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Over the past twelve years, the Centre for Medicines Research has
held a series of Workshops on a number of topics related to the
drug discovery and development process. The major objective of
these Workshops has been to provide an international forum for
regula tory, academic and industry representatives to debate
together, and suggest solutions to, specific problems. The meeting
reported in this volume represents a departure from this approach,
in that the par ticipants were drawn largely from the
pharmaceutical industry. Senior clinicians, pharmacologists and
toxicologists from companies in Europe, the USA and Japan met in
May 1994 to discuss a scientific rationale for the conduct of
toxicity studies to support the clinical development of new
medicines, and to begin to work towards an industry consensus.
Achievement of such a consensus is seen as an important step in the
process leading towards international harmon isation of the
recommendations on the timing of toxicity studies in relation to
clinical trials."
For a research-based pharmaceutical company to be successful in the
1990s. it must have a strategic plan for the global development of
new chemical entities. Global development can be defined as an
attempt to reach all major markets as rapidly as possible and for
many companies these will include the United States. Japan.
Germany. France. Italy. UK and Canada. which together represent
approximately 85% of the pharmaceutical market in the developed
world. The mutual acceptance of foreign clinical data would reduce
the time and resources required to develop a new medicine for the
international market by eliminating the requirement for the routine
repetition of clinical studies in local populations. In Japan this
has been largely based on the belief that genetic differences in
respon siveness may result in a different benefit/risk assessment
for a new mediCine. while requests in Europe and the United States
for local data relate mainly to methodological and cultural
considerations. The importance of this issue has been recognised
internationally as it was one of the topics discussed at the
International Conference on Harmonisation in Orlando (October 1993)
and it is currently on the programme for ICH3 which will be
convened in Yokohama in Japan in November 1995."
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.
Regulatory review is the last major development hurdle that must be
passed by a new medicine before it reaches the market. At a time
when pharmaceutical companies are reviewing their R&D
strategies, and attempting to reduce drug development times, it is
extremely important that the review process is made as efficient as
possible. The 11th CMR Workshop, held in September 1995, provided
the opportunity for regulatory authority and industry personnel
from Europe, North America, Australia and Japan to openly discuss
views and exchange experiences on the subject of improving the
review process. The proceedings of this meeting provide a
comprehensive overview of the current review process around the
world. The contributors describe the present situation and
highlight company strategies and regulatory initiatives to improve
the review process. This volume also summarises the suggestions
that were developed by the participants, covering many facets of
this process, including the quality and size of the dossier,
dialogue, submission strategies, feedback and the response to
questions.
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.
Regulatory review is the last major development hurdle that must be
passed by a new medicine before it reaches the market. At a time
when pharmaceutical companies are reviewing their R&D
strategies, and attempting to reduce drug development times, it is
extremely important that the review process is made as efficient as
possible. The 11th CMR Workshop, held in September 1995, provided
the opportunity for regulatory authority and industry personnel
from Europe, North America, Australia and Japan to openly discuss
views and exchange experiences on the subject of improving the
review process. The proceedings of this meeting provide a
comprehensive overview of the current review process around the
world. The contributors describe the present situation and
highlight company strategies and regulatory initiatives to improve
the review process. This volume also summarises the suggestions
that were developed by the participants, covering many facets of
this process, including the quality and size of the dossier,
dialogue, submission strategies, feedback and the response to
questions.
Over the past twelve years, the Centre for Medicines Research has
held a series of Workshops on a number of topics related to the
drug discovery and development process. The major objective of
these Workshops has been to provide an international forum for
regula tory, academic and industry representatives to debate
together, and suggest solutions to, specific problems. The meeting
reported in this volume represents a departure from this approach,
in that the par ticipants were drawn largely from the
pharmaceutical industry. Senior clinicians, pharmacologists and
toxicologists from companies in Europe, the USA and Japan met in
May 1994 to discuss a scientific rationale for the conduct of
toxicity studies to support the clinical development of new
medicines, and to begin to work towards an industry consensus.
Achievement of such a consensus is seen as an important step in the
process leading towards international harmon isation of the
recommendations on the timing of toxicity studies in relation to
clinical trials."
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