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Operating costs are the white-hot issue in the boardrooms of our life sciences clients and they tend to rule the site selection process. A soft economy, worldwide trade competition, drug cost containment pressures from the US government, and a lean and mean message sent by the venture capital community mean that quantitative factors that focus on the cost of doing business are trumping qualitative lifestyle factors, especially when evaluating sites for a new biopharmaceutical facility.

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The ripple effects of 9/11 are still being felt, creating changes among individuals, businesses, and government organizations. The biotech community is no different; companies are taking a new look at the way they do business and shifting their focuses in response to new opportunities presented by federal preparedness programs. In 2004, President Bush signed "Project BioShield," a bill that made $5.6 billion in federal funds available over a 10-year period to develop countermeasures against chemical, biological, radiological, or nuclear attack. An additional $2.5 billion was added to the initiative in 2005. Numerous grants and contracts have already been awarded to companies developing innovative prophylactic measures, treatments, and diagnostic tools to be used in the event of a biological attack.

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Formal process and operation improvement activities are being employed in almost every biopharmaceutical manufacturing company, according to a recent survey conducted by Tefen Ltd and Millipore Corporation. The industry-wide survey was conducted to assess current biopharmaceutical operations excellence (OpEx) trends and needs, as well as OpEx perceptions and expectations related to industry suppliers.

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Daunting but common challenges currently face many biotech, pharmaceutical, and device firms. These companies are encountering a restless public, worried investors, and a skeptical, publicity-hungry Congress that are all concerned about product safety and the reliability of regulators' scrutiny.

Licensing

Historically, the big pharmaceutical companies (Big Pharma) have sought to feed their marketing machines by manufacturing blockbuster drugs—chemical-based, one-type-fits-all products that treat chronic conditions such as heart disease or arthritis. This approach has yielded recurring revenue streams from large patient populations. In contrast, biotechnology companies typically have created protein-based drugs,or biologics, to treat acute or niche conditions and diseases. With few exceptions (such as the biotech giant Amgen), biotech companies have foregone doing the marketing and sales of their drugs themselves, and have, instead, relied on others to perform their marketing and sales functions.

Your research and development team has just shouted "Eureka!" after long and expensive years of research, exclaiming they have developed a next-generation pain reliever. What do you do next? This article explores and suggests your next steps and identifies pertinent questions to ask a patent attorney. The focus is on intellectual property; this article does not address the myriad regulatory issues that must be resolved.

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It's summer and the living is easy if you don't mind heat, insects, and thunderstorms. The biopharm indexes are listless, because August and September are notorious for inactivity in the various life sciences stock market indexes. Earnings announcements taper off and life sciences companies keep their gunpowder dry by holding off new announcements until after Labor Day. As of mid-July, the American Biotech Index (Symbol: BTK) has leveled off at the tail end of a year of unbridled growth. If history is any indication, the autumn months will see another rise from the 550 or so levels we're now seeing in the BTK.

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The pharmaceutical and biotechnology industries are at a critical point in their evolution. Industry experts at Datamonitor, an independent market analyst firm, say that in 2002 about $30 billion worth of blockbuster drugs lost patent protection. By 2008, an additional $35.5 billion worth of products is expected come off patent. At the same time, a host of scientific innovations in drug discovery including the use of high-throughput screening techniques, new classes of therapeutics such as aptamer technology and RNAi, and genomics-driven discovery methods, have resulted in large numbers of new drug candidates.

Successful acquisition of funding from venture capital (VC) partnerships requires a carefully planned, well-executed marketing campaign. You are, after all, selling ownership interests in your company when you seek VC investors. This sale requires an attractive product, nicely packaged, and presented in a way that allows the potential customer to understand and appreciate its value. The attractiveness of your company is the sum of many factors including revenue potential, intellectual property estate, time-to-milestones, existing competition, ease of entry, quality of management, and the perceived interest in your work by "the big guys" in your sector. Every potential venture investor will not perceive your company the same way.

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As the fourth largest center for biotechnology and life sciences in the US, New Jersey is home to 15 of the world's 20 largest pharmaceutical companies. More than half of all new medicines approved in the US are developed by New Jersey companies. New Jersey is an ideal location because it offers close proximity to the financial markets in New York and Philadelphia, and a highly skilled workforce, strong funding, government support, and academic expertise.