The Business of Biotech

Calivin Coolidge, who served as president of the United States from 1923 to 1929, is often misquoted as saying “The business of America is business.” According to historians, however, what he really said was, “The chief business of the American people is business.” And he went on in the same speech to say, “Of course, the accumulation of wealth cannot be justified as the chief end of existence.” So the real Coolidge (as opposed to the caricature implied by the misquote) would have been impressed by the biotechnology industry, which was spawned in his home state of Massachusetts. Its business may be to make money, but that is certainly not the chief end of its existence. There are easier ways to make money, after all. But the people involved in biotech want to improve the quality of life on planet Earth — whether through health care, new energy, agriculture, or biomaterials and industrial biotechnology.

The new US president, Barack Obama, was elected on a platform of change during a time when not only the United States, but much of the world was facing what’s being called the most severe economic downturn since the Great Depression, which began the year Coolidge left office. The changes are likely to be sweeping: from economic stimulus to business regulation to healthcare reform. Some other countries have already enacted financial “bail-outs” of their local biotech industries, and the Biotechnology Industry Organization is lobbying for the US Congress to include its own biotechnology industry in any stimulus action that it passes. The organizers, speakers, and presenters involved in the business-related tracks at BIO’s 2009 International Convention will be addressing both the current situation its possible future consequences.

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Finance

Even during good economic times, raising capital can be a challenge. And in these tough economic times, it can be very difficult for a biotech company with no proven technology or commercialized product to raise the cash it needs to stay in business. Todd Davis, cofounder and managing director of Cowen Healthcare Royalty Partners, will present during a session on this topic at the 2009 BIO International Convention.

Here’s how he describes it: “We have brought together a seasoned groups of industry executives (all have close to or more than two decades experience) that are each leaders in their respective areas: banking, legal, private equity and venture capital (VC), and public equities. We believe this blend of expertise will foster an informative but also well-rounded discussion on the latest financing trends for biotechs.

“The recent economic slowdown has posed a number of new challenges for biotechs looking to raise capital. Our panelists will explore these in detail and provide first-hand insight on how they have helped companies overcome these challenges.” Davis says 2009 will be one of the most volatile years for biotechnology ever. “The intersection of science and finance is addressed in many key panel discussions,” he reports.

Looking for Capital Alternatives: Stiff competition among governments and economic development regions to attract and retain biotechnology companies has led to a variety of available tax credits, incentives, and cash grants to use for supplementing their operating capital. For example, the US federal government recently enacted refundable R&D tax credits and an alternative minimum tax. The commonwealth of Massachusetts has established incentive and grant programs for FDA filing fees, staff training and hiring costs, property and sales tax exemptions, refundable research credits, investment credits, and extensions to the carryover periods for operating losses.

Other models for obtaining product development financing outside the capital markets include royalty acquisitions, revenue-based structured finance deals, debt (if available), the formation of clinical collaborations with sources of finance, and vendor financing of clinical trials. Cutting-edge companies need financing options as innovative as they are. Especially with the equity window closed as it is now, nondilutive financing options are critical to providing essential growth capital. Royalty monetization, revenue interest financing and clinical development funding provide nondilutive capital to companies around the globe. Such deals have been made in the United States, Europe, and India.

Mark Kessel, managing director of Symphony Capital, LLC, is presenting at a session on this topic. “As biotech companies are unable to access the capital markets,” he says, “alternative forms of financing provide a much needed funding lifeline.”

Currently, Kessel explains, “the capital markets are for the most part shut, and investors are looking at those companies with sufficient cash to ride out the storm. Seeking ways to raise funds in a less dilutive manner provides a basis to preserve shareholder value.”

Michael White of Silicon Valley Bank is also presenting. “With the equity and debt markets closed to all but the largest biopharmaceutical companies, alternative funding strategies have never been more critical to our industry than they are today,” he says. “This session will provide insight into a variety of financing transactions that can help development-stage companies fund clinical trials and give commercial stage companies access to transformative growth capital.

White adds, “With a global recession predicted to last at least another 12 moths, this convention offers participants the opportunity to gain first-hand knowledge of strategies and tactics for surviving — and thriving in — a dynamic and challenging financial environment.”

Private and Public Markets: Debate continues as to how long the financing drought will last for initial public offerings (IPOs) of drug discovery and development companies. One thing is certain: The longer the IPO window remains closed, the more business models will have to change and adapt to it.

Nigel Sheail (global head of licensing) and Eric De La Fortelle (global head of external research and technologies) are both with F. Hoffmann-La Roche, Inc. and will be presenting at a session on this topic. “With panel members representing big pharma, biotech, and venture capital, our session promises to provide interesting and informed debate on the topic. Delegates will take away an understanding of how leaders in this industry are interpreting and responding to the ramifications of the current financial situation.”

Brian Atwood, managing director of Versant Ventures, will also present at the same session. “Attendees will hear about one of the most challenging times ever in the management of pharma and biotech companies,” he says, “and the new models we’re creating to respond to the economic and governmental changes in health care.”

Another presenter is Michael Ross, a managing partner with Schroder Ventures Life Sciences. “VC has financed the vast majority of biotech start-ups since the industry began,” he explains. “The model involves returning money to investors in VC funds within a 10-year or less time horizon. Doomsday types say that if there are no exits, there will be no returns and eventually no venture-financed biotech industry. Yet there is a huge and increasing need in pharma for biotech products. So getting to exits really should not be a problem. But how will this market evolve?”

Ross continues, “In the past 5–10 years, public markets have transitioned from being exits for biotech investors to being funding vehicles. There has been an ongoing argument about whether the funding of early stage biotech companies should or can include the public markets, and 2008-2009 has definitively answered that question in the negative. Our session will deal with different ways to finance and run biotech companies in the future to make money for investors and deliver their products.”

Ross’s final warning: “The biotech liquidity crisis is just as real as the credit crisis in the real-estate sector. How well we deal with this crisis will determine the strength of the industry as we come out of the recession.”

RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION

Finance Sessions: Monday 18 May 2009

Raising Capital in an Economic Slowdown

Life Cycle of a Life Sciences Company: Best Practices from Fundraising through the Exit

Finance Sessions: Tuesday 19 May 2009

Strategic vs. Financial Investing: A Dealmaker’s Discussion of Goals, Targets, and Strategies

Super Models: A New Breed of Life Science Funding

Undiscovered Capital! Realizing the Potential of Government Incentives and Grants

Finance Sessions: Wednesday 20 May 2009

“Where’s the Door? I Want to Get Out!” Searching for the Exits

Nondilutive and Other Nontraditional Forms of Financing

Raising Venture Capital in the United States: A Practical Roadmap for Foreign Companies to the World’s Largest Venture Capital Pool

Is Venture Philanthropy the New Venture Capital?

Finance Sessions: Thursday 21 May 2009

Specialty Pharma Play: Are We Near the End?

Financing the Southeast Biotech Sector

Darwinism Comes to Strategic Finance: Evolving Business Models and Implications for Biotech and Pharma

For complete session information, visit http://convention.bio.org.

US companies aren’t competing with each other alone for dwindling venture capital. Each year, more foreign companies have sought venture capital in the United States. Many of their managers have never raised US venture capital before and have limited knowledge of the process. Sonia Mangino, marketing manager of Choate, Hall, and Stewart LLP, is organizing a session on this topic at the 2009 BIO International Convention.

“Foreign life sciences companies seeking funding often do not understand how to secure a hearing from US venture capitalists flooded with business plans, nor how to effectively present to them once a hearing is obtained,” she explains. “Even US life sciences companies that have never raised venture capital are unlikely to understand the rules of the road. Many companies may not even know the pros and cons of seeking venture capital as opposed to other types of investments such as from strategic partners or understand the particular business value-add of US venture capital.”

Mangino predicts, “Because of the economic deterioration in economies throughout the world, 2009 will be an especially difficult year to raise venture capital. The practical tips provided by this panel should be invaluable in successful venture capital fund raising.”

RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION

Business Development Sessions: Monday 18 May 2009

A Marriage of Convenience? Big Pharma and Venture Capital

For Better or Worse, Richer or Poorer: Partners Who Will Go the Distance

Business Development Sessions: Tuesday 19 May 2009

Biotech M&A: How to Sell Your Company in an Environment of Consolidation

M&A for US Biotech: Think Outside the Box

Alliance Management’s Role in Building Partner-Centric Organizations: Recipe for Successful Alliances

Business Development Sessions: Wednesday 20 May 2009

Global IP Due Diligence

Deal-Making with Japanese Pharmaceutical Companies

Maximizing Value: How Tough Markets Are Reshaping the Business Models of Big Pharma and Venture Capital

Balancing the Equation in Leading Deals: Cherry Picking Value or a Sustainable Course?

Business Development Sessions: Thursday 21 May 2009

Business Model Conundrum: Focus on One Single Therapeutic Area or Multiple Areas?

Different Types of Partnerships that Compose PDPs for Improved Global Health

Effectively Managing Multiple Deals Across a Technology Platform

For complete session information, visit http://convention.bio.org.

The “specialty pharma” model (also called no-research-development-only, NRDO) has attracted significant amount of venture financing in recent few years as VC interest shifted away from funding early stage technologies. With investors looking to fund more established companies (with clinical-or preclinical-stage assets), fewer high-quality assets remain available. So the return-on-investment for NRDOs may be decreasing. Some in the industry are asking, “Are we near the end of the specialty pharma play? If so, what comes next?”

Given that the specialty pharma model has been popular over the past few years, people have been wondering if this is the only model VCs will continue to be interested in or whether other models will have a chance at financing. So far, NRDO successes have led some investors to see drug discovery or preclinical R&D as a “no-man’s land.”

Sofie Qiao, president and COO of LEAD Therapeutics, Inc., is organizing a session on this topic. “We are talking about the next trend in the biotech,” she declares, “a topic that everyone cares about and is dying to know. There have been memorable trends or fads in the past — e.g., monoclonal antibodies, genomics/proteomics/bioinformatics, gene therapy, and RNA interference, with specialty pharma being the latest. Clearly people are hungry to know the next trend.”

Qiao says that in business, winners are those who spearhead trends, whereas following a trend “will always make you a loser. If you cannot spearhead a trend, at least do not follow blindly, because as Warren Buffett said, ‘we simply attempt to be fearful when others are greedy, and to be greedy only when others are fearful.’ If everyone else has jumped on the wagon of investing in a particularly fad, chances are that it’s fundamentally overvalued.”

She further quoted Buffett when asked about the importance of attending the BIO International Convention in 2009. “[He] said that we have had an economic Pearl Harbor. Perhaps it is time we start thinking about revolutionalizing business models, as opposed to making incremental changes within the same old system.”

The NRDO phenomenon raises the question of who will fund real innovation. James Schaeffer, executive director of worldwide licensing and external research at Merck & Co, Inc, is organizing a session focusing on diverse approaches to support early-stage innovation through licensing. He describes this as a place where entrepreneurs and executives from early stage companies can “eavesdrop on a group of experienced life science professionals as they discuss innovative approaches to identifying, nurturing and advancing the early stage biotechs that are so important to the future of this industry.”

In the first half of 2008, not one life-science company completed an initial public offering, although many were acquired for substantial sums by bigger companies. Of those that did go public in recent years, few have successfully kept their stock prices above their initial offerings. Some people ask whether IPOs are still good options for achieving profitable exits for early investors. Should smaller biotech companies focus on selling themselves to larger corporations instead? If so, at what stage in their growth and development should those sales be made for greatest returns?

Raising a successful round of VC financing is critical for entrepreneurs; but equally as important is a successful, well-timed exit by those investors. The VC market has changed dramatically over the past 10 years. As the economy attempts to right itself, private investors are increasing their scrutiny and due diligence in finding viable, growing companies as investment targets — and fundraising itself will continue to evolve. Savvy companies excel in all areas of the life cycle: from an initial business plan through fundraising efforts and eventually a successful exit. By securing financing and valuable partnerships early on, a company positions itself to continue to grow and develop its business model — and eventually secure a lucrative exit that benefits all parties involved.

James Datin, executive VP and managing director of the life science group at Safeguard Scientifics, Inc., is chairing a session on the topic of the investment life-cycle. “Today’s economic climate is one of great uncertainty,” he explains. “With this instability, the success of many life-science companies will increasingly depend on VC investments.… Our panel, which will consist of speakers with diverse perspectives and unique industry expertise, will explore all aspects of the venture capital life cycle, including the importance of raising a successful round of financing and preparing for a well-timed exit. The goal of this panel is to arm life-science companies with a comprehensive understanding of VC investments and how they may be able to help them survive and succeed in this economic storm.”

How is that storm affecting the financing market? Datin says, “VC firms will be more selective in financings and increase the amount of due diligence performed for each deal. As the economy continues to struggle, VCs may encounter difficultly raising new funds, and with a lack of capital available to spend, valuations will drop. The IPO market for life-science companies was virtually non-existent in 2008, and it may not correct itself until 2010. In the interim, companies will rely heavily on their investors, which may prevent VCs from participating in many new deals in 2009. Life-science companies seeking capital will need to ensure that their businesses are well-positioned to meet investor requirements before the actual fundraising beings — as well as through fundraising to exit. Attending this convention will give companies a chance to learn first-hand about the difficulties facing VC in 2009 — and ultimately help them secure their own funding to keep their companies afloat during this economic rough patch.”

Business Development

One characteristic of this economic “rough patch” is an increase in big corporate merger/acquisitions, from stronger banks buying weak ones to big pharmaceutical mergers such as Pfizer-Wyeth and Roche-Genentech. Biotech companies large and small, public and private, are considering M&A transactions either as strategic growth opportunities or exit events. So consolidation among biotechs is an increasingly important and expanding trend. As large companies face the upcoming expiration of patents on many of their important drugs, some look to M&As for expanding their product pipelines. Smaller companies with both proven and promising products are prime targets for acquisition. And the challenging economic environment has made it difficult or impossible for many smaller companies to fund their R&D, making sales more necessary than desirable.

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Because consolidation is increasing, the need for smaller biotech companies to understand the M&A process and prepare for it is becoming all the more important. Many companies around the world have adopted M&A as their dominant mode of growth. With a weak dollar, US biotech companies are becoming especially appealing targets for international buyers.

Laura Stoffel with Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC, is organizing a session on these trends at the 2009 BIO International Convention. “This program provides a cutting-edge topic delivered by a first-class panel,” she promises, “focusing on providing developing life-science companies with the ability to prepare for and successfully navigate through the acquisition process. The audience will learn what steps they can take to prepare for M&A transactions as well as ways to leverage their assets and make them more enticing, highly valued targets.”

Robert Easton, chairman of Scisive Consulting LLC, will present at Stoffel’s session. “Access to capital is and will be the most critical issue for biotechnology companies for 2009,” he says, “and likely into 2011 and maybe 2012. The primary source of capital for the industry over this time-frame is almost certain to be larger medical companies. Astute biotech executives will position their companies to be maximally attractive to the larger companies most likely to be the source of capital to move them forward.”

Easton warns, “This will be one of the most difficult years in the history of the industry. More insight, more knowledge, and more networking will help differentiate winners form losers in an environment far more competitive and challenging than most biotech companies have ever experienced.”

For companies that don’t choose the M&A answer, partnering is another powerful option. Product development partnerships (PDPs) are becoming important contributors to global public health by developing essential tools that support disease-control efforts. PDPs leverage existing expertise at different companies to develop and make available new treatments for neglected diseases. As the industry evolves toward creating partnerships among companies, nonprofits, and academia, managers need to structure these collaborations to benefit all involved.

Jean Paccaud, director of business development for DNDI, is presenting

RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION

Legal Issues Sessions: Monday 18 May 2009

Contract Workshop: Best Practice Indemnification Provisions

Legal Issues Sessions: Tuesday 19 May 2009

Working within the Post-FDAAA Regulatory System to Mitigate the Risks of Marketing Biopharmaceuticals

Current Challenges in Managing Relationships Between Industry and Physicians

Launching a Commercial Product: The Key Legal and Regulatory Issues You Need to Know

Legal Issues Sessions: Wednesday 20 May 2009

Shaping Follow-On Biologics Policy: The Interplay of Data Exclusivity, Patient Safety, and Patents

Injunctions in the Post-eBay World: Will Compulsory Licensing and Price Competition Become the New Paradigm for Biologics?

Strategic Considerations in Considering Acceleration of International Patent Prosecution

The Narrowing Scope of Biotech Patent Claims: What It Means for the Industry

Legal Issues Sessions: Thursday 21 May 2009

The Unique Role of In-House Pharma/Biotech Lawyers: Legal and Ethical Risks

Technology Transfer and Licensing Sessions: Wednesday 20 May 2009

Town and Gown: Novel Industry–University Partnerships to Drive Innovation

Technical Standards Development in the Biosciences: Legal Issues and Pitfalls

Academia and Industry Going for the Gold

PDPs and Alternative IP Management and Tech Transfer Strategies for Improved Global Health

Technology Transfer and Licensing Sessions: Thursday 21 May 2009

Early Stage Investment Strategies: If Not Us, Who? If Not Now, When?

Crossing Borders and Barriers to Healthcare in Developing Countries

Antibiopiracy Restrictions on Patenting and Use of Genetic Resources

BioMS and Eli Lilly: Dissecting a Billion Dollar Collaboration

For complete session information, visit http://convention.bio.org.

In an era that has been defined by blockbuster product-licensing deals as well as mergers/acquisitions, product-option strategic collaborations and other risk–benefit arrangements have become increasingly prevalent for early and middle-stage development arrangements. For commercialization partners, measured payments for demonstrated success offers clear benefits. For development partners, such higher-risk deals can be fraught with pitfalls but may offer uniquely attractive benefits too.

Such risk-sharing deals have been increasingly used to further product pipeline development. Structured correctly, they can provide significant benefits to all sides; if not balanced, however, they can do more harm than good. One recent evolution has been in cross-border partnerships, which give rise to additional complexities based on differing business and cultural contexts on each side.

Andres Liivak, a partner in life-sciences transactions with Reed Smith, LLP, is chairing a session on this topic at the 2009 BIO International Convention. “In an interactive roundtable format,” he describes, “attendees will be presented with candid assessments of the current leading deal structures as well as new ideas for the deals that will be done in the next two years.”

Smith echoes the sentiments of so many involved in the convention this year: “We are in the midst of the most challenging period ever faced by the modern life-sciences industry. Collecting valuable information regarding these developments in well-run sessions and meeting colleagues to talk about it and network are critical for individual organizations and the industry to succeed into the future.”

Identifying attractive partners and determining what makes them attractive for successful relationships can be a daunting task. Managers need to understand the expectations for themselves and their partners to make a partnership succeed. Changes in technology, medicine, focus areas, and organization of a partners may disrupt its progress.

Partnering is an effective strategy for both early stage and mature companies. It’s often critical to young companies for funding development and a successful exit and to mature companies to maintain pipelines. Often early stage companies don’t yet have know how to identify which attributes in a potential partner will lead to a successful partnership. Many established biopharmaceutical companies continue to apply the metrics that were appropriate during their early stages when they should be considering other attributes of potential partners instead. Large pharmaceutical companies often focus on attributes in their potential partners that may not reflect their true value.

Lauren Kelley of Baker Botts, LLP, is organizing a session on this topic at the 2009 BIO International Convention. “In these turbulent economic times,” Kelly warns, “it is increasingly important to choose your corporate partners with care. This session will provide information on what early stage companies should be looking for and how to go about doing it. And it will provide information on how metrics change as companies develop. The session will also discuss what types of metrics have been used successfully by large pharmaceutical companies in identifying and building particularly strong partnerships.”

Kelly expects an audience of lawyers and managers. “Attendees will take away crucial metrics useful to executives interested in identifying successful partnering opportunities, regardless whether they are looking to add to their own pipeline or to push a promising lead forward. Similarly, the lawyers in attendance will take away key concepts that underlie successful partnerships and can be incorporated into agreements that maximize the strengths of both parties.”

This year is shaping up to be a year of unprecedented challenge and opportunity, Kelly predicts, “whether it is changes on the US national political scene or ongoing turbulence in the international financial sector.… Intelligent allocation of existing assets (for larger companies) and identifying opportunities to partner with or obtain funding (for start-ups and small companies) will make more of a difference to a market in which it is almost unavoidable that weaker companies or those with less cogent business plans will falter and in some cases fail. This year, more than ever before, it is crucial for members of the biotechnology community to attend the BIO International Convention. Not only will attendees have an unparalleled opportunity to meet and discuss such pressing political and economic issues with their peers, but it will also provide them with insights from the very policy makers and market movers that are pushing the industry forward every day. Finally, although 2009 will prove to be one of the most challenging years on record for biotech companies in particular, it will also set the stage for windfall gains to the companies who spent 2009 positioning themselves wisely, once a broad economic recovery gets underway.”

More Changing Business Model: Bioexecutives building company pipelines inevitably face the question of whether to diversify their development programs and address more than one therapeutic area. At this decision-making juncture, many issues must be addressed, including whether the company has appropriate expertise and available resources, what its commercial opportunity might be, and what kind of impact a broader pipeline would have on its positioning and valuation. Pam Lord, VP of Porter Novelli Life Sciences, is organizing a session on this topic at the 2009 BIO International Convention.

“What does success look like if a company is no longer focused or ‘a cancer company,’ but instead tackles a variety of perhaps disparate therapeutic areas that lack R&D or market synergies?” she asks. “This session will present viewpoints from R&D and commercial perspectives and address several questions related to this oft-experienced conundrum. BIO attendees can benefit by learning from executives who have successfully led companies that focus on one disease or product class and those who pursue a mix of programs.”

Lord says that nearly everyone in the industry is now grappling with the need to “do more with less…. Now more than ever, peer-to-peer networking can accelerate access to information and experience that can be critical to success. This convention is the best place to draw from an incredibly rich pool of practiced and talented individuals.”

Legal Issues, Licensing, and Technology Transfer

With M&A and partnering reaching historic levels all over the biotech world, intellectual property continues to grow in importance. Today some two-thirds of the value of most large businesses can be traced to intangible assets such as patents, trademarks, and copyrights. So IP due diligence (the process of investigating and confirming the status of IP assets) is becoming increasingly important as well. Tamsen Valoir of Baker & McKenzie LLC, is chairing a session on this topic at the 2009 BIO International Convention. “The panel discusses why intellectual property due diligence (IPDD) is important and how to do diligence in the global life science context,” Valoir explains. “In 2009, we expect companies to concentrate their partnering efforts on fewer, high value meetings. This convention is the one place where the entire industry gathers, and it remains the best opportunity to develop leads and make new contacts from around the world along with providing unparalleled opportunities for education and exposure to cutting-edge science.”

One kind of deal that will never lose importance to the biotechnology industry is technology transfer to commercialize intellectual property originating from academia. These partnering/licensing agreements help develop and market products to benefit society as well as generate revenue. Research collaborations have also been a cornerstone of the industry for years. Today, rather than serving primarily as a corridor for technology transfer, companies and researchers are exploring new models with an eye to fostering the next generation of entrepreneurs and speeding transitions from discovery to innovation while advancing the specific and diverse interests of the partners involved.

IN THE BIO EXHIBITION

As of press time, the exhibit hall product focus zones were only beginning to fill up. For updates, visit the BIO exhibitor floor-plan at http://convention.bio.org/vr/shows/bio2009/start.html.

Business Services

Emerging biotechnology companies need a wide range of products and services to get their laboratories up and running, to design and build productive working environments, and to keep up with growth. Organizations in this zone have the answers for them and include the following: law firms, intellectual property services, logistics providers and shipping products/services, consulting firms, suppliers of office equipment and services, insurance companies, employee benefits services, and other business support organizations.

Exhibitors (as of 1 February 2009)

Avance — Valuation in Life Sciences (Booth #5233), Barnes & Thornburg LLP (#5339), Biocair (#5247), Biologics Consulting Group, Inc. (#5232), BioSpace (#5250), Bird & Bird (#5257), Campbell Alliance (#5240), Commissioning Agents, Inc. (#5234), CRB (#5352), Edwards Angell Palmer & Dodge, LLP (#5336), Frommer Lawrence & Haug LLP (#5346), GenomeWeb LLC (#5933), Hyde Engineering & Consulting (#5255), Incisive Media (#5345), Marks & Clerk (#5237), and Wolters Kluwer Health (#5357)

Connie Matsui, former executive vice president of knowledge and innovation networks at Biogen Idec, Inc., is chairing a session on this topic at the 2009 BIO International Convention. “Attendees looking for creative ways to expand their research network and capacity should consider this session,” she advises. “Universities and companies face the same challenges of shrinking resources yet have complementary strategies for overcoming these constraints. Learning how to create and sustain mutually supportive and productive relationships is the key.”

Matsui promises, “Attendees will gain insight into the perceptions and motivations of both universities and companies and learn about best practices in academic and research collaborations.” And she adds, “Attending the BIO International Convention is a cost-effective investment in shaping the future of your organization.

David Steinberg, CEO of Enlight Biosciences at PureTech Ventures, will present at Matsui’s session. “Many entrepreneurial efforts,” he explains, “especially those based on university licenses, start with a technology and look for a need (they try to find a problem to fit the solution). We will talk about doing the opposite: starting with an unmet need and working with universities to identify the most promising technologies to meet it.”

Steinberg points out, “As the economy staggers, innovation is becoming ever more important; repurposing, repositioning, and repackaging are no longer enough. Connecting with leaders in the industry to drive innovation has never been more critical.

Presenter Will Charles, general manager of technology development at Auckland Uniservices, Ltd., agrees. “In a recession, the role of the universities becomes pivotal in driving innovation. Come and learn how it is being done on an international level.”

Jilda Diehl Garton, associate vice provost for research and general manager of GTRC and GTARC at the Georgia Institute of Technology, is also presenting at their session.

“Negotiating agreements rapidly and productively is even more important,” she says, “as resources for research, not to mention negotiation, become more constrained. My presentation will introduce tools and models developed by the University-Industry Demonstration Partnership to bring the parties together.”

Immigration Issues: In a global industry, most companies will face immigration issues. In biotechnology challenges include the limited number of work-authorized visas allowed each year; how best to approach the visa process; and how to avoid many of the pitfalls that affect the work authorization of foreign nationals. Biotech companies recruit talented scientists daily; many are foreign nationals holding student or work-authorized visas. With ever-changing immigration laws and growing antiimmigrant sentiment in many countries, these companies face even tougher obstacles.

Ian Band, a partner with Hunton & Williams, LLP, is chairing a session on this topic at the 2009 BIO International Convention. He says, “Immigration issues arise in all biotechnology companies. Visas are needed to employ foreign nationals at a time when the immigration process has grown more complicated. Navigating these waters can be a headache for managers wishing to hire foreign nationals and HR staff charged with making that happen. This session will provide an overview of the immigration process, the pitfalls to avoid, and how best to obtain visas for the best and brightest. Those attending will gain a better understanding of the visa options available for prospective and current employees, how to retain them for longer periods of time, and the common pitfalls experienced by employers trying to navigate the tricky and often confusing immigration laws.”

It’s another reason 2009 is an especially crucial year for attending the BIO International Convention, Band points out. “The changing economy will certainly have an impact on hiring generally, which creates more obstacles for hiring and retaining qualified foreign nationals. This makes it even more important than ever for employers to understand the immigration process to ensure they can recruit and retain foreign talent. In addition, the new administration may enact new laws that benefit employers hiring foreign nationals. Employers need to be ready to take advantage of new legislation to assist employees holding visas.”