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December 2004 From Concept to Development
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Volume 7, Issue 12
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Cutting things down to size Cutting things down to size
by Kevin Hrusovsky and
Mark Roskey

PDF version (152 KB PDF)
A disparity between pharmaceutical industry levels of R&D investment and the development of innovative drugs exists in part because technology innovation has been focused on optimizing individual processes. Broad use of standardized technologies, such as microfluidics, can help scientists move and share better-quality data across therapeutic areas or between R&D groups.


PAT pending PAT pending
by Randall C. Willis

PDF version (216 KB PDF)

Technical innovation in pharmaceutical manufacturing has been relatively slow compared with that in drug R&D, with many methods used for process analysis remaining largely unchanged for decades. To address this problem and ensure the safety and efficacy of drug production, the FDA has developed process analytical technology guidelines for quality testing.


Connecting the dots Connecting the dots
by Tom Laz, Kevin Fisher, Mitch Kostich, and Mark Atkinson

PDF version (360 KB PDF)

Technical innovation in pharmaceutical manufacturing has been relatively slow compared with that in drug R&D, with many methods used for process analysis remaining largely unchanged for decades. To address this problem and ensure the safety and efficacy of drug production, the FDA has developed process analytical technology guidelines for quality testing.


BioValley BioValley
by Allison L. Byrum

PDF version (156 KB PDF)

Nestled at the junction of France, Germany, and Switzerland, BioValley strives to become a leading biotechnology region in Europe, and its trinational status affords it some unique opportunities. The young biocluster is building a network ranging from universities and research institutions to major pharmaceutical firms.

 

Content in Context
Parting words (32 KB PDF)
by Ann M. Thayer

New and Noteworthy (216 KB PDF)
T-oligos target melanomas · · Neurodegeneration pathway discovered Pinpointing SNPs · Upping insulinís staying power · Nanobody collaboration · Transplant to asthma indication? · Nuclear defense Hard cells to crack

Focus on Business

Marketplace, deals, and people (52 KB PDF)

Drug discovery in Singapore (104 KB PDF)
by Jim Kling
The Novartis Institute for Tropical Diseases confronts new challenges and opportunities.

Breaking into the pipeline (52 KB PDF)
by Allison L. Byrum
A British company taps into the U.S. market, with help from others.

Diseases and Disorders
Multiple sclerosis
(84 KB PDF)
by Linda Richards
Although interferon-based drugs were a breakthrough, a better understanding of the disease process is leading to new therapies.

Rules and Regulators
Close enough?
(104 KB PDF)
by David Filmore
The prospect of off-patent blockbuster biotechnology drugs is triggering a complex legal, policy, and scientific debate on a new type of generic.

Clinical Trials Track
Flu trials
(112 KB PDF)
by David Filmore
Compliance and supply issues with influenza vaccines intersect with growing fears of a pandemic outbreak.

Applications Notebook
Industrializing microarrays
(96 KB PDF)
by Steve Lombardi
High-throughput microarray analysis can help improve drug discovery and development.

Sites and Software
Information avalanche (56 KB PDF)
by William Illsey Atkinson
Enterprise content management is helping laboratories make sense of all the facts.

The Tool Box
Hit the fluor
(64 KB PDF)
by Pili A. Hawes
Researchers are using fluorous technologies to facilitate organic synthesis.

Product Info Now (html)

On the Calendar
LabAutomation and PepTalk
(56 KB PDF)
California is the location for these annual winter conferences.