Abstract: It has been said that, just as the 20th century was the century of the physical sciences, the 21st century will be the century of the life sciences. The process will accelerate as we unlock the fundamental secrets of the cell and develop new ways to prevent, treat, and cure many of the most deadly afflictions, as well as other public health conditions that shorten lives or impair the quality of life. But the kind of medical miracles we all seek will not come by chance. They require highly skilled researchers and a sustained commitment to medical research by both the government and the private sector. The United States (US) biotechnology industry is one of the most successful and most promising sectors of our modern economy. Never before have the pipelines of biotechnology companies held so many promising products for the care and treatment of disease. Research at universities and teaching hospitals is fueling new biotech start-ups that will bring new therapies to patients around the world. As these firms grow and prosper, new jobs and new investment opportunities are created. One of the highest priorities for the biotechnology industry and the nation as a whole is developing a highly-skilled and well-educated workforce. An educated workforce is an indispensable resource in the modern economy. The nation's long term vitality depends on the creation of an effective, accessible, and accountable system of job training and career development available to all our citizens. Schools and universities must assume greater responsibility for preparing students to meet the challenges of the 21st century workplace. Disadvantaged adults and out-of-school youth deserve genuine opportunities to develop skills which will make them productive members of the community. Workers displaced by rapid technological change deserve the chance to pursue new careers. Individuals with disabilities deserve the opportunity to develop their full career potential. The way in which we respond to these challenges today will determine how prosperous a nation we are in coming years.

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

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Abstract: Two substantial events in the recent past herald significant changes in the testing and labeling of drug and biological products as they relate to pediatric populations. The first event was the passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which contains provisions that establish economic incentives for conducting pediatric studies on certain products. More recently, on December 2, 1998, the Food and Drug Administration (FDA) issued final regulations regarding the generation of information necessary to support pediatric labeling. These regulations break new ground in that they establish, for the first time, a presumption that all new drugs and biological products must be studied in pediatric patients. The notion that manufacturers may no longer exercise absolute control over the uses they choose to pursue for their products is a novel concept that dramatically changes FDA's involvement in and control over the product development process. The purpose of this article is to provide a context for general understanding of the new pediatric labeling requirements and to identify and describe several of the changes most likely to impact manufacturers of biological products. Manufacturers obviously must fully evaluate all of the provisions in the context of their specific products.

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

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Abstract: Confidentiality and non-disclosure agreements are crucial to the successful development and financial integrity of biotechnology and medical device companies. These documents protect the key documents and proprietary information of these companies of which information represents their intellectual and financial core value. Confidentiality agreements are increasingly being drafted, negotiated and used in multiple situations; with various individuals, including, employees, directors, scientists, advisors and consultants; in protecting proprietary information before a patent application is filed, and for general corporate activities, involving, acquisitions, partnerships, strategic alliances, and mergers. A properly structured confidentiality agreement must be in place prior to the dissemination of the material so that public disclosure is inadvertently prevented. Once information is disclosed and placed in the public domain, the patentability and/or copyright protection of the information is jeopardized with the inevitable negative impact on the Company's financiability and ultimate value. This article will look at the critical components of confidentiality agreements, their structure and how they can be negotiated. Depending upon the circumstances, the agreement may be structured as a stand alone document or embodied in: (1) a letter of intent; (2) an employment agreement; or (3) partnering agreement; acquisition or other transactional document.

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

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Crisis Preparedness: What It Means and Why It's So Important for the Biotech and Life Science Industries A Communications Perspective Fabia D'Arienzo and Wayne L. Pines

Abstract: The first in a series on crisis preparedness and management for The Journal of BioLaw & Business, this article provides a primer for healthcare companies that want to be well-prepared for potential crises. It explains what a crisis is, what it can mean to a company, and why preparedness is so important. It is written to guide companies through the four key steps of crisis preparedness: (1) the vulnerabilities audit, (2) the crisis response manual, (3) simulation training, and (4) key, everyday communications systems that make a difference. Unlike many articles on crisis management, this piece focuses exclusively on the months before a crisis, allowing for advance planning and review of policies.

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

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Abstract: Genetic theories of crime causation date back to early civilization. This article explores the research regarding genetic causes or predispositions to criminal behavior and examines several criminal court cases in order to identify how judges and juries have reacted to genetic predisposition theories. While future genetic research may identify biological factors that impact criminal behavior, scientific evidence in this area has not been sufficiently validaded. Speculative theories of crime causation must be approached with caution in the courts.

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

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Abstract: With the dawning of a new era of consolidation in the biopharmaceutical industry, the issue of how to properly value these organizationsí intellectual property has become critical. The hardest part is organizing the information and placing it in a framework that is easily understandable and that really gives the inquiring party an overview of what is going on with the company. One useful technique is to attempt to associate with every machine, product and process owned or produced by the company an intellectual property cost and benefit. A checklist as well as some conceptual tools are provided to the reader to help accomplish this task.

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

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Abstract: Upon reading about the use of DNA technology to exonerate an individual wrongfully convicted of rape and homicide, United States Attorney General Janet Reno raised concerns about the extent to which similar cases existed. In April of 1997, a DNA focus group meeting was held in Washington, DC which assembled representatives from the broad spectrum of the criminal justice system to discuss issues related to the future of forensic DNA. Upon identifying the breadth and scope of those issues, the Attorney General requested that the National Institute of Justice (NIJ) establish a national commission to examine the future of DNA evidence and how the Department of Justice can best encourage its effective use. The Commission is charged with forwarding recommendations to the Attorney General which will facilitate a more thorough and effective use of this powerful crime fighting tool.

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

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Abstract: Imagine for a moment a society in which government agencies keep records of the genetic information of every individual - a society where the government takes a blood sample and a hair sample from each person at birth in order to procure critical DNA (deoxyribonucleic acid) information which is then to be kept in a database that exists for the entire life of the individual and even after death, and which may be accessed within seconds by computers all over the country. For people who are not born in the country, the information could be obtained through the immigration process. The DNA information in that database could then be used by law enforcement agencies, public and private employers, insurance companies, educational institutions, adoption agencies, and various other institutions. While such a scenario may sound like science fiction, it is actually closer to science fact given the current uses of genetic information by various government agencies.

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

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Abstract: Reliable forecasts of brand sales are fundamental to a value-based evaluation of research and development projects in the pharmaceutical and biotechnology industry. The well-recognized product life cycle (PLC) concept offers a useful framework for analyzing the development of sales and profit contribution. This paper introduces the concept of product life cycle to biotech firms and outlines its potential for identifying and solving the varying management tasks at each stage of a productís life. An empirical case study is provided to describe a cross sectional and time series analysis of sales data over one decade in four major segments of the market for cardiovascular drugs; this analysis is designed to lead to the detection of an international product life cycle system of classification.

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

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Abstract: The Drug Price Competition and Patent Term Restoration Act, commonly referred to as the Waxman-Hatch Act, was enacted to strike a balance between the interests of consumers in obtaining lower drug prices and their interests in having available new therapies to meet unmet medical needs. The Waxman-Hatch Act both eased the burden on generic drug manufacturers in obtaining approval to market generic versions of pioneer firm products and restored portions of the patent terms that pioneer firms had lost while their new products were under development and regulatory review. The expectation was that increased generic competition would lead to lower average prices and that restored patent terms would increase incentives for pioneer firms to innovate. The Act has restored meaningful patent protection for new drugs and biologics. For example, the average effective patent life (time from marketing approval to loss of patent protection) for new drugs and biologics approved from 1993 to 1995 is 11.2 years with Waxman-Hatch restoration. Without patent term restoration, the average effective patent life for these products would have been only 8.2 years. However, the period during which innovator firms can earn returns on their products without generic competition is still significantly restricted; on average, approximately only one-third of the patent term lost during clinical development and regulatory review has been restored by the Waxman-Hatch Act.

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

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Abstract: The biotech industry raised $1.4 billion in the second quarter of 1999, a 63 percent increase from the first quarter of the year ($834 million) and a 70 percent increase over the same quarter last year. While initial public offerings (IPOs) remained below previous yearsí levels, the second quarter of 1999ís convertible debt and venture capital funding more than tripled from $338 million in the first quarter of 1999 to $1047 million in the second quarter of 1999. The alliance/merger side of the industry was especially active toward the end of the quarter. Biotech is coming back, at least selectively by the capital markets, although clearly the Internet and communications continue to be a main focus. Industry analysts have for some time been predicting massive consolidation within the biotech industryóbut we have yet to see that happen. Instead, we continue to see active strategic partnering and dealmaking, especially this quarter with big pharma and big ag consolidations, and deconsolidations, dominating the scene.

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

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