, Volume 21, Issue 3, pp 235-237
Date: 24 Aug 2012

The 2006 Adrian Salter Lecture

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Medicines regulation and the health of the patient are so interlocked that they can actually be considered as a single enterprise. Thus, there are two fundamental aspects to the title of this lecture, which can, perhaps, be put in an unfamiliar order: what can the patient do for the regulator? and, perhaps less surprisingly, what can the regulator do for the patient?

The purpose of this lecture is to look at these two questions with some practical and topical examples drawn from the recent regulatory and clinical environments. However, before dissecting these questions let us consider the recent case of natalizumab (Tysabri®

The use of trade names is for product identification purposes only and does not imply endorsement.

) because it evokes many of the complexities and dilemmas that we must resolve.

An abridged history of this humanised monoclonal antibody to α integrin, which has been investigated in patients with Crohn’s disease and disseminated (multiple) sclerosis (MS) is:

    ...

The Lecture is a bequest of Dr Adrian Salter, and is held annually under the auspices of the Society of Pharmaceutical Medicine. Dr Salter had a pivotal role in bringing the Society into existence, and was its founding secretary. This year’s lecture was delivered by Professor Sir Alasdair Breckenridge in the house of the Royal Society of Medicine, London, UK on 9th November 2006 and the manuscript was prepared with the assistance of Dr Tony Fox, the Consulting Editor of the International Journal of Pharmaceutical Medicine; graciously, the Lecturer also dined with the Society afterwards. The Society is now almost 20 years old, and next year’s Adrian Salter Lecture will be part of a larger anniversary celebration.