In addition to various product approvals, the R&D organization has a variety of further substantial outcomes for the organization and public as well, based on their research. In this section, we will present science leadership, overview of study types, pipeline, research techniques, and investigators.
In science, that is, the discovery phase, the scientists have major interim scientific goals and accomplishments that eventually lead to product candidates, such as four discoveries noted in the next figure (Fig. 3.11). New disease biology or mechanisms responsible for disease pathogenesis are uncovered (e.g., in the late 1990s and early 2000, the proteasome pathway and the impact in cancer). Novel targets that are associated with a disease and favorably influenced by drug therapy are discovered (e.g., TNF and ulcerative colitis with Remicade®, or protein kinases in cancer and Iressa®). Chemicals and biologicals are screened and created to influence the target (hits), which are confirmed and validated to become drug candidates. Whole new drug categories can be discovered that address the new targets and mitigate a new disease pathway (e.g., statins in high cholesterol, or oxicams for infections). Finally, novel mechanisms of action may be discovered (e.g., receptor antagonists for various diseases with identifiable cell receptors involved in a disease [e.g., oncogene her2neu in breast cancer mitigated by Herceptin® monoclonal antibody]). Process improvements such as in biological manufacturing or product analysis can be scientific advances as well [35, 36].
In product discovery over time, whole new techniques are created to identify product leads that could develop into new product categories for one or several diseases. Medicinal chemistry with structural modification of a drug, along with structure-activity relationships and product screening, have been and remain hallmarks of product development in the industry to develop new drug categories or follow-on molecules with improved properties to treat a disease. Over the past 20 years, the approaches to product discovery have grown immensely especially in the biological arena, as represented on Fig. 3.12. Process improvements in research include, for example, trans-genic animals to create more reliable and predictable disease models, high-throughput screening to accelerate and increase
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