As business development professionals, we must have global vision to embrace drivers of value and create innovative partnerships and deal structures that capture the full global potential of our assets. Competing drugs approved for use in other countries can quickly move into new markets, pricing issues transcend borders, license rights to the product you seek may be available in countries outside your company’s span of commercial operations, and many other international issues can “flavor” even single country license deals. Deal assessment is complicated when variables like treatment protocol, patient behavior, epidemiology, competitive environment, regulatory frames, partner behaviors and a host of other factors vary significantly country to country.

In this workshop you will get an insight into researching, assessing and architecting partnering opportunities with global potential. What are the challenges faced by deal-makers in today’s fiercely competitive licensing and M&A environment? What are the partnering, due diligence and deal structuring issues and how can they be addressed? What are the analysis techniques for global market models?
Real world examples (both good and not so good!) will be shared and the panel will culminate with an interactive brain-storming session where all the attendee’s will be invited to share their experience on international business development good practice.

Translational medicine is certainly a new favorite buzzword within the research community, but, like all buzzwords, the term can mean different things to different people.

This interactive session will cut through the clutter with the help of an expert panel of leading industry scientists, clinicians, and technology thought leaders to focus on the following key areas:

What is Translational Medicine as it applies to the biotech & pharmaceutical industry?
- What is the role of all these new Translational Medicine departments?

How is Translational Medicine changing practices within the industry?
- The search for biomarkers, companion diagnostics, drug response and drug resistance “signatures”

What does Translational Medicine mean to business developers? Why should we care?
- Is Translational Medicine just a bunch of hand-waving or is there something real here?
- What do these signatures and biomarkers mean to the risk and value of a drug?
- How does Translational Medicine fit into your diligence activities?

This session will be structured with multiple Q&A breaks to ensure an interactive, informative and fun session.

Europe has a strategy for biotechnology as a continent but its best achievements are driven nationally and by the achievements of individual companies, entrepreneurs and investors. Europe has great strengths in many areas of R&D, in technology diversity, and in its enthusiasm for success in biotechnology. In areas such as cancer biology, immunology, enzyme technology, and bio energy, European efforts are world leading. Social healthcare creates better national bioinformatics, biobanking, and clinical trial networks. Its governments are competing to create better business environments - cutting taxes, incentivising investment, and promoting the commercialization of research.

But it is the responses of companies to this environment that determines the level of success. This session will show how European companies have built on technological strengths, channeled scarce resources like management and finance, and ultimately succeeded. When European companies get it right, they compete on the world stage.

This workshop will showcase several of these examples and explore different ways to raise capital in Europe. Until recently there has been limited specialized VC money available in Europe – Is this slowly changing? Are there any EU countries that offer new investment opportunities? Why? Which role do corporate funds play for young companies in Europe? How can European companies attract international investors?

The global drug development industry is changing rapidly and dramatically. While big pharma is trying to reinvent itself with R&D and in-licensing operations that are more nimble, decisive, and entrepreneurial in character, private equity, specialty pharma, and mid-sized pharma are also looking to acquire and develop the most promising phase II assets. Who will emerge as the dominant force in this competition for assets? How will Biotech companies position themselves to work with a growing variety of potential partners or acquirers? Will they be suppliers or competitors to big pharma in the future?

There are always difficulties in moving a young and under funded life science company forward. Most of these companies don't recognize the issues, having rarely dealt with them before. Many young companies fail because the founders do not understand the businesses implications on how to "run" the company as a real company; young companies fail to recognize that some initial deals can be made to create value and continue the development of their products, the "quid pro quo" deals; and these companies have little training on how to make the right licensing deal.

These three issues are only a few that will stymie the ability of a young company to create value. In addition, young companies don't understand the importance of such items as a cap table, realistic time lines as well as the value of, and usefulness of letting its board manage the business. These topics will be discussed with some case study examples during this session.

Not many big pharma players are very proactive in out-licensing, however some of them seem to revive out-bound partnering activities recently and there are more and more examples of successful deals and out-licensed compounds reaching the market. Shelved compounds from big pharma can still be of high interest to small companies and specialty pharma. Investors would like to fund more out-licensing deals, but the originators often want to keep their stake in the asset. It takes creative deal structuring to allow both partners to identify sufficient value in a deal and to avoid regrets later on.

In a market environment where reimbursement and access pressures may diminish returns and regulatory demands are increasing the investment required, deal values continue their resilient march forward. Are these factors changing the “sweet spot?”

In many instances, significant out-licensing deals are completed when a product enters phase 2 of development; however, in 2007, we saw several early stage deals for compounds whose INDs were recently filed as well as deals surrounding theoretically unproven platform technologies.

What market indicators can be identified from when deals are completed and what can we learn from these events to help guide future deals?

During this interactive panel we will review timing trends over the past year and analyze the indicators for when a deal might or should occur. Learn from personal experiences shared by those who have made—or helped make—the decision of when to do a deal.

Issues that they will consider will include what was the biggest surprise that they had when they were promoted and what is still surprising them today? What are the challenges that CEOs face every day and what are the issues that keep them up at night?

CEOs will also discuss their personal view on the good and bad habits CEOs either should want to acquire or avoid.

How do you value preclinical and clinical-stage assets in a disease area where the success heretofore has been almost non-existent? Nevertheless, because of the massive unmet medical need and market potential in Alzheimer’s Disease and other neurodegenerative disorders, the demand for even pre-clinical programs has led to record deals in the last two years. Almost every large pharmaceutical firm is desirous of having an Alzheimer’s therapeutic program in its portfolio.

This session will feature the principals involved in some of the most recent transactions in the Alzheimer’s field and will examine how the rapidly shifting opinion around the various pathophysiological orthodoxies (aBeta vs. Tau) affects deal valuations. The participants will also discuss the important interplay between biological markers, early disease diagnosis, and drug development.

In 2007 Venture Capitalists (VC) poured more than $4 billion into privately held drug discovery and/or development companies in 181 financing deals according to Windhover’s Strategic Transaction Database.

The biggest challenge for oncology-focused companies seems to be the ability to differentiate. It is not just about creating another start-up, it is about finding the best way to leverage on a specific technology and approach the oncology market with a clear strategy. The final aim is to become attractive candidates for pharmaceutical companies and create value by advancing programs in later stage clinical trials before out-licensing to a major partner.

What is the thought process of early-stage companies in the oncology space? What are the specific challenges that they face? Is there a best fund-raising or partnering strategy to adopt? What are VCs looking for when planning their investments in oncology companies?

This session will feature a panel of experts exploring current market dynamics and trends in the oncology therapeutic space. Panelists will also discuss the competitive landscape and the market potential of the most promising oncology drugs.

Therapeutic advances and increased funding for novel, more effective treatments have positively affected the global healthcare market. At the same time, life expectancy has increased along with the incidence of diseases associated with aging. Many of these age-related diseases develop from the loss or mis-regulation of specific cell types in the body, including a variety of neurological diseases (Parkinson's disease, Alzheimer's disease), metabolic diseases (diabetes) and cardiovascular diseases (heart failure, myocardial infarction). While many therapies currently exist to address these multi-billion dollar markets, none offer the long-term curative potential to fundamentally alter the disease like regenerative medicine.

This revolutionary field offers unique opportunities to explore and develop new therapeutic approaches to potentially prevent, treat and cure many debilitating and life-threatening diseases. A growing knowledge base has helped to ascertain the potential of these new technologies, but many challenges remain, including commercialization, and the lack of a clear clinical and regulatory pathway. This panel will explore some of these issues and the impact they are having on deal valuations in this field.

Funding and partnership opportunities for oligonucleotide-based therapeutics and technologies are at an all time high. RNA interference and antisense technology platforms are at the forefront of both licensing and M&A activity; for example, Alnylam’s $331 million up-front alliance with Roche or Isis’ recent deal with Genzyme, and Merck’s $1.1 billion takeout of Sirna Therapeutics. Innovative delivery technologies and other oligonucleotide-based technologies such as aptamers may also come into play.

But different technology platforms and IP positions mean a wide variety of deal structures are available for oligonucleotide therapeutics companies. Different technologies may be suited to different partnership structures or therapeutic spaces. Smaller firms must balance the need for pharmaceutical deal dollars and validation with dilution concerns and eventual M&A exit opportunities. Pharmaceutical companies eager for large molecule expertise in these exciting technological areas face buy-vs-ally decisions; which deal structures help buyers get the best from these technologies?

In this session we will review some of the industry’s most interesting platforms and discuss the licensing deals they’ve generated—whether target-based, therapeutic area-covering, exclusive rights to therapies or non-exclusive rights for technology access. RNAi and antisense remain high on pharmaceutical companies’ wish lists; how do yesterday’s deals set the stage for further licensing and acquisition going forward?

After years of discussions, the consensus view is that an expedited approval pathway for follow-on biologics (F0Bs) will soon be established in both Europe and the United States. Even some of the most steadfast opponents of FOBs have come to the realization that their just say “no” and “the science isn’t here yet” arguments are no longer tenable. Against this backdrop industry must now navigate the shoals of uncertainty as the U.S. Congress, the FDA, EMEA, and indeed the rest of the world slowly begin to role out their own, unique regulatory policies for approval of FOBs. In Europe the EMEA appears to be very cautious, but nevertheless is moving forward on a case-by-case approach for each biological and each indication. The US approach is still very uncertain and may be influenced greatly by what happens in the presidential elections in November. It is clear, however, that the political tide has shifted in the U.S. and it is no longer a question of if legislation will be passed, but when. This panel of experts will discuss how these uncertainties affect their decision making process and the positioning of their products during transaction negotiations.

With the much discussed declining R&D productivity, patent expirations, rise of generics, biosimilars and reduced effectiveness of the small molecule blockbuster model, the specialty pharma industry is beginning to look to new opportunities for growth beyond the traditional markets. This session will explore some of the new acute and specialty care market opportunities emerging in other parts of the world. It will evaluate options available to drug development companies to consider regional partnering options for their programs that will provide a better return and better access to rapidly maturing acute care markets in these new territories.

Biotechnology offers interesting business opportunities and is one of the most promising high technology sectors in Spain. The number of companies in Spain with biotechnology related activities is 581. Most of these companies are located in bioclusters which are fostering the development of this sector through the generation of synergies. The business relevance of the Spanish biotechnology is growing with very positive rates. According to Genoma España from 2000-2006 the number of biotechnology companies has grown 166%, their turnover has increased 200% and employment has experienced a growth of 750%. During the same period public investment in biotechnology has been four-fold up to 1000 M€. Moreover, according to the Spanish bioindustry association (Asebio) the number of Spanish biotechnology alliances has grown in the last two years and 37% of these alliances have an international partner.

This workshop will showcase four examples of pioneer and successful Spanish companies that will explain their keys to success, international agreements and future strategies. Advancell, a world leader in nanomedicine is developing a product for the topical treatment of psoriasis and other skin diseases. Biopolis produces high value products by fermentation of microorganisms with industrial applications in the agrifood and pharmachemical fields. Biotools is leader in real time kits platform based on its patented Lionprobes technology and PharmaMar is the world leader biopharmaceutical company, with five novel compounds committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines.