GUEST EDITORIAL
	Achieving Digital Dividends In The Life Sciences STUART N. BROTMAN
	FEATURE ARTICLES
	The “Biosimilars” Debate DANIEL A. KRACOV
	Contract Research Organizations (CROs) May Be the Next Trend in Clinical Trials Liability SONIA VALDES AND PENNY MCGUIRE
	How Molecular Medicine Transforms Policy (and Everything Else) MARCIA A. KEAN AND KEITH F. BATCHELDER
	Canada’s New Natural Health Product Regulations CONAN MCINTYRE
	Minimum Variance Frontier Analysis for Product and Technology Licensors CHARLES T. HARDY
	SPECIAL SEGMENT
	The Business Case for Using Forensic DNA Technology to Solve and Prevent Crime RAY WICKENHEISER
	BIOCOLUMNS
	Case Study / Curtailment Of "Reach-Through" Infringement Claims: Bayer Ag V. Housey Pharmaceuticals, Inc. Case Study ROCHELLE SEIDE AND MICHELLE LECOINTE
	Taxation / Effective International Intellectual Property Strategies to Mitigate U.S. Taxes DENNIS S. FERNANDEZ AND INNA S. SHESTUL
	International / Understanding Orphan Drug Regulations: An EU and U.S. Comparative Analysis AURÉLIE GRIENENBERGER
	Financing / Biotech Posts Its Best 1Q in Four Years G. STEVEN BURRILL
	Regulatory / Major EU Pharmaceutical Regulatory Changes Effective May 1, 2004 LINDA R. HORTON, JAIME A. TOMHAVE AND JACQUELINE MAILLY

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Achieving Digital Dividends In The Life Sciences Stuart N. Brotman

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

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Abstract: Under the Public Health Service Act ("PHS Act") and Federal Food, Drug, and Cosmetic Act ("FFDCA"), FDA currently has limited authority to construct a regulatory framework for biosimilars. The FDA's ongoing development of a scientific basis for a "generic biologics" or "biosimilars" framework will be highly controversial. Indeed, FDA's efforts, and the legal framework that could follow, may shape the future of therapeutic biologic products. This article highlights key policy and regulatory issues in the current "biosimilars" debate. (4 pages)

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

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Abstract: Pharmaceutical companies, medical device manufacturers and other biotechnology firms face increasing financial pressure as research and development expenses rapidly rise, mostly because of the need for longer, larger and more complex clinical trials. This environment creates valuable outsourcing opportunities for contract research organizations in traditional clinical research and an expanding variety of other services. But as contract research organizations (CROs) assume more responsibilities for conducting clinical trials, they may also be assuming liability risks for injuries to participants and for financial losses that may delay the regulatory approval process for a product. This article provides an overview of risk management strategy with an analysis of potential liabilities and establishes steps that may help minimize these risks. (5 pages)

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

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Abstract: Molecular medicine (also known as pharmacogenomics, pharmacogenetics, gene-based medicine, personalized medicine), after being heralded prematurely as the next revolution in medicine, is in the process now of becoming the first big change in healthcare of the 21st century. Because its scientific, clinical, ethical, financial, and regulatory implications are so far-reaching, it is important to define who and what will be affected in order to put the right societal systems and policies in place to cope with the change. Leaders of the personalized medicine field will be those organizations that see the wave and prepare to adjust their traditional planning, relationships, attitudes and management approach. (4 pages)

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

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Abstract: Canada's Natural Health Product (NHP) Regulations came into force on January 1, 2004. The extent to which these new regulations will alter Canada's health regulatory and patent law regime remains to be seen. However, as outlined in this article, regulatory pathway, data protection, patent register and pricing review are a few of the issues that may need to be freshly considered by manufacturers seeking to market medicinal products in Canada. (4 pages)

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

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Abstract: Collaborative business agreements are critical inter-organization alliances for companies in the biotechnology and pharmaceutical industries. These deals can be quantitatively valued with different outcome scenarios differentiated based on cash flow expected value and variance (risk), greatly assisting the negotiating process. This report illustrates that collaborative product licensing agreements are portfolios of risky assets, and modern investment theory can be utilized to efficiently diversify the cash flows associated with these deals, yielding agreements with the highest expected returns for the least risk. The construction of a minimum variance efficient frontier is desirable for all collaborative agreements before a business organization actually signs a deal, as value and risk characteristics can be optimally aligned. Furthermore, because these agreements are risky-asset portfolios, they should be structured collectively, both in case of single and multiple deals. Risk can be eliminated most rapidly while keeping expected returns as high as possible if every collaborative agreement a company participates in is quantitatively structured, balanced and optimized from the beginning of a company's evolution and development. (10 pages)

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

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Abstract: Use of technology to associate individuals with crimes has produced a revolution in the way crimes are solved. Current forensic DNA technology now has the ability to conclusively eliminate or implicate an individual as the perpetrator of a crime even when the suspect in unknown to the victim. Previous to the advent of forensic DNA, crimes with unknown suspects, such as sexual assaults committed by a stranger to the victim, have been very difficult, if not impossible to solve. Crime laboratories historically see a small percentage of reported sexual assaults, including those committed by strangers. A two-pronged approach including the broad application of crime scene DNA to a large known offender DNA database has shown the potential to solve and prevent many crimes of sexual assault. This article provides the business case for the broad application of DNA to all cases of sexual assault demonstrating an extraordinary return on investment. It explores the costs and benefits of DNA, the necessary size of a known offender DNA database to achieve success, and discusses estimated expenditure levels required to maximize this return on investment. Spending comparisons with other major preventative social spending are provided, and an optimal cost benefit level for forensic DNA is proposed. (17 pages)

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Abstract: The scope of intellectual property (IP) protection afforded to research tools has been the subject of much contention in all facets of biotechnology intellectual property, from patent prosecution to licensing and enforcement. This contention stems from how far the basic invention is allowed to "reach-through" along the subsequent research and discovery pathway. This article explores recent legal trends that define how far one may "reach-though" a research tool invention to obtain future benefits. (3 pages)

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

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Abstract: Intellectual property rights (IPR) are essential in today's technology driven society. Almost every company has IPR that requires protection from excessive U.S. tax exposure. To reduce U.S. tax exposure, various international strategies regarding development, manufacture, and marketing of intellectual property are discussed. In particular, international strategies pertaining to IPR co-ownership and other sharing arrangements are discussed. Additionally, effective tax-mitigation strategies are discussed regarding specific cross-border IPR and royalty transactions with certain countries. (4 pages)

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

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Abstract: Whereas orphan regulations exist in almost all ICH regions, they may correspond to significantly different types of reality in terms of principles and regulatory requirements. The apparent similarity in regulations may lead to misunderstanding and cultural gaps between sponsors and regulatory authorities. Based on the European and the US experience, we decipher the main points stumbling blocks that US sponsor may strike when applying for an orphan designation in the EU. An update of the orphan drugs designations is provided as well as the upcoming challenges that orphan regulations will meet with the development of pharmaco-genomics and personalized medicines. (4 pages)

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Abstract: Beginning the year with a bang, biotech posted one of its best funding quarters in its 30+ year history, and the best first quarter since 2000. Coming off the 4Q 03 opening of the IPO window, biotech continued to access large amounts of capital both publicly and privately. During the first quarter of the year, biotech had significant FDA approvals, forged significant partnerships, watched the FDA chairman Mark McClellan head to the CMS adding new uncertainty to the FDA equation, endured some product disappointments, but closed big deals and raised more money than ever before. It was a great start for 2004 and it's an industry clearly back on track. (5 pages)

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Abstract: Two days-April 30 and May 1, 2004-signaled important changes in European Union (EU) pharmaceutical regulation, EU clinical trials regulation, EU membership, and export controls applied by the U.S. Food and Drug Administration (FDA). This column describes the May 1 effective date of the EU's Clinical Trials Directive and the effect of the EU's expansion from 15 to 25 countries on U.S. FDA export controls. In the next issue of The Journal of BioLaw & Business, we will describe the April 30 changes in the EU's overall legislative framework for medicines. (2 pages)

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