Handbook of Biomarkers and Precision Medicine

 
 
Routledge Cavendish (Verlag)
  • erschienen am 16. April 2019
  • |
  • 657 Seiten
 
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
978-0-429-57462-7 (ISBN)
 

"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.

    • Englisch
    • London
    • |
    • Großbritannien
    Taylor & Francis Ltd
    • Für höhere Schule und Studium
    100 farbige Abbildungen, 60 schwarz-weiße Tabellen
    • 39,08 MB
    978-0-429-57462-7 (9780429574627)
    Claudio Carini, MD, PhD, FRCPath, has been involved in the application of biomarkers in precision medicine for the past 18 years. He is currently appointed as H. Faculty in the Department of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences & Medicine at King's College, School of Medicine, London. He is a member of the F-NIH Biomarkers Consortium Steering Committees for Cancer, Inflammation & Immunity, and Neuroscience. He is also a senior member of the Scientific Advisory Boards for several biotechnology companies and a member of the New York Academy of Sciences. Claudio was formerly the Global Head of Clinical Immunology and Biomarkers at Pfizer Inc., where he led precision medicine activities across multiple therapeutic areas and facilitated international collaborations with prestigious academic institutions. He also held senior roles in pharmaceutical companies (Wyeth, Novartis, and Roche) and faculty positions at Harvard and Johns Hopkins Medical School. He is a strong believer of open innovation networks, and in his roles he has been collaborating extensively with different stakeholders to speed up the clinical application of scientific research through public-private partnerships. He has served in several national and international scientific boards: F-NIH Inflammation/Immunity; MRC, Inflammation/ Immunology Initiative-Rheumatoid Arthritis Consortium; MRC, "Stratified Medicine, SLE Consortium; IMI, ABIRISK, EU/EFPIA"; The PML Consortium. Claudio has over 200 publications in national and international peer-reviewed journals. He has also co-edited three books in the field of Biomarkers and Precision Medicine: Biomarkers in Drug Development: A Handbook of Practice Application and Strategy, (2010), Clinical and Statistical Considerations in Personalized Medicine, (2014), and Handbook of Biomarkers & Precision Medicine (2019 in press).


    Mark D. Fidock, PhD, is Vice President of Precision Medicine Laboratories within the IMED Biotech Unit, AstraZeneca, Cambridge, UK. He received his PhD from the University of East Anglia, UK, in Molecular Pharmacology. Mark is a trained molecular biologist/pharmacologist and gained extensive experience in drug development early in his career while at Pfizer Ltd, Sandwich, UK. He supported the development and approval of four new therapies and provided leadership for the Biomarker and Translational Medicine activities across multiple therapeutic areas. Mark joined AstraZeneca in 2013, appointed to the role of Head of Precision Medicine Laboratories and a member of the Precision Medicine and Genomics Leadership Team. He has overall accountability for all clinical testing activities that enables diagnostic development and regulatory approval. Mark leads a global multidisciplinary team providing strategy and direction in the development of Companion Diagnostic tests linked to targeted therapeutics across Oncology; Respiratory; and Cardiovascular, Renal, & Metabolism. These laboratory tests are deployed across both early- and late-phase clinical trials with the intent for global regulatory approval. By 2019 Mark had achieved >25 regulatory approved companion diagnostic tests across 3 major markets (USA, EU and Japan) linked to 4 AstraZeneca targeted therapies. Mark has a passion for innovative diagnostic science, driving research such as the use of artificial intelligence across tissue and molecular diagnostics to enable approaches that improve clinical testing outcomes with the ambition to change clinical care pathways. Mark has published more than 30 peer-reviewed articles in scientific journals and an active editor of the Journal of Precision Medicine. As an internationally recognized expert in Precision Medicine he holds an honorary position at the University of Cambridge and a member of the Institute of Translational and Stratified Medicine, Plymouth, scientific advisory board.


    Alain J. van Gool, PhD, is a professor of Personalized Healthcare and heads the Translational Metabolic Laboratory at the Radboud university medical center, Nijmegen Netherlands, with a strong passion in the application of biomarkers in translational medicine and personalized healthcare. Being trained as biochemist and molecular biologist, Alain worked at pharmaceutical industry (Organon, Schering-Plough, MSD), academia, applied research institutes, and university medical centers in EU, USA, and Singapore. He has been leading technology-based laboratories, cross-functional expert teams, therapeutic project 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. His technical expertise resides most strongly in molecular profiling through x-omics, analytical biomarker development, and applications in translational scientific research. Alain is a strong believer of public-private partnerships and thrives to work with specialists to translate research findings to applications. With that background, he currently also acts as Strategic Advisor to the Executive Board of Radboudumc, coordinates the Radboudumc Technology Centers, is Scientific Lead Technologies of DTL (the Dutch Techcenter for Life Sciences), is Chair Biomarker Platform of EATRIS (the European infrastructure for Translational Medicine), is co-initiator of Health-RI (the Netherlands Personalized Medicine and Health Research Infrastructure), and project leader and PI of the Netherlands X-omics Initiative, thus contributing to the organization and coordination of local, national, and European technology infrastructures. Alain has published 40 peer-reviewed articles in scientific journals and is a frequently invited keynote speaker at scientific conferences and public events. Complementing his daily work, he enjoys contributing as translational biomarker scientist to editorial boards of scientific journals, funding agencies, and scientific advisory boards of start-up enterpreneurs, multinational companies, diagnostic organizations, public-private consortia, and conference organizers.
    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, Andre Dekker, Remond JA Fijneman, Arnoud van der Maas, Morris Swertz, Jeroen AN Belien, 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-Mullerian 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






    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 Pertega-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 Garcia Bermejo


    Targeted proteomics for absolute quantification of protein biomarkers in serum and tissues
    Coskun Guzel, 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 Cancer


    George Santis, Richard Lee and Crispin T Hiley






    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 Le 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

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