integrate these new approaches. The responsibility of academia is not only to train
scientists in the very specialised techniques of genomics, analytical chemistry and
bioinformatics, but also in the traditional disciplines so that these novel data can be
interpreted and applied to the design of actual drugs. The paradox is that we need
more scientists at the cutting edge of modern biology and technology, but at the
same time we require generalists who can adapt and integrate these specialised
disciplines as the basis of a novel product development. This is a major challenge
that academia has not yet successfully addressed in this era of specialisation and
increasingly narrowly focused research.
Similarly, the animal health industry and the corresponding regulatory agencies
must appoint individuals with new perspectives and expertise, while retaining
others with the experience to integrate them into the drug development and regu-
latory assessment systems. A more daunting challenge is to first update and then
harmonise regulations developed for mid- and late-twentieth century drugs and
technology to effectively regulate twenty first century products. This has not yet
been achieved. Adoption of a new evaluation paradigm requires an almost absolute
certainty that the new approach is equivalent to, or better than, the traditional
approach, which in itself may be seriously flawed. Only time and perseverance
can overcome these problems.
4 Continued Advances in Computer Technology
One of the most pervasive influences, having a transformational impact on all areas
of medicine, is the continuing developments in computer technology, comprising
the speed of data processing, the amount of data that can be dealt with and the
integration of existing separate and independent systems to allow automation of
processes and devices previously not thought possible only a decade or so ago. The
portability of diverse software between different computing systems has acceler-
ated the development of many novel systems that can be expected to have great
impact on the separate processes of drug discovery, development and regulatory
approval. The dramatic improvements in wireless communication coupled to the
growth of the so called “cloud computing” will facilitate and accelerate this change.
A good example of this is the modern cell phone, which combines phone, internet
and personal digital assistant into a single integrated device. Similar integration of
once diverse functions and devices is occurring in the pharmaceutical arena.
A prime illustration of the enabling power of computational sciences on biology
was the development some 20 years ago of the basic local alignment search tool
(BLAST). This allowed non-mathematicians to rapidly comprehend the vast
increase in the number of gene sequences being generated by sequence analysis
studies (Altschul et al. 1990 ). The simultaneous emergence of increasingly econo-
mical gene sequencers with the computational tools to interpret them enabled
significant advances in understanding the genetic basis of modern medicine to be
made. This development will translate into new approaches to therapy in the near
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