BioPharm International, September 2005 - BioPharm International

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BioPharm International, September 2005
Special Section
Information Management Systems Enable Manufacturing Facilities to Ramp Up Productivity
By Dave Femia
Pharma industry equipment utilization hovers below 40 percent, which would be an unacceptable figure in most industries.
Articles
The Search for Cancer Diagnostic Markers: A Race Against Time
By K. John Morrow, Jr., PhD
At this time there are no effective diagnostic tests for cancer that are rapid, economical, highly specific, and highly sensitive. This deficiency means that many cases of malignancy go undetected until long past the time of effective treatment. Much cancer research, including investigations carried out by both the academic and private sector, is focused on combining therapy and diagnostics as "theragnostics."
International Patents and International Harmonization
By Paul Sharer, J.D. , Martina Simpkins, LL.M.
...biopharmaceutical companies still face rampant piracy and counterfeiting of patented products.
Building Automation Systems in a PAT Framework
By Jonathan T. Whitney , Mark A. Granger
A well-understood, validated, and correctly maintained BAS reduces the chance of a critical room parameter slipping out of specification.
The United Kingdom: Leading the Global Competition for Biotech
By James L. Kupferer, Jr. , J. Wood Hydrick
As a company that performs site selection for biopharmaceutical companies worldwide, Fluor Global Location Strategies has witnessed one country truly distinguishing itself from the competition as a worldwide leader in the industry: the United Kingdom. The global competition for biotech investments has been at a fever pitch over the past few years, with varied results.
Biosafety for Large-scale Operations Using Recombinant DNA Technology
By Enda Moran, Ph.D. , Richard Fink, SM (NRM)
Current best practices of containment reduce the risks associated with biotech development.
Columns and Departments
StreetTalk: No Cure for Cancer? Wall Street Waits - and Hesitates
By Brian O'Connell
Part of the problem with cancer drugs as investment picks is that investors don't trust the underlying studies that seem to prop up vaccine maker stocks.
Regulatory Beat: Crawford Faces Policy and Program Challenges
By Jill Wechsler
The Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration (FDA). Crawford's nomination had been put on hold as various legislators pressured FDA to approve an over-the-counter version of the "morning-after" pill, Plan B, and to support broader drug importing.
Final Word: Collaborate to Compete?
By Ernst R. Berndt, Ph.D.
Daunting but common challenges currently face many biotech, pharmaceutical, and device firms. These companies are encountering a restless public, worried investors, and a skeptical, publicity-hungry Congress that are all concerned about product safety and the reliability of regulators' scrutiny.
Outsourcing: All Eyes on Asia
By Jim Miller
In addition to India and China, other Asian countries are establishing themselves as destinations for biopharma companies.
Operations Excellence: BioPharma Operations Excellence
By Amir London
Formal process and operation improvement activities are being employed in almost every biopharmaceutical manufacturing company, according to a recent survey conducted by Tefen Ltd and Millipore Corporation. The industry-wide survey was conducted to assess current biopharmaceutical operations excellence (OpEx) trends and needs, as well as OpEx perceptions and expectations related to industry suppliers.
From the Editor in Chief: From Leeches to Lawsuits
By Carol L. Fisher
Hurricane Katrina is slamming into the Gulf Coast of the US at the moment, with wind gusts of up to 140 mph. As many as 10,000 residents of New Orleans, LA have taken shelter in the city's Superdome, while others obeyed the mandatory evacuation order and fled to safer ground earlier.

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