Abstract
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.
View Cart
