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It was over five years ago that the Centre for Medicines Research
organized a workshop entitled "Quality of Life: Assessment and
Application". This workshop brought together a unique group of
participants, some of whom had been involved in studies on quality
of life for well over a decade, whilst others were meeting the
subject for the first time. This blend of experienced researchers
and enthusiastic newcomers was a great stimulus to the discus sions
which followed individual presentations as well as that resulting
from the study groups. In the ensuing publication, a balance was
sought between a consideration of the complex principles underlying
the assessment of quality of life and the application of such
assessments to specific clinical conditions which necessitated this
approach. The organization in 1991 of a second workshop entitled
"Quality of Life Assessment: Key Issues in the 1990s" resulted in a
further consideration of the quality of life philosophy, concepts
and key instruments together with an update on assessing quality of
life in a number of major disease areas. Of particular importance
was an examination of various viewpoints concerned with ethical
questions and their implications, and quality oflife from industry,
regulatory and health care purchasers' perspectives. As a result of
this second workshop, the editors of the original book referred to
above decided to produce a second edition with a number of updates
and additional chapters.
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."
At a time when it is becoming usual for medicines to be developed
for a global market and pharmaceutical companies are endeavouring
to expedite the drug development process, Regulatory Authorities
are concentrating on improving their efficiency and effectiveness.
Therefore, it is not surprising that questions are being asked as
to how performance might be measured and compared between different
authorities who are now often in receipt of dossiers that have been
submitted to several agencies at the same time. Issues such as
'what target should be set for the review of new medicines?' and
`how can quality be assured?' are now considered to be of critical
importance. The twelfth CMR International Workshop, held in January
1997, provided the opportunity for Regulatory Authority and
industry personnel from Europe, North America, Australia and Japan
to openly discuss experiences and exchange views on how to improve
the review process. The proceedings of this meeting provide a
comprehensive overview of the current review process in different
countries and the need for performance measures and targets. This
volume summarises the many suggestions that were debated at the
Workshop, and includes chapters on measuring performance, and on
the integration of quality into the review process.
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."
The third CMR Workshop prov. ided the opportunity for a group of
experts from the Industry, academia and the regulatory authorities
to meet and discuss ways and means by which risk benefit decisions
are made during the various stages of drug development. It became
apparent from the discussions that took place in October 1985, at
the CIBA Foundation, that decisions are often made with limited
data and inadequate methodology. The conclusions drawn from the
day's deliberations were as follows: 1. Current methodology for
assessing risk and particularly benefits must be improved; 2.
Safety must be assessed in association with benefits as it is
ultimately the benefit/ risk ratio which should decide the future
of medicines; 3. Risks from medicines must always be viewed in
relation to the risks from untreated diseases. It seemed to be the
consensus of the group that such a meeting was both useful and
informative and, hopefully, the publication of these proceedings
will stimulate further discussion in this important area which may
improve the decision-making process in drug development. The
Editors wish to thank the participants for contributing to the Work
shop, together with Dr. Cyndy Lumley for providing the initial
transcript of the meeting and Mrs Sheila Wright for producing the
final version and for carrying out all the additional work that is
entailed in producing such a publication. Professor S. R. Walker A.
W."
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.
As 1992 looms on the horizon and preparation is made for the
completion of the internal market in Europe, the CMR realised the
value of addressing some of the issues involved and defining the
objectives and achievements of medicines regulations in a number of
EEC countries in comparison with Japan and the USA. The overall aim
was to use the lessons of past experience to determine the most
appropriate way forward. The final debate focused on two
possibilities for assessing and granting marketing authorisations
for Europe, namely mutual recognition or a centrally organised
European Med icines Office. These two views were discussed in
detail at both the workshop at the Ciba Foundation and the
international symposium at the Royal College of Physicians. It is
hoped that this sharing of ideas and the publication of the
proceedings of this fifth CMR Workshop will have encouraged all
concerned to continue the debate so that the final outcome will be
the establishment of an efficient system in the community for the
benefit of patients, the practising physician and the
pharmaceutical industry. We would like to take this opportunity of
thanking Brenda Mullinger for the considerable amount of scientific
and editorial work that she carried out on the manuscripts, Sheila
Wright for providing the secretarial support which allowed the
proceedings to be submitted to Kluwer Academic Publishers on disk
and Sandra Cox who organised the administrative aspects so vital to
the successful running of a Workshop and major international
symposium. S. R."
The 20th Anniversary of a Learned Society is a momentous event in
its af fairs, and it is fitting that, in the Appendix to the
Proceedings of the 20th An niversary Meeting, the history of the
Society for Drug Research is outlined. The aim of the Society, to
encourage an interdisciplinary approach and to act as an
organisation freed from any specific scientific branch of
knowledge, was achieved and is exemplified by the publication of
these proceedings of the Anniversary Meeting held at the
Pharmaceutical Society of Great Britain. In only two other cases
have the Society's proceedings been published, main taining the
original decision and policy to allow membership to enjoy com
munications from those who may not have agreed to speak had
publication been mandatory. The papers presented at the Anniversary
Meeting covered a wide range of scientific disciplines, and it is
fitting that work of such calibre should have been published under
the able editorship of Stuart and Bryan Walker. They should prove
invaluable to those who are interested in Drug Research."
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."
The 20th Anniversary of a Learned Society is a momentous event in
its af fairs, and it is fitting that, in the Appendix to the
Proceedings of the 20th An niversary Meeting, the history of the
Society for Drug Research is outlined. The aim of the Society, to
encourage an interdisciplinary approach and to act as an
organisation freed from any specific scientific branch of
knowledge, was achieved and is exemplified by the publication of
these proceedings of the Anniversary Meeting held at the
Pharmaceutical Society of Great Britain. In only two other cases
have the Society's proceedings been published, main taining the
original decision and policy to allow membership to enjoy com
munications from those who may not have agreed to speak had
publication been mandatory. The papers presented at the Anniversary
Meeting covered a wide range of scientific disciplines, and it is
fitting that work of such calibre should have been published under
the able editorship of Stuart and Bryan Walker. They should prove
invaluable to those who are interested in Drug Research."
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