Niche drug developers

Combined with the trend of small niche companies in drug development has come the parallel corporate trend of downsizing and the hesitancy to expand divisions to take on temporary projects. A great number of large companies are contracting for critical aspects of drug discovery and development. Compounds can be manufactured xmder contract. 

Examples abound regarding the role of serendipity in the discovery of new therapeutic approaches, which on closer examination usually turned out to be the result of clinicians paying attention to unexpected clinical effects rather than discounting them. For example, lithium was tried first for hypertension, chlorpro-mazine was initially developed as an anesthetic, and imipramine was originally regarded as an antihistamine and an antipsychotic agent. Without astute clinical observations, these drugs would not have found their niche, nor would clozapine have been revived for the benefit of millions of the most difficult to treat schizophrenic patients. Other examples include the expanded indications of newer... 

The lymph node microenvironment represents a niche where CLL cells interact with different types of cells including monocyte-derived nurse-like cells (NLC), CD3+ CD4+ CD154+ T cells, mesenchymal stromal cells, dendritic cells, and endothelial cells (15). In addition to cell-cell interactions, CLL cells are also exposed to a variety of soluble factors such as antigens, cytokines, and chemokines (2). It is the combination of such signals that renders CLL cells less susceptible to chemotherapy and promotes clonal evolution and drug resistance. Thus, the role of the microenvironment needs to be carefully considered in order to develop novel and more effective therapies for CLL treatment (16). In particular, the efficacy of new drugs must be evaluated under experimental conditions that recapitulate (or at least partially mimic) the CLL microenvironment. 

The lead compound for this series, nalidixic acid (38-6), which is acmally a naphthyridine rather than a quinolone, was first introduced over four decades ago. That compound for many years found its niche as a rather effective drug for the treatment of urinary tract infection. The rediscovery of the general stmcmral class in the early 1980s hinged on the discovery of the importance of fluorine at the 6 position and basic nitrogen at position 7. This renewed research led to the development of a very large series of potent broad spectmm antibiotics. This is reflected in the fact that more than 20 quinolone antibiotics have been granted U.S. nonproprietary names. 

DoD, then, is a minor customer in a specialized niche market of minimal commercial interest. The needs of homeland security may expand the potential for a dual-use military and civilian market, but that has yet to occur. Public-sector financing may be required, therefore, to a greater extent in the development of CBW drugs and vaccines than for general military health needs. 

Marketing to determine that the drug candidate has a potential market niche in light of what other companies are developing or drugs that are already on the market for the disease indication... 

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