Click to buy Editorial (5 Pages)

Tissue Engineering? Xenotransplantation? Zoonoses and Xenozoonoses?: Emerging Lexicon in Biotechnology, Law, Business and Health Policy Robin J.R. Blatt

Abstract:  Thousands of individuals worldwide are awaiting donor organs, and claims for organ transplantation are mounting. Within the last decade, the number of patients on waiting lists has doubled, and this population is increasing by 15 percent annually. The United Network for Organ Sharing (UNOS) estimates that the median waiting time for a kidney transplant is now nearly two years. The demand for human cells, tissues, and organs is creating a number of new markets. At one end of the spectrum, the desperation has resulted in the creation of a black market, with international trade and organ-trafficking on the rise....The need to successfully improve transplantation procedures has also led to a burgeoning pharmaceutical market...For the future, however, some researchers have ambitious plans to address this public health need and to create a new biotechnology market. Tissue engineering is now underway; further, the shortage of human donor organs has led to the emergence of a new era of biomedical research

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Human cellular and tissue-based products embody an extraordinarily diverse universe of therapies, ranging from traditional tissue products used in transplants, to somatic cell and gene therapy products, to the most recent entries into the field of products derived from umbilical cord and peripheral blood stem cells. Until very recently, the Food and Drug Administration’s (FDA’s) regulation of human cellular and tissue-based products has been sparse and inconsistent, a patchwork quilt of individual decisions that have resulted in no comprehensive protection of the public or guidance to the burgeoning industry. Rather than develop a comprehensive federal scheme for the regulation of cellular and tissue-based products, the FDA’s regulatory decisions applied the requirements of the existing regulatory authorities for medical devices and biological products.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Featured Article (4 Pages)

The Rise of the Platform Technology Deal Michael Lytton and Marc A. Rubenstein

Abstract: Recently a new form of corporate partnering deals between pharmaceutical companies and biotechnology companies with proprietary platform technologies has emerged and become prevalent. For these companies, the traditional, exclusive, single therapeutic deal has given way to nonexclusive licensing arrangements in which the biotechnology company can grant access to the same platform technology to multiple pharmaceutical companies. These deals allow the partners to tailor the different risks and values inherent in platform technologies to the collaborative arrangement.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Featured Article (4 Pages)

Written Description After University of California v. Eli Lilly U.S. Patent Office Publishes New Guidelines Steven P. O’Connor and Howard W. Levine

Abstract: This article discusses the holding of the Federal Circuit in a landmark case regarding the written description requirement and the implementation of the holding as reflected in the Patent and Trademark Office’s interim Guidelines. The authors discuss those Guidelines as they pertain to biotechnology inventions and the importance of accurate and complete written disclosure in patent application claims.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Featured Article (7 Pages)

The Food and Drug Administration Modernization Act of 1997 Impact and Implementation Geoffrey M. Levitt and Kristin K. Woody

Abstract: The enactment of the Food and Drug Modernization Act of 1997 (FDAMA) brought dramatic changes at the FDA. This article summarizes the major provisions of the FDAMA, such as those pertaining to pediatric drugs, shortened approval periods for applications, and changes in off-label promotion that are relevant to pharmaceutical products, and then briefly examines some of the possible effects the FDAMA might have on the life cycle of a hypothetical product.1

 ©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Federal Court Biocolumn (4 Pages)

Judgment Upheld, Treble Damages Awarded for Willful Infringement Steven P. O’Connor

Abstract: In an infringement challenge of two patents involving biotechnology inventions used in cancer treatments, the author provides a vivid description of the patents at issue and a narrative of the events leading up to the district court trial. The rulings in the jury trial, with its surprisingly punitive outcome, and a point-by-point report on the appellate court decision are then provided.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Health Economics Biocolumn (8 Pages)

Health Care Decision-Making Health Economics Research and the Pharmaceutical/Biotechnology Industry R. Thwaites and P. M. Anderson

Abstract: The primary purpose of health economics is to assist in health care decision-making. Health economics research contributes by identifying and evaluating the likely costs and benefits associated with the choices available and can be useful to health care -ers at all levels. Data supplied by the pharmaceutical and biotechnology industry, provided they are perceived as relevant and reliable and are communicated to the appropriate-ers, can aid resource allocation in health care. In practice, however, evidence suggests that the influence of health economics research on decision-making is limited and that decision-makers appear unwilling or unable to respond to health economic arguments. If evidence of the value of health economics in health care decision-making continues to be limited, pharmaceutical and biotech companies with resources currently devoted to such activities may invest those resources elsewhere. Conversely, if the influence of health economics can be demonstrated and expanded, companies will not only invest in their health economics expertise, but will also make efforts to increase the influence by becoming further involved in study collaboration and project risk-sharing with their customers.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Policy Biocolumn (7 Pages)

Accelerating Access to Cancer Drugs Sheila R. Shulman and Maria J. Wood-Armany

Abstract: After a decade in which the emphasis in drug development appeared to shift away from cancer therapies, the FDA in 1996 announced an initiative specifically directed toward early access and accelerated approvals for investigational new anticancer drugs. This commentary highlights the trends in FDA procedures and discusses the FDA policy goals implemented by the initiative. The commentary reviews the provisions of the initiative and provides an historical, development-time profile for antineoplastic therapies against which to gauge the impact of the initiative in future years.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Regulatory Biocolumn (6 Pages)

Regulating Xenotransplantation Research Developments in Federal Policy Ralph B. Dell

Abstract: The success rate for human-to-human organ transplants (allografts) has made transplantation an accepted therapy for end organ failure. In addition to achieving survival, most patients are now able to lead nearly normal lives, raising families and working full time. Broader application of this successful therapy has been hindered, however, by the limited availability of donor organs. Because of this organ shortage, surgeons have turned to considering the transplantation of animal organs into humans (xenotransplantation). This article summarizes the scientific and public policy issues raised by the prospect of widespread xenotransplantation. Portions of this article have been drawn from an Institute of Medicine report titled "Xenotransplantation: Science, Ethics, and Public Policy."

 ©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy MBC Roundtable Biocolumn (4 Pages)

Later-Stage Issues: Managing Liabilities in the Market Place Craig Stewart and Joseph Blute

Abstract: As the complexity of biotechnology increases, so does its relationship with society at large. In this environment, both biotech products and the people who direct their development are becoming more and more exposed to forms of legal liability that affect companies, patients regulatory agencies, and payers, just as with other, more mature industries. In this column, Craig Stewart and Joseph Blute examine the implications in the U.S. and abroad of director and officer liability and of products liability, respectively. The following remarks are based on presentations made at the 1998 Massachusetts Biotechnology Council’s Annual Meeting.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Civil Justice Biocolumn (8 Pages)

Biotechnology’s Next Priority Civil Justice Reform David Wescott

Abstract: Biotechnology and high technology companies have recently mounted efforts to address frivolous shareholder suits, but results have been mixed. The future for civil justice reform for the biotechnology industry lies primarily on two fronts—in the states, where the new breed of shareholder and product liability suits are being introduced, and on the broader provisions of tort law that affect all industries—namely, joint and several liability. This column discusses the effects that various systems of liability have on the biotechnology industry and examines the arguments presented by trial lawyers and industry members in the debate surrounding civil justice reform. The author concludes by proposing a plan of action for the biotechnology industry.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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Click to buy Financing Biocolumn (2 Pages)

Biotech Industry Experiences Good Third Quarter for FDA Approvals, Tough Quarter in Capital Markets G. Steven Burrill

Abstract: The biotechnology sector experienced a very favorable quarter at the Food and Drug Administration (FDA), yet had a very tough quarter in the current capital market environment. During the third quarter of 1998, the FDA approved or recommended for approval ten new products developed by the biotechnology industry, some of which are the first of their kind. Notwithstanding the industry’s regulatory success, this quarter’s stock market "correction" had a dramatic impact on the biotechnology industry. The industry lost 25 percent of its market capitalization during July and August but recovered half of that during September. However, even with the overall capital markets drying up, the U.S. biotechnology industry still managed to raise $134 million in public offerings during the third quarter, compared to $293 million for the second quarter of 1998. With product approvals in place, long-term investors may finally be rewarded for their patience.

©1999 by The Journal of BioLaw & Business. All Rights Reserved.

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