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Dr. Davide Staedler is CEO of TIBIO Sagl, a consulting company, and chief scientific officer of Scitec Research S.A., a private analytical laboratory. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Miniaturization in the fields of chemistry and molecular biology has resulted in the "lab-on-a-chip." Such systems are micro-fabricated devices capable of handling extremely small fluid volumes facilitating the scaling of single or multiple lab processes down to a microchip-sized format. The convergence of lab-on-a-chip technology with the field of cell biology facilitated the development of "organ-on-a-chip" systems. Such systems simulate the function of tissues and organs, having the potential to bypass some cell and animal testing methods. These technologies have generated high interest as applications for disease modeling and drug discovery. This book, edited by Drs. Sean Murphy and Anthony Atala, provides a comprehensive coverage of the technologies that have been used to develop organ-on-a-chip systems. Known leaders cover the basics to the most relevant and novel topics in the field, including micro-fabrication, 3D bio-printing, 3D cell culture techniques, biosensor design and microelectronics, micro-fluidics, data collection, and predictive analysis. The book describes specific tissue types amenable for disease modeling and drug discovery applications. Lung, liver, heart, skin and kidney "on-a-chip" technologies are included as well as a progress report on designing an entire "body-on-a-chip" system. Additionally, the book covers applications of various systems for modeling tissue-specific cancers, metastasis, and tumor microenvironments; and provides an overview of current and potential applications of these systems to disease modeling, toxicity testing, and individualized medicine.
This contributed volume reviews the latest advances on relevant 3D tissue engineered in vitro models of disease making use of biomaterials and microfluidics. The main focus of this book is on advanced biomaterials and microfluidics technologies that have been used in in vitro mimetic 3D models of human diseases and show great promise in revolutionizing personalized medicine. Readers will discover important topics involving biomaterials and microfluidics design, advanced processing techniques, and development and validation of organ- and body-on-a-chip models for bone, liver, and cancer research. An in depth discussion of microfabrication methods for microfluidics development is also provided. This work is edited by two truly multidisciplinary scientists and includes important contributions from well-known experts in their fields. The work is written for both early stage and experienced researchers, and well-established scientists enrolled in the fields of biomaterials, microfluidics, and tissue engineering, and is especially suited to those who wish to become acquainted with the principles and latest developments of in vitro models of diseases, such as professionals working in pharma, medicine, and engineering.
This book compiles multidisciplinary efforts to conceptualize the environment in research and clinical setting that creates the fertile ground for the practical utility of personalized medicine decisions and also enables clinical pharmacogenomics for establishing pharmacotyping in drug prescription. Its covers innovative drug formulations and nanotheranostics, molecular imaging and signatures, translational nanomedicine and informatics, stem cell therapy approaches, modeling and predictability of drug response, pharmacogenetics-guided drug prescription, pediatric drug dosing, pharmacovigilance and regulatory aspects, ethical and cost-effectiveness issues, pharmacogenomics knowledge bases, personal genome sequencing, molecular diagnostics, as well as information-based medicine.
Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop.
Accelerated Path to Cures provides a transformative perspective on the power of combining advanced computational technologies, modeling, bioinformatics and machine learning approaches with nonclinical and clinical experimentation to accelerate drug development. This book discusses the application of advanced modeling technologies, from target identification and validation to nonclinical studies in animals to Phase 1-3 human clinical trials and post-approval monitoring, as alternative models of drug development. As a case of successful integration of computational modeling and drug development, we discuss the development of oral small molecule therapeutics for inflammatory bowel disease, from the application of docking studies to screening new chemical entities to the development of next-generation in silico human clinical trials from large-scale clinical data. Additionally, this book illustrates how modeling techniques, machine learning, and informatics can be utilized effectively at each stage of drug development to advance the progress towards predictive, preventive, personalized, precision medicine, and thus provide a successful framework for Path to Cures.
Animal Models in Cancer Drug Discovery brings forward the most cutting-edge developments in tumor model systems for translational cancer research. The reader can find under this one volume virtually all types of existing and emerging tumor models in use by the research community. This book provides a deeper insight on how these newer models could de-risk modern drug discovery. Areas covered include up to date information on latest organoid derived models and newer genetic models. Additionally, the book discusses humanized animal tumor models for cancer immunotherapy and how they leverage personalized therapies. The chapter on larger animal, canine models and their use in and their use in pre-investigational new drug (pre-IND) development makes the volume unique. Unlike before, the incorporation of several simplified protocols, breeding methodologies, handling and assessment procedures to study drug intervention makes this book a must read. Animal Models in Cancer Drug Discovery is a valuable resource for basic and translational cancer researchers, drug discovery researchers, contract research organizations, and knowledge seekers at all levels in the biomedical field.
3D Printing in Medicine, Second Edition examines the rapidly growing market of 3D-printed biomaterials and their clinical applications. With a particular focus on both commercial and premarket tools, the book looks at their applications within medicine and the future outlook for the field. The chapters are written by field experts actively engaged in educational and research activities at the top universities in the world. The earlier chapters cover the fundamentals of 3D printing, including topics such as materials and hardware. The later chapters go on to cover innovative applications within medicine such as computational analysis of 3D printed constructs, personalized 3D printing - including 3D cell and organ printing and the role of AI - with a subsequent look at the applications of high-resolution printing, 3D printing in diagnostics, drug development, 4D printing, and much more. This updated new edition features completely revised content, with additional new chapters covering organs-on-chips, bioprinting regulations and standards, intellectual properties, and socio-ethical implications of organs-on-demand. Reviews a broad range of biomedical applications of 3D printing biomaterials and technologies Provides an interdisciplinary look at 3D printing in medicine, bridging the gap between engineering and clinical fields Includes completely updated content with additional new chapters, covering topics such as organs-on-chips, bioprinting regulations, intellectual properties, medical standards in 3D printing, and more
On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This workshop builds on prior efforts to explore how virtual clinical trials facilitated by digital health technologies (DHTs) might change the landscape of drug development. To explore the challenges and opportunities in using DHTs for improving the probability of success in drug R&D, enabling better patient care, and improving precision medicine, the workshop featured presentations and panel discussions on the integration of DHTs across all phases of drug development. Throughout the workshop, participants considered how DHTs could be applied to achieve the greatest impactâ€"and perhaps even change the face of how clinical trials are conductedâ€"in ways that are also ethical, equitable, safe, and effective. This publication summarizes the presentations and discussions from the workshop.
This inclusive text describes 3D Printing for pharmaceutical applications, including emerging 3D technologies. The book focuses on the functionality of the materials/biomaterials used for the preparation of dosage forms and devices, fundamentals for preparing these systems and novel applications using these additive manufacturing techniques. Also, the text includes clinical relevance and regulatory considerations for the future of personalized medicine. Authored by experts with a broad range of experience, extensive insight into the science of 3D printing technology used to produce these systems is provided. Highlighting viewpoints from the academic, polymer excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying techniques of additive manufacturing for drug product and device development while also providing insight into the path forward for the technology in years to come.