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Research and Development of Vaccines and Pharmaceuticals from Biotechnology
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 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
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