Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval The National Cancer Institute and the Food and Drug Administration (2005) / Chapter Skim
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1 Scientific Rationale
1 Scientific Rationale
Pages 1-6
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, tumor suppressors, and other factors that act in complex molecular pathways to control cell physiology and proliferation, cancer drug discovery occurred in at least three important ways. It could be fortuitous, stemming from unexpected findings in the course of studies not directed toward controlling the disease; it was often highly empirical, relying on the screening of large numbers of compounds and complex biochemical extracts derived at random (or nearly so)
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. Approaches to Cancer Drug Discovery Concerted efforts to find effective anticancer agents began after World War II, following observations that personnel exposed to mustard gas during World War I had experienced severe bone marrow depression, and that this feature of mustard gas derivatives was a dominant theme in molecules synthesized through the World War II era.
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and to guide the differentiation of cells into specialized types, several antiproliferative "don't grow" signals operate within and between cells, which either may cause cells to permanently exit the cell division cycle and adopt specialized properties, or alternatively divert cells from the cell division cycle and lead them into a quiescent state from which they may resume proliferating if future conditions dictate. In normal cells, anti-growth signals are relayed in large part by a pathway that is controlled by a prototypical tumor suppressor protein.
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, normal human cell types, after 60 or 70 doublings, sense that their chromosome tips have become too short to support additional cell division without compromising chromosome integrity, and they either cease proliferating or die. In stem cells and in cancer cells, an enzyme actively maintains the DNA sequences located at the tips of chromosomes, and provides stem cells and cancer cells limitless replicative potential.
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Biologists, programmers, and others engaged in bioinformatics research are developing increasingly sophisticated analytical software, powerful statistical methods, databases, and user interfaces for the management, manipulation, and mining of experimental genomic and proteomic data and other allied information (such as human knowledge and the vast amount of published information about a particular topic)
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, both of which will be supported by improved and accelerated methods for determining structure-activity relationships of drug candidates. Progress in every stage of cancer drug discovery and therapy -- from target identification, to compound development, to rational treatment regimens based on precise molecular diagnoses of individual patients -- is poised to provide the next generation of cancer patients, and certainly the generation after that, with far better options for eliminating or controlling their disease than exist today.
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