Handbook of Biomarkers and Precision Medicine: 1st Edition (Hardback) book cover

Handbook of Biomarkers and Precision Medicine

1st Edition

Edited by Claudio Carini, Mark Fidock, Alain van Gool

Chapman and Hall/CRC

650 pages | 100 Color Illus.

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Hardback: 9781498762588
pub: 2019-04-29
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Provides perspective, covers recent developments in technologies that have enabled the expanded use of biomarkers, discusses biomarker characterization and validation, and applications throughout the discovery-development continuum, including Companion Diagnostic ( CDX) development.

Table of Contents


Maria Freire

  1. What is a Biomarker and their Role in Drug Development?
  2. Definitions and conceptual framework of Biomarkers in Precision Medicine

    Claudio Carini, Mark D Fidock, Alain J van Gool

    In search of predictive biomarkers in cancer immunotherapy: Establishment of collaborative network for the validation process

    Giuseppe Masucci, Paola A Ascierto, Lisa Villabona

    Integrating personalized medicine in the healthcare: Payers and reimbursements

    Dominic Galante, Marylou Buyse

    Regulatory strategies to accelerate the implementation of biomarkers and companion diagnostics (CDX)

    F Owen Fields

  3. Biomarkers in Preclinical Sciences
  4. Lost in Translation – the challenges with the use of animal models in translational research

    Attila Seyhan,Claudio Carini

    Application of pharmacokinetic and pharmacodynamic modelling of biomarkers of efficacy in

    Translational research

    Neil Benson

    The DIAMONDS platform: Providing Decision Support for Toxicological Assessment based on Integration

    of Structural, Toxicological and Biomarker information

    Rob H Stierum, E Dinant Kroese, Jack TWE Vogels, Harrie Buist, Danyel GJ Jennen, Eugene P van Someren

    Predicting the (non)clinical toxicity of novel drug targets: an in silico perspective

    Jennifer Venhorst, Lars Verschuren, Annemette V Thougaard, Jorrit J Hornberg, Tanja Rouhani Rankouhi

    Unwanted Immunogenicity Responses to Biotherapeuitcs

    Shobha Purushothama, Boris Gorovits

    Biomarker use for advanced screening of drug-induced kidney injury

    Martijn J Wilmer, Frans GM Russel

    Soluble biomarkers for Cardiotoxicity

    Amy Pointon and Nick Edmunds

  5. Biomarkers in Translational Medicine
  6. Lost in Translation- Bridging the Pre-Clinical and Clinical Worlds Concepts, Examples, and Successes and Failure in Translational Medicine

    Attila Seyhan and Claudio Carini

    Necessary Characterization of Biomarkers to be "Fit for Purpose"

    Suso Platero 

    Crucial role of high quality biosamples in biomarker development

    Cornelia Stumptner, Karine Sargsyan, Penelope Kungl, Kurt Zatloukal

    Informatics solution for biomarker discovery and personalized medicine in clinical care

    Jan Willem Boiten, Rita Azevedo, Marinel Cavelaars, André Dekker, Remond JA Fijneman, Arnoud van der Maas, Morris Swertz, Jeroen AN Beliën, Gerrit A Meijer

    Systems Biology Approaches to Identify New Biomarkers

    Lars Kuepfer, Andreas Schuppert

    The need for global collaboration in translational medicine

    Florence Bietrix, Antoni L Andreu, Giovanni Migliaccio, Anton E Ussi

  7. Biomarker-informed Clinical Trials
  8. Overview of biomarker discovery and statistical considerations

    Overview of classical design in biomarker informed clinical trials

    Bo Huang, Jing Wang, Sandeep Menon and Weidong Zhang

    Novel biomarker guided clinical trials design: A practical view

    Bo Huang, Jing Wang, Sandeep Menon and Weidong Zhang

    Outsourcing Biomarker Clinical Trials: Advantages and Disadvantages

    Robert Holt

    Case studies for biomarker based clinical trials

    Bo Huang, Jing Wang, Sandeep Menon and Weidong Zhang

    Informational designs and potential applications to Rare Disease

    Robert Beckman, Cong Chen

  9. The road ahead: Identification of the hurdles and solutions to the implementation of Precision Medicine in healthcare
  10. Paving a new era in patient centric care through innovations in Precision Medicine

    Mark Fidock, Glen Hughes, Alain J van Gool, Claudio Carini

    Integrating Molecular Testing into Early Stage Clinical Applications


    Ectopic gene deregulations and chromosome conformations: integrating novel molecular testing into clinical applications, from leukemias to gliomas"

    Francis Hector Grand, Matthew Salter, Ewan Hunter, Alexandre Akoulitchev

    Challenges and Opportunities of Next Generation Sequencing Companion Diagnostics

    Benoit Destenaves

    Implementing companion diagnostics

    Martina Kaufmann

    Publishing biomedical research findings - what are the odds?

    Andreas Scherer

    Computational Biology: Modeling from Molecule to Disease and Personalized Medicine

    Nina Kusch, Lisa Turnhoff, Andreas Schuppert

    Expectations for Quality Control: Challenges with multi-plex assays

    John L Allinson

  11. Lessons from the past and pioneers of the future
  12. Development of Mariviroc and the Companion Diagnostic HIV Tropism Assay

    Elna van der Ryst, James Demarest, Jayvant Heera, Mike Westby,Charles Knisch

    Case studies: Infertility and Anti-Müllerian Hormone

    Martin Hund, Joan-Carles Arce

    Factor Xa: Case Study

    Boris Gorovits

    Delivering Companion Diagnostics for Complex Biomarkers: The BRCA Companion Diagnostic Story for LYNPARZATM (Olaparib)

    Maria C M Orr and Simon P Dearden

    Delivering the personalized medicine promise: best practice recommendations for designing biomarker development processes

    Karen KY Lam, Mary Zacour, Ji-Young V Kim, Zsuzsanna Hollander, Rhonda Wideman, Raymond T Ng, Scott J Tebbutt, Bruce M McManus

    Development, Launch and Adoption of a Pharmacodiagnostic: Planning Versus Reacting for Pharmaceutical Companies

    Mike Montalto, George Green

    Biomarker Consortia to drive BM discovery and clinical applications in the UK – lessons learned from RA-MAP

    John Isaacs, Sarah Brockbank, Ayako Pedersen Andrew Cope

    Measuring the Success of US biomarker Consortia

    Menetski Joseph

    The value of public-private partnerships in the Netherlands

    Hanna L Groen, Nico LU van Meeteren

  13. Paving a new era of personalized medicine: Emerging technologies
  14. A new era of personalized medicine: emerging technologies - functional proteomics, companion diagnostics and precision cancer medicine

    Michela Perani, Peter Parker

    The impact of epigenetics on the future of personalized medicine

    Jane Mellor

    Incorporating predictive imaging biomarkers in clinical trials for personalised healthcare

    John C Waterton

    Innovation in Metabonomics to improve personalized healthcare

    Nelma Pértega-Gomez and Massimo Loda

    Ultra-sensitive immunoassays to detect low abundant protein biomarkers

    Paul Wheeler

    Glycomics as an innovative approach for personalized medicine

    Stefanie Holst, Nurulamin Abu Bakar, Monique van Scherpenzeel, Manfred Wuhrer, Dirk J Lefeber

    miRNA as novel biomarkers of health and disease

    Laura García Bermejo

    Targeted proteomics for absolute quantification of protein biomarkers in serum and tissues

    Coşkun Güzel, Christoph Stingl, Frank Klont, Roel Tans, Esther Willems, Rainer Bischoff, Alain J van Gool, Theo M Luider, the Biomarker Development Center Consortium

    Integrated omics for tissue-based mapping of the human proteome

    Cecilia Lindskog

    Proteogenomics and multi-omics data integration for personalized medicine

    Peter Horvatovich, Corry-Anke Brandsma, Frank Suits, Rainer Bischoff, Victor Guryev

    Sequencing Approaches for Personalized Cancer Therapy Selection in Pathology

    Wendy de Leng, Manon Huibers, John Hinrichs, Edwin Cuppen, Stefan Willems

    Mass spectrometry imaging: enabling comprehensive spatial analysis of molecular biomarkers in tissue for personalized medicine

    Tiffany Porta, Steven WM Olde Damink, Ron MA Heeren

    Insights for personalized medicine from the gut microbiome: Lesson learned from celiac disease

    Gloria Serena, Anna Sapone, Alessio Fasano

  15. The next frontiers of therapeutic target areas: Autoimmunity, inflammation, respiratory, metabolic, cardiovascular and neurological diseases
  16. Precision Mucosal Sampling and Biomarkers in Allergic Rhinitis and Asthma

    Ashillesh Jha, Ryan S Thwaites, Nehmat Singh, Trevor Hansel

    Stratified medicine in autoimmune diseases

    John A Reynolds, Ian Bruce

    Biomarkers of Systemic Lupus Erythematosus

    Hiroshi Kato, Andras Perl

    Advances in cardiovascular Diagnostics – Use of cardiac biomarkers in clinical research and care of the patient

    Mark Effron and Zahoor Khan

    Biomarkers for psychiatric disease: an overview

    Roy Perlis

    Progressing towards precision psychiatry: current challenges in applying biomarkers in psychiatry

    Victor L Kallen, Brisa S Fernandes

    Identification of Biomarkers for the diagnosis, prediction and progression of Alzheimer’s Disease

    Bennett P Greenwood, Vladimir Tolstikov, Paula P Narain, Jeremy Chaufty, Viatcheslav R Akmaev, Vivek Vishnudas, Stephane Gesta, Rangaprasad Sarangarajan, Niven R Narain, Mike Kiebish

    Biomarkers in Lung Cancer

    George Santis, Richard Lee and Crispin T Hiley

  17. Lessons Learned: What have we learned and what is the next challenge?

Translational science in modern pharmaceutical R&D: the influence of organizational

structures on successes and failures

Peter MA Groenen

Biomarkers Qualification and Companion Diagnostics- Failure and Success of

regulatory Process

Federico Goodsaid

Not all Biomarkers Are Worthwhile: An Unsuccessful Use and Pitfalls to Avoid

Abdel Halim

Research Reproducibility: The Case for Standards

Leonard P Freedman, Raymond H Cypess

Can Big Data Analytics Recapitulate Biology? A Survey of Multi-omics Data

Integration Approaches

Armit Singh, Casey P Shannon, Kim-Anh Lê Cao, and Scott J Tebbutt

Can healthcare be made more affordable by the use of biomarkers?

Rene L Sluiter, Wietske Kievit, Gert Jan van der Wilt

Omics driven medicine for democratizating healthcare delivery and health economics

Mike Kiebish, Viatcheslav R Akmaev, Vivek Vishnudas, Stephane Gesta, Rangaprasad

Sarangarajan, Niven R

About the Editors

Claudio Carini MD, PhD, FRCPath

Dr. Carini is currently appointed as H. Faculty in the Division of Cancer & Pharmaceutical Sciences, King’s College, School of Medicine, and London. He is also a member of steering committees of the F-NIH Biomarkers Consortium for Cancer, Inflammation-Immunity and Neuroscience. He is a senior member of the Scientific Advisory Board for several biotechnology companies and a member of the New York Academy of Sciences. Formerly, Dr. Carini was the Global Head of Clinical Immunology & Biomarkers at Pfizer where he led Precision Medicine activities across multiple therapeutic areas and facilitated several international collaborations with prestigious academic institutions. Dr. Carini has served in many senior roles in prestigious pharmaceutical companies and government organizations (Roche, Novartis, F-NIH, MRC and IMI). For several years, he served as a faculty in the Department of Immunology at John Hopkins University, School of Medicine, and the Department of Cancer Biology at the Harvard University. Dr. Carini has authored more than 200 publications in peer reviewed journals and is the editor of several books in the field of biomarkers and precision medicine.

Mark Fidock, PhD is Vice President Precision Medicine Laboratories within the IMED Biotech Unit, AstraZeneca. He received his PhD from the University of East Anglia, UK in Molecular Pharmacology. Mark gained extensive experience of drug development whilst at Pfizer R&D UK, where he led Biomarker and Translational Medicine activities across multiple therapeutic areas. In 2013, Mark joined AstraZeneca appointed to the role of Head of Precision Medicine Laboratories, a multidisciplinary team developing innovative companion diagnostic tests deployed across early and late phase clinical development gaining regulatory approval for the identification of patients most likely to benefit from targeted medicines. Mark is an honorary senior lecture at the University of Cambridge, UK and has in excess of 30 scientific peer reviewed publications.

Alain van Gool is professor of Personalized Healthcare at the Radboud university medical center (Nijmegen, Netherlands) where he leads the Translational Metabolic Laboratory. He also coordinates biomedical technology infrastructures on a local (Radboudumc), national (DTL) and European (EATRIS) level. Before, Alain has worked at academia, applied research institute (TNO) and pharmaceutical industry (Organon, Schering-Plough, MSD) in Europe, USA and Asia. He has been leading x-omics technology-based laboratories, cross-functional expert teams, drug/biomarker development teams and public-private consortia, many of which were focused on the discovery, development and implementation of translational biomarkers in a variety of therapeutic areas.

Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Biotechnology
MEDICAL / Pharmacy