Terry Plasse

Background

About Terry Plasse

Development of new drugs and biologics is inherently complex. Careful planning, with attention to preclinical data, intended clinical indication and the regulatory climate can often avoid problems. Even when issues such as unexpected toxicity arise, active management may reclaim a development program, resulting in ultimate success. Oncology presents special opportunities because of the severity of the diseases treated. While toxicities have to be defined, risk/benefit analyses in oncology are different from those for chronic conditions with low or late mortality. Paradoxically, because of the differences in assessments of both efficacy and toxicity, initial clinical development of oncology products can often be accomplished with fewer patients and more limited overall resources than are needed for development of products for other indications, such as hypertension or depression. Key to development is understanding the clinical situation: how, for example, to separate adverse events due to treatment from the very high background due to advanced cancers. Also key is defining achievable, clinically meaningful efficacy, and demonstrating that in a limited cohort of patients. I have been fortunate over the course of my career to participate in development of a variety of agents, from cytotoxics such as Taxotere to novel agents such as Iressa and Zolinza and monoclonal antibodies such as Erbitux. Each product has a different “story”, but the lessons learned overlap: define and learn how to manage toxicity, characterize efficacy and appropriate patient populations based on early clinical leads, and continuously redefine the development plan as new information becomes available.