Considerable investment has been made by both pharmaceutical and
biotechnology companies in pharmaceutical products of biotechnology.
However, because relatively few of these products have been marketed,
lack of relevant experience means that uncertainty still surrounds the
most appropriate strategy for their safety evaluation. The 13th CMR
International Workshop, held in February 1997, provided the opportunity
for regulatory authority and industry experts from Europe, Japan and the
USA to share their experiences of designing safety evaluation programmes
for specific product classes: colony stimulating factors, growth
factors, hormones, interferons, interleukins, monoclonal antibodies for
therapeutic use, and gene therapy products. Participants worked together
to recommend those studies that should be considered for such safety
evaluation, and those that may be unnecessary. These recommendations
subsequently made a valuable contribution to the ICH guideline `Safety
Studies for Biotechnological Products', which was finalised at ICH 4 in
Brussels in July 1997. The Workshop proceedings not only describe the
recommendations but also provide the reader with an appreciation of the
science behind safety evaluation strategies used by experts, the
influence of different regulatory systems on these strategies, and the
type of data required by both toxicologists and clinicians before they
have sufficient confidence to administer pharmaceutical products of
biotechnology to humans.
