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As an academic or a small business owner, you will need to write grants at some point in your career. Writing them though is not enough, what you also need to know is how to win grants. Much has been written about writing grants, the mysterious special ability called ¿grantsmanship¿, so it occurred to me that there is a need to come at this differently and spill the beans. The difficulty in getting a grant, in particular an NIH grant like an R01 in the USA is often described, it is competitive and gets tougher every year. Your proposal therefore must stand out, it must connect with the reviewers. This is true for all types of grants, give the reviewer what they want always. But also, you need to connect to the program officer, the committee that ultimately makes funding decisions and you must take care of a myriad of other details outside of the main event which is describing the ¿science¿. This means you cannot rely on just out-writing the competition, it is more than that as you have to out-think, out-strategize and out-schmooze them. If you have been continually funded for decades that is terrific, but if you want to keep being funded there is no guarantee what got you there will keep you there. What was a hot technology 4-5 years ago is not the new thing anymore, you will need to do something different, but what? You therefore need to not only think about writing great grants, you need to put it into practice and win them. Having written and won grants from the NIH and DOD over the past 17 years (and longer by the time you read this) I possess a valuable perspective.Each grant and study section will be different. Whether a big or small grant it does not seem to make a difference the reviewers will critique your efforts, they may not like it, they may reject your ideas or they may love it. You have some small degree of control until the proposal leaves your hands or more correctly you click ¿submit¿. You will need to differentiate your grant from the hundreds of others in many ways, but you cannot change who you are, your history so how you describe yourself and team will also have an impact. You could spend hundreds of hours on your proposal or just a day and the outcome might still be the same. This small book is a summary of my own personal experiences and will provide some advice that will help you learn how to do a better job of winning grants.This book is written by a scientist who writes the grants and develops commercial products;Provides a unique perspective on what you need to write better grants;Teaches you how to continually win grants;This book provides examples from the authors own grant applications;The reader will be inspired to start a company to win small business grants.
This book provides an overview of Data Monitoring Committees(DMC) - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotechnology and pharmaceutical company and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity.This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to expertly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the impact of DMC activity on safeguarding the trial is so important.This book provides the following:Provides thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation;Includes practical and hands-on information on DMC implementation;Discusses a wide range of clinical trial ¿ by phase and therapeutic area.
The purpose of this book is to highlight some of latest developments and applications of CRISPR, RNA, and DNA to treat diseases ranging from cancers to cardiovascular and degenerative disorders. It also features innovations of the delivery methods for nucleic acids ranging from nanodevices made from DNA and pseudo amino acids to viral vectors. This is an ideal book for academics, clinicians, and students interested in gene therapy.
The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future.A total of four books are covered under the series of Infectious drug diseases.- Malarial drug delivery systems- Tubercular drug delivery systems- Viral drug delivery systems- Infectious disease drug delivery systemsInfectious diseases are the world¿s greatest killers that present one of the most significant health and security challenges. Humans have lived with emerging and re-emerging pathogens since before the documented history of civilization. The only determining fact today is - If the situation is ¿worse¿ or ¿better¿ than in past. The answer is probably ¿worse¿, may be due significant increase in human population, increased cross-continent mobility, imbalanced (stressed) life style, irregular food habits leading to compromised innate immunity and over or under practiced hygiene routine. When the incidence of such a disease in people increases over 20 years or threatens to increase, it is called an ¿emerging¿ disease, and a growing number have made watch lists andheadlines in nearly every country -like highly pathogenic H5N1 avian influenza, severe acute respiratory syndrome (SARS), Ebola virus, food- and waterborne illnesses, and a range of antimicrobial-resistant bacterial diseases TB. This book addresses current and new therapy developments in treating such infectious diseases, updates on finding new drugs, identification of innovative diagnostic methods, understanding of disease research models and clinical trials performances of new treatment modalities.Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of infectious diseases and related research.
The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis.Many often-overlooked approximations and concepts in drug discovery are fully covered. Drug Target Selection and Validation includes both introductory sections and research-based sections to be of use to both students and research scientists in drug discovery, design, kinetics and metabolic analysis. Pharmaceutical scientists, pharmaceutics, drug developers, pharmacologists, biomedical researchers in computer science, medicinal chemists, and precision medicine developers benefit from the information provided. The book concludes with a chapter on chemical and structural databases.
This third and final volume in the "e;Ion Transport in Tumor Biology"e; collection presents novel diagnostic and therapeutic approaches in cancer based on the exploitation of ion transport proteins. The authors critically examine several transportome members, particularly Na+, K+, Ca2+, and Cl- channels, as well as organic solute carriers regarding their suitability as therapeutic targets. Synergistic effects resulting from the combined use of classical cytostatics with ion transport-inhibiting drugs are pointed out, and the capability of bispecific antibodies to function as anticancer drugs is discussed. As readers will also learn, the use of ion channel inhibitors could improve the outcome of radiotherapy because the development of radio-resistance during radiotherapeutic treatment often correlates with increases in the expression levels and conductance of ion channels. The translational topics of this volume form a bridge between biochemical research and therapeutic application.As part of a three-volume collection, this book will fascinate members of the active research community, as well as clinicians in the cancer field.
Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms. Pictorial/graphical illustrations provide easier understanding of complex pharmaceutical concepts, manufacturing processes of pharmaceutical dosage forms. Since it is imperative for pharmacy students to have a clear understanding of the basic concepts used in development of drugs into suitable and stable dosage forms.This book offers a wealth of information regarding basic aspects of pharmaceutical processes and dosage forms, in a single book, for undergraduate pharmacy students or science students (with no pharmacy background) intended to work in the pharmaceutical Industry.
This book provides an up-to-date overview of key areas of ageing research and bridges the gap between the subcellular events and the reality of ageing as seen in clinical practice.To this end, the reader learns about the historical development and progression of clinical ageing research. All chapters address the biochemistry or cell biology of various ageing events (to the extent that the data are available) and work their way to the clinical understanding we have of ageing. The focus of this volume is on how dietary restriction, virus infection and chronic inflammation affect the ageing process. Additionally, this book discusses how phosphate metabolism and metabolic dysfunction contribute to ageing events and how various organs and tissues (e.g. tendons, ears, heart muscle, and the endocrine system) age. This book follows on from Parts I, II and III of Biochemistry and Cell Biology of Ageing within the Subcellular Biochemistry book series and aims to bring the subcellular and clinical areas into closer contact by including interesting and significant biomedical ageing topics that were not included in the earlier volumes. Comprehensive and cutting-edge, this book is a valuable resource for experienced researchers and early career scientist alike, who are interested in learning more about the fascinating and challenging question of why and how our cells age.
New materials and manufacturing techniques are evolving with the potential to address the challenges associated with the manufacture of medicinal products that will teach new tricks to old drugs. Nano- and microfabrication techniques include manufacturing methods such as additive manufacturing, lithography, micro-moulding, spray drying, and supercritical fluids among many others. The increasing resolution of new techniques allow researchers to produce objects with micrometric resolutions. This book follows a consecutive order, beginning with a background in the current field and limitations in the manufacturing of different pharmaceutical products, moving on the classification of each method by providing recent examples, and future prospective on a variety of traditional and new Nano and microfabrication techniques. A focus on the materials used to prepare these systems and their biocompatibility, including applied topics such as clinical applications and regulatory aspects also covered, offering the reader a holistic view of this rapidly growing field.
This third edition is a comprehensive and extended study about the best known approaches for preparing the main types of glycosides, covering the classic and more recent glycosylation reactions used for preparing simple and challenging glycosides currently used as potent antiviral and antineoplastic drugs, or fluorogenic substrates used for enzymatic detection in cell biology. Besides, this new edition provides more examples of the glycosidic methodologies followed for preparing complex glycoconjugates such as glycoproteins and glycosphingolipids and gangliosides used as adjuvants or as synthetic vaccines candidates.Also, additional mechanistic evidence is presented for better understanding of the glycosylation reaction, trying to identify the variables mainly depending on protecting and leaving groups, as well as catalyst and reaction condition which altogether directs the anomeric stereo control.A chapter on the glycoside hydrolysis is included in view of the increasing interest in the use of biomass as a natural and renewable source for obtaining important intermediates or products used in food or valuable materials.The author includes information in the characterization of glycosides section with the aim of giving additional tools for the structural assignment through NMR, X-Ray and mass spectra techniques.
This volume focuses on the potential use of probiotics in treating metabolic disorders such as diabetes mellitus, metabolic acidosis, and gut dysbiosis. Chapters draw an association between gut microbiota and its diversity with metabolic diseases like diabetes, obesity, related liver and gut disorders; gut-brain axis; increased inflammation, and a compromised immune system resulting from these manifestations and scope of intervention with probiotics. Special attention is laid on describing the mechanisms of action of such beneficial effects of probiotic administration. The ability of probiotics to decrease metabolic endotoxemia by restoring the disrupted intestinal mucosal barrier is also included.The volume is a comprehensive compilation describing the scope and application of probiotic and prebiotic therapy in treating metabolic disorders. Readers will discover how probiotics are not just confined to the microbiology industry but are showing promising results in the medical and pharmaceutical sectors.
This volume highlights natural products, molecular methods for identifying, and current trends in designing non-natural natural products. Chapters guide readers through protocols on heterologous expression techniques, gene disruption, modified pathway regulators, and in-vitro studies. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols.Authoritative and cutting-edge, Engineering Natural Product Biosynthesis: Methods and Protocols aims to be a useful and practical guide to new researchers and experts looking to expand their knowledge. Chapter 13 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
This book covers the design and development of glucocorticoid receptor modulators (GRM) from cortisol to antibody-drug conjugate payloads over the last 70 years. The author starts with an introduction to the background of glucocorticoid receptor modulators as potential therapeutic modalities. This is followed by seven chapters in which he collates and discusses the medicinal chemistry journey of GRMs, reviewing topics such as cortisol-based glucocorticoids, the different approaches that have been pursued to enable chronic dosing of GRM compounds by inactivation in plasma and the liver, the application of prodrugs to GRMs, selective GRMs, targeted delivery of GRMs using polymers and nanoparticles, and rational drug design approaches applied in the development of GRMs. Particular attention is given to the development of glucocorticoid receptor modulators as immunology antibody-drug conjugate payloads. In the book¿s final chapter, the author critiques the medicinal chemistry progress madesince the discovery of cortisone and the promise of the latest antibody-drug conjugates that release a GRM payload. In this book, readers will also find an overview of the X-ray structures of glucocorticoid receptor antagonists and a list of all the earlier reviews that cover part of the medicinal chemistry story of GRM collated by keywords organized in a table. With several examples of crystal structures and molecular modeling, this book illustrates the huge effort by multiple companies and research groups to develop glucocorticoid receptor modulators. Professionals and scholars alike will find it a handy tool, and appreciate the latest research findings that it presents.
The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future, primarily due to increased longevity that almost always comes at a cost of impaired immunity.A total of four books are covered under the series of Infectious drug diseases.- Malarial drug delivery systems- Tubercular drug delivery systems- Viral drug delivery systems- Infectious disease drug delivery systemsThe third volume of series is focused on viral drug delivery systems. Typically, virus attaches to the cells (referred as host cell) and releases its DNA or RNA inside the cell. In second stage, virus¿s genetic material takes control of the cell and forces it to replicate the virus leading to onset of disease symptoms. DNA class of viruses include Herpes, Papilloma and Adeno viruses. RNA class of viruses include retroviruses, such as HIV immunodeficiency virus and SARS COV ¿ 2 / Corona virus. This book addresses recent developments in viral drug delivery systems. It covers many different aspects of viral infections, ways to treat them using modern drug delivery systems like nano particulate carriers. The choice of viral delivery systems mainly depends upon the type of virus, duration of life cycle, presence of drug resistance, cellular and mucosal interaction of virus, accordingly gene or non-gene drug delivery systems are selected. Besides that, this book also reports global dynamics of viral diseases, future predictions of infection rate, current treatment options, details of drug carriers like nanoemulsions, polymeric nanoparticles, role of biofunctionalization, and phyto-molecules in treatment of viral infections particularly herpes, Covid-19, Ebola, HIV/AIDS, influenza and viral hepatitis.Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of viral drug delivery research.
Active Site-directed Enzyme Inhibitors provides readers with a quick and efficient reference for obtaining effective active site-directed inhibitors for any of the enzymatic reactions under study without a need to resort to costly library screening- and biostructure-based techniques.
Das Abweichungsmanagement ist eines von vielen Qualitätssystemen in pharmazeutischen Unternehmen. Der pharmazeutische Prozess, von der Beschaffung von Ausgangsstoffen bis zur Fertigung des Endprodukts, erfolgt über Wochen und teils Monate gemäß schriftlichen Arbeitsanweisungen, deren korrekte Ausführung eine konsistente Produktqualität sicherstellen. Bei all diesen Schritten können unerwartet Abweichungen von den festgelegten Prozeduren auftreten. Diese müssen dokumentiert und hinsichtlich des möglichen Einflusses auf die Produktqualität und die Patientensicherheit bewertet werden. Weiterhin sollte die Ursache für die Abweichung identifiziert werden, um die Fehlerquelle durch geeignete Maßnahmen abstellen zu können. Regelmäßige Trendanalysen wichtiger Kennzahlen helfen ferner, die Situation bei Abweichungen zu überwachen.
This volume explores the latest technological advances and covers all facets of systems medicine with respect to precision medicine. The chapters in this book are organized into four parts. Part One highlights the recent achievements in proteomics for biomarkers identification, integration of omics and phenotypic data for precision medicine, and medicine-guided treatment of drug-induced Stevens-Johnson syndrome. Part Two covers systems-based computational approaches for pharmaceutical research and drug development, the principle of optimizing systemic exposure of drugs, and Animal Rule for drug repurposing. Part Three looks at computational tools and methodologies of network biology, quantitative systems toxicology, and modeling and stimulating patient response variabilities. Part Four talks about how systems medicine can address unmet medical and health needs, and identify educational needs. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.Cutting-edge and thorough, Systems Medicine: Methods and Protocols is a valuable resource for the scientific community that will help researchers work together toward the further advancement of achieving the goal of promoting global health.Chapter 8 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com
This book addresses the recent trends and clinical research being reported in last 5 to 10 years in the field of nasal drug delivery systems. In recent years, interest in using nasal passage as drug absorption site has received increased attention from formulation scientists. Nasal passages, even though a small surface area of the body as compared to other absorption passage such as Gastrointestinal tract or skin, show significant possibility for drug absorption at a quicker rate. There is also a possibility of delivering drugs to the brain using this passage and targeting drugs through the nasal passage. The book has 19 chapters addressing various aspects of nasal drug delivery systems such as an overview of anatomy and physiology of the nasal passage from a drug delivery point of view to global market opportunities for nasal drug delivery. In between, it addresses various aspects of nasal drug delivery. There are very few titles exclusively dedicated to nasal drug delivery, covering the formulation and developmental aspects, and addressing the challenges and solutions. The primary audiences for the book are graduate students in field of medicine, pharmacy and also various researchers who are working in the area of nasal drug delivery in addition to students who are specializing in field of medicine in ENT. This book provides comprehensive information on all the aspects related to the nasal drug delivery of various drug molecules.
The book targets new advances in areas of treatment and drug delivery sciences for tuberculosis. It covers advances in drug therapy and drug targeting that focus on innovative trend defining technologies and drug delivery platforms in the understanding of host-pathogens relationship for providing better therapy. A wide variety of novel and nano-formulations using promising technologies are being explored to deliver the drug via different administration routes. This book It addresses the gap between new approaches and old treatment modalities and how they are superior in pharmacological performance when tested in in-vitro and in-vivo. Audience from wide range group like from researchers to regulatory bodies can benefit from the compiled information to find out patient needs and current research advances in the field of tuberculosis research..
This comprehensive text provides information on fundamental principles of clinical practice and how these can be implemented to provide excellent treatment to the patients. The triads of health care delivery include Physicians, Pharmacist and Nurses that have distinct roles and responsibilities of patient care. Effective pharmacy practice requires an understanding of the social context within which pharmacy is practiced, recognizing the particular needs and circumstances of the users of pharmaceutical services and of pharmacy's place within health service provision. This book presents a contemporary view of pharmacy practice research covering theories, methodologies, models and techniques that are applicable. The initial chapters describe the basics of pharmacy profession and what is the key role and responsibilities of Pharmacist in health care delivery. The central part of the book illustrates the community, hospital and ethics regarding drug formulation. The last chapters cover the therapeutic aspect of pharmacy and how these can be employed to improve patient's health care facilities.
This book targets new advances in areas of treatment and drug delivery sciences for Malaria. This is the only published book which compiles the complete road map of malarial drug delivery systems along with an overview on the pathology, current state of malaria across the globe, new clinical trials, emerging drugs and evolving novel drug delivery platforms. A wide variety of novel micro-and nano-formulations using promising technologies are being explored to deliver the malarial drug via different administration routes. This book addresses the gap between new approaches and old treatment modalities and how the former is superior in pharmacological performance when tested in in-vitro and in-vivo. Audience from wide range group like from researchers to regulatory bodies can benefit from the compiled information to find out patient needs and addresses a much-needed update to the existing malaria drug delivery research.
The book provides essential information on some of the promising edible medicinal plants and how these possess both nutritional as well as therapeutic value. The significance of the edible plants in traditional medicine and the importance of the distribution of their chemical constituents are discussed systematically concerning the role of these plants in ethnomedicine in different regions of the world. The current volume deals with the individual plants' phytochemical and pharmacological properties, emphasizing human health. The title would demonstrate the value of natural edible plants and introduce readers to state-of-the-art developments and trends in omics-driven research.This book is a single-source scientific reference to explore the specific factors that contribute to these potential health benefits and discuss how to maximize those potential benefits. Chemists, food technologists, pharmacologists, phytochemists, and all professionals involved with quality control and standardization will find in this book a valuable and updated basis for their work.
This book focuses on the different compounds (polyphenols, sterols, alkaloids terpenes) that arise from the secondary metabolism of plants and fungi and their importance for research and industry. These compounds have been the backbone and inspiration of various industries like the food, pharmaceutical and others to produce synthetic counterparts. Furthermore, many of these compounds are still widely used to carry out specific functions in all these industries. This book offers a compilation of different texts from world leading scientists in the areas of chemistry, biochemistry, plant science, biotechnology which compile information on each group of secondary metabolism compounds, and their most important applications in the food, pharmaceutical, cosmetic and textile industry. By showcasing the best uses of these compounds, the chemistry behind their production in plants and fungi, this book is a valuable resource and a "go to" artifact for various audiences. The new approach this book offers, by linking research and the application of these compounds, makes it interesting as an inspiration for new research or as a hallmark of what has been done in the secondary metabolism of plants and fungi in recent years. Although this book may be technical, it is also enjoyable as an integral reading experience due to a structured and integrated flow, from the origins of secondary metabolism in organisms, to the discovery of their effects, their high intensity research in recent years and translation into various industries. Beyond learning more on their chemistry, synthesis, metabolic pathway, readers will understand their importance to different research and industry.
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