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04.03.15 -- Making The Most of Biomarkers In Preclinical Studies
2015-04-02 02:37:18| drugdiscoveryonline Home Page
04/03/15 Drug Discovery Online Newsletter
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preclinical
biomarkers
Why Do Preclinical Humane Endpoints Matter?
2015-03-13 12:15:35| drugdiscoveryonline Home Page
By Dale M. Cooper, DVM, MS, DACLAM, MPI Research When people are suffering or dying from disease, there’s a powerful incentive to move new treatments through the pipeline as quickly as possible. But while speed is important, it cannot come at the expense of quality and compliance. The care of animals involved in preclinical safety studies is a compliance expectation by several regulatory bodies, and because the animal is the test system, good animal welfare is also good science. Establishing humane endpoints before a study begins is the right thing to do. It is an ethical expectation of the public, and it makes good business sense; humane endpoints can reveal crucial insights on a drug candidate’s mechanism of action and strengthen the rationale for a go/no-go decision.
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preclinical
Making The Most of Biomarkers In Preclinical Studies
2015-03-09 12:05:46| drugdiscoveryonline Home Page
By Adam Aulbach, DVM, DACVP, MPI Research Biomarkers are a useful tool in clinical trials, especially in identifying a drug’s impact on organs or tissues before any injury is clinically evident. It’s still early in their use in preclinical development; however, they are proving helpful in identifying major safety issues and showing promise for future use. Presently, biomarkers are used with clinical and pathology endpoints to identify the effects of a preclinical drug candidate far earlier than do traditional tests alone. But sometimes those biomarkers can lead to conflicting data. The assays may be so sensitive that they show evidence of toxicity—often a submicroscopic effect—that doesn’t appear in conventional study endpoints. How to explain those results, and whether they are relevant, presents a challenge best addressed by consulting with a pathologist before designing a study. Understanding the timing of pathologic processes is critical to interpreting results.
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studies
preclinical
biomarkers
The Role Of Swine As Preclinical Models For Cardiovascular Disease
2015-03-09 11:59:54| drugdiscoveryonline Home Page
By Mark Johnson, M.S. Senior Director of Surgery Classically, pharma, biotech, and device researchers have relied on rodent models to discover and validate disease targets and mechanisms, as well as for the preclinical development of therapeutics. However, the biology of rodents often fails to accurately predict outcomes in patients – perhaps not surprisingly, as mice are not simply miniature people, but have differences in immune function, lifespan, hematological function, regenerative capacity, and environment (sterile and controlled versus complex and dirty). This lack of translational validity has contributed, in part, to the high failure rate for drug development, particularly in the expensive clinical stage. The use of models in larger animals can help address some of these differences between rodents and human, particularly in cardiovascular disease.
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models
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cardiovascular
Acetylon's Selective HDAC Inhibitors To Be Featured In Multiple Presentations Of Positive Clinical And Preclinical Data At The 56th ASH Annual Meeting And Exposition
2014-12-03 06:58:10| drugdiscoveryonline News Articles
Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, recently announced that ricolinostat, the Company’s lead selective HDAC6 inhibitor, and selective HDAC1/2 inhibitors will be featured in one oral presentation and five posters at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 6-9, 2014, in San Francisco, CA
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featured
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positive