing good portfolio management.

Monday, November 2, 2009
17:15–18:15

With traditional financing sources dried up, companies are being told by their investors to be more creative raising money. Alternative forms of financing, including corporate venture, government funds, and philanthropic foundations are now on the radar screen. This panel will consider the pros and cons of such alternative financing options. When is the work involved in accessing government money worth the administrative effort? Is there a risk that corporate venture closes more doors than it opens? What strings are attached to money from charities? How do companies need to position themselves to take advantage of non-dilutive capital?

Monday, November 2, 2009
13:30–14:30

The vaccines area is one of steady increase in revenues and investment returns, and this trend is expected to continue in the coming years. While market surges due to diseases like swine flu occur, vaccine market growth is largely driven by rising usage in high risk adult populations, and the introduction of new products, especially combined vaccines for both adults and children.

Monday, November 2, 2009
14:45–15:45

CNS disorders affect approximately two billion people worldwide and generate healthcare costs and lost income totaling in excess of USD two trillion annually. As the aging population expands the economic burden intensifies, as does the unprecedented demand for safe and effective therapeutics. Despite the high unmet medical need and substantial global market opportunity, CNS-focused companies must contend with costly and extended R&D protocols, ill defined regulatory pathways, and significant investor skepticism given the high rate of development failures.

Monday, November 2, 2009
16:00–17:00

Healthcare reform in the United Sates is at the top of President Obama’s to-do-list. The debate continues as to exactly how the plans will alter access, quality and affordability, and subsequently for the biotech industry, how it will continue to foster the USA’s current high level of biotech innovation. This debate becomes an international industry issue as any company—from a big pharma to a Phase III-company preparing to launch its first product, to a 10-person start up—faces uncertainty about product pricing and reimbursement in the US market. Yet, in order to continue to attract funding, biotech innovation must maintain value for investors, business development partners and the public.

Monday, November 2, 2009
17:15–18:15

Ten years of investment in monoclonal antibodies (mAbs) have transformed innovative, technology-driven companies into product-focused entities. With several key leaders in this space now acquired by biopharma, opportunities remain buoyant for investment in and partnering of next generation antibody technologies. The panel will discuss their strategies for identifying and investing in biologics capability beyond mAbs, with a particular emphasis on strategic partnering as a forerunner to M&A.

Monday, November 2, 2009
13:30–14:15

To encourage international collaborations between science and industry, Austrian funding agencies offer tailored financial support for both academic and industrial partnerships. This workshop will provide a detailed overview of the various initiatives that are available to support these international partnerships. After an introduction to each program, the following executives will talk about their personal experiences of these initiatives and the results thereof.

Monday, November 2, 2009
14:30–15:15

Monday, November 2, 2009
15:30–16:15

As home to Canada’s largest biopharmaceutical cluster, Québec is a nucleus of creative thinking, development and discovery in the life sciences. Visit the Québec Pavilion (Booth 82) to learn about our most promising companies, technologies and development partners, as well as how you can advance your organization’s competitiveness by capitalizing on Québec’s strengths. Meet the people whose innovation has led to developments like 3TC, flu vaccines and Singulair®.
 
Québec’s life science sector includes over 400 companies employing 25,000 people, 20 university hospitals and close to 16,000 general and specialized care beds. You will understand why major pharmaceutical firms, contract research organizations and biotechnology companies have chosen to establish themselves in the province. Furthermore, you will learn about the Québec way of doing business, the province’s main players, and growth areas in which you can develop partnerships.

Québec is a great place to do business, since it offers:
- easy access to the North American market
- state-of-the-art scientific expertise
- a highly qualified work force
- a wide range of companies looking for partnerships
- technologies for your pipeline

Monday, November 2, 2009
16:30–17:15

An introduction to UK strengths by UK Trade & Investment, followed by short company presentations to demonstrate the diverse range of biotechnology R&D and services available in the UK.

Monday, November 2, 2009
17:30–18:15

The Biotechnology Report: “Biotech in the New EU Member States: An Emerging Sector” prepared by EuropaBio and Venture Valuation in 2009 ranks Hungary with the highest DCI (Development Capacity Index–a tool for the assessment and comparison of the biotechnology development status and potential of a country at a certain point in time, based on available data).
In the presentation the Hungarian Biotechnology Association will give a general overview of the Hungarian biotechnology industry including among others the major sectors, areas of activity, R&D and investment outlook, with a special attention turned to business climate, regulations and policies. The lecture will illustrate, using comparative tools, the position occupied by the country on the international biotech market. Last but not the least it will pinpoint the key factors that provide the basis for Hungary.

Tuesday, November 3, 2009
11:45–13:00

Now in its 7^th consecutive year, this provocative session is a true panel debating strategic dealmaking issues by dealmakers of major companies and investors. The panel topics will include:

• Strategic deal issues for biopharmaceutical companies: Partnerships and M&A
• Accessing capital through traditional methods versus the growing role of private equity
• The status and future of large company spin outs, project financing, out-licensing and divestments