Intelligent Drug Development

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

Michael Tansey is the former Senior Vice President, Chief Medical Officer, and Head of Medical Development at Pharmacia Corporation. He currently provides clinical, regulatory, and process improvement advice to pharmaceutical and biotechnology companies.

PART 1: SETTING THE SCENEIntroduction: Cutting the Gordian KnotChapter 1: Aiming for Excellence
PART 2: PLANNING: FROM CHAOS TO COSMOSChapter 2: The Target Product Profile and Its UsesChapter 3: Planning the Individual Clinical Trial
PART 3: THE PRACTICABLE PROTOCOLChapter 4. Distilling the Essence of the Protocol: The Protocol SynopsisChapter 5. Redistillation: Eliminating Impurities By Carrying Out Protocol Chapter 6. The Optimal Blend: The approved Synopsis and the Final Protocol
PART 4: THE SPONSOR, THE PHYSICIAN AND THE PATIENT; THE ETERNAL CLINICAL TRIAL TRIANGLEChapter 7: Of Chickens and Eggs: The Sponsors' DilemmaChapter 8: Clinician or Clinical Trialist: the Physicians' DilemmaChapter 9: what About the Customer? the Patients' Dilemma
PART 5: AND ANOTHER THING...Chapter 10: About Time: Making Meetings MatterChapter 11: The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor