Treating Life-Threatening Bleedings: Development of Recombinant Coagulation Factor VIIa provides a comprehensive understanding of the first new drug within the area of hemostasis, describing a new mechanism of action that has resulted in a modified concept of the whole hemostasis mechanism. As the treatment of life-threatening bleedings is a serious challenge for clinicians, this powerful and historic case study presents a detailed roadmap on how a new medicine can be developed, stressing the interaction between science and clinical work.
The book stresses the importance of patient care in the learning process and provides new ideas on how to approach diseases and their treatment. Users will find a real world example that will act as a timely resource for those learning about, or engaged in, performing and supervising research across the biomedical sciences.
- Documents the successful roadmap of the development of a new concept of treating major bleedings in the most life-threatening situations
- Stresses the importance of the close connection between the clinic and research, describing how a new concept of hemostasis was revealed by careful clinical observation
- Offers real-world research and development context for drug discovery, and for the treatment of hemophilia and other bleeding disorders
Residents, fellows and professionals in hematology, pathology, surgery, internal/hospital medicine, public health
About the Author
Preface and Acknowledgments
1. Classical Bleeding Disease (Hemophilia)
2. My Encounter With Hemophilia (1959-82)
3. The First Years at Novo Nordisk
4. The Development of Recombinant FVIIa (rFVIIa) (1985-88)
5. The Further Use and Development of rFVIIa (1989-96)
6. Legal Issues Regarding the Use of rFVIIa in Hemophilia Patients With Inhibitors
7. Treatment With rFVIIa in Malmö (1996-99)
8. The Launching and Uses of rFVIIa
9. Mechanism of Action and Dosage
10. The Continued Development of rFVIIa During the 2000s
11. Safety and Health Economy of rFVIIa
12. Three Different Descriptions of How rFVIIa Was Developed
13. Some Final Remarks
- No. of pages:
- © Academic Press 2017
- 6th July 2017
- Academic Press
- eBook ISBN:
- Paperback ISBN:
Dr. Hedner has been active in the field of Thrombosis and Haemostasis for more than 40 years and initiated the idea to use FVIIa as a hemostatic drug when working as a clinician at the University Hospital of Malmö, Lund University, Sweden, in the 1970s. Later, she led the development of recombinant FVIIa when being part of the Department of Research & Development at the Danish pharmaceutical company Novo Nordisk A/S, Bagsværd, Denmark.
Dr. Hedner was a physician at the Department of Bleeding Disorders including a Haemophilia Comprehensive Clinic, Malmö University Hospital, University of Lund, Sweden from 1972-1983 . Her research and teaching experience was at the Medical Faculty of Lund University, Sweden and Professor in Clinical Coagulation Research at the University of Gothenburg and at the University of Lund.
Emeritus Professor, University of Lund, Lund, Sweden