Dr. Angela Christiano presents an update on genetic and immunological studies in alopecia areata. Dr. Christiano’s research has helped clarify the immunologic mechanisms behind the disease. Now, early clinical trials with existing drugs that specifically target these mechanisms are showing promising hair regrowth. Dr. Christiano is the Richard and Mildred Rhodebeck Professor of Dermatology and Professor of Genetics & Development, and Vice Chair for Basic Science Research in Dermatology at Columbia University.
Dr. Maria Hordinsky provides an informative, straightforward presentation of everything you need to know about alopecia areata, including risks and benefits of current and evolving off-label treatment options. Dr. Hordinsky is Professor and Chair of the Department of Dermatology at the University of Minnesota and is recognized for her clinical expertise in alopecia areata.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
The document discusses various topics related to drug development including:
- Selection of therapeutic targets based on unmet medical needs and commercial potential.
- Approaches to drug discovery including traditional empirical and modern molecular methods.
- Stages of clinical development including pre-clinical and several phases of human trials.
- Major challenges in drug development like high costs, complex regulation, and individualizing treatment.
From Bits to Bedside: Translating Big Data into Precision Medicine and Digita...Dexter Hadley
Lecture Objectives:
1) To use examples from my research to define and introduce the ideals of precision medicine and digital health. 2) To introduce how large scale population-wide analysis of data can be used to facilitate these two ideals. 3) To introduce how freely available open data can be used to facilitate these two ideals. 4) To show how mobile technology can be used to facilitate these two ideals.
Hypersensitivity reactions to nonsteroidal anti-inflammatory drugsNatacha Santos
Reis-Ferreira A, Santos N, Botelho C, Castro E, Cernadas JR. Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs: single versus multiple reactors. Allergy 2011;66(Suppl.94):51-52.
Dr. Angela Christiano presents an update on genetic and immunological studies in alopecia areata. Dr. Christiano’s research has helped clarify the immunologic mechanisms behind the disease. Now, early clinical trials with existing drugs that specifically target these mechanisms are showing promising hair regrowth. Dr. Christiano is the Richard and Mildred Rhodebeck Professor of Dermatology and Professor of Genetics & Development, and Vice Chair for Basic Science Research in Dermatology at Columbia University.
Dr. Maria Hordinsky provides an informative, straightforward presentation of everything you need to know about alopecia areata, including risks and benefits of current and evolving off-label treatment options. Dr. Hordinsky is Professor and Chair of the Department of Dermatology at the University of Minnesota and is recognized for her clinical expertise in alopecia areata.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
The document discusses various topics related to drug development including:
- Selection of therapeutic targets based on unmet medical needs and commercial potential.
- Approaches to drug discovery including traditional empirical and modern molecular methods.
- Stages of clinical development including pre-clinical and several phases of human trials.
- Major challenges in drug development like high costs, complex regulation, and individualizing treatment.
From Bits to Bedside: Translating Big Data into Precision Medicine and Digita...Dexter Hadley
Lecture Objectives:
1) To use examples from my research to define and introduce the ideals of precision medicine and digital health. 2) To introduce how large scale population-wide analysis of data can be used to facilitate these two ideals. 3) To introduce how freely available open data can be used to facilitate these two ideals. 4) To show how mobile technology can be used to facilitate these two ideals.
Hypersensitivity reactions to nonsteroidal anti-inflammatory drugsNatacha Santos
Reis-Ferreira A, Santos N, Botelho C, Castro E, Cernadas JR. Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs: single versus multiple reactors. Allergy 2011;66(Suppl.94):51-52.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Presenter: Marina Sirota, UCSF
Recent advances in genome typing and sequencing technologies have enabled quick generation of a vast amount of molecular data at very low cost. The mining and computational analysis of this type of data can help shape new diagnostic and therapeutic strategies in biomedicine. In this talk, I will discuss how such technological advances in combination with data science and integrative analysis can be applied to drug discovery in the context of drug target identification, computational drug repurposing, and population stratification approaches.
This study analyzed 2,000 antibiotic prescription records from Bangladesh to evaluate rational antibiotic prescribing practices. It found that the majority (63%) of patients visited unlicensed village healthcare workers due to their widespread availability. The most commonly prescribed antibiotic classes were cephalosporins (36%), macrolides (25.5%), and quinolones (21%). However, 81% of prescriptions lacked clinical tests to justify antibiotic use. Only 66.5% of patients completed their full antibiotic course. The study concludes that irrational antibiotic prescribing in Bangladesh contributes to growing antibiotic resistance and calls for national treatment guidelines and public education programs.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Two phase III trials, OPERA I and OPERA II, compared ocrelizumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis. The studies found that ocrelizumab significantly reduced annualized relapse rates, disability progression, and MRI activity compared to interferon beta-1a over 96 weeks with an acceptable safety profile. Ocrelizumab was generally well-tolerated with a higher rate of infusion-related reactions but lower rates of serious adverse events and infections compared to interferon beta-1a. The trials provide support for the role of B
The document discusses several new methods for diagnosing diseases through the immune system. One method called immunosignaturing uses blood samples to create "immune system snapshots" that can provide rapid presymptomatic diagnosis for a variety of infectious and chronic conditions. Another discusses using modified food allergens to help those with allergies and diagnosing allergies through low-cost ELISA testing of food samples. The techniques aim to provide low-cost, early diagnosis to improve treatment outcomes.
This document discusses the importance of safety evaluation in the process of drug development. It notes that safety assessment is a fundamental component of the drug development lifecycle from preclinical to all clinical trial stages. The goal of safety evaluation is to characterize a drug's safety profile and establish its risks and benefits in order to obtain regulatory approval. Key aspects of safety evaluation discussed include conducting clinical trials according to good clinical practice guidelines, determining dose-response relationships and adverse effects, monitoring drugs post-marketing through pharmacovigilance, and using novel technologies to better understand drug safety.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Assessment of the Prevalence of Proactive Penicillin Allergy Testing in Patie...BRNSS Publication Hub
This study aims to promote penicillin allergy testing in an outpatient to penicillin allergy and educate both patients and clinicians about testing. Patients with a history of penicillin allergy were screened for penicillin allergy testing. The results of allergy testing and patient satisfaction after testing were the main outcomes. A total of 82 patients were recruited, although only 37 actually underwent testing. None of these 37 had a positive skin test and none of 36 had a positive oral challenge (one refused it). Following testing, 2 patients (5%) had subjective reactions within 24 h. Three (10%) were subsequently treated with a beta-lactam, and all reported that testing provided important information to their medical history. In conclusion, the penicillin allergy testing safely evaluates patients labeled as penicillin allergic. It is well tolerated and embraced by the patients who undergo testing. In our study, none of the patients tested had an allergic reaction, but we identified multiple barriers to developing a protocol for testing patients from the primary care setting.
Two Phase III clinical trials found that the investigational drug ocrelizumab significantly reduced relapses and disability progression in people with relapsing multiple sclerosis compared to interferon beta-1a. Ocrelizumab also significantly reduced lesions in the brain. The safety profile was similar between the two drugs. Based on these results, Roche plans to submit the data to regulatory authorities in early 2016 for review. A Phase III study of ocrelizumab in primary progressive multiple sclerosis is ongoing.
Summary, outcomes and action plan presented by Dr. Angela Christiano at the end of the two-day Alopecia Areata Research Summit held November 14-15, 2016 in New York, NY.
Different pathways might drive the inflammation in alopecia areata and clinical trials utilizing narrow-targeted
therapeutics will be able to elucidate the role of each cytokine pathway in the disease phenotype.
ACT is conducting three clinical trials for dry age-related macular degeneration (AMD) and Stargardt's disease (SMD) using retinal pigment epithelium (RPE) cells derived from human embryonic stem cells. The trials have shown no adverse events and persistence of the transplanted cells, with functional vision improvements in most patients. ACT has additional clinical programs planned or underway for myopic macular degeneration and has a pipeline of other ophthalmology and regenerative medicine programs. It has strong intellectual property around RPE cell production and therapy. Upcoming milestones include further patient follow-up data and the potential start of Phase II trials. ACT is led by an experienced management team and board of directors.
- Genes are regions of DNA that code for proteins. Defective genes can cause disorders like cystic fibrosis and some cancers.
- The first authorized gene therapy study took place in 1989 and showed that human cells could be genetically modified without harm. Over 2200 gene therapy trials have since been approved or completed worldwide.
- Gene therapy involves delivering genes into target cells using viral or non-viral methods to treat diseases caused by abnormal genes or their expression. While promising, gene therapy also faces challenges like ineffective delivery methods and safety issues that researchers continue working to overcome.
Therapeutic Vaccines for Alzheimer’s — Are We Close Enough?Aranca
Could a vaccine for Alzheimer's be a reality any sooner? Find more on Alzheimer Therapy Market Challenges from Aranca's Technology Intelligence & IP Research Experts.
The document discusses recent advances in biosimilars and their future prospects. It begins with an abstract about a student's seminar presentation on personalized medicine and pharmacogenomics. The contents section lists topics like what biosimilars are, literature reviews on the use of targeted drugs and clinical trials, the need for and advantages of personalized medicine, and case studies on using genetic testing to target lung cancer treatments. It explores how pharmacogenomics can optimize drug responses based on a patient's genetics and discusses patents and the future of personalized healthcare.
The document summarizes several studies on new treatments for chronic urticaria and atopic dermatitis. It discusses how omalizumab is currently the primary treatment for antihistamine-resistant chronic urticaria. Newer monoclonal antibodies like ligelizumab and UB-221 show promise. Other potential treatments discussed include interleukin inhibitors and kinase inhibitors. The document also reviews trials of JAK inhibitors, TSLP antagonists, and other targeted treatments for atopic dermatitis subtypes.
Subcutaneous Immunotherapy: Is it Worth a Shot? Cost-effectiveness of Allerge...KSAAI
This document summarizes a presentation on the health economics of immunotherapy. It discusses trends showing increasing allergic rhinitis prevalence and expenditures dominated by prescription medications. While evidence demonstrates clinical and economic benefits of immunotherapy (SIT), access, coverage, and utilization have not increased. Two studies of Medicaid patients are summarized, finding poor adherence to SCIT and economic benefits of $800-5,400 annually from SIT versus symptomatic treatment. Overall it argues more work is needed to demonstrate SIT value to increase acceptance and adoption.
GRF One Health Summit 2012, Davos: Presentation by Prof. Cezmi A. Akdis - Director - Swiss Institute of Allergy and Asthma Research SIAF / President - European Academy of Allergy Clinical Immunology EAACI
This document summarizes research on the immunological and toxicological implications of COVID-19, focusing on the innate immune response and immune evasion. It discusses how the virus can trigger a "cytokine storm" through overactivation of the innate immune system and proinflammatory cytokines like IL-6. This storm can lead to widespread inflammation and multi-organ failure. The document also explores potential therapeutic strategies aimed at modulating the cytokine response, such as using corticosteroids or chloroquine to reduce IL-6 levels and calm the storm. Understanding the immune dysregulation and identifying key signaling pathways may help develop new clinical management approaches and prevent progression to severe illness.
This document summarizes research on vitiligo from April to June 2012. 41 relevant papers were identified from a PubMed search. Key findings include: 4 review papers summarized approaches in vitiligo research; a case report found skin cancer in a vitiligo lesion; quality of life studies found vitiligo affects pediatric quality of life less than other diseases. Research also explored vitiligo comorbidities, mechanisms of pathogenesis like oxidative stress and immune dysfunction, candidate biomarkers, genetic risk factors, and mechanisms of treatments like phototherapy and herbal extracts.
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Presenter: Marina Sirota, UCSF
Recent advances in genome typing and sequencing technologies have enabled quick generation of a vast amount of molecular data at very low cost. The mining and computational analysis of this type of data can help shape new diagnostic and therapeutic strategies in biomedicine. In this talk, I will discuss how such technological advances in combination with data science and integrative analysis can be applied to drug discovery in the context of drug target identification, computational drug repurposing, and population stratification approaches.
This study analyzed 2,000 antibiotic prescription records from Bangladesh to evaluate rational antibiotic prescribing practices. It found that the majority (63%) of patients visited unlicensed village healthcare workers due to their widespread availability. The most commonly prescribed antibiotic classes were cephalosporins (36%), macrolides (25.5%), and quinolones (21%). However, 81% of prescriptions lacked clinical tests to justify antibiotic use. Only 66.5% of patients completed their full antibiotic course. The study concludes that irrational antibiotic prescribing in Bangladesh contributes to growing antibiotic resistance and calls for national treatment guidelines and public education programs.
Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20-positive B cells. Two phase III trials, OPERA I and OPERA II, compared ocrelizumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis. The studies found that ocrelizumab significantly reduced annualized relapse rates, disability progression, and MRI activity compared to interferon beta-1a over 96 weeks with an acceptable safety profile. Ocrelizumab was generally well-tolerated with a higher rate of infusion-related reactions but lower rates of serious adverse events and infections compared to interferon beta-1a. The trials provide support for the role of B
The document discusses several new methods for diagnosing diseases through the immune system. One method called immunosignaturing uses blood samples to create "immune system snapshots" that can provide rapid presymptomatic diagnosis for a variety of infectious and chronic conditions. Another discusses using modified food allergens to help those with allergies and diagnosing allergies through low-cost ELISA testing of food samples. The techniques aim to provide low-cost, early diagnosis to improve treatment outcomes.
This document discusses the importance of safety evaluation in the process of drug development. It notes that safety assessment is a fundamental component of the drug development lifecycle from preclinical to all clinical trial stages. The goal of safety evaluation is to characterize a drug's safety profile and establish its risks and benefits in order to obtain regulatory approval. Key aspects of safety evaluation discussed include conducting clinical trials according to good clinical practice guidelines, determining dose-response relationships and adverse effects, monitoring drugs post-marketing through pharmacovigilance, and using novel technologies to better understand drug safety.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Assessment of the Prevalence of Proactive Penicillin Allergy Testing in Patie...BRNSS Publication Hub
This study aims to promote penicillin allergy testing in an outpatient to penicillin allergy and educate both patients and clinicians about testing. Patients with a history of penicillin allergy were screened for penicillin allergy testing. The results of allergy testing and patient satisfaction after testing were the main outcomes. A total of 82 patients were recruited, although only 37 actually underwent testing. None of these 37 had a positive skin test and none of 36 had a positive oral challenge (one refused it). Following testing, 2 patients (5%) had subjective reactions within 24 h. Three (10%) were subsequently treated with a beta-lactam, and all reported that testing provided important information to their medical history. In conclusion, the penicillin allergy testing safely evaluates patients labeled as penicillin allergic. It is well tolerated and embraced by the patients who undergo testing. In our study, none of the patients tested had an allergic reaction, but we identified multiple barriers to developing a protocol for testing patients from the primary care setting.
Two Phase III clinical trials found that the investigational drug ocrelizumab significantly reduced relapses and disability progression in people with relapsing multiple sclerosis compared to interferon beta-1a. Ocrelizumab also significantly reduced lesions in the brain. The safety profile was similar between the two drugs. Based on these results, Roche plans to submit the data to regulatory authorities in early 2016 for review. A Phase III study of ocrelizumab in primary progressive multiple sclerosis is ongoing.
Summary, outcomes and action plan presented by Dr. Angela Christiano at the end of the two-day Alopecia Areata Research Summit held November 14-15, 2016 in New York, NY.
Different pathways might drive the inflammation in alopecia areata and clinical trials utilizing narrow-targeted
therapeutics will be able to elucidate the role of each cytokine pathway in the disease phenotype.
ACT is conducting three clinical trials for dry age-related macular degeneration (AMD) and Stargardt's disease (SMD) using retinal pigment epithelium (RPE) cells derived from human embryonic stem cells. The trials have shown no adverse events and persistence of the transplanted cells, with functional vision improvements in most patients. ACT has additional clinical programs planned or underway for myopic macular degeneration and has a pipeline of other ophthalmology and regenerative medicine programs. It has strong intellectual property around RPE cell production and therapy. Upcoming milestones include further patient follow-up data and the potential start of Phase II trials. ACT is led by an experienced management team and board of directors.
- Genes are regions of DNA that code for proteins. Defective genes can cause disorders like cystic fibrosis and some cancers.
- The first authorized gene therapy study took place in 1989 and showed that human cells could be genetically modified without harm. Over 2200 gene therapy trials have since been approved or completed worldwide.
- Gene therapy involves delivering genes into target cells using viral or non-viral methods to treat diseases caused by abnormal genes or their expression. While promising, gene therapy also faces challenges like ineffective delivery methods and safety issues that researchers continue working to overcome.
Therapeutic Vaccines for Alzheimer’s — Are We Close Enough?Aranca
Could a vaccine for Alzheimer's be a reality any sooner? Find more on Alzheimer Therapy Market Challenges from Aranca's Technology Intelligence & IP Research Experts.
The document discusses recent advances in biosimilars and their future prospects. It begins with an abstract about a student's seminar presentation on personalized medicine and pharmacogenomics. The contents section lists topics like what biosimilars are, literature reviews on the use of targeted drugs and clinical trials, the need for and advantages of personalized medicine, and case studies on using genetic testing to target lung cancer treatments. It explores how pharmacogenomics can optimize drug responses based on a patient's genetics and discusses patents and the future of personalized healthcare.
The document summarizes several studies on new treatments for chronic urticaria and atopic dermatitis. It discusses how omalizumab is currently the primary treatment for antihistamine-resistant chronic urticaria. Newer monoclonal antibodies like ligelizumab and UB-221 show promise. Other potential treatments discussed include interleukin inhibitors and kinase inhibitors. The document also reviews trials of JAK inhibitors, TSLP antagonists, and other targeted treatments for atopic dermatitis subtypes.
Subcutaneous Immunotherapy: Is it Worth a Shot? Cost-effectiveness of Allerge...KSAAI
This document summarizes a presentation on the health economics of immunotherapy. It discusses trends showing increasing allergic rhinitis prevalence and expenditures dominated by prescription medications. While evidence demonstrates clinical and economic benefits of immunotherapy (SIT), access, coverage, and utilization have not increased. Two studies of Medicaid patients are summarized, finding poor adherence to SCIT and economic benefits of $800-5,400 annually from SIT versus symptomatic treatment. Overall it argues more work is needed to demonstrate SIT value to increase acceptance and adoption.
GRF One Health Summit 2012, Davos: Presentation by Prof. Cezmi A. Akdis - Director - Swiss Institute of Allergy and Asthma Research SIAF / President - European Academy of Allergy Clinical Immunology EAACI
This document summarizes research on the immunological and toxicological implications of COVID-19, focusing on the innate immune response and immune evasion. It discusses how the virus can trigger a "cytokine storm" through overactivation of the innate immune system and proinflammatory cytokines like IL-6. This storm can lead to widespread inflammation and multi-organ failure. The document also explores potential therapeutic strategies aimed at modulating the cytokine response, such as using corticosteroids or chloroquine to reduce IL-6 levels and calm the storm. Understanding the immune dysregulation and identifying key signaling pathways may help develop new clinical management approaches and prevent progression to severe illness.
This document summarizes research on vitiligo from April to June 2012. 41 relevant papers were identified from a PubMed search. Key findings include: 4 review papers summarized approaches in vitiligo research; a case report found skin cancer in a vitiligo lesion; quality of life studies found vitiligo affects pediatric quality of life less than other diseases. Research also explored vitiligo comorbidities, mechanisms of pathogenesis like oxidative stress and immune dysfunction, candidate biomarkers, genetic risk factors, and mechanisms of treatments like phototherapy and herbal extracts.
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Daniel Pallin, MD, MPH, and Douglas B. Johnson, MD, MSCI, prepared useful practice aids pertaining to immune-related adverse events for this CME/MOC/CE activity titled "Emergency Medicine and Immuno-Oncology Intersect: Recognizing and Managing Cancer Immunotherapy–Related Adverse Effects in the Emergency Department." For the full presentation, monograph, complete CME/MOC/CE information, and to apply for credit, please visit us at http://bit.ly/2PRv8Ul. CME/MOC/CE credit will be available until November 20, 2019.
CEL-SCI presented results from its Phase III IT-MATTERS study evaluating Multikine as a neoadjuvant therapy for advanced primary squamous cell carcinoma of the head and neck at ASCO 2022. The study showed a 14% absolute improvement in overall survival for lower-risk patients, representing the first positive randomized results in over 25 years for this population. Based on these results, CEL-SCI plans to file a BLA with the FDA for approval of Multikine for this indication.
The document summarizes recent news and events in oncology, including:
1) Daiichi Sankyo's acquisition of Plexxikon for its promising drug PLX4032 that targets the BRAF mutation in melanoma.
2) Positive results from Roche's phase 2 trial of its hedgehog pathway inhibitor vismodegib for advanced basal cell carcinoma.
3) How next-generation sequencing is enabling more personalized cancer treatment by matching drugs to patients based on their tumor's molecular profile.
1) The document discusses new complement inhibitor drugs and their implications for clinical practice and vaccination policy. It reviews complement activation pathways and deficiencies.
2) Patients receiving complement inhibitor treatments like eculizumab are at higher risk for invasive meningococcal disease due to vaccine failures or non-vaccine serogroup infections. One case study showed IMD from a vaccine-targeted but penicillin-resistant strain in a patient on eculizumab.
3) The document recommends vaccination against meningococcal serogroups A, C, W, and Y for those with complement deficiencies from inherited or acquired causes like treatment. It also suggests continuing antibiotic prophylaxis and planning for self-treatment rescue antibiotics
This document discusses therapeutic antibodies that are used to treat autoimmune and inflammatory diseases. More than 25 antibodies have been approved for human therapy and over 240 are currently in clinical development. The clinical success of antibodies has led to annual sales exceeding $27 billion in 2007. While early mouse antibodies had limitations, advances like chimerization and humanization overcame many of these issues. Current antibodies provide experience to guide future development in overcoming limitations and pursuing new opportunities.
This document discusses the presentation, testing, and management of pituitary adenomas and hypothalamic syndromes. It provides guidance on testing a 66-year-old man with a confirmed pituitary adenoma discovered on MRI after presenting with stroke symptoms. Testing strategies and their limitations are reviewed. Factors affecting decisions around intervention and appropriate follow-up strategies are also discussed, drawing on literature to support recommendations. Long-term management of patients with prolactinomas on dopamine agonists is explored, including monitoring, treatment withdrawal, and surveillance of side effects.
James T. Kenney, RPh, MBA, and Michael B. Atkins, MD, prepared useful Practice Aids pertaining to cancer immunotherapies for this CME/MOC/CE/CPE activity titled "Incorporating Cancer Immunotherapies Into the Oncology Treatment Arsenal in Managed Care Settings: Navigating the Complexities of Value Assessment & Cost Optimization in the Era of Immuno-Oncology." For the full presentation, monograph, complete CME/MOC/CE/CPE information, and to apply for credit, please visit us at http://bit.ly/2Er15gR. CME/MOC/CE/CPE credit will be available until December 23, 2019.
Similar to 2018 Alopecia Areata Research Summit: Summary of First Day (20)
Dr. Angela Christiano presented an update on genetic and immunological studies in alopecia areata. Her research is focused on defining the genetic basis of alopecia areata to clarify how the disease develops—a key initial step toward creating novel therapies. Dr. Christiano is the Richard and Mildred Rhodebeck Professor of Dermatology, Genetics and Development, Vice Chair for Basic Science Research in Dermatology, and Director of the Center for Human Genetics at Columbia University.
Dr. Leslie Castelo-Soccio presented an overview of what parents need to know about alopecia areata in children and adolescents, including the differences between pediatric and adult patients, and the risks and benefits of current and evolving off-label treatment options. Dr. Castelo-Soccio is Assistant Professor of Pediatrics and Dermatology at the University of Pennsylvania School of Medicine and head of the Pediatric Hair Clinic and Director of Research in Pediatric Dermatology at the Children’s Hospital of Philadelphia. Her clinical and academic research focus is on pediatric hair disorders.
Dr. Maria Hordinsky presented an overview of key things adults need to know about alopecia areata, including the risks and benefits of current and evolving off-label treatment options. Dr. Hordinsky is Professor and Head of the Department of Dermatology at the University of Minnesota. She is recognized for her clinical expertise in alopecia areata and hair diseases.
Dr. Natasha Mesinkovska, NAAF’s Chief Scientific Officer, presented the latest progress of NAAF’s Treatment Development Program and how your involvement is critical to developing treatments for alopecia areata. In addition to overseeing NAAF’s research efforts, Dr. Mesinkovska is Director of Clinical Research in Dermatology at the University of California Irvine.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
AA is not necessarily a single disease entity, but rather a stereotypic hair follicle damage response pattern that can be triggered by various pathogenic mechanisms. In some patients with autoreactive T cells, AA represents an autoimmune disease (AAA), while in others it may occur in response to stress, infection, or dysbiosis without specific autoimmunity. The classic AA clinical presentation arises when hair follicle immune privilege collapses during the growth (anagen) phase, attracting inflammatory cells that secrete IFNγ and induce premature regression (catagen). While causal therapy targeting autoreactive T cells may be possible for AAA, symptomatic therapies aiming to protect immune privilege and repair follicle damage are generally beneficial across AA variants.
Presented at the joint International Eczema Council and National Alopecia Areata Foundation Symposium, "Atopic Dermatitis and Alopecia Areata: Comparison and Contrast”, held during the 2019 Annual American Academy of Dermatology meeting in Washington, DC to explore the similarities and differences between these two common but complex skin diseases and the implications from bench to bedside.
This document summarizes the key discussion points from a breakout group at a genetics, immunology, and therapeutic targets conference. The group discussed that while some new targets have been identified for alopecia areata, more exploration is needed into other potential targets, cell types, and signaling pathways. Questions remain about how to better stratify and select patients for current and new treatments. Additional resources are needed, including more funding for immunological and genetic studies, as well as research into the hair follicle biology and environmental factors. The North American Alopecia Areata Foundation can help by continuing to support exploratory research ideas, driving drug development, and convening research summits to define research priorities.
This document summarizes the discussions from a health economics and burden of disease breakout group on alopecia areata. The group discussed questions that still need answers around how alopecia areata impacts work, income, mental health, and patients' life courses. They also identified the need for partnerships to measure clinically relevant outcomes, better database access, and connections between stakeholders. The group suggested the North American Alopecia Areata Foundation could help fund research to address practice gaps, identify patients for research, and coordinate among pharmaceutical companies and payers.
This document summarizes a breakout group report on clinical outcome assessments for alopecia. It discusses several existing assessment measures, including the SALT Score, ALODEX Score, and Lesional Density Score. It notes that these measures have limitations and do not fully capture new areas of hair loss or incremental increases in density. The report identifies questions around defining meaningful response from both investigator and patient perspectives. It also outlines resources needed, such as tools to assess eyebrows/lashes, training for SALT scoring, and developing an overall assessment measure. The group recommends NAAF continue efforts to develop new outcome measures through stakeholder collaboration.
Discussion of the immune privilege collapse model of alopecia areata pathogenesis, available evidence to support this hypothetical scenario, and promising avenues for future investigation.
The FDA plans to prioritize improvements in the quality of demographic subgroup data collection, reporting and analysis, encourages greater participation of diverse patients, and supports the transparency of subgroup data. To this end, ways to recruit, engage, educate, and study those of diverse backgrounds to alopecia areata trials will be discussed.
Measuring willingness to pay in patients with alopecia areata to gauge their willingness to pay out of pocket for a cure or control of their condition.
The document summarizes research on identifying genetic risk factors for alopecia areata. It describes analyzing genetic data from over 700 patients to identify 64 candidate genes and 701 variants potentially involved in monogenic causes. Pathway analysis found these genes enriched for extracellular matrix functions. Further studies will validate co-segregation of variants in families and test for genetic burden using exome data from 10,000 controls. The research aims to elucidate pathogenesis by studying extracellular matrix integrity and signaling in patient samples.
Novel induction of alopecia areata in C3H/HeJ mice shows a potential role of previously unrecognized endogenous SSEA-positive myeloid cells in driving inflammatory cascade and hair loss mechanisms.
Expert clinicians and patients with alopecia areata were interviewed to develop a new outcome measure called the Alopecia Areata Investigator Global Assessment (AA-IGATM) to evaluate treatment success in clinical trials. Through iterative development and feedback, the measure was refined to a 5-grade scale assessing scalp hair loss from 0-100%. Both clinicians and patients agreed that regrowing hair to the 21-49% range defined as the 'Limited' category would be considered a clinically meaningful treatment success for patients originally having ≥50% scalp hair loss. The finalized AA-IGATM incorporates input from experienced clinicians and patients to capture what constitutes meaningful improvement from both perspectives.
Report on the progress of NAAF’s Patient-Reported Outcome (PRO) Consortium to develop a single, consensus-defined PRO instrument that can be shared across industry partners and other ongoing initiatives to incorporate the voice of the patient in alopecia areata research.
Bruce Patsner is an Oncologist and has served as Director of North American Operations for Legacy Healthcare since 2017; he is based in Boston, Massachusetts.
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Histololgy of Female Reproductive System.pptxAyeshaZaid1
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Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
2018 Alopecia Areata Research Summit: Summary of First Day
1. Alopecia Areata Research Summit
“Forging the Future”
Summary of Day 1
DAVID A. NORRIS MD
PROFESSOR AND CHAIRMAN
DEPARTMENT OF DERMATOLOGY
UNIVERSITY OF COLORADO
2. Alopecia Areata Research Summit
“Forging the Future”
Summary of Day 1
-Ten Years of Research Summits have focused the basic,
clinical and translational research program
-Based on clinical trials present at the last research summit, JAK
inhibitors have been used widely in practices specializing in
AA, with impressive effect.
-Partnerships with multiple pharmaceutical companies promise
to lead to a new generation of systemic and topical treatments
for AA.
- The historic success of NAAF in partnership with NIAMS has
been expanded to include the partnership with the FDA , and
clinical research organizations such as the International
Dermatology Outcomes Measures and the Patient Reported
Outcomes Consortium
3. Elaine Fuchs
Coping with Stress: Stem Cells in Injury and Inflammation
Stem Cells in the Hair Follicle bulge are susceptible to damage
by multiple stresses: Mechanical, microbes and other
pathogens, toxins insects and oncogenic wounds.
The HF bulge and inner bulge are susceptible to damage that
may stimulate the DP to initiate cycling of the HF and
proliferation of the bulge stem cells.
Damage to inner bulge adherens junctions may lead to
inflammation involving Dendritic cells and Tregs, mediated
by chemokines and NFkB.
Similar inflammation and epithelial repair may also occur in
the IFE.
If this inflammation/immunity related to initiating AA?
4. Natasha Mesinkovska
Summary of Preceding Alopecia Areata
Research Summits
-Founding Principle: Organize the NAAF-funded research
program , coordinate with the NIH, get new hair
investigators working on AA.
-Results:
1. Research Summits communicate and facilitate research
program
2. NIAMS-funded Registry for 20 years helped to organize
basic and clinical research program
3. Results of genetics and immunologic research provided the
bases for translational research program
4. New investigators , a clinical and translational research
network were developed
5. Close organizational ties with NIH, FDA, Pharma
5. Angela Christiano
Genetics and Immunology of Alopecia Areata
Genetics and Immunology are central to understanding AA
3 new areas of research:
1. JAK critical in initiation of AA and in acquired immunity
involving NKG2D+T cells , IL15 and IFNg
2. JAki may induce” immune exhaustion” (what a tumor
does to T cell); k/o Jak 1/3 – increase markers of
exhaustion including IFNg
3. Gut microbiome
– Oral antibiotics block AA in C3H HeJ mice – affect gut
microbiome, not skin microbiome
-New AA pts show bidirectional dysbiosis
• Firmicutes up, Bacteroides down
•
6. Maria Hordinsky
Current Treatment of Alopecia Areata
A concise and knowledgeable review of treatment in
AA
JAKi becoming mainstream Rx
Warmed about the long-term toxicities of chronic
JAKi
7. Ralf Paus
AA: Autoimmune Disease or Hair Follicle
Response Pattern to Immunological Disease
Alternative Mechanisms of AA:
1. Not all AA is due to Autoimmunity, Cytotoxic T cells,
genetic control of acquired immunity
2. Do NKG2D+ NK cells respond to local triggers, causing
gamma interferon storm, induction of Catagen, loss of
Immune Privilege, and further cytotoxicity as a response
to NK initiated inflammation?
3. Or is there only a subset of AA patients in whom there is
autoimmunity?
8. Amos Gilhar
Pre-Clinical Research in Vivo: Pros and Cons
of the C3H/HEJ models versus the
Humanized Mouse Model
-C3H HeJ: TLR 7
-Humanized mouse: Human skin, Human NKG2D+
or C56+ cells
Use humanized mouse model to screen drugs
E.g. Apremilast protective but not therapeutic
9. Brittany Craiglow
Jak INH for the Treatment of AA in the
Pediatric Population
-5 Publications addressing use of JAKi in AA
Using Tofacitinib, Ruxolitinib, or Baracitinib
- Effective in at least 50% of cases
-Multiple ongoing trials now enrolling
subjects 12-17 years old
- Safety and efficacy needs to be determined
in future investigations
10. Brett King
Responses of Eyebrows and Eyelashes
to Tofacitinib I Patients with Severe AA
-Involvement of Brows and/or lashes in 76% of AA
Patients
-Reviewed records of AA patients treated with
tofacitinib from 2014-2018
-98 patients with total scalp loss- 86% had
improvement of eyebrows and lashes; complete
regrowth of all sites in 16%
- Regrowth of brows and lashes variable; can occur
in subjects with AA > 10 years.
11. Melissa Peck Piliang
Long-Term Treatment for Severe AA with
Oral Tofacitinib
-retrospective cohort of 20 patients
-20% with AA totalis
-60% received tofacitinib for at least 12 months
-94% some regrowth; 60 % achieved SALT 50; 24%
SALT 90
-35% had lab abnormalities; six clinical adverse
events
12. Hind Almohanna
Platelet-Rich Plasma in the Treatment of AA
-Platelet derived GF, bind to stem cells
-Increase BC-2; Bcat promote melanoblast, FGF7
-No consensus of standard approach
5 studies and some case reports
IL PRP plus IL TAC produced hair regrowth in AA;
not very useful in AA totalis or universalis
-More larger studies needed
13. Jessica Lin
In Vivo Imaging in Alopecia Areata
Patients Using Multiphoton Microscopy
MPM may be useful in non-invasive
following of AA
14. Emma Guttman-Yassky
Cytokine Targeted Treatments of Alopecia
Areata
-Th1 is believed to be central to AA; recent evidence
suggests Th2 and IL-23 might contribute
- AA and atopic dermatitis (AD) have phenotypic
similarities
- AD is highest comorbidity of AA
- Initiating a new treatment paradigm for AA, using
small molecules and targeted therapies for IL-4, IL-
13, IL31, IL23
- Dupilumab works, Ustekinumab does not
15. Mark Lebwohl
AA: Lessons from Other Inflammatory
Skin Diseases
-Psoriasis has been a great model to dissect the
immune pathways in inflammatory skin disease.
Many similarities (but also differences) between
immune response in Psoriasis and AA.
-Cyclosporine
-TNFa inh
-IL 12/23
IL-17
16. T Cell Cytotoxicity Versus Inhibiting
Cellular Pathways
Pathway blockade
JAKi – Inhibit IFN-g and IL15 pathways
Cellular Cytotoxicity
-Prednisone
-Methotrexate
-Ultraviolet radiation
17. Industry Panel
-Representatives from 7 pharmaceutical companies:
Aclaris, Bioniz, Concert, Lilly, Legacy, Leo,
Pfizer
- Committed to eliciting patient input in study
design and outcomes and to help access
- Discussion of problems in American Medicine;
important dialogue for the future
18. Pfizer: 2 PDE4 inh for skin dz
Jak1 Phase 3
Jak3 Phase 2 “Breakthrough”
Tyk2/Jak1 : PS and AA
Lilly: Severe AA
Legacy: Botanicals Phase 2
Concert: TP543
Ruxolitinib Phase IIa
Aclaris: “Soft JAKs”
Topical JAKs Phase IIb
Looking at sequence of Rx Bioniz: BN7-1 inh IL2, IL15, IL7
Industry Panel
19. Elise Olsen
Objective Outcome Measures: Collecting
Meaningful Data on AA
-Discussed problems with developing
accurate data on alopecia areata
-Salt I
-Salt II
-ALODEX
Canfield has made a tool for this
-Global Score
20. Justin Ko
The Importance of Eyebrows in the
Treatment of Alopecia Areata
Online survey of 1,741 AA patients
Satisfaction with scalp and eyebrow regrowth
is non-linear
More subjects satisfied having complete
eyebrows with no scalp hair (69%) than
partial scalp hair (51%)
21. Dory Kranz
AA: Patient Reported Outcome
Consortium
-Bringing patients into drug development process
-AA PRO Industry Partners
Leo Science and Technology Hub
Aclaris
Lilly
PATIENT DERIVED OUTCOME MEASURE
•PHASE I CONCEPT ELICITATION INTERVIEW
•PHASE II TEST IN COMMUNITY
•PHASE III VALIDATE IN CLINICAL TRIAL
22. Alice Gottlieb
Lessons From the International Dermatology
Outcomes Measure (IDEOM)
“Don’t Get Mad…Get Data”
• Develop validated and patient generated outcome measures;
these must be included in clinical trials
• Payers want outcomes that lead to lower cost; effects on
patient productivity; make outcomes predictable; biomarker
indicating response
• Needs to decrease data input on EMR
• Derm needs to demonstrate quality of the care we provide
• Social media score
• “If you are not at the table you are on the menu”.
23. Alopecia Areata Research Summit
“Forging the Future”
Summary of Day 1
-Ten Years of Research Summits have focused the basic,
clinical and translational research program
-Based on clinical trials present at the last research summit, JAK
inhibitors have been used widely in practices specializing in
AA, with impressive effect.
-Partnerships with multiple pharmaceutical companies promise
to lead to a new generation of systemic and topical treatments
for AA.
- The historic success of NAAF in partnership with NIAMS has
been expanded to include the partnership with the FDA , and
clinical research organizations such as the International
Dermatology Outcomes Measures and the Patient Reported
Outcomes Consortium