David Cavalla has 35 years experience in various senior scientific and commercial roles within the pharmaceutical industry. He is currently involved with a number of biotech companies at Board level. Previously he was founder and CEO of Arachnova Ltd, a company focused on therapeutic switching; previous affiliations included Glaxo Group Research Ltd and Napp Research Centre.

He is author of Modern Strategy for Pharmaceutical R&D — Towards the Virtual Research Centre, and Off-Label Prescribing: Justifying Unapproved Medicine. He is one of the first advocates of drug repurposing, and has used this strategy to create three first-in-class developmental products to have successfully passed human proof of concept clinical stages. He frequently contributes articles on pharmaceutical strategy and is on the editorial board of Drug Discovery Today. Formerly he was Chairman of the Society for Medicines Research. He obtained a first degree and PhD at Cambridge University and spent two years as a visiting Fellow at the NIMH, Washington, DC. He is author/inventor of over 70 published papers and patents.

Off-label Prescribing

Today’s medicines are regulated for their efficacy and safety and, once approved, they can be marketed for certain uses as justified by the data. Once marketed, medicines can be used for any purpose the prescriber thinks fit, and one in five prescriptions is written outside regulatory purview. Off-label Prescribing looks into this medical practice, where a drug is used on a different set of patients from the ones it is approved for, or at a different dose, and usually without the patient’s informed consent. As well as lacking information on efficacy, off-label medicine is on average 2-3 times less safe than on-label practice. This book will therefore be of interest to all those who prescribe (as well as receive) medicines.