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"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health
Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development.
Features :
Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies
Lessons-learned from successful Precision Medicine case studies
A variety of exciting and emerging biomarker technologies
The next frontiers and future challenges of biomarkers in Precision Medicine
Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.
Preface
Maria Freire
What is a Biomarker and their Role in Drug Development?
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
Biomarkers in Preclinical Sciences
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
Biomarkers in Translational Medicine
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
Biomarker-informed Clinical Trials
Overview of biomarker discovery and statistical considerations
Overview of classical design in biomarker informed clinical trials
Bo Huang, Jing Wang, Robert A. Beckman, Sandeep Menon and Weidong Zhang
Novel biomarker guided clinical trials design: A practical view
Bo Huang, Jing Wang, Robert A. Beckman, 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, Robert A. Beckman, Sandeep Menon and Weidong Zhang
Informational designs and potential applications to Rare Disease
Robert Beckman, Cong Chen
The road ahead: Identification of the hurdles and solutions to the implementation of Precision Medicine in healthcare
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 JonathanIWilde
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
Lessons from the past and pioneers of the future
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 LYNPARZA TM (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
Paving a new era of personalized medicine: Emerging technologies
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
The next frontiers of therapeutic target areas: Autoimmunity, inflammation, respiratory, metabolic, cardiovascular and neurological diseases
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 Can