Exploratory Development

Exploratory Development is a multisectional group that performs a central role in the early evaluation of candidate compounds that may eventually become drugs benefiting patients with serious and unmet medical needs.

The process of evaluating the effects of candidate drugs, as well as their metabolism, begins in the Bioanalytical section through the development of methods to measure drugs and metabolites in biological fluids. In our GLP*-certified laboratory, rigorous testing and evaluation of candidate compounds are conducted on-site in accordance with GLP standards.

Exploratory development continues through the efforts of the toxicologists and scientists in the Transactional Science section. In vitro and preclinical data are evaluated, and recommendations are made regarding the evaluation of mechanism of action (MOA), safety and tolerability, and additional potential studies that may need to be conducted.

Next, the scientists and research managers in the Clinical Pharmacology, Pharmacokinetics, and Transactional Science sections begin to study the desired and undesired effects of the compounds in early clinical trials. Tolerability, safety, and pharmacological activity as well as the rate of drug absorption, distribution, metabolism, and excretion are determined in very intense studies. The results of these studies are described in mathematical models which help plan for further studies in late-stage clinical and paediatric development, and for profiling studies.

Throughout the exploratory development process, rigorous quality control standards are ensured by the Quality Assurance (QA) section. Compliance with good laboratory practice (GLP) and standard operating procedure (SOP) standards are monitored by QA.

*GLP: Good Laboratory Practice (standards governing nonclinical trials of drug safety).