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August 2004 From Concept to Development
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Volume 7, Issue 8
Article Indexes
Author Indexes


Devil in the detailsDevil in the details
by Randall C. Willis and David Filmore

PDF version (240 KB PDF)
Metabolic profiling provides functional information at the biochemical level that can be used to see what pathways and mechanisms are altered by specific interventions or diseases. Thus, pharmaceutical and biotechnology scientists are investing a lot of time and resources into developing new tools and techniques to identify metabolic markers that will explain disease pathogenesis and/or serve as biochemical signposts during preclinical and clinical drug screening.

Clinical pharmacogenomics: Almost a reality?Clinical pharmacogenomics: Almost a reality?
by David Filmore

PDF version (224 KB PDF)
The prospect of performing clinical trials in which the analysis of safety or efficacy is put in the context of genetic or genomic subgroups, or in which patients are stratified on the basis of this type of data, is still uncertain, as is the outlook for making the resulting data available to regulatory agencies and the public. But signs are becoming more evident that opportunities for integrating pharmacogenomics, the science of linking genetic determinants to drug response, into clinical research are on the rise.



Sites and Software
Pharma and the seven keys (72 KB PDF)
by Randall C. Willis
Over the next decade, critical informatics technologies will revolutionize the drug industry.

The Tool Box
Addressing “the three Rs”
(76 KB PDF)
by Christina Burtsoff Asp
Microfluidics can help reduce the number of animals used in research and preclinical studies.

Product Info Now (html)

On the Calendar
SBS and Chips to Hits
(72 KB PDF)
Two major meetings are slated in September.

Content in Context
On the same page (32 KB PDF)
by Ann M. Thayer

New and Noteworthy (152 KB PDF)
HIV vaccine testing • Leave a message • Lithium and AD • BioShield strikes back? • Structural alliances • Tigecycline trials • Riding the nanotube • Measuring immune-response memory

Focus on Business

Marketplace, deals, and people (64 KB PDF)

Warning, merge with care: Sanofi-Aventis (84 KB PDF)
by Kimberly S. Cleaves and Ann M. Thayer
A near-shotgun marriage for France’s two largest pharmaceutical companies.

Decommissioning knowledge silos (84 KB PDF)
by Randall C. Willis
To succeed, R&D, clinical, and marketing departments must see each other as assets.

People and Perspectives

Closing the loop on information (52 KB PDF)
by David Filmore
IBM’s life sciences manager has some words of advice.

Honoring Syntex’s “Big Three” (68 KB PDF)
by Bryan D. Tweedy
The trio of scientists involved in the development of oral contraceptives receives awards.

Diseases and Disorders
New drugs hold promise for osteoporosis
(80 KB PDF)
by Linda Richards
Although a potentially debilitating disease, with treatment it can be prevented.

Rules and Regulators
The NIH “swivel chair”
(72 KB PDF)
by David Filmore
The Health and Human Services agency’s conflict-of-interest policies are under heavy scrutiny.

Applications Notebook
From the laboratory to the patients
(168 KB PDF)
by Nadine Pavloff
Strategies for the rapid development of cell-culture manufacturing processes for human enzymes