Current Topics in Medicinal Chemistry - Volume 5, Issue 11, 2005

The biopharmaceutical industry is facing challenges from increased generic competition, regulatory changes and other factors negatively impacting pharma economics. Industry is also presented with opportunities for improving overall research & development and business efficiency via de-risking development of novel drug candidates. Approaches to improve efficiency and decrease risk include in vitro and in vivo AD Read More

The high-throughput screening in drug discovery for absorption, distribution, metabolism and excretion (ADME) properties has become the norm in the industry. Only a few years ago it was ADME properties that were attributed to more failure of drugs than efficacy or safety in the clinic trials. With the realization of new techniques and refinement of existing techniques better projections for the pharmacokinetic properties of co Read More

To deliver on the promise of personalized medicine requires the integration of pharmacogenomics into the discovery and development of medicines. Over the last few years the pharmaceutical industry has been building considerable resources to achieve that. However, this requires new skill sets, capabilities and infrastructures which have not been a traditional part of the industry's efforts. In this article we describe h Read More

Biomarkers in the clinical oncology field can have tremendous therapeutic impact especially if the marker is detected before clinical symptoms. This impact can be extended to the evaluation of clinical oncology treatments allowing evaluation of potential compounds to determine their efficacy in the disease treatment. The discovery of clinical biomarkers can consume time, resources and costs. Therefore, it is important Read More

Positron Emission Tomography (PET) is a sophisticated nuclear imaging modality that affords researchers the ability to conduct both functional and molecular imaging on biological and biochemical processes in vivo. In functional imaging, biological parameters such as metabolic rate and perfusion that can be altered by disease or treatment are monitored. In molecular imaging, PET can be used to examine and quantify c Read More

In psychiatry, particularly in antidepressant clinical studies, placebo-controlled trials often yield results that are very difficult to interpret because of robust placebo responses. Meta-analyses of trials in major depressive disorder (MDD) suggest that drug-placebo differences in response rates range from 11% to 18%. However, in trials of marketed antidepressants present in the FDA databases, antidepressant drugs were super Read More

The ever increasing cost of discovery and development of new pharmaceutical agents mandates that risk be managed more aggressively. Decisions that are based on data, well-understood experience, and the value of the project itself must be made sooner in the overall process. Uncontrolled risk must be addressed and managed. The reward system within pharma must treat negative decisions as productive and i Read More