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Guest Editorial
(3 pages)
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Perspectives
from the Street:
Life
after Enron in the World of Biotech
Stelios Papadopoulos
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Abstract:
At another time, the Enron affair,
complete with the parallel mini-dramas of its multiple protagonists,
could have been another transient, headline-grabbing business failure
and would have amounted to nothing more than the subject of cocktail
party chatter. Not this time. Enron will be with us for quite some time
and its implications will be far reaching, stretching all the way to
the our cozy little world of biotechnology.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature Article
(12 pages)
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Genomic
and Enabling Platform Technology Companies In Transition
Raymond S. Fersko and Ebun S. Garner
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Abstract: This article discusses the shifting
focus of genomics and platform technology companies from concentrating
solely on licensing tool technologies towards becoming true drug and
product developers. The article examines this issue in the context of
public policy, the licensing of research tools, and shifting paradigms
in drug development as a result of genomics.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature Article
(10 pages)
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Vendors
and Suppliers as a Source of Capital For Biotechnology Companies:
Opportunities and Pitfalls
Gary N. Sutton and Eileen Smith Ewing
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Abstract: The biotechnology company in need
of an infusion of new capital should look not only to traditional venture
investors, but also to its natural allies in related industries - suppliers
and vendors whose own economic success depends on the success of their
customers. Nonetheless, the parties must bear in mind that raising capital
while cementing a supplier relationship raises significant potential
legal issues for both parties. Though conceptually similar in nature
and structure to equity collaborations between biotechs and pharmas,
this article describes the unique opportunities and pitfalls associated
with this form of transaction.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature Article
(4 pages)
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Financing
Biotechnology Companies: Is Your Investment Safe?
Philip W. Fiscus
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Abstract: Since the dotcom bubble burst,
venture capital (VC) firms have been looking for new places to put their
money, and biotechnology companies are one of the beneficiaries. The
sector saw the largest gains in terms of percentage of investment, rising
to 8.2 percent in 2001 from 3.5 percent in 2000. According to recent
surveys, it was the second best year in biotech financing. Today's renewed
trend toward investing in this sector is a welcome one, especially in
a business where the cost of developing a drug averages $810 million.
However, a key question is how can VC firms make sure their investment
in a biotech company is a safe one? This article addresses risk management
issues and solutions for investors in the biotechnology and life sciences
sector.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Feature
Article
(7 pages)
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Key
Factors in the Valuation of Biotechnology Companies
Adrian Ciocoi
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Abstract: Chief
financial officers, venture capitalists, financial analysts, and other
advisers who provide services in the biotech industry should be aware
of the main factors affecting the value of companies operating in the
biotechnology industry, and capable of assessing the presence or absence
of key factors at a particular company; in addition, they should be
able to quantify the impact that identified or absent factors may have
on the value of a certain biotech company. The purpose of this article
is to present an overview of the valuation methodologies employed for
biotechnology companies found in the early-stages of development as
well as for developed companies.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Special Segment
(2 pages)
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Massachusetts
Biotechnology Council (MBC): Strong and Growing
Janice Bourque
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Abstract: In April (2002) the Massachusetts
Biotechnology Council (MBC) convened its annual meeting bringing together
members of industry, academia, government and the media. This article
provides an overview of the event as well as an update on activities
and agenda of the MBC.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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Special Segment
(2 pages)
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An
Address to the Massachusetts Biotechnology Sector
Governor Jane Swift
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Abstract: It was Socrates who taught us that
Science seeks the meaning of prolonging, increasing, facilitating and
amplifying life -- or making it tolerable, and acceptable. As pioneers
in biotechnology, Massachusetts has made this its mission for more than
50 years
From the first genetically-engineered blood clotting factor,
to biotech drugs for cancer, these achievements are indeed remarkable.
(Based on Remarks Presented at the Massachusetts Biotechnology Council
(MBC) Annual Meeting (April 23, 2002) in Boston, Massachusetts.)
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(6 pages)
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Finance
The Perfect Series B Financing: Steps to Take Before Meeting
with VCs
Angela Rossetti
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Abstract: Current market conditions unfortunately
bear out the fact that the "Perfect Series B" is hard to find.
In fact, the percentage of completed Series B financings for venture-backed
companies trended sharply down last year, averaging about 9% of all
companies seeking funding in 2001, down from 22% in the fourth quarter
of 1999. This distinct downward trend provides example of not only the
irrational exuberance that peaked in 1999, but also defines the current
caution. Although there is no "perfect" Series B either in
presentation, valuation or format, it is true that there are some characteristics
of early stage companies raising Series B financing that can make for
a strong offering. This article defines those characteristics and provide
examples of successful Series B financings that readers may find useful
in their quest for funding.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(4 pages)
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Federal
Circuit University Research and the Experimental Use Exception
to Patent Infringement
Edward R. Ergenzinger Jr. and W. Murray Spruill
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Abstract:
Many university officials, researchers, and some attorneys have
interpreted the experimental use exception to patent infringement as
providing protection for most research activities that are conducted
within a university setting and that are not tied to commercialization
efforts. Not so, according to the recent decision by the Federal Circuit
Court of Appeals. In Madey v. Duke Univ., the Federal Circuit held that
even where university research projects have arguably no commercial
application, these projects further the institution's legitimate business
objectives, including educating and enlightening students and faculty
participating in these projects, and are therefore not eligible for
the experimental use exception to patent infringement. This article
provides a brief discussion of the historical development of the experimental
use exception to patent infringement as well as the recent holding in
Madey v. Duke Univ. as it relates to the experimental use exception.
In addition, a discussion of the implications of this holding for biological
university research is provided.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(3 pages)
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BioConversations
A Thought Leader Interview with Robert Mashal, MD
Robin JR Blatt
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Abstract: .A physician and venture capitalist
at Boston Millennia Partners talks about investment trends in the biotechnology
and life science sector and how the current economy requires entrepreneurs
and VCs to revise and manage expectations. Robert Mashal, MD, is a Partner
at Boston Millennia Partners. His work focuses on Life Sciences opportunities,
primarily drug discovery and development and enabling technologies for
the drug development process, including genomics, systems biology, and
chemical genomics.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(2 pages)
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Venture
Capital Beware the Clawback
Howard S. Rosenblum
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Abstract: As
private equity fund managers have taken pause over the past several
months to assess their portfolios and the projected performance of their
funds, recent valuation declines have given them reason for great concern.
In particular, some fund managers have focused on the size of early
carried interest distributions made by their funds and the prospects
of triggering the so-called "clawback" provisions contained
in the governing limited partnership agreement.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(2 pages)
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Strategy
Running On Empty
Stephen T. Mears
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Abstract: By nearly all measures, the second
half of the 1990s was a tremendous period for the venture capital industry.
Now, with the dramatic changes in the public and private investing environments,
many funds formed in the late 1990s are facing shortages of cash that
may hinder their ability to continue to finance their existing portfolio
companies. These portfolio companies are expected to require significant
amounts of follow-on financing from existing venture investors because
of the weak mezzanine financing environment and the current unavailability
of public equity financing. This article addresses the issues and possible
alternatives that fund managers can consider to address liquidity problems.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(6 pages)
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BioDefense
Training for Strategic Decision-Making Post 911
Hilda Blanco
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Abstract: This
article focuses on the heightened need for training in strategic decision-making
for leaders in the emergency response and planning community post 9-11.
Although emergency management has a tradition of strategic planning,
the Federal Emergency Management Agency's (FEMA's) conceptual framework
for dealing with disasters has several assumptions that are violated
by terrorist activities. Specifically this paper calls for three new
strategic thrusts in emergency planning: a) ongoing monitoring of situations
requiring new technology, and coordination and communication systems;
b) a more dynamic, game-theoretic approach that utilizes simulation
and modeling; and, c) greater emphasis on training for decision-making
skills and judgment that employs recent research findings in naturalistic
decision-making. Higher education training in decision-making skills
can benefit from recent findings in naturalistic decision making that
indicate we can quicken the pace of acquiring decision making skills
by "learning how experts learn" and instruction in how to
develop back-up models for decision-making.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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BioColumn
(4 pages)
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International
Financing Mechanisms for Biotechnology Start-Up
Companies in Hong Kong
David Richardson
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Abstract: In
the last few years, the Hong Kong government has increased its efforts
to develop the biotechnology industry in Hong Kong. Whether a local
biotech company is relatively new in the industry or has been around
for a few years, there are a number of ways it can raise funds to expand
and develop its business. The Hong Kong government has set-up various
funds to provide financial support to local biotech companies. Such
companies can also enlist the support of private investors and venture
capitalists if suitable investors can be found. However, if a biotech
company requires substantial financial support, it can consider listing
on the General Enterprise Market ("GEM"), the second board
of the Hong Kong Stock Exchange. In comparison to the Main Board of
the Hong Kong Stock Exchange, the less stringent listing requirements
of GEM makes it more attractive for less established companies to raise
funds.
©2002
by The Journal of BioLaw & Business. All Rights Reserved.
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