Doug Lorenz, David Lyon, and Jim Nightingale oversee the team of scientists in the applied technology group. This group focuses on applying new technologies to the development of pharmaceutical candidates from their initial stages to their manufacture for human clinical testing. All of Bend Research’s work in the candidate area is done in collaboration with its major client.

In developing new pharmaceutical formulations for future medicines, researchers at Bend Research focus on improving several key areas:

1. the compound’s solubility in the body,
2. the taste of the compound through tastemasking,
3. the delivery profile of the compound, and
4. the delivery mechanism of the compound.

New pharmaceutical formulations must go through a careful testing process to demonstrate their safety, efficacy, and feasibility before they can be approved by the Food and Drug Administration (FDA) for human trials. Some of the stages include discovery, pre-clinical development, exploratory development, and full development. Bend Research is directly involved in all of these stages.

Bend Research performs dissolution testing, potency analysis, and purity analysis, as well as thermal and microscopy techniques. Scientists first screen new pharmaceutical formulations to determine their performance in simulated biological solutions. Additionally, the physical and chemical stability of the compounds is assessed at various temperatures and humidities. After initial screening, formulations that have optimal performance, manufacturability, and stability are developed. If a formulation has proven potential, it is nominated and scaled up for clinical manufacture at larger facilities such as Bend Research Pharmaceutical Process Development.

To determine whether a formulation will be an effective medicine, the FDA requires that it pass through several phases of clinical trials. In Phase 1, the primary focus is assessing the drug’s safety. Phase 2 studies focus on demonstrating the efficacy of a new formulation in human trials. In Phase 3, the new formulation is tested in a large number of patients, from several hundred to several thousand. This large-scale study provides more information about the compound’s effectiveness or about any side effects from the compound. If the formulation successfully passes all of these phases, then a pharmaceutical company can request FDA approval to market the new pharmaceutical formulation.