Autoimmune Disease Featured Articles
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The Race In Diabetes R&D
1/31/2013
GSK and other drug discovery and development companies are taking new aim on the global diabetes explosion – sometimes alone, sometimes in league together.
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HIV/AIDS Vaccine Development: Are We Any Closer?
11/29/2012
With more than 20 years of lab experimentation of a HIV/AIDS vaccine, a leading researcher proves that the concept is possible, but must do better to create the vaccine.
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Strategic Application Of Regulatory Pathways For Medical Devices
11/15/2012
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) signed into law by President Obama last July is a sweeping piece of legislation that, among many other provisions, enacts reforms aimed at improving various FDA regulatory procedures, including the medical device review and approval processes. By Evan L. Rosenfeld, MD, JD, FCLM, Vice President of Medical and Scientific Affairs, Medical Device and Diagnostics, Theorem Clinical Research
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Smart Sourcing At the Outset
10/31/2012
When companies don’t have the in-house resources to characterize and refine truly novel compounds, they must rely on suppliers who do. Embrace the idea of early, painstaking characterization – using the most well-equipped and innovative suppliers as needed to put your product and company on sound strategic footing.
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Genzyme: Helping Sanofi Break Free Of Blockbuster Medicines
10/28/2012
Sanofi’s 2009 annual report indicated that the company needed to transition away from a reliance on blockbuster medicines, instead, optimize its approach to R&D, which is something Genzyme could help with.
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Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing
10/1/2012
Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes. From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International
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Can Rapid Mobile Diagnostics Speed Up Clinical Trials And Regulatory Reviews?
8/30/2012
As a new technological space containing all the alternatives, the most practical and immediate application for Rapid Mobile Diagnostics (RMDx) may be in clinical trials.
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Using A Diabetes Patient’s Own Liver Cells As A Novel Source Of Insulin
6/11/2012
Diabetes currently afflicts approximately 285 million people worldwide, about 6.4 percent of the global population. The World Health Organization projects that this number is set to rise to 366 million by the year 2030. By Sarah Ferber, Ph.D., Chief Science Officer and founder, Orgenesis
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Are Your Foreign Manufacturing Sites FDA-Ready?
2/24/2012
FDA inspections of overseas plants manufacturing pharmaceuticals and medical devices sold in the U.S. market are on the rise. The inspection frequency for a foreign manufacturing plant was once in nine years, as compared to once in 30 months for plants based in the United States, according to a 2010 GAO Report. By James Prutow, Frances Palomar, and Vignesh Ramesh
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A Novel Approach To Shortening The Drug Approval Process
12/14/2011
Two pharmaceutical industry stories recently caught my attention. The first involves Nabi Biopharmaceuticals (NASDAQ: NABI), which recently announced the company's smoking cessation vaccine NicVAX failed a second late-stage trial.