Review of Translational Medicine and Drug Discovery
- PDF / 73,885 Bytes
- 1 Pages / 602.986 x 782.986 pts Page_size
- 80 Downloads / 178 Views
Review of Translational Medicine and Drug Discovery
Littman BH, Krishna R, eds. Translational Medicine and Drug Discovery. New York, NY: Cambridge University Press; 2011. 361 pages. Reviewed by: Edward Tabor, PhD Quintiles, Rockville, Maryland, USA
Although the term ‘‘translational research’’ first appeared in PubMed in 1993,1 it was not widely used until about 2000. Attention to it has surged since then in response to the discovery of new biomarkers and, more recently, to advances in biomarkers research. As a result of this trend, this book, Translational Medicine and Drug Discovery, is really about the role of biomarkers in translational research. A good biomarker can allow investigators to select patients for a targeted approach to treatment, increasing the chances that a study will have a successful outcome if the treatment is effective. A good biomarker also can shorten the time to completion of clinical (or nonclinical) studies, by permitting the early detection of safety or efficacy, or lack thereof. The need to validate biomarkers, to show their clinical relevance, is an important part of preparing to use them in clinical studies, and sometimes the validation can be incorporated in the first clinical study with the biomarker, establishing its usefulness for future studies as well. A philosophy of using biomarkers to build a program of drug discovery is described in one chapter of the book, written by a Merck executive. Merck has used biomarkers to develop targeted therapies, to reduce the length of clinical Phases 1 and 2 (Merck claims to have reduced the time from the industry average of 3.7 years to 2.5 years), and to identify sooner those products that will not make it past Phase 2. A culture was created in which a ‘‘failed’’ trial or program was considered really to be a success if the failure occurred early enough to allow the advancement of better programs. Their slogan is ‘‘Fail Fast, Fail Cheap,’’ and biomarkers have made this possible. The core chapters of the book address translational medicine and biomarkers in each of several diseases or conditions, and these chapters make this book valuable. They cover diabetes mellitus, atherosclerosis, obesity, bone disorders, neuroscience, and oncology. There is also an extensive chapter on ‘‘imaging biomarkers.’’ I found the core chapter on translational medicine in diabetes mellitus to be particularly good. In studying anti-diabetic medications in normal volunteers in Phase 1, it is not possible to observe a glucose-dependant lowering of blood glucose since normal
Drug Information Journal 46(2) 237 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512436757 http://dij.sagepub.com
volunteer subjects are not hyperglycemic. However, biomarkers can allow one to study proof-of-mechanism in these normal subjects, to get a preliminary indication of activity of the molecule in humans at an early stage of development. This approach was used successfully in the development of DPP-4i drugs by measuring the effec
Data Loading...
