The New Zealand Anti-Vivisection Society (NZAVS) is a campaign group that opposes all animal testing. It achieves this through research, education, public awareness and political lobbying.
This document summarizes the work of Thomas Hartung and the CAAT (Center for Alternatives to Animal Testing) team over several decades to advance alternative methods to animal testing. It discusses their efforts to promote better science through alternative methods that are less reliant on animals, more relevant to humans, and faster and cheaper. It outlines CAAT's work developing new tools and methods as well as establishing think tanks, policy programs, and collaborations across Europe and the US to validate and implement alternative approaches.
The Center for Alternatives to Animal Testing (CAAT-Europe), housed at the University of Konstanz (Germany), brings together industry representatives, regulators, and academics to address the needs for human-relevant alternative methods to animal testing.
This document discusses alternatives to animal testing in three areas:
1. It describes the establishment of the Danish 3R-Center, a collaboration between the government, pharmaceutical industry, and animal welfare organizations aimed at promoting alternatives to animal testing.
2. It discusses the researcher Lisbeth Knudsen's work studying biomarkers to assess human exposure to chemicals as an alternative to animal and cell studies. Her research involves biomonitoring chemicals in humans through samples like blood, urine, and hair.
3. It outlines a EU project that used biomonitoring to study levels of 64 chemicals and their effects in 145 mother-child pairs in Denmark, measuring samples like urine, hair, and blood to assess chemical exposure.
The Africa Network for Animal Welfare (ANAW) was established in 2006 as a Pan African Non-Governmental Organisation.
It is registered under the provisions of the Non-Governmental Organisations Co-ordination Act, of the Laws of Kenya and its mission is to work together with Communities, Governments and other animal welfare stakeholders in promoting humane treatment of all Animals across Africa.
Thit Aarøe Mørck is a PhD student at the University of Copenhagen who studied human exposure to environmental chemicals. Her project involved collecting urine, hair, and blood samples from 145 mother-child pairs in Denmark to measure 64 biomarkers of exposure and early effects from chemicals like phthalates, PBDEs, PCBs, and metals. She plans to use the funding from the LUSH prize to analyze the data for associations between exposure measurements and early effects, and to identify patterns of chemical exposure.
The document discusses using neurite growth as an endpoint for assessing developmental neurotoxicity in vitro. It describes how neurite outgrowth is critical for proper brain wiring and is sensitive to toxicants. A human neuronal cell line called LUHMES can be used to measure neurite growth in automated high-content assays allowing efficient screening of chemicals. Several known neurotoxicants were found to reduce neurite growth in the LUHMES cells. The document proposes applying omics technologies like transcriptomics and metabolomics to the LUHMES model to identify pathways of toxicity and classify chemicals. A proof-of-principle study on MPP+ is described where multi-omics analysis revealed perturbed genes, metabolites and pathways in MPP+-treated
The Karolinska Institute (KI) is the largest centre for medical education and research in Sweden and the home of the Nobel Prize in Physiology or Medicine.
KI consists of 22 departments and 600 research groups dedicated to improving human health through research and higher education.
The role of the Kohonen/Grafström team has been to guide the application, analysis, interpretation and storage of so called “omics” technology-derived data within the service-oriented subproject “ToxBank”.
This document summarizes Horst Spielmann's presentation on implementing alternative methods. It discusses his role as State Animal Welfare Officer in Berlin where he provides expert advice on animal welfare issues. The presentation covered topics like ending cosmetics testing in Europe, developing adverse outcome pathways, and alternative methods like embryonic stem cells, organ-on-chip technology, and using human cells for disease and infection models. It also discussed increasing collaboration between international regulatory agencies and researchers to advance alternative methods through information sharing and establishing performance standards.
This document summarizes the work of Thomas Hartung and the CAAT (Center for Alternatives to Animal Testing) team over several decades to advance alternative methods to animal testing. It discusses their efforts to promote better science through alternative methods that are less reliant on animals, more relevant to humans, and faster and cheaper. It outlines CAAT's work developing new tools and methods as well as establishing think tanks, policy programs, and collaborations across Europe and the US to validate and implement alternative approaches.
The Center for Alternatives to Animal Testing (CAAT-Europe), housed at the University of Konstanz (Germany), brings together industry representatives, regulators, and academics to address the needs for human-relevant alternative methods to animal testing.
This document discusses alternatives to animal testing in three areas:
1. It describes the establishment of the Danish 3R-Center, a collaboration between the government, pharmaceutical industry, and animal welfare organizations aimed at promoting alternatives to animal testing.
2. It discusses the researcher Lisbeth Knudsen's work studying biomarkers to assess human exposure to chemicals as an alternative to animal and cell studies. Her research involves biomonitoring chemicals in humans through samples like blood, urine, and hair.
3. It outlines a EU project that used biomonitoring to study levels of 64 chemicals and their effects in 145 mother-child pairs in Denmark, measuring samples like urine, hair, and blood to assess chemical exposure.
The Africa Network for Animal Welfare (ANAW) was established in 2006 as a Pan African Non-Governmental Organisation.
It is registered under the provisions of the Non-Governmental Organisations Co-ordination Act, of the Laws of Kenya and its mission is to work together with Communities, Governments and other animal welfare stakeholders in promoting humane treatment of all Animals across Africa.
Thit Aarøe Mørck is a PhD student at the University of Copenhagen who studied human exposure to environmental chemicals. Her project involved collecting urine, hair, and blood samples from 145 mother-child pairs in Denmark to measure 64 biomarkers of exposure and early effects from chemicals like phthalates, PBDEs, PCBs, and metals. She plans to use the funding from the LUSH prize to analyze the data for associations between exposure measurements and early effects, and to identify patterns of chemical exposure.
The document discusses using neurite growth as an endpoint for assessing developmental neurotoxicity in vitro. It describes how neurite outgrowth is critical for proper brain wiring and is sensitive to toxicants. A human neuronal cell line called LUHMES can be used to measure neurite growth in automated high-content assays allowing efficient screening of chemicals. Several known neurotoxicants were found to reduce neurite growth in the LUHMES cells. The document proposes applying omics technologies like transcriptomics and metabolomics to the LUHMES model to identify pathways of toxicity and classify chemicals. A proof-of-principle study on MPP+ is described where multi-omics analysis revealed perturbed genes, metabolites and pathways in MPP+-treated
The Karolinska Institute (KI) is the largest centre for medical education and research in Sweden and the home of the Nobel Prize in Physiology or Medicine.
KI consists of 22 departments and 600 research groups dedicated to improving human health through research and higher education.
The role of the Kohonen/Grafström team has been to guide the application, analysis, interpretation and storage of so called “omics” technology-derived data within the service-oriented subproject “ToxBank”.
This document summarizes Horst Spielmann's presentation on implementing alternative methods. It discusses his role as State Animal Welfare Officer in Berlin where he provides expert advice on animal welfare issues. The presentation covered topics like ending cosmetics testing in Europe, developing adverse outcome pathways, and alternative methods like embryonic stem cells, organ-on-chip technology, and using human cells for disease and infection models. It also discussed increasing collaboration between international regulatory agencies and researchers to advance alternative methods through information sharing and establishing performance standards.
Troy Seidle is Director of Research & Toxicology for Humane Society International.
He manages the AXLR8 (pronounced “accelerate”) project, which aims to hasten the transition toward animal-free approaches to safety testing through internationally coordinated research and development.
This document summarizes Korea's growing interest in non-animal testing and efforts to end cosmetics testing on animals. It outlines Korea's regulations around animal testing from the 1990s to present and the government bodies involved. It also discusses Korea's increasing development of alternative test methods, including the establishment of KoCVAM in 2009 and CAMSEC in 2013. Finally, it describes efforts to revise laws to ban cosmetics animal testing and increase public awareness campaigns around companies' non-animal testing policies.
The Laboratory of Mathematical Chemistry (LMC) was established 30 years ago, in Burgas, Bulgaria, within the University ‘Prof. Dr. Asen Zlatarov’.
Nowadays, the Laboratory is one of the most influential molecular modelling labs worldwide.
Future Health Challenges: Developing Global Norms for Data and Results Sharin...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Work Package (WP) 12 – PEARL Barriers In search for an inventory and assessme...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
International challenges regarding the future sharing of sequence data. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
National Program on Prevention and Control of Infection and Antimicrobial Resistance – PPCIRA / PORTUGAL
Before 2013, Portugal had a high prevalence of hospital-acquired infections and high antimicrobial consumption compared to other EU countries. Carbapenem and quinolone use was among the highest. Through the PPCIRA program established in 2013, Portugal implemented initiatives like establishing epidemiological surveillance, antimicrobial stewardship programs, and a standard precautions campaign. These efforts led to reductions in antimicrobial consumption in both hospital and community settings, lower rates of methicillin-resistant Staphylococcus aureus, and decreases in some hospital-acquired infections like surgical site infections and infections in neonatal and adult ICUs.
Phytothreats WP1: Phytophthora diversity, distribution and management in UK n...Forest Research
WP1 aims to analyze the distribution and diversity of Phytophthora in UK nursery systems using metabarcoding to improve disease management. The objectives are to (1) use metabarcoding to analyze Phytophthora community structure in nurseries and associated ecosystems, and (2) model variation in Phytophthora communities among nurseries based on trade, management, and ecology. Methods include surveying nurseries, sampling them broadly and at fine scale, detecting and metabarcoding Phytophthora, and using computational analysis and modeling. This will provide insights into Phytophthora problems to advise best practices.
NADIR: the European “Network for Animal Diseases Infectiology Research” faci...Global Risk Forum GRFDavos
The document describes the NADIR project, a European network of animal disease research facilities. The objectives of NADIR are to 1) promote collaboration between animal research centers, 2) facilitate research to improve existing facilities, and 3) provide transnational access to external researchers. NADIR received 7.5 million euros in funding to coordinate its 17 partner institutions over 5 years. Activities included networking exchanges, joint research projects, and providing access to facilities for 45 external research projects covering various animal species and disease topics. The project aims to optimize European research on infectious livestock diseases and zoonoses.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
This document summarizes the work of Task 4.1 of the AniBioThreat project, which aimed to implement the Laboratory Biorisk Management CWA 15793 standard across partner institutions. It describes conducting a gap analysis to evaluate current compliance, developing recommendations and tools like training to support full implementation. While institutions already had biorisk programs, the analysis identified gaps to address. Exercises also helped evaluate preparedness and response plans. Full implementation of the CWA 15793 across network laboratories would help strengthen the European response to animal bioterrorism threats by promoting standardized biorisk management.
Strengthening data sharing for public health: ethical, legal and political is...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Strengthening data sharing for public health: ethical, legal and political issues. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
This document summarizes a study methodology that aims to determine pesticide exposure levels in residents living near agricultural land through the analysis of urine samples. The study recruited farmers and residents across 3 regions in the UK. Urine samples were collected from residents on a weekly basis, as well as 1-2 days after pesticide spray events to compare metabolite levels within and outside the spraying season. The study also aims to compare measured urinary levels to exposure estimates from regulatory risk assessments. Over 3,000 urine samples were collected in total. Statistical analysis of the results will help evaluate current risk assessment methods and estimate long-term pesticide exposure levels for residents.
The document summarizes a close out meeting for the BioSHaRE project. It includes an agenda with summaries of the various work packages, including coordination and management (WP1), data repository and epidemiological harmonization (WP2), and biospecimen harmonization (WP5). The core projects of statistical methods for longitudinal harmonization and data harmonization and federated analysis are also summarized. Participating biobanks and their countries are listed for the Healthy Obese Project and Environmental Core Project. UMCG involvement and realization of budget and publications are provided.
The document summarizes the work of the European Mobile Laboratory (EMLab) project from 2012-2015. Key points include:
- EMLab units were deployed to test over 10,000 samples for Ebola virus in Guinea and Sierra Leone.
- Operational research was conducted on Ebola virus immunology, pathogenesis, and genome sequencing.
- The mobile labs provided diagnostic and clinical support to Ebola treatment centers and trials.
- Long-term partnerships for disease surveillance and research capacity building were established across Africa.
On Dec. 20th 2016, the HRB published their "Health Research In Action" booklet that detailed a small selection of recent success stories from their research funding portfolio which "...really show health research in action".
The corneal-limbal stem cell research work carried out at NICB (by Finbarr O’Sullivan and Prof. Martin Clynes) and which led to the first corneal-limbal stem cell transplant in Ireland (carried out by Mr. William Power of the RVEEH) on June 7th, 2016 got an honorable mention (Page 17)
Applications of Whole Genome Sequencing (WGS) technology on food safety manag...ExternalEvents
http://tiny.cc/faowgsworkshop
Applications of genome sequencing technology on food safety management-United States of America. Presentation from the FAO expert workshop on practical applications of Whole Genome Sequencing (WGS) for food safety management - 7-8 December 2015, Rome, Italy.
Current regulation on biosafety and bisecurity in tunisia Pasteur_Tunis
Présentation de Hazar Belli Abdelkefi, du ministère de l'environnement, durant le symposium organisé conjointement entre le Robert Koch Institute et l'Institut Pasteur de Tunis "Current challenges of Biological Risks and Heealth Security" (22-23 septembre 2016)
Presentation of the EFSA's second scientific conference, held on 14-16 October 2015 in Milan, Italy.
DRIVERS FOR EMERGING ISSUES IN ANIMAL AND PLANT HEALTH
Alternative and integrated testing strategiesEFSA EU
The document discusses alternative and integrated testing strategies for toxicity assessment. It describes the development of such strategies over time, from early proposals in 2002 for integrated testing schemes, to the current use of adverse outcome pathways (AOPs) and predictive toxicology approaches using cellular assays. Validation and regulatory acceptance of alternative methods has allowed reduction in animal testing, especially for skin and eye irritation/corrosion hazards.
Plain packaging- Why it matters, and making it happenUCT ICO
1) The document discusses Australia's efforts to reduce smoking through implementing plain packaging of tobacco products from 2008 to the present.
2) Key measures included advocacy, health warnings, advertising bans, taxation increases, and smoke-free policies building on decades of evidence.
3) Plain packaging legislation in 2012, despite intense industry opposition, led to a decline in smoking rates with the government report attributing 25% of the reduction to plain packaging.
GlobeImmune is a biotechnology company founded in 1995 by three University of Colorado faculty to commercialize their inventions from the lab. The company developed recombinant yeast-based immunotherapies and vaccines, with an initial focus on HIV. After hiring a professional CEO in 2002 and obtaining venture capital financing, the company shifted its focus to cancer immunotherapy. GlobeImmune has raised over $180 million in financing to date and completed multiple clinical trials. Its lead products are whole, heat-killed recombinant yeast immunotherapeutics for various cancer indications.
Troy Seidle is Director of Research & Toxicology for Humane Society International.
He manages the AXLR8 (pronounced “accelerate”) project, which aims to hasten the transition toward animal-free approaches to safety testing through internationally coordinated research and development.
This document summarizes Korea's growing interest in non-animal testing and efforts to end cosmetics testing on animals. It outlines Korea's regulations around animal testing from the 1990s to present and the government bodies involved. It also discusses Korea's increasing development of alternative test methods, including the establishment of KoCVAM in 2009 and CAMSEC in 2013. Finally, it describes efforts to revise laws to ban cosmetics animal testing and increase public awareness campaigns around companies' non-animal testing policies.
The Laboratory of Mathematical Chemistry (LMC) was established 30 years ago, in Burgas, Bulgaria, within the University ‘Prof. Dr. Asen Zlatarov’.
Nowadays, the Laboratory is one of the most influential molecular modelling labs worldwide.
Future Health Challenges: Developing Global Norms for Data and Results Sharin...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
Work Package (WP) 12 – PEARL Barriers In search for an inventory and assessme...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
International challenges regarding the future sharing of sequence data. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
National Program on Prevention and Control of Infection and Antimicrobial Resistance – PPCIRA / PORTUGAL
Before 2013, Portugal had a high prevalence of hospital-acquired infections and high antimicrobial consumption compared to other EU countries. Carbapenem and quinolone use was among the highest. Through the PPCIRA program established in 2013, Portugal implemented initiatives like establishing epidemiological surveillance, antimicrobial stewardship programs, and a standard precautions campaign. These efforts led to reductions in antimicrobial consumption in both hospital and community settings, lower rates of methicillin-resistant Staphylococcus aureus, and decreases in some hospital-acquired infections like surgical site infections and infections in neonatal and adult ICUs.
Phytothreats WP1: Phytophthora diversity, distribution and management in UK n...Forest Research
WP1 aims to analyze the distribution and diversity of Phytophthora in UK nursery systems using metabarcoding to improve disease management. The objectives are to (1) use metabarcoding to analyze Phytophthora community structure in nurseries and associated ecosystems, and (2) model variation in Phytophthora communities among nurseries based on trade, management, and ecology. Methods include surveying nurseries, sampling them broadly and at fine scale, detecting and metabarcoding Phytophthora, and using computational analysis and modeling. This will provide insights into Phytophthora problems to advise best practices.
NADIR: the European “Network for Animal Diseases Infectiology Research” faci...Global Risk Forum GRFDavos
The document describes the NADIR project, a European network of animal disease research facilities. The objectives of NADIR are to 1) promote collaboration between animal research centers, 2) facilitate research to improve existing facilities, and 3) provide transnational access to external researchers. NADIR received 7.5 million euros in funding to coordinate its 17 partner institutions over 5 years. Activities included networking exchanges, joint research projects, and providing access to facilities for 45 external research projects covering various animal species and disease topics. The project aims to optimize European research on infectious livestock diseases and zoonoses.
In vitro data and in silico models for predictive toxicologyEFSA EU
The SEURAT project is a 7-year, 50 million Euro collaboration between the European Commission and Cosmetics Europe to develop non-animal approaches for repeated dose systemic toxicity testing. It involves over 70 research partners across 16 countries. The project aims to adopt a toxicological mode-of-action framework and use this knowledge to develop complementary in vitro and computational models that can predict toxicity endpoints needed for safety assessment. Key activities include developing genetically engineered cell lines, multi-scale models of organ toxicity, and an adverse outcome pathway knowledgebase to structure toxicity information. The models and data generated will be stored in online repositories to support regulatory safety evaluation.
This document summarizes the work of Task 4.1 of the AniBioThreat project, which aimed to implement the Laboratory Biorisk Management CWA 15793 standard across partner institutions. It describes conducting a gap analysis to evaluate current compliance, developing recommendations and tools like training to support full implementation. While institutions already had biorisk programs, the analysis identified gaps to address. Exercises also helped evaluate preparedness and response plans. Full implementation of the CWA 15793 across network laboratories would help strengthen the European response to animal bioterrorism threats by promoting standardized biorisk management.
Strengthening data sharing for public health: ethical, legal and political is...ExternalEvents
http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/
Strengthening data sharing for public health: ethical, legal and political issues. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.
This document summarizes a study methodology that aims to determine pesticide exposure levels in residents living near agricultural land through the analysis of urine samples. The study recruited farmers and residents across 3 regions in the UK. Urine samples were collected from residents on a weekly basis, as well as 1-2 days after pesticide spray events to compare metabolite levels within and outside the spraying season. The study also aims to compare measured urinary levels to exposure estimates from regulatory risk assessments. Over 3,000 urine samples were collected in total. Statistical analysis of the results will help evaluate current risk assessment methods and estimate long-term pesticide exposure levels for residents.
The document summarizes a close out meeting for the BioSHaRE project. It includes an agenda with summaries of the various work packages, including coordination and management (WP1), data repository and epidemiological harmonization (WP2), and biospecimen harmonization (WP5). The core projects of statistical methods for longitudinal harmonization and data harmonization and federated analysis are also summarized. Participating biobanks and their countries are listed for the Healthy Obese Project and Environmental Core Project. UMCG involvement and realization of budget and publications are provided.
The document summarizes the work of the European Mobile Laboratory (EMLab) project from 2012-2015. Key points include:
- EMLab units were deployed to test over 10,000 samples for Ebola virus in Guinea and Sierra Leone.
- Operational research was conducted on Ebola virus immunology, pathogenesis, and genome sequencing.
- The mobile labs provided diagnostic and clinical support to Ebola treatment centers and trials.
- Long-term partnerships for disease surveillance and research capacity building were established across Africa.
On Dec. 20th 2016, the HRB published their "Health Research In Action" booklet that detailed a small selection of recent success stories from their research funding portfolio which "...really show health research in action".
The corneal-limbal stem cell research work carried out at NICB (by Finbarr O’Sullivan and Prof. Martin Clynes) and which led to the first corneal-limbal stem cell transplant in Ireland (carried out by Mr. William Power of the RVEEH) on June 7th, 2016 got an honorable mention (Page 17)
Applications of Whole Genome Sequencing (WGS) technology on food safety manag...ExternalEvents
http://tiny.cc/faowgsworkshop
Applications of genome sequencing technology on food safety management-United States of America. Presentation from the FAO expert workshop on practical applications of Whole Genome Sequencing (WGS) for food safety management - 7-8 December 2015, Rome, Italy.
Current regulation on biosafety and bisecurity in tunisia Pasteur_Tunis
Présentation de Hazar Belli Abdelkefi, du ministère de l'environnement, durant le symposium organisé conjointement entre le Robert Koch Institute et l'Institut Pasteur de Tunis "Current challenges of Biological Risks and Heealth Security" (22-23 septembre 2016)
Presentation of the EFSA's second scientific conference, held on 14-16 October 2015 in Milan, Italy.
DRIVERS FOR EMERGING ISSUES IN ANIMAL AND PLANT HEALTH
Alternative and integrated testing strategiesEFSA EU
The document discusses alternative and integrated testing strategies for toxicity assessment. It describes the development of such strategies over time, from early proposals in 2002 for integrated testing schemes, to the current use of adverse outcome pathways (AOPs) and predictive toxicology approaches using cellular assays. Validation and regulatory acceptance of alternative methods has allowed reduction in animal testing, especially for skin and eye irritation/corrosion hazards.
Plain packaging- Why it matters, and making it happenUCT ICO
1) The document discusses Australia's efforts to reduce smoking through implementing plain packaging of tobacco products from 2008 to the present.
2) Key measures included advocacy, health warnings, advertising bans, taxation increases, and smoke-free policies building on decades of evidence.
3) Plain packaging legislation in 2012, despite intense industry opposition, led to a decline in smoking rates with the government report attributing 25% of the reduction to plain packaging.
GlobeImmune is a biotechnology company founded in 1995 by three University of Colorado faculty to commercialize their inventions from the lab. The company developed recombinant yeast-based immunotherapies and vaccines, with an initial focus on HIV. After hiring a professional CEO in 2002 and obtaining venture capital financing, the company shifted its focus to cancer immunotherapy. GlobeImmune has raised over $180 million in financing to date and completed multiple clinical trials. Its lead products are whole, heat-killed recombinant yeast immunotherapeutics for various cancer indications.
This document discusses the use of laboratory animals in biomedical research and testing. It notes that annually between 100-115 million animals are used for medical and veterinary investigations and training, drug testing, cosmetic testing, and educational programs. It provides background on the history of animal experimentation and the development of the modern animal rights movement since the 1970s. It also outlines some of the key laws and policies governing animal research in the United States.
The PCPNDT Act prohibits sex selection techniques before and after conception to protect the girl child. It restricts clinics, medical personnel, and machines that can be used for prenatal sex determination. Only registered genetic clinics using qualified practitioners can perform prenatal diagnostic techniques. The act aims to maintain sex ratio and promote the birth of the girl child by banning practices that determine the sex of the fetus. Violations of the act are considered cognizable offenses with non-bailable imprisonment. The Central Supervisory Board provides oversight and the code of conduct outlines proper procedures for clinics.
The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles, or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context, “research” includes both medical and behavioral studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.
Right-to-Try is legislation that allows terminally ill patients to access investigational treatments which have passed Phase I testing through the Food and Drug Administration (FDA), but are not available yet to the public because they have not yet been approved by the FDA. Int his webinar, Professor Bateman-House, Assistant Professor in the Division of Medical Ethics at New York University Langone Medical Center, discusses the legislation, breaks down the language, and explains how Right-to-Try can affect cancer patients.
Cannabis Program Webinar Series - Paul Armentano of Deputy Director of NORMLEilera Deathfire
This document summarizes the existing legal landscape around cannabis regulation in the United States, including at the state and federal level. It also discusses the positions of major presidential candidates on cannabis issues and analyzes the potential impact of the 2016 election outcomes. Additionally, it reviews the history of efforts to reschedule cannabis under federal law and considers what rescheduling may achieve.
Chesapeake IRB: The evolution of ethics in clinical researchChesapeake IRB
This presentation is about the evolution of the Declaration of Helsinki, and it is appropriate to note that, indeed, all of ethics is an evolution – a continual discovery.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.
The document discusses the scientific and legal/procedural aspects of clinical trials. It defines clinical trials and describes the different phases of clinical trials (Phase I-IV). Phase I trials test safety in healthy volunteers, Phase II evaluates dosing and side effects in patients, Phase III tests efficacy in large patient groups, and Phase IV involves post-marketing surveillance. Clinical trials must follow scientific protocols and obtain regulatory and ethics approvals to protect participants. Placebos and blind/double-blind designs help ensure trial validity. The roles of investigators, sponsors, ethics committees and regulatory authorities are outlined to legally and ethically conduct clinical research.
Clinical trials involve testing investigational drugs or medical devices on humans to determine safety and efficacy. They are conducted in phases, starting with small healthy volunteer groups (Phase I) to test safety, then expanding to larger patient groups (Phase II) to determine dosing and side effects, and finally large multi-site trials (Phase III) to assess efficacy. Clinical trials require approval from ethics committees and regulatory authorities, and all participants must provide informed consent. Placebos are often used to blind both participants and researchers to reduce bias. Randomization assigns participants randomly to treatment or control groups. Together, these scientific and legal/procedural aspects aim to ethically and rigorously evaluate new treatments.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
Mitochondrial Replacement Case Study Part 2InvolveReema
This document summarizes a public dialogue case study conducted by Sciencewise to explore emerging in vitro fertilization techniques for preventing mitochondrial disease transmission. Over 3,000 public and stakeholder participants were involved through surveys, workshops, focus groups and open consultations. The dialogue found broad support for allowing the techniques with certain conditions. It directly influenced policy by providing recommendations to the HFEA and UK government. The multi-method engagement process was seen as exemplary and helped promote new legislation currently being debated in Parliament.
Preliminary findings _OECD field visits to ten regions in the TSI EU mining r...OECDregions
Preliminary findings from OECD field visits for the project: Enhancing EU Mining Regional Ecosystems to Support the Green Transition and Secure Mineral Raw Materials Supply.
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHOChristina Parmionova
The 2024 World Health Statistics edition reviews more than 50 health-related indicators from the Sustainable Development Goals and WHO’s Thirteenth General Programme of Work. It also highlights the findings from the Global health estimates 2021, notably the impact of the COVID-19 pandemic on life expectancy and healthy life expectancy.
Combined Illegal, Unregulated and Unreported (IUU) Vessel List.Christina Parmionova
The best available, up-to-date information on all fishing and related vessels that appear on the illegal, unregulated, and unreported (IUU) fishing vessel lists published by Regional Fisheries Management Organisations (RFMOs) and related organisations. The aim of the site is to improve the effectiveness of the original IUU lists as a tool for a wide variety of stakeholders to better understand and combat illegal fishing and broader fisheries crime.
To date, the following regional organisations maintain or share lists of vessels that have been found to carry out or support IUU fishing within their own or adjacent convention areas and/or species of competence:
Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR)
Commission for the Conservation of Southern Bluefin Tuna (CCSBT)
General Fisheries Commission for the Mediterranean (GFCM)
Inter-American Tropical Tuna Commission (IATTC)
International Commission for the Conservation of Atlantic Tunas (ICCAT)
Indian Ocean Tuna Commission (IOTC)
Northwest Atlantic Fisheries Organisation (NAFO)
North East Atlantic Fisheries Commission (NEAFC)
North Pacific Fisheries Commission (NPFC)
South East Atlantic Fisheries Organisation (SEAFO)
South Pacific Regional Fisheries Management Organisation (SPRFMO)
Southern Indian Ocean Fisheries Agreement (SIOFA)
Western and Central Pacific Fisheries Commission (WCPFC)
The Combined IUU Fishing Vessel List merges all these sources into one list that provides a single reference point to identify whether a vessel is currently IUU listed. Vessels that have been IUU listed in the past and subsequently delisted (for example because of a change in ownership, or because the vessel is no longer in service) are also retained on the site, so that the site contains a full historic record of IUU listed fishing vessels.
Unlike the IUU lists published on individual RFMO websites, which may update vessel details infrequently or not at all, the Combined IUU Fishing Vessel List is kept up to date with the best available information regarding changes to vessel identity, flag state, ownership, location, and operations.
Donate to charity during this holiday seasonSERUDS INDIA
For people who have money and are philanthropic, there are infinite opportunities to gift a needy person or child a Merry Christmas. Even if you are living on a shoestring budget, you will be surprised at how much you can do.
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RFP for Reno's Community Assistance CenterThis Is Reno
Property appraisals completed in May for downtown Reno’s Community Assistance and Triage Centers (CAC) reveal that repairing the buildings to bring them back into service would cost an estimated $10.1 million—nearly four times the amount previously reported by city staff.
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC CharlotteCori Faklaris
Working with data is a challenge for many organizations. Nonprofits in particular may need to collect and analyze sensitive, incomplete, and/or biased historical data about people. In this talk, Dr. Cori Faklaris of UNC Charlotte provides an overview of current AI capabilities and weaknesses to consider when integrating current AI technologies into the data workflow. The talk is organized around three takeaways: (1) For better or sometimes worse, AI provides you with “infinite interns.” (2) Give people permission & guardrails to learn what works with these “interns” and what doesn’t. (3) Create a roadmap for adding in more AI to assist nonprofit work, along with strategies for bias mitigation.
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC Charlotte
NZAVS - Lush Prize Conference 2014
1. PSYCHOACTIVE SUBSTANCES ACT
‘Legal Highs’ were being sold with no regulation.
Prohibition didn’t work; a new approach was needed.
Govt wanted manufacturers
to prove safety before sale
Asked one “expert” for
a model testing regime…
2. RESEARCH AND INFORMATION
Initial report from Cabinet papers: some testing on rodents…
NEEDED TO FIND OUT MORE
Ministry of Health documents released to NZAVS showed:
• Acute toxicity – small and large
animals; LD50
• Repeat dose toxicity – small and large
animals
• Toxicokinetic – small and large
animals
• Genotoxicity – a test battery with in
vitro and rodent testing
3. INITIAL LOBBYING AND SHARING
TO INFORM
• Other NGOs, activists
and grassroots groups
• Supportive MP
AND LOBBY
• Minister responsible
• Ministry Officials
HAD LIMITED IMPACT…
4. PUBLIC AWARENESS / MEDIA
• Inform people
• Create a national issue
• Political Pressure
FIRST VICTORY – LD50 test ruled out the next day
5. LOBBYING PARLIAMENT (PART ONE)
Wanted to go from no mention of the testing
regime in the Bill to a ban on all animal testing.
• Petition
• Submissions
• Mock hearing
• Direct lobbying
• By supportive MPs
Led to a ban proposed by Green Party to be voted on…
6. CHANGES TO LEGISLATION
A big ask but got 53:61:7 for the ban
No ban yet but significant gains
Animal testing now addressed:
• No animal testing when a “suitable alternative” exists
• Regular reviews of testing requirements
• NZ’s Animal Welfare Act restrictions apply to overseas
testing
7. NATIONWIDE PROTESTS
Immediate grass-roots response to
the govt rejecting the ban – 19 days
later in 13 centres (on a Tuesday!);
biggest animal related marches in NZ.
8. WORKING WITHIN THE REGIME
Alternatives mandatory so needed to show
in vitro tests were suitable for the purposes
• PSEAC member
• Expert advice
Problems:
• Pre-conceptions
• Pre-judged outcomes
• Unwillingness to find a
non-animal testing regime
9. LOBBYING PARLIAMENT (PART TWO)
Second chance: Animal Welfare Amendment Act 2014
Amendment for a ban proposed (SOP 341)
• Lobbying for the SOP
– Public submissions
– Substantial submissions
– Select Committee hearing
– Email campaign
Then waiting, waiting…
10. LOBBYING PARLIAMENT (PART THREE)
An Unexpected Opportunity
PSA to be quickly amended –
temporary product ban
announced (27 April 2014)
until testing regime in place
• Focus then on testing
→ 1 week intensive campaign
to include animal test ban
11. EIGHT DAYS LATER… SUCCESS!
5 May 2014:
Prime Minister announces an
animal testing ban on morning TV
Q: So you’ve ruled it out?
PM: Yep.
6 May 2014:
Passed into law