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1949stone

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[资源] Research and Development of Vaccines and Pharmaceuticals from Biotechnology

This book has been written for researchers in academic laboratories and industry,
who are currently experiencing exciting scientific changes in the traditionally
empiric life sciences, which coincide with a growing economic awareness in these
areas. The biomedicinal sciences are particularly affected by an increasing dicotomy
between highly innovative research and -due to regulatory limitations - very
conservative development of pharmaceutical products. Scientists who are engaged
in applied research or development, spanning the widening gap between fundamental
research and its application, have to cope with increasing scientific and
regulatory demands. Rising concerns about the cost of research and development,
time performance and competitiveness cause additional distress.
Conventional biological products were mostly developed by very small, highly
interactive groups. The basic methodological repertoire was limited and most of it
was shared by researchers, developers and manufacturers. This situation is near
optimal for the development of new products. It is fast and effective and is affordable
for small companies which operate on a national basis, but it no longer applies
to modern biotechnological products.
Biological products and particularly vaccines always had a special position
among medicinal products and enjoyed several regulatory privileges. Modern
biological products deviate from the traditional ones by more defined active ingredients,
more complex formulations and by their manufacturing and analytical
methods. Vaccines of the future will be applied for purposes other than the prevention
of infections and will probably even differ by their mode of action, e.g. by the
direct application of DNA. These new products have more and more in common
with chemical pharmaceutical products. Thus pharmacokinetic, pharmacodynamic,
safety and analytical investigations rank much higher and many more
specialists are required to develop these products.
As a consequence, modern biological pharmaceuticals are no longer developed
on the fast track. Their development times are much longer, the costs will be similar
to those of drugs and they will have to recoup the investment into research and
development on larger, international markets. The technical, regulatory and commercial
basis for biomedicinal products has changed and with it the underlying
research activities. Scientists in biomedicinal research should be aware of the
changed situation and its impact on their activities.
This book is an attempt to summarize information on the fundamentals of
pharmaceutical product development for modern biomedicinal products and to
combine these with specific recommendations for effective planning and management
of applied research and development projects. A reasonable selection of
information was necessary to avoid confusions by too many details. This inevitably
leads to omissions and simplifications, particularly on patent and registration
issues. The reader should bear in mind that these sections are primarily intended to
explain the fundamental rules. For specific advice and interpretation of special
cases the original and official documents should be consulted.
Acknowledgements
I gratefully acknowledge the efforts of several colleagues at Biotech Australia Pty.
Ltd. and Hoechst AG who contributed greatly to this work. Gary Cobon critically
reviewed the manuscript and made many important suggestions for its improvement.
Richard Brown, Gerard Henry, Katrine Hill, Jim Hungerford, Rosalind
Kaldor, Peter Kennedy, Jiirgen Lindner and Werner Schmidt corrected and improved
several major sections. Catherine Nelson-Smith and Sheila Yong provided
valuable ongoing library and information support, Stephen Harston generously
provided information material on regulatory aspects and Beverly Smallbone and
Anne Marshall helped in typing the manuscript.
I also wish to thank all those colleagues at Behringwerke AG, Hoechst AG and subsidiaries
and Biotech Australia Pty. Ltd. who contributed directly or indirectly,
voluntarily or unwittingly to this book by providing competent advice and by
setting countless good examples of achievements by cooperation and putting
effective management into practice, without neglecting human interrelationships.
The views expressed in this book are those of the author and are not necessarily
those of the persons and companies mentioned in the acknowledgements.
Frankfurt, March 1994 Jens-Peter Gregersen

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2016-06-25 08:46:13, 8.65 M