Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Download or read book Innovative Brain Tumor Therapy written by Gerardo Caruso and published by Woodhead Publishing. This book was released on 2014-10-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite recent advances, therapeutic efforts have not been successful establishing a definitive strategy of treatment for brain gliomas, because of the presence of the blood-brain barrier. Innovative Brain Tumor Therapy presents a synopsis of the studies on nanoparticles as ideal devices for brain tumor treatment. Their nanometric size, electrostatic charge, and lipophilic characteristics allow them to penetrate into the brain tissue freely. Promising in-vitro results have been reported, but remain to be validated in humans. This title focuses on the blood-brain barrier pathophysiology in brain tumors, and the possibilities of overcoming this with nanoparticle-based systems. Relevant patents of nanoparticles used as drug delivery carriers are also reported, as well as future scenarios in nanoparticles and stem cells.
Download or read book Nanotechnology in Therapeutics written by Costas Demetzos and published by John Wiley & Sons. This book was released on 2024-07-22 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanotechnology in Therapeutics Comprehensive reference delivering a framework to develop and assess nanosystems that provide unique advantages in biomedical applications Nanotechnology in Therapeutics explores the idea that by studying in depth the behavior of living organisms, especially the functionality of their cell membranes, we can develop and evaluate innovative bio-inspired nanosystems that are able to deliver small molecules, biomolecules like proteins, peptides, and other genetic material in terms of the production of new therapies and vaccines. The main concept promoted in this book is an integrated approach for producing new medicines following the nanotoxicity, biotoxicity, regulatory, and ethical guidelines, which are also covered in the book. The book is divided into three parts. Part A provides an introduction and a historical overview of nanotechnology. Part B delves deeper into issues relating to lipid and polymeric nanostructures in medicine. Part C presents the regulatory landscape around nanotechnology and nanomedicine, while highlighting the need to keep an eye on emerging technologies such as artificial intelligence and machine learning. Overall, this book opens up biomedical applications for previously challenging drugs and drug targets. Written by a highly qualified professor with significant pertinent research experience, Nanotechnology in Therapeutics includes discussion on: Eukaryotic cell membranes, their structural properties, and the thermodynamic payload of their lipid bilayers The DLVO (Derjaguin, Landau, Verwey and Overbeek) theory as a scientific tool for studying the stability and the behavior of nanoparticles Liposomes, lipid nanoparticles, and solid lipid nanoparticles, as well as polymeric nanoparticles, like micelles, polymersomes, and dendrimers Issues in the approval process of nanomedicines by the regulatory agencies, such as complexity, chaos, and nonlinear dynamics With comprehensive coverage of novel concepts that have the potential to transform how new medicines are designed and developed, Nanotechnology in Therapeutics is an essential resource on the subject for chemists in industry, as well as biomedical and pharmaceutical engineers.
Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.
Download or read book Protein based Therapeutics written by Dev Bukhsh Singh and published by Springer Nature. This book was released on 2023-03-01 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the essential characteristics and clinical applications of therapeutic proteins against human diseases, including cancers, immune disorders, infections, and other diseases. It presents the latest advancements in protein engineering techniques for producing desirable therapeutic proteins. The book also covers the strategies used to formulate and deliver systemic therapeutic proteins, approved protein therapeutics and their targets, and pharmacogenetic biomarkers. Further, it discusses challenges associated with the clinical implications of therapeutic proteins, including safety, immunogenicity, protein stability, degradation, and efficacy. It illustrates the development of biosimilar antibodies, optimization strategies for producing biobetter antibodies, and presents fundamental concepts about biosuperior therapeutics. Lastly, it includes a discussion about protein-based vaccines against bacterial and viral infections.
Download or read book Innovative Therapeutics written by Ted Rosen and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This issue of Dermatologic Clinics, guest edited by Dr. Ted Rosen, covers the innovative management of dermatologic disorders including Severe Hand Eczema, Pruritus, Furunculosis, Lupus Erythematosus, CTCL, Hidradenitis Suppurativa. Innovative uses of Topical Metronidazole, Topical Calcineurin Inhibitors, Rituximab, TNF-alpha Inhibitors, Thalidomide, Zinc, Dapsone, Spironolactone as an antiandrogen in the treatment of female pattern hair loss, and Therapeutics in Pediatric Dermatology are also reviewed.
Download or read book Science and Innovation written by Aldo Geuna and published by Edward Elgar Publishing. This book was released on 2003 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chapters in this book issue a series of challenges to the next generation of science and technology policy.
Download or read book Innovative Technologies and Treatments Helping Veterans written by United States. Congress. House. Committee on Veterans' Affairs and published by . This book was released on 2009 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Wash and Be Healed written by Susan Cayleff and published by Temple University Press. This book was released on 2010-05-18 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: An exploration of the relationship between hydrotherapy and the women who took the cure.
Download or read book Innovative Therapeutics from Molecules to Medicines Athens GREECE July 3 July 13 2006 written by and published by . This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bioprocess and Analytics Development for Virus based Advanced Therapeutics and Medicinal Products ATMPs written by Saurabh Gautam and published by Springer Nature. This book was released on 2023-08-10 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control. The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.
Download or read book Microbiome Therapeutics written by Nar Singh Chauhan and published by Elsevier. This book was released on 2023-05-17 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiome Therapeutics: Personalized Therapy Beyond Conventional Approaches addresses the current knowledge and landscape of microbiome therapeutics, providing an overview of existing applications in health and disease as well as potential future directions of microbiome modulations and subsequent translation to the global industry and market. This important reference provides the most current status of microbiome therapeutics as well as possible future perspectives through coverage of topics including the application of microbiome therapeutics; various additive, subtractive and modulatory approaches; microbiome composition of health and diseases, insights into live bio-therapeutics and the clinical data supporting their efficacy. Case studies are provided throughout the book to further define, describe and evaluate microbiome therapeutics success and failure. Provides chapters focused on illness types to address the potential of microbiome therapeutics in several significant disorders Offers human gut microbiome explorations that have enriched the understanding of microbiome colonization, maturation, and dysbiosis in health and disease subsets Addresses important concepts like economic potential in the global therapeutics market as well as ethical, technical, and regulatory aspects
Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-02 with total page 755 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Download or read book The Business of Healthcare Innovation written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.
Download or read book Signalling Molecules as Targets in Cancer Therapy written by Vittorio de Franciscis and published by Nova Publishers. This book was released on 2007 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents state-of-the-art information on the molecules of cell signalling pathways that represent actual or future targets for cancer therapy. By giving an update of the most promising approaches in this rapidly evolving field, the book contributes to the translation of the recent advances in the knowledge of intracellular signalling into the generation of innovative biomolecules as specific tools to target the most promising tumour-specific candidates. The book begins logically with the molecules first encountered along the signalling pathways, the membrane receptors for growth factors (Part I). Next, Part II presents several examples of intracellular molecular targets that are situated one step beyond in the pathways, while Part III addresses the difficult task of tuning the delicate balance between cell death and survival. In Part IV, the reader is taken into the practical problems raised by the therapy of specific cancers (glioma, childhood leukaemia), and into an original strategy from the field of nuclear medicine with the potential to generate innovative molecular-targeted cancer therapies.
Download or read book An Innovative Approach to Understanding and Treating Cancer written by Tomas Koltai and published by Academic Press. This book was released on 2020-02-15 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: The New pH-Centric Paradigm In Cancer Research: From Etiopathogenesis To New Therapeutic Avenues describes one of the few characteristics of cancer that is not shared by normal tissues: the reversal or inversion of the pH gradient, when intracellular pH becomes alkaline and extracellular pH becomes acid. This is now recognised as one of the most selective and differential hallmarks of all cancer cells and tissues, being the opposite of the condition found in normal tissues and a potential target in order to achieve either a stable disease or even regression with no toxicity. The book discusses topics such as lactic acid and its transport system in the pH paradigm; mechanisms to decrease extra cellular pH and increase intracellular pH; NHE-1 activity in cancer; carbonic anhydrases; vacuolar ATPase proton pump; and the sodium-bicarbonate cotransporter system. Additionally, it discusses complementary pharmacological interventions and cellular acidification and extracellular alkalinisation as a new and integral approach to cancer treatment. Analyzes thoroughly the mechanisms that lead to the inversion of pH gradient in cancer tissues Summarizes almost 100 years of research on pH inversion in cancer in one single source, discussing the most relevant and updated researches in the field Proposes new efficient treatments against cancer using pH inversion mechanisms, either with new drugs like proton transport inhibitors and proton pump inhibitors (PTIs and PPIs) as well as with repurposed drugs
