|
|
Click to buy
Guest Editorial
(4 pages)
|
An Interview & Tribute to Carl Feldbaum
Robin JR Blatt
|
Abstract: Carl Feldbaum led the Biotechnology Industry Organization from (1993 to 2004). During his tenure at BIO, numerous developments occurred in the field of genetics, biotechnology and public health. With great skill he led BIO through a rapidly changing and high growth period; and, as developments occurred in the sector, he worked diligently to build consensus and spearhead new initiatives in response. A frequent Contributor to The Journal of BioLaw & Business, Carl was a voice for industry and at the same time was cognizant and spoke to the ethical and social concerns in the field. This interview was conducted prior to his departure and retirement from BIO. The Journal of BioLaw & Business is pleased to provide this Tribute to Carl Feldbaum and extends our appreciation to him for his years of service and dedication to the field.(4 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
Feature
(9 pages)
|
Biologics Move Off Patent but New Paradigms are Unlikely to Emerge in the Absence of Public or Private Economic Incentives
Raymond S. Fersko and Nazlie S. Latefi
|
Abstract: Pioneer biologics (protein-based, biotechnology derived compounds) are coming off patent. Biologic manufacturers are not granted expedited FDA approval for follow on products like generic small molecule manufacturers. The Drug Price Competitions and Patent Term Restoration Act of 1984 ("Hatch Waxman") granted chemical drug manufacturers the option of filing an Abbreviated New Drug Application (ANDA). The rational was to enable lower cost drug manufacturers with adequate lead-time to satisfy regulatory requirements for generic concluded by the innovators patent expiration date. This article analyzes the likelihood of biological products being treated like chemical pharmaceuticals and concludes that because bioequivalency of biologicals cannot be proven with the requisite certainty it is unlikely that there will be any Hatch Waxman like scheme for biolgoicals. The possibilities may result from collaborations and/or consortia that provide innovation unlikely to be developed absent an anti-trust exception on an ad hoc basis some private collaboration in anticipation of economic justification.(9 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
Feature
(6 pages)
|
Patents, Pharmaceuticals and the Implementation of Paragraph 6 of the Doha Declaration on the Trips Agreement and Public Health
Meir Perez Pugatch
|
Abstract: It is interesting to observe how the most politically contested subjects can evaporate overnight, leaving all those affected to pick up the pieces and to try to make sense of what has just happened. The WTO deal on drug patents (or in its official title: 'Implementation of Paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health', dated 2 September 2003) is such an example. This purpose of this article is twofold: 1) to describe the complex and paradoxical nature of pharmaceutical IPRs; and 2) to analyze the TRIPs deal on drug patents (or as commonly referred to as the 'Paragraph 6 Deal'), to explain its implications, and identify the potential winners and the likely losers from this deal.(6 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
Feature
(5 pages)
|
Genetic Discrimination and the Need for Federal Legislation
John J. Quick
|
Abstract: The advent of the Human Genome Project signaled a new era in preventative care. However, this Project threatens to create a new form of employment discrimination, which legislation has yet to sufficiently address. Courts are attempting to utilize a variety of currently enacted laws to combat such discrimination but it is clear that this may be an inadequate deterrence. To combat this problem, a new set of laws and regulations will need to be enacted to ensure that the interests of employers are upheld while maintaining proper protection of employees from genetic discrimination. This paper focuses on genetic testing in the workplace and the need for Federal legislation.(5 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
Feature
(7 pages)
|
The Biopharmaceutical Innovation Plane: A New Industry Structure and Solution for the Drug Development Bottleneck
George Gaines and Kevin Pang
|
Abstract: The effective use of biomarkers will revolutionize both clinical trial design and biopharmaceutical research. This will spur dramatic changes to both the structure and business model of the biopharmaceutical industry. Broad application of biomarkers in clinical trials promises to dramatically shorten cycle length, improve patient outcomes measurements, select patient populations most likely to benefit from specific drugs, and eliminate patients at risk for adverse reactions, thus significantly decreasing the cost of each trial. However, the current structures of the biotech and pharmaceutical industries, including their interactions with the FDA, slow the adoption of biomarkers as a critical component of clinical trial measurements and drug R&D. Fundamental changes in the industry are required to speed the adoption of this new approach and technology. In this paper we explore a new, system-wide and operational view of drug discovery and development, using a model we call the 'innovation plane.' This view states that in order to increase the speed and capacity of the system to deliver molecules to market, much greater focus on the bottleneck step of clinical trials must be exerted. Too much emphasis is given in traditional R&D efforts to novel molecular discovery without ever impacting the overall rate of the system. R&D needs to be redefined and refocused on the practical applications of biomarkers in clinical trial redesign.(7 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
Feature
(5 pages)
|
Biotechnology and Biosafety Regulations in Mexico
Isabel Saad, José Luis Solleiro and Rosario Castañón
|
Abstract: This article presents a brief analysis of the institutional and regulatory foundations for the development of biotechnology in Mexico. The analysis is based on research carried out by the authors with the purpose of evaluating the needs for reform so that Mexico can fulfill the requirements of the Cartagena Protocol and can also capitalize on the potential benefits of biotechnology. This study is based on interviews with key persons in industry, congress, universities and government institutions who are responsible for biotechnology policy and regulation in Mexico, and on a detailed review of the relevant legal framework. The results of the analysis have been discussed in two inter-institutional forums coordinated by the authors in which representatives from all the interested sectors participated.(5 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
Recent Developments "International" Is the Keyword
Bryan A. Liang
|
Abstract: "International" seems to be the keyword in recent developments in the biotechnology and pharmaceutical industries. Globalization, of course, has created significant opportunities, and liabilities, in the biolaw and business world. Other pressing international issues in formulated drugs and research have also arisen and are outlined in this issue's Recent Developments.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
Allocating Responsibility for Counterfeit Prescription Drugs
Laura A. Willard
|
Abstract: New York District Court ruling suggests distributors, not manufacturers, are responsible for counterfeit pharmaceuticals.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
The State Challenge of Overturning the Federal Ban of Importing International Prescription Drugs
Lisa M. Smith
|
Abstract: States, in various ways, are beginning to challenge the federal ban disallowing them to import prescription drugs.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
FDA Recommendations for Antidepressant Use in Children
Arlene Luu
|
Abstract: FDA concludes warnings appropriate for antidepressant use in children.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
International Stem Cell Use and Regulation in Research
Laura Lin
|
Abstract: International rules have broadened permitted use of stem cells.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
Women and Minority Recruitment in Clinical Trials
Moira Brennan
|
Abstract: Minority participation in clinical trials remains low but education and community outreach may increase effectiveness in recruitment.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
RECENT DEVELOPMENTS
(2 pages)
|
World Health Organization Removes HIV/AIDS Drugs from Prequalification List
Jannine M. Green
|
Abstract: Recent removals of HIV/AIDS drugs from the WHO prequalification list give warning that biotech outsourcing requires compliance.(2 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
BIOCOLUMNS
(4 pages)
|
M&As / "Something's Gotta Give": Possible M&A and Commercialization Trends in Life Science from 2005 Forward
David E. Schulman and Martyn Postle
|
Abstract: Not surprisingly, articles that predict industry trends are often "authoritative" but less often "right." Nevertheless, there is value to examining industry trends-Even if wrong on timing or repetition of theme, these examinations help focus attention on more likely versus less likely potential challenges and opportunities. This article highlights emerging trends in the life sciences in 2005.(4 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
BIOCOLUMNS
(4 pages)
|
Trade Secrets / Follow-On Biologics and the Unauthorized Use of Trade Secrets
Meredith Manning, Stefanie L. Berman, and Ellen Y. Chung
|
Abstract: In a response to a citizen petition submitted last year, the Federal Food, Drug, and Cosmetic Act (FDCA) left open the possibility that applications for follow-on protein products could be approved based on findings of safety and effectiveness about proprietary data and information submitted to FDA by the innovator in support of a marketing application. Given that the data on which these "findings" are based constitute confidential commercial information protected by law from use and disclosure by others, FDA's pursuit of this policy raises numerous legal questions - primarily whether FDA's policy violates both the FDCA and whether, on implementation, it would constitute a taking under the Fifth Amendment of the United States Constitution.(4 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
BIOCOLUMNS
(4 pages)
|
International / Stem Cell Research in Canada: Business Opportunities for U.S. Companies
Cheryl Reicin and Eileen McMahon
|
Abstract: The ban on the use of United States (U.S.) federal funds to support new embryonic stem cell research has had a chilling effect on such research in the U.S. In Canada, significant research opportunities are available for conducting stem cell research. The opportunities include using embryos that were originally produced for reproductive purposes, and using stem cells derived from adults and animals. Stem cell research in Canada is made even more attractive in view of the availability and quality of research facilities, the lower cost of conducting research in Canada than in the U.S., and the government tax credits.(4 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
|
Click to buy
BIOCOLUMNS
(4 pages)
|
Finance / Predications and Outcomes on Biotech Looking Back and Looking to the Future
G. Steven Burrill
|
Abstract: As we reflect on 2004, the biotech industry had a good (not great) year. Looking to 2005, the biotech sector can expect a number of positive developments. This article highlights the developments in the year past and predictions for the current year. In addition, it reviews previous predications for 2004 and provides specific outcomes.(4 pages)
©2004
by The Journal of BioLaw & Business. All Rights Reserved.
Back
to Top
| 
to order articles 
