Mullan Alzheimer
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Nilvadipine is an Alzheimer’s drug that was recently developed by a research team led by Dr. Michael Mullan- the Director of Roskamp Institute.
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Guido Bertucci is the Executive Director of Governance Solutions International. Previously, he was the Director of the United Nations Programme on Public Administration, Finance and Development from 1993 to 2008. In this role, he launched the flagship World Public Sector Report and advocated for sound public policy, good governance, and efficient public administration worldwide.
Guido Bertucci
Currently serving as the Executive Director of “Governance Solutions International”, Guido Bertucci was in charge of the United Nations Programme on Public Administration, Finance and Development from 1993 until 2008. The United Nations Programme on Public Administration, Finance and Development focuses on the worldwide promotion of sound public policy, good governance and efficient and competent public administration.
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2. The operational role focuses on ensuring compliance with laws and filling openings through interviews and training.
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Dr. Eman Mortada's lecture discusses the history and phases of clinical trials. It begins with early examples of clinical trials like James Lind's experiments in 1747 and Edward Jenner's smallpox vaccination trials in the late 18th century. It then covers the four phases of modern clinical drug trials - phase I tests safety on healthy volunteers, phase II assesses efficacy on patients, phase III tests larger groups for efficacy and safety, and phase IV monitors effectiveness and side effects post-approval. The lecture also discusses types of clinical trials based on the unit of study and ethics considerations around clinical equipoise.
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Guiddo bertuci
Guido Bertucci is the Executive Director of Governance Solutions International. Previously, he was the Director of the United Nations Programme on Public Administration, Finance and Development from 1993 to 2008. In this role, he launched the flagship World Public Sector Report and advocated for sound public policy, good governance, and efficient public administration worldwide.
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Currently serving as the Executive Director of “Governance Solutions International”, Guido Bertucci was in charge of the United Nations Programme on Public Administration, Finance and Development from 1993 until 2008. The United Nations Programme on Public Administration, Finance and Development focuses on the worldwide promotion of sound public policy, good governance and efficient and competent public administration.
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1. The administrative role involves processing records, maintaining employee files, and submitting required reports.
2. The operational role focuses on ensuring compliance with laws and filling openings through interviews and training.
3. The strategic role emphasizes that people are valuable organizational resources and requires HR to focus on the long-term implications of HR practices and how they can provide a competitive advantage. Framing HR strategically justifies investing in people development.
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Dr. Eman Mortada's lecture discusses the history and phases of clinical trials. It begins with early examples of clinical trials like James Lind's experiments in 1747 and Edward Jenner's smallpox vaccination trials in the late 18th century. It then covers the four phases of modern clinical drug trials - phase I tests safety on healthy volunteers, phase II assesses efficacy on patients, phase III tests larger groups for efficacy and safety, and phase IV monitors effectiveness and side effects post-approval. The lecture also discusses types of clinical trials based on the unit of study and ethics considerations around clinical equipoise.
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The document outlines the stages of drug development from discovery through clinical trials and FDA approval. It discusses 4 main stages: 1) Discovery and preclinical research involving animal testing, 2) Clinical research consisting of 4 phases starting with small safety trials and increasing in size, 3) Filing an Investigational New Drug Application with the FDA to begin clinical trials, and 4) Final FDA review and potential approval or denial to market the drug. Only about 25-30% of drugs make it through the entire process, which can take 10-15 years and costs over $2 billion on average.
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Drug repurposing involves finding new uses for existing drugs to treat rare diseases. It has advantages over developing new drugs including being faster, cheaper, and leveraging existing safety and use data. Opportunities for repurposing can be identified through screening compound libraries, literature mining, and 'omics approaches. A example is using the epilepsy drug sodium valproate identified from screening as a potential treatment for Wolfram syndrome, which is now in clinical trials.
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The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It begins with an overview of the iterative process involving biology, animal testing, and medicinal chemistry. It then outlines the typical 5 steps in drug development according to the FDA: discovery/screening, pre-clinical research including in vitro and in vivo testing, clinical research consisting of Phase I-III trials, FDA review, and post-marketing monitoring. The document provides details on each stage of development including pre-clinical and clinical research requirements and processes.
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The document summarizes the stages of drug development from discovery through clinical trials and regulatory approval. It describes 10 main stages: 1) discovery and development, 2) preclinical research, 3) investigational new drug application, 4) clinical research including 3 phases of trials, 5) FDA review and approval, and 6) post-market safety monitoring. Preclinical research involves testing for safety and efficacy in animal and lab models. If promising, the drug enters clinical trials with humans starting with small Phase 1 safety studies, then Phase 2 dosing studies, and larger Phase 3 trials to confirm efficacy before the FDA reviews the final application for approval. The overall process takes around 10-15 years from discovery to patients.
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1 how you look in pictures tells a lot about you
1. Researchers found that judges were able to identify certain personality traits like extroversion and self-esteem based solely on controlled photos of people. However, they struggled to determine most other traits from these photos.
2. When the photos showed people smiling and standing naturally, judges were highly accurate in identifying nine out of ten personality traits. The study confirms the importance of first impressions based on appearance.
3. The researchers concluded that a person's appearance, especially whether they are smiling, communicates important information about their personality and traits to others.
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Mark Lemmon has been named the David A. Sackler Professor of Pharmacology at Yale University. He joined Yale's faculty in 2015 and was also named co-director of Yale's new Cancer Biology Institute, which will bring together 120 researchers examining cancer's molecular causes and potential new treatment targets. Lemmon's research focuses on receptor tyrosine kinase signaling pathways and their implications for cancer research.
principle of drug delivery
During drug discovery, researchers first identify a biological target involved in a disease and validate it. They then work to identify a lead compound that interacts with the target. The lead compound is optimized for efficacy and safety through testing in cell and animal models. If successful, the drug progresses through three phases of clinical trials on human subjects to test its safety, effectiveness, and side effects. If clinical trials are successful, the FDA reviews the drug application and may approve the drug, allowing it to enter the market with ongoing monitoring and research.
Drug development and discovery
The drug development process involves lengthy preclinical and clinical testing that can take over 12 years and cost $350 million. It begins with drug discovery followed by preclinical studies to test the drug's toxicity, pharmacokinetics, and efficacy in animals. If successful, an IND application is submitted to the FDA to begin human clinical trials. Clinical trials involve 4 phases to test the drug's safety and efficacy in humans. If phase 3 is successful, an NDA is submitted for FDA review and potential approval to market the new drug. Post-approval monitoring continues to ensure safety.
Emergency Interventions: The use of Oxygen
Kathryn Maitland describes the challenges faced with oxygen therapy as an emergency intervention in critical illness in African children.
Where Kathryn works, in East Africa, there is no access to intensive care. Caring for critically ill children is all done in the Emergency Department.
70% of the global burden of disease and deaths from pneumonia occurs in Southeast Asia and Sub-Saharan Africa. The WHO has published guidelines as to what classifies as pneumonia, severe pneumonia, and very severe pneumonia.
These classifications rely on clinical signs. However, Kathryn in her research has discovered that these classifications are rarely correlated with the actual underlying disease process.
Clinical signs are non-specific for the diagnosis of pneumonia. Oxygen is recommended for severe and very severe pneumonia.
This has led to calls to prioritise oxygen delivery in African hospitals. However, it has not led to change from a health department or funding viewpoint.
There are also oxygen delivery practicalities to consider. Often there is only one source of oxygen on a ward (if at all) with patients clustered around it.
The production of Oxygen may only happen in a few places.
Poor cylinder quality leads to leaks and therefore, low supply.
Concentrators are useful however they need regular servicing. They also rely on power, and in a region that experiences regular power outages, this can be problematic. When the power goes off, there is no oxygen available.
Kathryn asks – do all children actually need oxygen? There is still however a hidden burden of hypoxia.
Outside of Africa, Kathryn discusses the current state of equipoise on oxygen therapy.
Moreover, oxygen can be harmful if given inappropriately. This leads to concerns more broadly on the harms of oxygen therapy.
Kathryn concludes her talk by looking to the future. She discusses ongoing research and the implications for future practice in resource poor settings, and indeed the world.
8-Clinical Trial Studies
Clinical trials have evolved over centuries to become the gold standard for evaluating the efficacy and safety of medical treatments. Key developments include the introduction of control groups, randomization, blinding, placebos, and multicenter studies. Strict regulations now govern clinical trials to protect patient rights and safety. Trials generally involve selecting participants, measuring baseline data, randomizing subjects to treatment or control, administering blinded interventions, following subjects over time, and analyzing outcomes. Randomization and blinding help reduce bias. Reporting requires detailing the study design, population, interventions, objectives, outcomes, and results.
Phase 1 protocol
This phase 1 clinical trial protocol aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a new investigational bronchodilator drug, CF-021, in healthy adult volunteers. The study is a randomized, open-label, single ascending oral dose trial. It will enroll approximately 30 subjects in sequential dose cohorts to determine the maximum tolerated dose of CF-021. Safety monitoring, pharmacokinetic profiling and bronchodilator effects will be assessed after single oral doses. The study aims to establish a safe clinical dosing range to enable further evaluation of CF-021 in phase 2 trials for chronic obstructive pulmonary disease.
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This document provides information about COVID-19 vaccines, including their development process and types. It discusses the phases of clinical drug trials, with Phase 1 trials testing safety in a small group and Phase 3 trials comparing the new vaccine to the standard treatment in thousands of participants. The document also outlines regulatory bodies involved in vaccine development and describes two main types - mRNA vaccines, which introduce mRNA coding for the antigen, and viral vector vaccines, which use another virus to produce the spike protein antigen.
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Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
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The document discusses several recent studies on COVID-19. It describes how a study found no link between hypertension drugs and increased COVID-19 risk. It also discusses how a study in Wuhan detected genetic material of the coronavirus in airborne particles, reinforcing the importance of sterilization and ventilation. Additionally, it mentions a new drug candidate identified by Chinese scientists that inhibits a key part of the virus's machinery.
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I was invited to give a talk on Open Source Malaria (OSM) - an open source drug discovery initiative, and to share the open tools used by our project with the Astronomy Community.
About .Astronomy: http://dotastronomy.com/
The Internet provides an incredible platform for astronomers and astrophysical research. .Astronomy (pronounced ‘dot-astronomy’) aims to bring together an international community of astronomy researchers, developers, educators and communicators to showcase and build upon these many web-based projects, from outreach and education to research tools and data analysis.
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Drug repurposing involves finding new uses for existing drugs to treat rare diseases. It has advantages over developing new drugs including being faster, cheaper, and leveraging existing safety and use data. Opportunities for repurposing can be identified through screening compound libraries, literature mining, and 'omics approaches. A example is using the epilepsy drug sodium valproate identified from screening as a potential treatment for Wolfram syndrome, which is now in clinical trials.
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This document summarizes the student's three-part study in the Netherlands over the summer. Part I involved studying nonalcoholic steatohepatitis (NASH), including lipid accumulation and inflammation in the liver. Part II focused on using ultra-weak photonic emission (UPS) to investigate natural products and biomarkers for diseases like Parkinson's and Alzheimer's from blood and phenotype samples. Part III had the student collecting blood samples from Alzheimer's patients to analyze potential DNA biomarkers for the disease.Cure for Type 1 Diabetes Is One Step Closer
Several diabetes research foundations and Eli Lilly have signed agreements to collaborate on research to find a cure for Type 1 Diabetes. The goal is to understand how cells can be reprogrammed to produce insulin by regenerating pancreatic beta cells. This early-stage research may lead to new treatments for Type 1 Diabetes and is an example of regenerative medicine. JDRF is a leading non-profit focused on curing Type 1 Diabetes and funds research collaborations like this one between Lilly and other organizations to accelerate progress towards a cure.
Drug Development and Clinical Studies
The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It begins with an overview of the iterative process involving biology, animal testing, and medicinal chemistry. It then outlines the typical 5 steps in drug development according to the FDA: discovery/screening, pre-clinical research including in vitro and in vivo testing, clinical research consisting of Phase I-III trials, FDA review, and post-marketing monitoring. The document provides details on each stage of development including pre-clinical and clinical research requirements and processes.
Drug development process
The document summarizes the stages of drug development from discovery through clinical trials and regulatory approval. It describes 10 main stages: 1) discovery and development, 2) preclinical research, 3) investigational new drug application, 4) clinical research including 3 phases of trials, 5) FDA review and approval, and 6) post-market safety monitoring. Preclinical research involves testing for safety and efficacy in animal and lab models. If promising, the drug enters clinical trials with humans starting with small Phase 1 safety studies, then Phase 2 dosing studies, and larger Phase 3 trials to confirm efficacy before the FDA reviews the final application for approval. The overall process takes around 10-15 years from discovery to patients.
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The World Health Organization is launching a global megatrial called SOLIDARITY to test the effectiveness of four promising treatments for COVID-19. The treatments being tested are remdesivir, an experimental antiviral; chloroquine and hydroxychloroquine, existing malaria drugs; lopinavir and ritonavir, a combination used to treat HIV; and that combination plus interferon-beta. The trial aims to quickly determine which, if any, treatments work through a simple international study involving thousands of patients. Results are urgently needed to help overcome the pandemic.
1 how you look in pictures tells a lot about you
1. Researchers found that judges were able to identify certain personality traits like extroversion and self-esteem based solely on controlled photos of people. However, they struggled to determine most other traits from these photos.
2. When the photos showed people smiling and standing naturally, judges were highly accurate in identifying nine out of ten personality traits. The study confirms the importance of first impressions based on appearance.
3. The researchers concluded that a person's appearance, especially whether they are smiling, communicates important information about their personality and traits to others.
ASBMB-February-2016
Mark Lemmon has been named the David A. Sackler Professor of Pharmacology at Yale University. He joined Yale's faculty in 2015 and was also named co-director of Yale's new Cancer Biology Institute, which will bring together 120 researchers examining cancer's molecular causes and potential new treatment targets. Lemmon's research focuses on receptor tyrosine kinase signaling pathways and their implications for cancer research.
principle of drug delivery
During drug discovery, researchers first identify a biological target involved in a disease and validate it. They then work to identify a lead compound that interacts with the target. The lead compound is optimized for efficacy and safety through testing in cell and animal models. If successful, the drug progresses through three phases of clinical trials on human subjects to test its safety, effectiveness, and side effects. If clinical trials are successful, the FDA reviews the drug application and may approve the drug, allowing it to enter the market with ongoing monitoring and research.
Drug development and discovery
The drug development process involves lengthy preclinical and clinical testing that can take over 12 years and cost $350 million. It begins with drug discovery followed by preclinical studies to test the drug's toxicity, pharmacokinetics, and efficacy in animals. If successful, an IND application is submitted to the FDA to begin human clinical trials. Clinical trials involve 4 phases to test the drug's safety and efficacy in humans. If phase 3 is successful, an NDA is submitted for FDA review and potential approval to market the new drug. Post-approval monitoring continues to ensure safety.
Emergency Interventions: The use of Oxygen
Kathryn Maitland describes the challenges faced with oxygen therapy as an emergency intervention in critical illness in African children.
Where Kathryn works, in East Africa, there is no access to intensive care. Caring for critically ill children is all done in the Emergency Department.
70% of the global burden of disease and deaths from pneumonia occurs in Southeast Asia and Sub-Saharan Africa. The WHO has published guidelines as to what classifies as pneumonia, severe pneumonia, and very severe pneumonia.
These classifications rely on clinical signs. However, Kathryn in her research has discovered that these classifications are rarely correlated with the actual underlying disease process.
Clinical signs are non-specific for the diagnosis of pneumonia. Oxygen is recommended for severe and very severe pneumonia.
This has led to calls to prioritise oxygen delivery in African hospitals. However, it has not led to change from a health department or funding viewpoint.
There are also oxygen delivery practicalities to consider. Often there is only one source of oxygen on a ward (if at all) with patients clustered around it.
The production of Oxygen may only happen in a few places.
Poor cylinder quality leads to leaks and therefore, low supply.
Concentrators are useful however they need regular servicing. They also rely on power, and in a region that experiences regular power outages, this can be problematic. When the power goes off, there is no oxygen available.
Kathryn asks – do all children actually need oxygen? There is still however a hidden burden of hypoxia.
Outside of Africa, Kathryn discusses the current state of equipoise on oxygen therapy.
Moreover, oxygen can be harmful if given inappropriately. This leads to concerns more broadly on the harms of oxygen therapy.
Kathryn concludes her talk by looking to the future. She discusses ongoing research and the implications for future practice in resource poor settings, and indeed the world.
8-Clinical Trial Studies
Clinical trials have evolved over centuries to become the gold standard for evaluating the efficacy and safety of medical treatments. Key developments include the introduction of control groups, randomization, blinding, placebos, and multicenter studies. Strict regulations now govern clinical trials to protect patient rights and safety. Trials generally involve selecting participants, measuring baseline data, randomizing subjects to treatment or control, administering blinded interventions, following subjects over time, and analyzing outcomes. Randomization and blinding help reduce bias. Reporting requires detailing the study design, population, interventions, objectives, outcomes, and results.
Phase 1 protocol
This phase 1 clinical trial protocol aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a new investigational bronchodilator drug, CF-021, in healthy adult volunteers. The study is a randomized, open-label, single ascending oral dose trial. It will enroll approximately 30 subjects in sequential dose cohorts to determine the maximum tolerated dose of CF-021. Safety monitoring, pharmacokinetic profiling and bronchodilator effects will be assessed after single oral doses. The study aims to establish a safe clinical dosing range to enable further evaluation of CF-021 in phase 2 trials for chronic obstructive pulmonary disease.
Star v2 0 e 4-30-10
This is a slide show, with notes, about the CMTA's STAR initiative, created by Dana Schwertfeger and myself. It is to enhance your understanding of the CMTA's research STAR project and bring you up to date on recent news. Enjoy!
Covid- 19 Vaccines
This document provides information about COVID-19 vaccines, including their development process and types. It discusses the phases of clinical drug trials, with Phase 1 trials testing safety in a small group and Phase 3 trials comparing the new vaccine to the standard treatment in thousands of participants. The document also outlines regulatory bodies involved in vaccine development and describes two main types - mRNA vaccines, which introduce mRNA coding for the antigen, and viral vector vaccines, which use another virus to produce the spike protein antigen.
Overview of Pharmacovigilance by Yash Dhikale | Zumbar Pote | Santosh Ghuge |...
Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
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Mullan Alzheimer
- 1. Mullan’s Alzheimer Research Team Developed Nilvadipine
- 2. Nilvadipine is an Alzheimer’s drug that was recently developed by a research team led by Dr. Michael Mullan- the Director of Roskamp Institute. Dr. Mullan and his fellow scientists have been trying to find the causes and cures for Alzheimer’s disease for over 20 years, moving from the United Kingdom to Florida and then to Sarasota to establish Roskamp Institute.
- 3. Nilvadipine has been selected for funding and large-scale European clinical trial, and Roskamp Institute will provide research support for the trial, such as evaluating genetic and other signs for the disease in participants. As announced by an international research consortium led by the Trinity College Dublin, Ireland, more than 500 people will take part in this multi-center phase III clinical trial especially designed to examine the effectiveness of drug.
- 4. Dr. Mullan’s Alzheimer research team consisted of lead scientist Daniel Paris, Ph. D. and Associate Director Fiona Crawford, Ph.D. This study will be funded by European Commission Seventh Framework Program and over twenty European clinical sites will participate in the trial.
- 5. As per Dr. Mullan, the study findings of these trials will help speed up the process for getting approval from the United States Food and Drug Administration (FDA). The drug has already been approved for use in the mild cases of hypertension or high blood pressure.
- 6. About Dr Michael Mullan Dr Michael Mullan has been working in the biomedical field for many years. He is a leading researcher with special expertise in assessment of the earliest cognitive symptoms and stages of Alzheimer’s disease.
- 7. Mullan’s Alzheimer research works are also published in various articles which help students and researchers for making new discoveries. Find out more about his Alzheimer research works, by browsing through www.rfdn.org or www.mullanalzheimer.com or www.mullanalzheimer.info.
- 8. Thanks