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Elsevier

Principles of Translational Science in Medicine

From Bench to Bedside

  • 3rd Edition - July 15, 2021
  • Latest edition
  • Editor: Martin Wehling
  • Language: English

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically… Read more

Description

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics.

New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields.

Key features

  • Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine
  • Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology
  • Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

Readership

All biomedical researchers from preclinical to clinical scientists need to understand and apply translational science in medicine, which applies to scientists in pharmaceutical industry though almost all principles are applicable to device development. Additionally, academic researchers will need the book, as well.
Most major universities offer courses, programs (e.g. master programs) in translational medicine for which the book is ideal as the basic teaching material. It is currently used in courses on pharmaceutical medicine e.g. at Basle University.

Table of contents

Part I: Introduction

1. Introduction and definitions

2. Problems, challenges, and initiatives in translation
Part II. Target identification and validation

3. “Omics” translation: a challenge for laboratory medicine

4. The power of genomics, metabolomics, and other omics for target identification and validation

5. Potency analysis of cellular therapies: the role of molecular assays

6. Translational pharmacogenetics: pharmacogenetically driven clinical decision making

7. Tissue biobanks

8. Animal models: value and translational potency

9. Biomarkers in the context of health authorities and consortia

10. Human studies as a source of target information

11. Target profiling in terms of translatability and early translation planning
Part III. Biomarkers as key elements of successful translation

12. Biomarkers

13. Genetics, molecular biomarkers, and artificial intelligence to improve diagnostic and prognostic efficacy

14. Cardiovascular translational biomarkers: translational aspects of hypertension, atherosclerosis, and heart failure in drug development in the digital era

15. Biomarkers in oncology

16. Translational medicine in psychiatry: challenges and imaging biomarkers
Part IV: Early clinical trial design

17. Methodological studies

18. The pharmaceutical research and development productivity crisis: can exploratory clinical studies be of any help?

19. Adaptive trial design

20. Combining regulatory and exploratory trials

21. Accelerating proof of concept by smart early clinical trials
Part V: Toxicology in translation

22. Pharmaceutical toxicology

23. Translational safety medicine
Part VI: Special topics in translation

24. Cancer vaccines: translational strategies

25. Translational aspects of biologicals: monoclonal antibodies and antibody-drug conjugates as examples

26. Orphan drugs: why is translation so successful?
Part VII: Biostatistics and modelling

27. Translational science biostatistics

28. Computational biology and model-based approaches in translational medicine
Part VIII. Legal aspects and special interest groups

29. Intellectual property and innovation in translational medicine

30. Translational research in the fastest-growing population: older adults
Part IX. Integration and application of translational guidance

31. Translational medicine: the changing role of big pharma

32. Translational science in medicine: putting the pieces together-biomarkers, early human trials, networking, and translatability assessment

33. Learning by experience

Product details

  • Edition: 3
  • Latest edition
  • Published: July 22, 2021
  • Language: English

About the editor

MW

Martin Wehling

Martin Wehling is the Managing Director at the Institute of Experimental and Clinical Pharmacology and Toxicology. Martin Wehling is Director in Clinical Pharmacology at Mannheim Medical Faculty, Mannheim University of Heidelberg, Mannheim, Germany.
Affiliations and expertise
Managing Director, Institute of Experimental and Clinical Pharmacology and Toxicology, Director, Clinical Pharmacology, Mannheim Medical Faculty, Mannheim University of Heidelberg, Mannheim, Germany

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