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Bringing Biotechnology Health Innovations to Patients Requires a Stronger FDA
James C. Greenwood
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Abstract:
The rapidly advancing science of biotechnology is leading us to a way of life barely imaginable just a few short years ago. But to fulfill biotechnology's promise of personalized health care and new cures and preventions for age-old diseases, we must maintain a strong innovation pipeline that helps safe and effective new therapies reach patients in a timely way. To do so it is critical to provide adequate public funding to the Food and Drug Administration (FDA). The agency's budget has not kept pace with the demands placed upon in an era of rapid biotechnological and medical innovation and it is in danger of becoming a bottleneck to innovation. The Biotechnology Industry Organization (BIO) has joined a broad coalition of patient, consumer and industry organizations to advocate for increased funding and public support for the FDA so that the agency can fulfill its mission of ensuring the safety and efficacy of new therapies and other regulated products.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Ethics and Lobbying Reform in the 110th Congress
Thomas M. Susman and Margaret S. Moore
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Abstract:
A number of important issues affecting the biotechnology industry will come before Congress this session. At the same time, lobbying and ethics reforms are changing the way lobbyists operate in Washington. This article reviews the changing landscape on Capitol Hill and provides an overview of new travel and gift rules, earmark reform, and other new requirements and restrictions.
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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A Panoramic View: What Life Sciences Firms Can Learn from Insurance Carriers that Take a Holistic Approach to Underwriting
Philip W. Fiscus
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Abstract:
An insurance underwriter's job is to evaluate risk and determine how much of a particular risk the insurance company should assume and at what price. To really understand the risk profile of a specific biotech, underwriters must take a long-term view of the company and the exposures associated with different stages of product development. A biotechnology company can learn a lot by how its insurance carrier views the business.
5 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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The Critical Path of Medical Product Development: Challenges and Opportunities
Theresa Toigo and Rachel Behrman
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Abstract:
In March 2004, the FDA launched the Critical Path Initiative with a report titled Challenge and Opportunity on the Critical Path to New Medical Products. This report presents FDA's assessment of one of the scientific challenges underlying the medical product pipeline problem: the need to modernize the Critical Path of medical product development, facilitating the processes by which discoveries move from the laboratory to become effective therapies for patients to use in the safest manner possible. The Critical Path Initiative, although initiated only two years ago, is well underway. This article provides an overview of the FDA's Critical Path Initiative.
5 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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The "My-Health" Revolution: Communication Challenges in the Age of Personalized Medicine
Marcia A. Kean and Mike Silver
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Abstract:
A shift has taken place in the scientific community in recent years, away from the one-scientist/one-pathway model to Big Science initiatives. The concept of wide-scale collaboration among different disciplines and different institutions has driven the greatest advances. Personalized medicine is the dividend from investment in the most prominent of these Big Science initiatives, the Human Genome Project. But the scope of collaboration to support personalized medicine extends well beyond the scientists, and we must create a web of interaction among all the stakeholders.
In personalized medicine, there is no one organization-nor even one sector of the healthcare enterprise-that can be solely responsible for communications. This article highlights the spectrum of issues that impinge upon adoption of personalized medicine.
5 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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2006 Compensation and Entrepreneurship Report in Life Sciences
Contributed by Wilmer Cutler Pickering Hale and Dorr LLP, Ernst & Young and J. Robert Scott*
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Abstract:
A need exists for access to reliable, comparable compensation data to assist life science leaders in the critical decisions involved in attracting, motivating and retaining key executives at private companies. This article summarizes a study of the life sciences sector and provides information on the correlation between executive compensation and multiple variables, including financing stage, company size (both in terms of product stage and headcount), founder/non-founder status, industry segment, and geography. It also includes a number of new analytics, including how an organization evolves with additional financing; Boards of Directors compensation and make-up; and, a more granular look at company equity plans.
7 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Evidence and Action
Bryan A. Liang
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Abstract:
No Abstract
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Wal-Mart "Rolls Out" $4 Generic Prescription Drugs
Alexis Guanzon
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Abstract:
Wal-Mart has recently introduced a $4 generic prescription drug program in 26 states throughout the country for 314 different generic prescription drugs.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Coronary Drug-Eluting Stents May Cause Death and Myocardial Infarction
Aline Gaba
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Abstract:
Studies find a small but significant increase in the rate of death and myocardial infarction in patients eighteen months to three years after drug-eluting stent implantation.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Registered Nurse Safe Staffing Act Addresses Nurse-to-Patient Ratios with Acuity-Based Approach
Amber Zupancic
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Abstract:
The American Nurses Association (ANA) supports the 2005 Registered Nurse Safe Staffing Act because it promotes safer staffing levels and helps to increase quality of care. Nurses argue that basing staffing on acuity levels is more appropriate compared to mandated nurse-to-patient ratios.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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CMS New Coverage with Evidence Policy
Troy B. Krich
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The Centers for Medicare and Medicaid Services (CMS) is proposing a new policy called "coverage with evidence development" (CED) in which beneficiaries would have access to promising new technologies in health care that would not normally be covered as long as the patients participate in clinical trials or data registries.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Nanotechnology Issues and Challenges
Erizen Sei Bowles
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Abstract:
Nanotechnology is the ability to manipulate matter to create new and unique materials at the atomic, molecular, and macromolecular level. Nanotechnologies and nano-based products are a technological revolution. However, they present new challenges and potential risks. Lack of oversight and regulation could result in substantial harm to human life and the environment.
2 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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