BioPharm International-06-01-2002

by David Schulman, Dechert London; and Joe Zammit-Lucia, Chris Easley, Cambridge Pharma Consultancy The job of many a biotech CEO is scrambling to find and secure funds to support the company's development projects. For many biopharmaceutical companies in early development stages, collaboration with "big pharma" is a compelling answer to the cashflow problem. But strategic alliances should benefit those on both sides of the negotiating table.

by Mark D. Dibner, BioAbility, LLC, and Michael Howell Biotechnology appears to be "the place to be" for venture capitalists, capturing the largest percentage increase in investment for 2001. The value of biotech companies has risen sharply, and many economists are predicing an end to the IPO drought.

by Edward R. Ergenzinger, Jr. and W. Murray Spruill, Alston & Bird, LLP Patents on genes and proteins might be severely ? even retroactively ? affected and lose significant value if the Supreme Court upholds the Appeals Court ruling in the Festo case. Applicants seeking patents may be required to make and test thousands of functional variants and describe them all in patent specifications to claim them. The Supreme Court decision is anticipated this summer.

by Francois Gossieaux, eRoom Technology, Inc.

On 19 April, a group of experts gathered to discuss key issues in the ongoing debate about stem cell research and related issues pertinent to xenotransplantation. Participants were Bill Anthony (moderator) of Orrick, Herrington and Sutcliffe; David J. Earp of Geron Corporation; Liz Howard of Orrick, Herrington and Sutcliffe; Wayne Koberstein of Pharmaceutical Executive; Thomas G. Sanders of MitoKor; and Margaret R. McLean of the Markkula Center for Applied Ethics, Santa Clara University.

by Duncan Pass, and Martyn Postle, Cambridge Pharma Consultancy How does big pharma look at your biotech company as a potential partner? This often depends on how it looks at its own research and development investments ? and how it presents them to shareholders. This insider's look at biotech-pharma collaboration shows you the other side of the equation.

by Linda Magee, Bionow The United Kingdom has the second largest biotechnology industry in the world, a leading position in Europe, an excellent science base, proven capability in the development of drug candidates, and a record of several firsts in technology development.

by Edward R. Arling, Ralph Dillon, and Joseph Noferi, Pharmacia GS API Biopharma Bringing a drug product to market requires that all parts of the manufacturing and validation puzzle comply with an increasing number of regulations. Managing the quality aspects for far-flung organizations can be a colossal assignment. A quality assurance unit may be the answer you need, along with finding capable, competent people and ensuring that they have the right communication tools.

by Jill Wechsler Concerns about product safety and stiffer FDA regulation of manufacturers may be drying up the biotech pipeline

by Liz Howard, Orrick, Herrington & Sutcliff, LLP Trade secret theft and economic espionage laws apply to biopharmaceutical researchers. Learn what your company needs to do to retain protection under the Economic Espionage Act and what employees need to know to pretect themselves from criminal charges.

by Jim Miller, PharmSource Information Services, Inc. and Edward P. Moser

by G. Steven Burrill, Burrill & Company After a strong finish in 2001, biotech is back in the dumps.

by Eric DeRitis, Real PR Network Communicating presents an image of openness, engendering trust; when you don't communicate, people soon think the worst. Biopharmaceutical companies frequently ignore corporate marketing until too late in the game: Public relations should start at inception to help companies start out correctly.