GUEST EDITORIAL
	The Path to Better Healthcare: Regulate or Innovate? James C. Greenwood
	FEATURES
	Foreign Clinical Trials: Exploring the Regulations Governing Drug and Medical Device Development Abroad Lori G. Cohen and W. Gary Lowman
	BioRegulation/The Potential Impact of the FDA's Issuance of a "Complete Response Letter" on Publicly-Traded Life Sciences Companies David A. Kotler and Jennie B. Krasner
	Energy, Cleantech and Intellectual Property: Managing Technology Convergence and Protecting Innovation Joseph Teja, Jr. and Michael Pomianek
	When Like Minds Differ: The Potential for a "Shotgun Marriage" Between the Pharmaceutical and Diagnostic Industries in Personalized Medicine Mollie Roth, Tom Zietlow, Pat Considine and Dave Smart
	Business of Stem Cells: Business of Uncertainty Sorapop Kiatpongsan
	RECENT DEVELOPMENTS
	Legal and Medical issues in Emergencies and Disasters Bryan A. Liang
	Preparing for the Worst-Steady Hands to Reassure a Shaky World Thomas T. Kubic
	Government Powers in Emergencies and Disasters: Permitted Actions to Protect the Public's Health Bryan A. Liang
	Quarantine, Bioterrorism, and Protecting the Public Health Joya K. Raha
	Jihad and American Medicine Adam Frederic Dorin
	The Use of US Military in "Health Diplomacy" Dennis E. Amundson
	Rx Response: An Industry Approach to Getting Medicines to People in Times of Emergency James N. Class
	BIOCOLUMNS
	Clinical Trials/ Clinical Trial Deviations Nancy J Stark
	Branding/ Brand Building for Early-Stage Clean-Tech & Renewable Energy Companies: The Importance of Strategic Differentiation Nicolas Boillot
	BioRisk Mitigation/ How to Avoid Hazards When Investing in Medical Device Companies Susan M. Hendrickson and Teresa Salamon

Abstract: In this pivotal election year, Americans are demanding better, more affordable and more accessible healthcare. The members of the Biotechnology Industry Organization (BIO)-including companies that have pioneered hundreds of lifesaving therapies, vaccines and diagnostics-believe that continued biomedical innovation is the nation's best hope for reducing the burden of disease and improving our healthcare and quality of life. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Both national and foreign pharmaceutical and medical device companies are increasingly conducting clinical trials abroad. In fact, approximately 43% of FDA-regulated clinical trials for the leading American pharmaceutical companies are conducted outside the U.S. and that number is projected to rise to 65% by the year 2011. The growing interest and participation in foreign clinical trials prompted the Food and Drug Administration ("FDA") to review and revise its regulation governing such trials in order to improve the quality of clinical data that is submitted and to protect the human subjects participating in the trials. As the demand for foreign clinical trials continues to mount, it is imperative for pharmaceutical and medical device companies, as well as the clinical research organizations with which they work, to understand the FDA's requirements governing foreign clinical studies and the specific steps necessary to meet those requirements. This article addresses the rapid growth of foreign clinical trials and the rationale, requirements, and effect of the FDA's regulation over foreign clinical studies not conducted under an investigational new drug application. 7 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Effective August 11, 2008, the Food and Drug Administration ("FDA") will issue a "complete response letter" ("CRL") when it does not approve a new drug application ("NDA") instead of the "approvable" and "not approvable" letters that it formerly issued in that circumstance. This new rule will impact publicly-traded life sciences companies and their directors and officers-who already are squarely in the crosshairs of the plaintiffs' securities bar-because such companies will need to carefully consider whether the information they disclose upon receiving a CRL could be "materially misleading" under the federal securities laws. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: While intellectual property (IP) is always an important component to the success of any technology-based company, it is arguably especially important for "cleantech" ventures directed to energy and/or environmentally-related technologies. Cleantech is a broad field with several narrow subsectors-the technologies embraced run the gamut from older technologies already in the public domain and now being recycled, to cutting-edge research coming out of academic and industry labs. Some of the innovations involve fundamental technology breakthroughs that may warrant broad protection. In other cases, however, an incremental and seemingly narrow improvement in an already crowded area of development may provide an important enabling solution having significant commercial value. This article highlights key issues pertaining to energy, cleantech and IP and how best to manage technology convergence, protect innovation and develop an informed approach to IP protection. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: As the "one size fits all" model of drug development continues to struggle against the tide of the increasing complexity of the diseases being researched, the tremendous uptick in litigation over post-market adverse events and the FDA's increased oversight and requirements for Phase IV studies, the pharmaceutical industry continues its slow embrace of Personalized Medicine. The marriage of a drug to a diagnostic to ensure that the right drug gets to the right person in the right dose is the inevitable and correct outcome of the genomic evolution-correct for the patients, correct for the payers and correct for the industry. However, in order to effectively develop such targeted therapies-drugs that have a companion diagnostic to guide use or dosing of the drug-and launch them simultaneously, the pharmaceutical and diagnostic industries are going to have to work together more often and much more closely than they historically have done. This article highlights key issues and business models in use to address the emerging specialty area of personalized medicine. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Stem cell technology offers the path to transform health care in the coming decades. The business value has been estimated to be huge and the impact on the medical practice would unsurprisingly be substantial. However, there are still many uncertainties that make stem cell technology a hard sell. While generally the immature and unproven product is considered not ready to get onto the market in the other industries, stem cell technology brings up the new business model that could make profit by commercializing only hope not the real product at it immature stage. Private stem cell banking business model has demonstrated that an intangible and unproven product can be profitable. Interestingly, this business model poses challenges to all the stakeholders. Looking through the lens of policy makers, physicians, scientists and the public reveals many interesting issues and brings up many intriguing questions that there are no clear answers available yet. This article aims to provide better insights into the issues with some initial analysis to offer a basis for further in-depth examination and policy recommendation. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 2 Pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Planning to address emergencies and disasters is a key reality in the world today. Longstanding law enforcement activities have provided important lessons on first response coordination as well as crisis and consequence management and decision making under stress. These lessons are applicable to the private sector as well, both in terms of structure as well as coordination with public sector activities. All entities should endeavor to plan, coordinate, and implement effective processes using these approaches so that the impact of an emergency or disaster is minimized. 4 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The specter of emergencies and disasters are a reality. During these events, governmental public health activities to respond to these circumstances may impinge upon personal and private rights. Under the state's policy powers, the scope of permissible actions to protect the public's health is broad, and government activities may extend to allow intrusion onto individual, professional, property, and privacy rights in appropriate circumstances. The community should be knowledgeable about what may occur in emergencies and disasters to better assist in first responder efforts as well as to prepare themselves as to what may occur during these situations. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Public health strategies to contain a communicable disease in the event of a bioterrorist attack are presently insufficient and should be revised to meet 21st century biological warfare and 21st century pathogens. One key public health tool is quarantine. Quarantine can address the threat associated with a bioterrorist attack as part of a preparedness strategy. The public and policymakers should understand the definition of quarantine and its role in effective preparedness for an emergency involving a highly contagious agent. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The healthcare system is vulnerable to terrorism. This has been validated by the extensive history of healthcare workers who have killed within it. Those who would strike at the West would easily be able to exploit the weakest people and systems here-patients and healthcare. We must learn the lessons of the past so as to protect ourselves from terrorism in the future. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The United States of America continues to face significant strategic risks in its role as a face of U.S. policy internationally. To mitigate these risks, the ability to communicate, understand, and create a meaningful and sustainable dialogue is vitally important. Through the use of "Health Diplomacy," where military assets are used to provide health care benefits to high risk countries, important lasting bonds may be created that provide sound and solid foundations for both public and private stakeholder communication. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Rx Response: An Industry Approach to Getting Medicines to People in Times of Emergency

James N. Class