GUEST EDITORIAL
	Information-Based Medicine CAROLYN KOVAC
	FEATURE ARTICLES
	Real Estate Planning: Key Issues for a Life Science Company KATHARINE E. BACHMAN
	Legal Landscape Heats Up for Life Science Companies JILL WADLUND
	Food and Drug Modernization Act (FDAMA) ‘97: The Year in Review DONALD J. GREENE
	Quantitative Deal Valuation and Optimization in the Biotechnology and Pharmaceutical Industries CHARLES T. HARDY
	Biotechnology, Pharmaceuticals and the Bayh-Dole Act SHREEFAL MEHTA
	SPECIAL SEGMENT
	Gene Therapy, Fundamental Rights, and the Mandates of Public Health JOHN LYNCH
	BIOCOLUMNS
	Venture Capital Raising Money in a Difficult Environment: Eight Deadly Sins LAWRENCE S. WITTENBERG
	Regulation Who Will Lose From a War Against the Drug Industry? ITAY FRISHMAN
	Patents The Community Patent: Cutting the Gordian Knot of European Patent Litigation? DUNCAN CURLEY
	BioBook Review Prescriptions for Success in Venture Capital Financing VÉRONIQUE BARDACH and PAUL S. AUERBACH
	Financing Biotech’s Strong Fourth Quarter Tops Off A Great Year G. STEVEN BURRILL

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Information-Based Medicine CAROLYN KOVAC

Abstract: Three years ago, news broke that scientists successfully decoded the human genome. It was, unquestionably, one of the most significant scientific breakthroughs ever, providing the road map for the scientific community to search for knowledge about life. The metaphor that so appropriately described the triumph was, "a race to the starting line." The map of the human genome was the starting point in a race to understand origins of diseases, and how to combat them, and how genes and proteins can influence a person's well being. Information technology is an important driver in this supercharged race. Only when DNA sequencing could be done fast enough -- using powerful computing systems and high-throughput sequencing techniques -- was the international scientific community able to decipher the entire human genome. Today, it is virtually impossible to complete most biological research without high-speed computing, storage systems and software to manage large volumes of data and collaboration. (2 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Over the past two decades, there has been tremendous growth in the biotechnology and life science sector. Government funding for biomedical research, coupled with venture capital and private equity investments, has spawned new research and development, and the commercialization of novel products used at the bench and bedside. For each company that exists today whether a start-up or well-established firm a number of key decisions have been made along the way. One of the earliest decisions is the fundamental issue of where to locate the company. After this decision is made, the successful negotiation of the financial and legal arrangements for the space is critical. This negotiation is particularly complex for life science companies, with unique space needs and stringent environmental requirements. At each stage of its development, the right real estate choice for a life science company is a key component of its business plan. This article highlights the major issues to be considered in making this choice. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Drawing on their success with asbestos and tobacco litigation, trial lawyers are aggressively targeting pharmaceutical and medical device companies with class action lawsuits that seek billions of dollars for thousands of plaintiffs. While the largest and wealthiest companies stand first in the line of fire, smaller companies are vulnerable, too. This article discusses how biotechnology and life science companies can reduce the risk of product liability litigation and the prudent risk management steps that can be taken to improve their defense posture and reduce their exposure to large jury verdicts. (5 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No abstracts available

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Collaborative business agreements in the biotechnology and pharmaceutical industries formed with the purpose of joint developing human therapeutics are major elements of value creation for the participating organizations. Business development professionals and other executives, the individuals responsible for structuring these deals, commonly use comparable business agreements as models or structure deals using their own intuition. However, every deal is unique and the risk and return relationships in these collaborations are not intuitively obvious because of long deal life spans and the many risks and uncertainties associated with the development and manufacture of human therapeutics. Therefore, empirical deal structuring cannot accurately embody the value and risk characteristics inherit in these collaborative agreements, while quantitative structuring, using Monte Carlo analysis, stochastic optimization and real options analysis allows value and risk to be accurately determined for all areas of the deal. Thus, quantitative deal structuring allows agreement terms to be tailored to the uniqueness of each deal, company cash flow requirements and risk preferences, and agreements terms can be structured to align collaborative incentives giving the deal the highest priority for each participant.(10 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Reviews of the discovery commercialization process in biotechnology are particularly exacerbated in the current climate of rapidly rising costs of health care. Many recent discussions and articles have suggested that modifications in the application of the Bayh-Dole Act can be used to reduce the price of drugs or improve public access to new inventions and products stemming from basic life sciences research. The data discussed in this article show that prices for the most popular drugs will not likely be reduced significantly by leveraging specific provisions of the Bayh-Dole Act. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Recent and near-future developments in the field of molecular biology will make possible the treatment of genetic disease on an unprecedented scale. The potential applications of these developments implicate important public policy considerations. Among the questions that may arise is the constitutionality of a state-mandated program of gene therapy for the purpose of eradicating certain genetic diseases. Though controversial, precedents of public health jurisprudence suggest that such a program could survive constitutional scrutiny. This article provides an overview of gene therapy in the context of fundamental rights and the mandates of public health. (9 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: As many in the life sciences industry acknowledge, these are not the best of times for companies seeking to raise venture capital. According to Venture Source, only 82 companies in all segments of the United States Healthcare sector received venture financing in the first quarter of 2004, and only one of those was a start-up. This represents a continuation of a decline in financing activity in the sector that resulted in only 490 companies being financed in 2002, compared to 542 in 2001 and 703 in the peak year of 2000. These numbers reflect an environment in which even the best companies require a great deal of time and effort to get financed, while companies perceived to be weaker are unable to obtain financing. In times like these, it is critical for life sciences companies to avoid traps that too often make obtaining financing difficult, or even impossible. This article highlights eight of the most prominent traps. (2 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Everyone wants free access to drugs and the health system, but putting limitations on the free market and regulating prices will not solve the problem. The brand-name drugs makers (i.e. pharmaceuticals and biotechnology companies) are facing wars on all fronts with two subsequent losers - the public and innovation. (2 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Initial thought was given to the creation of a patent system applicable to the entire European Community in the 1960s. The idea of a Community Patent to complement the existing national and European Patent Office systems effectively sat on the shelf for over thirty years. The proposal for a Community Patent was resurrected by the European Commission in 1998, as a solution to some of the problems with the existing procedures. Although the negotiations between the various European countries on matters such as the system of jurisdiction and formalities (such as translations and renewal costs for the Community Patent) have been protracted, a political compromise was finally struck in March 2004 which looks set to make the Community Patent a reality. This article will examine the background to and rationale for the Community Patent, as well as describing how the Community Patent will be set up and how it may be challenged and enforced as a unitary right, with effect throughout the whole of the European Union. (6 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In the book Management Lessons from the E.R.: Prescriptions for Success in Your Business, (The Free Press, 2002), Dr. Auerbach describes how essential observations taken from an emergency room (E.R) setting can be applied not only to support the health of a business, but also for the acquisition of venture capital financing. All too often competent executives who seek financing for their companies make common errors that cost them time, or worse yet, the opportunity to successfully finance their companies. In this conversational article, excerpts and adaptations from the book are used to highlight some of the common mistakes of entrepreneurs and strategies for improving business success. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Biotech had another strong quarter and ended the year on very sound footing. Indeed, 2004 was a huge year for the biotech industry which took Wall Street by storm, won some big battles on Capital Hill regarding Medicare and drug reimbursements, raised $16.3 billion in financings and $9 billion through partnering transactions, and received approval for a slew of important new drugs from the Food and Drug Administration (FDA). In addition, the industry generated more revenues in 2004 than ever and broke all records for government funding. When considering the tough political and economic environment that prevailed in the first quarter of the year, the industry¹s performance is all the more remarkable. (4 pages)

©2004 by The Journal of BioLaw & Business. All Rights Reserved.

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