the design and development of novel drugs and vaccines

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The Design and Development of Novel Drugs and Vaccines
Author : Tarun Kumar Bhatt,Surendra Nimesh
Publisher : Academic Press
Release Date : 2021-01-15
ISBN 10 : 9780128214718
Pages : 320 pages

The Design and Development of Novel Drugs and Vaccines: Principles and Protocols presents both in silico methods and experimental protocols for vaccine and drug design and development, critically reviewing the most current research and emphasizing approaches and technologies that accelerate and lower the cost of product development. Sections review the technologies and approaches used to identify, characterize and establish a protein as a new drug and vaccine target, cover several molecular methods for in vitro studies of the desired target, and present various physiological parameters for in vivo studies. The book includes preclinical trials and research, along with information on FDA approval. Covers both in silico methods and experimental protocols for vaccine and drug development in a single, accessible volume Offers a holistic accounting of how developments in bioinformatics and large experimental datasets can be used in the development of vaccines and drugs Shows researchers the entire gamut of current therapies, ranging from computational inputs to animal studies Reviews the most current, cutting-edge research available on vaccine and drug design and development

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release Date : 2013-06-27
ISBN 10 : 0123948231
Pages : 432 pages

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies
Author : Manmohan Singh,Maya Salnikova
Publisher : Academic Press
Release Date : 2014-12-30
ISBN 10 : 012416661X
Pages : 520 pages

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies. Provides strategies for the development of safe and efficacious novel formulations for various modalities of biologics, vaccines and for cancer therapy Highlights novel cases from current clinical trials as well as marketed products Reviews overall successes and challenges in the development of novel formulations, including new molecular targets for the treatment of diseases, design of target-specific therapies, regulatory considerations, individualized therapies

Human Vaccines
Author : Kayvon Modjarrad,Wayne C. Koff
Publisher : Academic Press
Release Date : 2016-10-15
ISBN 10 : 0128025425
Pages : 186 pages

Human Vaccines: Emerging Technologies in Design and Development discusses the advances in molecular biology, biophysics, and informatics—among other disciplines—that have provided scientists with the tools to create new vaccines against emerging and re-emerging pathogens. For example, the virus-like particle technologies that led to licensing of highly efficacious HPV vaccines have only come into full realization in the last 10 years. Their success has, in turn, accelerated the pace with which nanoparticle vaccines are being developed Given the rapidity with which the field is changing and the absence of any text documenting this change, there is a need for a resource that surveys these new vaccine technologies, assesses their potential, and describes their applications. This book provides that resource and complements traditional vaccinology books, but also serves as an excellent standalone for researchers and students with basic knowledge in immunology. Introduces new topics in vaccine immunology in the context vaccine design and production Consolidates the growing body of knowledge on new vaccine technologies that have only emerged in the past 2 – 3 decades Reviews the currently licensed vaccines that have utilized leading-edge technologies and how this has translated into improved efficacy and safety Provides a broad overview of innovative vaccine technologies, including immunological aspects

Department of Defense Appropriations for Fiscal Year 2002
Author : United States,United States. Congress. Senate. Committee on Appropriations. Subcommittee on Defense
Publisher : N.A
Release Date : 2002
ISBN 10 :
Pages : 1089 pages

Preventing Chemical Weapons
Author : Michael Crowley,Malcolm Dando,Lijun Shang
Publisher : Royal Society of Chemistry
Release Date : 2018-08-20
ISBN 10 : 1788014723
Pages : 652 pages

The life and chemical sciences are in the midst of a period of rapid and revolutionary transformation that will undoubtedly bring societal benefits but also have potentially malign applications, notably in the development of chemical weapons. Such concerns are exacerbated by the unstable international security environment and the changing nature of armed conflict, which could fuel a desire by certain States to retain and use existing chemical weapons, as well as increase State interest in creating new weapons; whilst a broader range of actors may seek to employ diverse toxic chemicals as improvised weapons. Stark indications of the multi-faceted dangers we face can be seen in the chemical weapons attacks against civilians and combatants in Iraq and Syria, and also in more targeted chemical assassination operations in Malaysia and the UK. Using a multi-disciplinary approach, and drawing upon an international group of experts, this book analyses current and likely near-future advances in relevant science and technology, assessing the risks of their misuse. The book examines the current capabilities, limitations and failures of the existing international arms control and disarmament architecture – notably the Chemical Weapons Convention – in preventing the development and use of chemical weapons. Through the employment of a novel Holistic Arms Control methodology, the authors also look beyond the bounds of such treaties, to explore the full range of international law, international agreements and regulatory mechanisms potentially applicable to weapons employing toxic chemical agents, in order to develop recommendations for more effective routes to combat their proliferation and misuse. A particular emphasis is given to the roles that chemical and life scientists, health professionals and wider informed activist civil society can play in protecting the prohibition against poison and chemical weapons; and in working with States to build effective and responsive measures to ensure that the rapid scientific and technological advances are safeguarded from hostile use and are instead employed for the benefit of us all.

Development of Vaccines
Author : Manmohan Singh,Indresh K. Srivastava
Publisher : John Wiley & Sons
Release Date : 2011-10-11
ISBN 10 : 9781118023631
Pages : 448 pages

Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.

Development of Novel Vaccines
Author : Alexander von Gabain,Christoph Klade
Publisher : Springer Science & Business Media
Release Date : 2012-04-23
ISBN 10 : 3709107091
Pages : 306 pages

“Development of novel vaccines” gives an overview of the tasks in basic research leading to the final product – the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.

Post-Genomic Approaches in Drug and Vaccine Development
Author : Kishore R. Sakharkar,Meena K. Sakharkar ,Ramesh Chandra
Publisher : River Publishers
Release Date : 2015-04-11
ISBN 10 : 8793102844
Pages : 450 pages

Over the past decade, genome sequencing projects and the associated efforts have facilitated the discovery of several novel disease targets and the approval of several innovative drugs. To further exploit this data for human health and disease, there is a need to understand the genome data itself in detail, discover novel targets, understand their role in physiological pathways and associated diseases, with the aim to translate these discoveries to clinical and preventive medicine. It is equally important to understand the labors and limitations in integrating clinical phenotypes with genomic, transcriptomic, proteomic and metabolomic approaches. This book focuses on some key advances in the field. Technical topics discussed in the book include: Drug discoveryTarget identification and prioritizationHypothesis driven multi-target drug designGenomics in vaccine developmentGene regulatory networks Vaccine design and developmentPrediction of drug side effects in silico

Koenig and Schultz's Disaster Medicine
Author : Kristi L. Koenig,Carl H. Schultz
Publisher : Cambridge University Press
Release Date : 2016-04-18
ISBN 10 : 1107040752
Pages : 782 pages

This is the definitive reference on disaster medicine, outlining areas of proficiency for health care professionals handling mass casualty crises.

Pharmaceutical Design And Development
Author : T V Ramabhadran
Publisher : CRC Press
Release Date : 1994-03-31
ISBN 10 : 0203984153
Pages : 354 pages

This volume aims to introduce researchers in pharmaceutical and allied industries to the concepts and latest developments in the application of biotechnology recombinant DNA and monoclonal antibodies to drug development.

Pharmaceutical Biotechnology
Author : Carlos A. Guzmán,Giora Z. Feuerstein
Publisher : Springer Science & Business Media
Release Date : 2010-01-01
ISBN 10 : 9781441911322
Pages : 276 pages

Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives—basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins and vaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens’ genomes provides opportunities that never before have been available—identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated, replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.

Parasites, Molecular Biology, Drug and Vaccine Design
Author : Nina Agabian,Anthony Cerami
Publisher : N.A
Release Date : 1990
ISBN 10 :
Pages : 504 pages

This wide-ranging collection of edited papers examines the many mechanisms that allow parasites to survive and interact in a host environment. The research explains how a more knowledgeable understanding of host-parasite interactions aids in the development of unique strategies for vaccine design and applied research in clinical diagnostics and therapeutics. Divided into five parts, the text covers gene expression during parasite differentiation and development; the potential for molecular genetics in parasite systems; molecules of the parasite membrane; molecular modeling and parasite drug design; and vaccines.

Author : Alan D. T. Barrett
Publisher : John Wiley & Sons
Release Date : 2015-02-16
ISBN 10 : 0470656166
Pages : 400 pages

Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.

Molecular Farming of Plants and Animals for Human and Veterinary Medicine
Author : L. Erickson,W.-J. Yu,J. Brandle,R. Rymerson
Publisher : Springer Science & Business Media
Release Date : 2002-09-30
ISBN 10 : 9781402008351
Pages : 374 pages

Until recently, agriculture was seen as a minor customer of the pharmaceutical industry. However, as this book amply demonstrates, agriculture may be poised to become a much more important supplier rather than consumer of pharmaceuticals. This book is the most comprehensive and up-to-date compilation of bio-farming strategies to provide health products that are both safer and lower-cost than those produced conventionally. The style and information presented assumes a university undergraduate level of genetics and biology. Technical information regarding the methods used and the results, as well as perspectives on commercialization and regulation, is provided by scientists prominent in this diverse and burgeoning field. This book is an invaluable resource for undergraduate and graduate students, university faculty, and researchers in government and corporate labs, as well as research managers, planners, and consultants in biotechnology.

Novel Strategies in the Design and Production of Vaccines
Author : Sara Cohen,Avigdor Shafferman
Publisher : Springer Science & Business Media
Release Date : 2013-06-29
ISBN 10 : 1489913823
Pages : 198 pages

Vaccination is one of the most efficient and cost effective methods of promoting human health and has been in clinical use for at least 200 years. Nevertheless, infectious diseases continue to constitute a constant threat to the well being of humanity. Common pathogens, once believed to be under control, acquire increased virulence and resistance to drugs, while exotic microorganisms emerged from hidden reservoirs to cause yet incurable diseases in humans. These changes, together with epidemic outbreaks related to political and socio-economic instabilities, increase the needs for the development of new, advanced vaccines. In this volume, devoted to the proceedings of the 39th OHOLO Conference, we present some of the recent strategies for the design and production of novel vaccines. The advent of recombinant DNA technology has stimulated the production of several subunit vaccines. In spite of the obvious advantages to this approach, the limited immuno genicity of many subunit candidates has hindered their development. Strategies to enhance the immunogenicity of subunit vaccines is therefore critical. Several approaches toward this goal, including design of novel adjuvants and delivery systems as well as design of advantageous carriers, are presented here. Among the carriers evaluated here are polypep tides (flagellin, HBV core antigen, J3-galactosidase), attenuated virions (Vaccinia, Sindbis), and nonpathogenic licensed bacteria (Salmonella).

Evolution of Virulence in Eukaryotic Microbes
Author : L. David Sibley,Barbara J. Howlett,Joseph Heitman
Publisher : John Wiley & Sons
Release Date : 2012-06-07
ISBN 10 : 1118308131
Pages : 584 pages

A unique and timely review of the emergence of eukaryotic virulence in fungi, oomycetes, and protozoa, as they affect both animals and plants Evolution of Virulence in Eukaryotic Microbes addresses new developments in defining the molecular basis of virulence in eukaryotic pathogens. By examining how pathogenic determinants have evolved in concert with their hosts, often overcoming innate and adaptive immune mechanisms, the book takes a fresh look at the selective processes that have shaped their evolution. Introductory chapters ground the reader in principal evolutionary themes such as phylogenetics and genetic exchange, building a basis of knowledge for later chapters covering advances in genetic tools, how pathogens exchange genetic material in nature, and the common themes of evolutionary adaptation that lead to disease in different hosts. With the goal of linking the research findings of the many disparate scientific communities in the field, the book: Assembles for the first time a collection of chapters on the diversity of eukaryotic microorganisms and the influence of evolutionary forces on the origins and emergence of their virulent attributes Highlights examples from three important, divergent groups of eukaryotic microorganisms that cause disease in animals and plants: oomycetes, protozoan parasites, and fungi Covers how the development of genetic tools has fostered the identification and functional analyses of virulence determinants Addresses how pathogens exchange genetic material in nature via classical or modified meiotic processes, horizontal gene transfer, and sexual cycles including those that are cryptic or even unisexual Provides a broad framework for formulating future studies by illustrating themes common to different pathogenic microbes Evolution of Virulence in Eukaryotic Microbes is an ideal book for microbiologists, evolutionary biologists and medical professionals, as well as graduate students, postdoctoral fellows, and faculty members working on the evolution of pathogens.

The Handbook of Microbial Metabolism of Amino Acids
Author : J P F D'Mello
Publisher : CABI
Release Date : 2017-04-10
ISBN 10 : 1780647239
Pages : 539 pages

This book collates and reviews recent advances in the microbial metabolism of amino acids, emphasizing diversity - in terms of the range of organisms under investigation and their natural ecology - and the unique features of amino acid metabolism in bacteria, yeasts, fungi, protozoa and nematodes. As well as studying the individual amino acids, including arginine, sulfur amino acids, branched-chain amino acids and aromatic amino acids, a number of themes are explored throughout the work. As the volume of research into the metabolism of amino acids grows, this comprehensive study of the subject is a vital tool for researchers in the fields of biological, medical and veterinary sciences, including microbiology, biochemistry, genetics and pathology. This book is also essential for corporate organizations with active research and development programmes, such as those in the pharmaceutical industry.

Medical Principles and Practice
Author : N.A
Publisher : N.A
Release Date : 2004
ISBN 10 :
Pages : 329 pages

Novel Technologies for Vaccine Development
Author : Igor S Lukashevich,Haval Shirwan
Publisher : Springer
Release Date : 2014-11-13
ISBN 10 : 3709118182
Pages : 386 pages

This book presents a detailed overview of the development of new viral vector-based vaccines before discussing two major applications: preventive vaccines for infectious diseases and therapeutic cancer vaccines. Viral vector-based vaccines hold a great potential for development into successful pharmaceutical products and several examples at the advanced pre-clinical or clinical stage are presented. Nevertheless, the most efforts were focused on novel and very innovative technologies for new generation of vector-based vaccines. Furthermore, specific topics such as delivery and adjuvant and protection strategies for cell-mediated-based vaccines are presented. Given its scope, the book is a “must read” for all those involved in vaccine development, both in academia and industrial vaccine development.