Summary
The first version of this aid to understanding pharmaceutical R&D was published in 2003 and updated in 2005. It concentrated on small molecule drugs (molecular weights usually below 500 daltons) and the dangers of failing to integrate their discovery with the developmental demands of clinical research (pharmaceutics, pharmacokinetics and safety, for example).
Aimed at no particular specialists, it sought to inform all those involved with pharmaceutical R&D, however loosely, how each of the necessary disciplines fit together to take a new medicine from discovery to market launch. Feedback was positive but with one consistent request: to increase the detail on regulatory procedures and clinical evaluation. Version 2 was published in 2005 with this aim.
A second update is timely from several standpoints. True, the principles of R&D have not changed markedly in the intervening years, but like any industry, Pharma has been forced to take stock of the manner in which it operates. Analysis of financial profits and losses consistently shows that increasingly greater investment is required for reduced numbers of marketed products. Despite the introduction of new technologies aimed at faster and more innovative drug discovery, the number of new introductions with novel mechanisms of action has remained constant. And threats to public safety, whilst rare, demand ever more stringent regulatory procedures.
The industry continues to consolidate through M&A. Although these activities in themselves rarely bring long-term growth, they provide an opportunity to divest activities no longer considered essential for in-house ownership. From this has sprung the need for contract organisations, specialist companies with expertise in particular phases of pharmaceutical R&D ranging from the supply of drug targets and chemical building blocks through non-clinical development and on to clinical evaluation and regulatory affairs.
Innovation in the industry is not at a standstill: it has changed direction.
Where once small molecule research provided the mainstay, biological drugs are now making their presence felt. While the range of genomic sciences waits to make its impact, biologicals are providing the current focus for novel discovery. This move doesn't come without a price. Biologicals do not behave like small molecules: they have large molecular weights and are most usually species specific. The rules for their development are different and often little understood: witness the tragedy which occurred at Northwick Park following the administration of an immune activator to healthy volunteers in March 2006.
The 2007 update to 'How Drugs are Developed' responds to these changes.
Sections which previously focused on small molecules have been expanded where necessary to describe the corresponding processes for biologicals.
And there are two new chapters. The first deals with project management: the fundamentals of managing multidisciplinary teams and the ways in which the role is changing to encompass external as well as internal interfaces. The second concerns the growing interest in translational research, the ways in which laboratory concepts can be converted into medical advances.
In 2003, the impact of sequencing the human genome was just being felt throughout the industry. Now, in 2007, it is apparent that while providing promise for the future, there will be no 'quick fix' for the industry and it must pursue an ever wider range of opportunities to achieve its goals. The result is a networked industry without historical parallel.
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