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Drug Development
An Overview of the Consortia and Collaborative Initiatives, the Alzheimer's Research and Advocacy Space Over the Past Quarter Century BACKGROUND: 25 years ago, the number of organizations focusing on Alzheimer's research and advocacy was few and were often operating in geographic and functional silos. The Alzheimer's Association (founded in 1980), Alzheimer's Disease International (1984), the Alzheimer's Disease Research Centers (1984), the Consortium to Establish a Registry for Alzheimer's Disease (1986), the Alzheimer's Disease Cooperative Study (1991), and the National Alzheimer's Coordinating Center (1999) were the most prominent U.S. organizations, with a heavy focus on research. In Europe, organizations had a focus on policy, research funding, and care advocacy. Alzheimer's Europe (1990) drew member organizations together in Brussels to discuss pan-EU policy needs. Alzheimer's Research UK (1992) and Alzheimer's Society UK (1979), though both located in the UK, had outsized impact across Europe. In Japan, a super-aging society, the Health and Global Policy Institute, one of the largest international think tanks, has provided policy recommendations to the Japanese government since 2004.
Not only have the number and types of organizations expanded substantially, the silos have also begun to break down as groups have combined together on pre-competitive projects that span geographies and function to move the field forward faster and more collaboratively. We reviewed major consortia and summarized the projects by type and goals. Additionaly, we provide concept and network maps to show interconnectivity and influence between organizations, key stakeholders and funders.
Dozens of consortia have been working collaboratively to improve the lives of individuals with Alzheimer's disease and related dementias. Public, private and philanthropic entities provide funding and other support for projects with a priority for data sharing and collective action. Advocacy organizations use the output to effect policy and clinical practice change and increase awareness and support to move the field forward faster for patients and their loved ones.
Awareness of other organizations and their goals and efforts will reduce redundant efforts and will facilitate collaboration and progress. This awareness sets the stage for accelerated benefits for those impacted by ADRD over the next 25 years.
Journal Article
Accelerated Development of Pharmaceuticals Past, Present, and Future
This paper reviews the accelerated development of pharmaceuticals, exploring past, present, and future perspectives. It provides a historical overview of early strategies used to expedite development, beginning with initiatives from the 1990s. The work of Gardner and Byrn in accelerated development analysis during this era is highlighted. The narrative progresses to the 2000s, discussing the emergence of PK/PD in accelerating pharmaceutical development. The paper further examines case studies in the accelerated development field, including the INDIGO and Chorus programs. It concludes with an analysis of the current state of the field, referencing the NIPTE conference, which focused on the industrial perspective of accelerated development. Additionally, the paper outlines strategies for the rapid development of Solid Lipid Nanoparticle manufacturing and vaccine production.
Journal Article
Howard A. “Skip” Burris III, MD: An Oncology Pioneer Reflects on Patients, Progress, and Purpose
The originator of the phase 1 drug development program at Sarah Cannon Research Institute reflects on his career.The originator of the phase 1 drug development program at Sarah Cannon Research Institute reflects on his career.
Journal Article
Evaluation of Substituted Pyrazole-Based Kinase Inhibitors in One Decade (2011–2020): Current Status and Future Prospects
Pyrazole has been recognized as a pharmacologically important privileged scaffold whose derivatives produce almost all types of pharmacological activities and have attracted much attention in the last decades. Of the various pyrazole derivatives reported as potential therapeutic agents, this article focuses on pyrazole-based kinase inhibitors. Pyrazole-possessing kinase inhibitors play a crucial role in various disease areas, especially in many cancer types such as lymphoma, breast cancer, melanoma, cervical cancer, and others in addition to inflammation and neurodegenerative disorders. In this article, we reviewed the structural and biological characteristics of the pyrazole derivatives recently reported as kinase inhibitors and classified them according to their target kinases in a chronological order. We reviewed the reports including pyrazole derivatives as kinase inhibitors published during the past decade (2011–2020).
Journal Article
Drugs and vaccines in the 21st century for neglected diseases
Fexinidazole entered clinical trials in 2009 and is currently being registered as a treatment for early-stage and late-stage human African trypanosomiasis caused by Trypanosoma brucei gambiense in adults and children older than 6 years.5 Importantly, for the first time, human African trypanosomiasis can be cured with the use of pills alone. [...]no drugs have been developed for this condition since 1990 when eflornithine was repurposed from a clinical trial for cancer. Developed in the 1980s for cutaneous metastases of breast cancer, this alkylphosphocholine was repurposed for leishmaniasis and at present is the only oral drug available to treat all clinical forms of the disease.6 In another instance of repurposing, the veterinary drug moxidectin was approved by the FDA to treat onchocerciasis (river blindness) in patients aged 12 years and older in June, 2018,7 which rendered this macrocyclic lactone the first drug to be registered for onchocerciasis in 20 years. In 2016, Vaxchora—a single-dose attenuated virus vaccine indicated for active immunisation against Vibrio cholerae serogroup O1—was the first vaccine to be approved by the FDA for the prophylaxis of cholera.9 The other biologicals are human rabies immunoglobulins (KedRab and a new formulation of HyperRAB) indicated for post-exposure prophylaxis of rabies infection.10,11 The numbers above represent a rate of 1·1 products targeting neglected diseases approved per year from 2012 to 2018, which is lower than the three products per year approved in the 2000–11 period.
Journal Article
Hippocratic Recipes
Drawing on philological studies, social history and anthropology, this book offers the first extended study of the recipes included in the Hippocratic Corpus. It examines the links between oral and written traditions in the transmission of ancient pharmacological knowledge.
eBook
Drug Development Failure: How GLP-1 Development Was Abandoned in 1990
Many factors determine whether and when a class of therapeutic agents will be successfully developed and brought to market, and historians of science, entrepreneurs, drug developers, and clinicians should be interested in accounts of both successes and failures. Successes induce many participants and observers to document them, whereas failed efforts are often lost to history, in part because involved parties are typically unmotivated to document their failures. The GLP-1 class of drugs for diabetes and obesity have emerged over the past decade as clinical and financial blockbusters, perhaps soon becoming the highest single source of revenue for the pharmaceutical industry (Berk 2023). In that context, it is instructive to tell the story of the first commercial effort to develop this class of drugs for metabolic disease, and how, despite remarkable early success, the work was abandoned in 1990. Told by a key participant in the effort, this story documents history that would otherwise be lost and suggests a number of lessons about drug development that remain relevant today.
Journal Article
Twenty Years of Progress Toward West Nile Virus Vaccine Development
Although West Nile virus (WNV) has been a prominent mosquito-transmitted infection in North America for twenty years, no human vaccine has been licensed. With a cumulative number of 24,714 neurological disease cases and 2314 deaths in the U.S. since 1999, plus a large outbreak in Europe in 2018 involving over 2000 human cases in 15 countries, a vaccine is essential to prevent continued morbidity, mortality, and economic burden. Currently, four veterinary vaccines are licensed, and six vaccines have progressed into clinical trials in humans. All four veterinary vaccines require multiple primary doses and annual boosters, but for a human vaccine to be protective and cost effective in the most vulnerable older age population, it is ideal that the vaccine be strongly immunogenic with only a single dose and without subsequent annual boosters. Of six human vaccine candidates, the two live, attenuated vaccines were the only ones that elicited strong immunity after a single dose. As none of these candidates have yet progressed beyond phase II clinical trials, development of new candidate vaccines and improvement of vaccination strategies remains an important area of research.
Journal Article