Managing Drug Development Risk: Dealing with the Unknown and the Unknowable

The book reviews how uncertainty can be managed effectively in drug development operations, providing insight and advice on developing and implementing approaches to drug development uncertainty management. It explains the current practices, approaches, and methodologies used to manage uncertainty in the development of drugs in the pharmaceutical, biotechnology, biotherapeutics, and vaccine industries. The authors address the issues related to cultural and organizational change that must be successfully dealt with in order to embed uncertainty management into drug development firms. Case studies (some actual, some fictional) support the text and provide contextual information for the reader.