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BEGIN:VEVENT
DTSTART;VALUE=DATE:20230315
DTEND;VALUE=DATE:20230318
DTSTAMP:20221007T145216Z
CREATED:20221007T145024Z
LAST-MODIFIED:20221007T145216Z
UID:56539-1678838400-1679097599@globalbiodefense.com
SUMMARY:2023 ASPPH Annual Meeting
DESCRIPTION:The Association of Schools and Programs of Public Health will convene the 2023 ASPPH Annual Meeting from 15-17 March 2023 in Arlington\, Virginia. \nThis event convenes academic public health leaders\, faculty\, students\, and members of the public health community from around the world to engage in discussions and share new strategies and tools to strengthen education\, practice\, and research in public health. \nCall for Proposals\nASPPH seeks submissions for innovative ideas\, promising and emerging practices\, practical solutions\, and experiences in addressing challenges and opportunities in academic public health. The call for proposals is open until Monday\, November 14 at 11:59 PM PT. \nHighlighted submission topic areas include: \n\nEffective Communications Campaigns in Public Health Among Academia\nCreating and Sustaining Innovative Partnerships with Public Health Practice\nHow Schools and Programs of Public Health are Combatting Misinformation and Disinformation\nSupporting Continuing Professional Education and Professional Development for the Public Health Workforce\nMigration\, Climate Change\, and Global Health\nGlobal Student Experiences in a Hybrid World\nIncentivizing Research – Financial Models to Build and Grow Research with Non-Grant Funds\nInnovative Solutions with Remote Work: Faculty and Staff\nPromising Practices for Developing Competencies in Innovation\, Data Analytics\, and Forecasting\nSupporting Wellbeing and Physical and Mental Health in the Workforce\nPhD Funding Models – Cross-collaboration between Finance and Student Services\nLessons Learned from Integrating the Traditional Core MPH Requirements\nLeveraging Social Media in Public Health Communications\nDismantling Structural Racism in Academic Public Health: Case Examples\nRecruiting and Retaining a Diverse Public Health Workforce\n\nPlease visit the 2023 ASPPH Annual Conference website for more details.
URL:https://globalbiodefense.com/event/2023-aspph-annual-meeting/
LOCATION:Arlington\, VA\, Arlington\, VA
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230425
DTEND;VALUE=DATE:20230427
DTSTAMP:20230421T193514Z
CREATED:20230421T174138Z
LAST-MODIFIED:20230421T193514Z
UID:56972-1682380800-1682553599@globalbiodefense.com
SUMMARY:APEC Medical Product Supply Chain Resilience Dialogue
DESCRIPTION:FDA and United States Pharmacopeia (USP) are cosponsoring the Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue. This program aims to accelerate APEC and global efforts to strengthen the resilience of global medical product supply chains. This meeting will bring international medical product regulators\, multilateral organization representatives\, and industry and academic professionals together\, to discuss public health priorities\, the impact of the COVID-19 pandemic on supply chains\, and why the APEC Supply Chain Security ToolkitExternal Link Disclaimer continues to be a valuable tool to stakeholders. \nThis event is open to the public and free of cost. \nTopics will include: \n\nAPEC Roadmap to promote global medical product quality and supply chain security\nIdentifying vulnerabilities in the upstream supply chain\nMitigating and managing risks in raw material quality and supply chain security\nManufacturing solutions to strengthen global supply chain resilience\nExperiences strengthening quality assurance in the Asia Pacific\nSafeguarding patients from impurities in the drug supply chain\nThe supply chain imperative to fight AMR\nSecuring the downstream supply chain – good distribution practices & post-marketing surveillance\nSecuring the downstream supply chain – internet pharmacies\n\nPlease visit the APEC Medical Product Supply Chain Dialogue event website to register.
URL:https://globalbiodefense.com/event/apec-medical-product-supply-chain-resilience-dialogue/
LOCATION:USP Rockville\, 12601 Twinbrook Parkway\, Rockville\, MD\, 20852\, United States
CATEGORIES:Conference,Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2023/04/apec-medical-supply-chain-resilience.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230425T100000
DTEND;TZID=America/New_York:20230425T160000
DTSTAMP:20230421T193453Z
CREATED:20230421T165040Z
LAST-MODIFIED:20230421T193453Z
UID:56968-1682416800-1682438400@globalbiodefense.com
SUMMARY:FDA Public Meeting on Patient-Focused Drug Development for Long COVID
DESCRIPTION:The U.S. Food and Drug Administration (FDA) is hosting a virtual public meeting  25 April 2023 on Patient-Focused Drug Development for Long COVID. \nThis meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID\, including how Long COVID affects their daily life\, symptoms that matter most to patients\, their current approaches to treating Long COVID\, and what they consider when determining whether or not to participate in a clinical trial. \nThis virtual public meeting will be conducted with live translation in both English and Spanish. \nFDA encourages participants to submit written comments to the public docket by 26 June 2023: https://www.regulations.gov/document/FDA-2023-N-0363-0001 or visit www.regulations.gov and search for FDA-2023-N-0363-0001. \nPlease visit the U.S. FDA Meeting Information page for more information and Register here for the Meeting on Patient-Focused Drug Development for Long COVID. \n\nPublic Meeting on Patient-Focused Drug Development for Long COVIDDISCUSSION QUESTIONS\nTopic 1: Health effects and daily impacts that matter most to patients\n1. Which symptoms of Long COVID have the most significant impact on your life? (Examples may include pain\, difficulty thinking\, fatigue\, heart palpitations\, recurring blood clots\, depression\, or anxiety). \n2. Are there specific activities that are important to you that you cannot do at all or as fully as you would like because of your Long COVID? (Examples may include reading\, sleeping\, or exercising). \na. Is there a particular impact of Long COVID (such as need to work a reduced work schedule\, inability to complete daily tasks\, anxiety\, or depression) that worries you? If so\, what worries you most? \n3. How has your Long COVID changed from original diagnosis to now (have you noticed differences in severity\, change in symptoms)? \nTopic 2: Patients’ perspectives on current approaches to treatment\n1. What are you currently doing to treat or manage your Long COVID? (Examples may include prescription medicines\, over-the-counter products\, nutritional supplements\, and other therapies including non-drug therapies such as pulmonary rehabilitation\, aerobic exercises\, or diet modifications). \na. Has your treatment regimen changed over time\, and why? \nb. What factors went into your decision making when it came to selecting a course of management for your Long COVID? \n2. Would you say your Long COVID today is well-managed? Please explain. \n3. Assuming there is no complete cure for your Long COVID\, what specific things would you look for in an ideal treatment for your Long COVID? \na. Is there a particular symptom of Long COVID (such as fatigue\, brain fog\, or loss of sense of smell/taste) that you would prioritize for treatment? If so\, which symptom would you prioritize? \nb. What would you consider a successful treatment outcome? \nTopic 3: Patients’ perspectives on clinical trials for Long COVID\n1. If you considered participating or have participated in a clinical trial for Long COVID\, please tell us about your experience. \na. What factors (if any) of the clinical trial enabled you to participate? \nb. What factors (if any) of the clinical trial made it more difficult for you to participate? \n2. How would the following factors weigh into your decision if you were considering participating in a clinical trial? \na. The clinical trial intervention (Examples may include side effects of the medical intervention\, how the intervention is administered etc.). \nb. The logistics of the clinical trial (Examples may include the duration of the trial\, whether the trial is fully remote or requires clinic visits\, the number of in-person clinic visits required\, distance from home to clinic site\, or whether you might receive a placebo or not). \n3. What outcomes for Long COVID are most important to measure in a trial setting? (Examples may include reduction in pain\, brain fog\, fatigue\, or other aspects; or improvement in your ability to perform daily activities such as reading\, sleeping\, or exercising)
URL:https://globalbiodefense.com/event/fda-public-meeting-on-patient-focused-drug-development-for-long-covid/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230426T120500
DTEND;TZID=America/New_York:20230426T130000
DTSTAMP:20230421T193433Z
CREATED:20230421T180910Z
LAST-MODIFIED:20230421T193433Z
UID:56982-1682510700-1682514000@globalbiodefense.com
SUMMARY:Test Development and Validation During the COVID-19 Public Health Emergency
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will host a virtual town hall on 26 April 2023 for test developers to discuss the final guidances for the: \n\nTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency\nTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)\n\nThe guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations\, including the FDA’s recommendations for: \n\nDeveloping a transition implementation plan for in vitro diagnostics (IVDs) with an EUA\,\nSubmitting an IVD marketing submission\,\nTaking other actions with respect to these IVDs\, and\nAdditional information related to test developers and COVID-19 tests.\n\nNo registration is required. \nTime: 12:05 p.m. – 1 p.m. ET\nTo ensure you are connected\, please join 15 minutes before the start of the virtual town hall. \nPlease click the link below to join the webinar: \n\nhttps://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09External Link Disclaimer\nPasscode: ^8@HvK\n\nYou will have an opportunity to ask questions live during the virtual town hall and you may also submit questions in advance by emailing CDRHWebinars@fda.hhs.gov. \n\nPlease submit questions by Monday 12 p.m. ET before the Wednesday virtual town hall.\nIn the subject line of the email\, type Questions for the Virtual Town Hall Test Development and Validation During Public Health Emergencies.\n\n\nBackground:\nThe final transition guidances provide recommendations and clarity for medical device manufacturers that may or may not want to continue to distribute their devices after the relevant device EUA declaration related to COVID-19 under section 564 of the Federal Food\, Drug\, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances are no longer in effect. \nThe FDA encourages stakeholders to review the two final guidances\, attend the CDRH webinar on April 18\, and reach out to the FDA if they have questions or concerns. In particular\, for manufacturers planning to seek marketing authorization for their devices\, the FDA recommends beginning work on a marketing submission\, including a transition implementation plan\, as described in the guidances. \n\nTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)\nTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
URL:https://globalbiodefense.com/event/test-development-and-validation-during-the-covid-19-public-health-emergency/
LOCATION:https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09#success
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T090000
DTEND;TZID=America/New_York:20230427T130000
DTSTAMP:20230421T193407Z
CREATED:20230421T163659Z
LAST-MODIFIED:20230421T193407Z
UID:56966-1682586000-1682600400@globalbiodefense.com
SUMMARY:Recombinant Protein-Based COVID-19 Vaccines Workshop
DESCRIPTION:The Biomedical Advanced Research and Development Authority (BARDA) and FDA will host a virtual workshop titled Recombinant Protein-Based COVID-19 Vaccines April 27\, 2023\, from 9:00 am EDT to 1:00 pm EDT. \nThe goals of the workshop are to provide a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. \nHighlighted topics include: \n\nPandemic preparedness\, target product profile\, timelines\, and the need for continued investment\nEpidemiology\, disease burden\, continued need for COVID-19 vaccines\nFeatures of novel vaccines\, need for next generation vaccines\nOvercoming challenges to address strain updates and pandemic readiness\nRecombinant COVID-19 vaccine presentations from Novavax\, Sanofi\, SK Bioscience\, Dyadic\, Biological E\, and Intravacc\n\nPlease visit the FDA’s Recombinant Protein-Based COVID-19 Vaccines Workshop site to register to attend online.
URL:https://globalbiodefense.com/event/fda-recombinant-protein-based-covid-19-vaccines-workshop/
LOCATION:https://fda.zoomgov.com/meeting/register/vJIsd-GvrDgqGKQjMEzpDtzTCvGTY4xmZxk
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230427T120000
DTEND;TZID=America/New_York:20230427T163000
DTSTAMP:20230421T193340Z
CREATED:20230421T180232Z
LAST-MODIFIED:20230421T193340Z
UID:56980-1682596800-1682613000@globalbiodefense.com
SUMMARY:Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting on 27 April 2023 to solicit input on methods and approaches (e.g.\, use of real-world evidence (RWE)\, registries) for capturing post approval safety and efficacy data for cell and gene therapy products. \nThe rapid pace of innovation for cell and gene therapy products holds promise for transforming medicine and creating treatment options for patients living with difficult\, rare\, and often incurable diseases. With an increasing number of cell and gene therapy products in development and the potential for more of these treatments to become available to patients in the future\, it is important to understand the full spectrum of long-term effects and collect accurate\, timely\, and comprehensive data to ensure these products remain safe\, effective\, and of high quality. The FDA is seeking input on methods\, approaches\, logistics\, privacy concerns\, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies. \nThis is a virtual public listening meeting and will be held via Zoom. The meeting is free and open to the public; however\, registration is required. Early registration is recommended. \nRegistration will close on Wednesday\, April 26\, 2023 at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. \nPlease visit the FDA CBER OTP Public Listening Meeting — Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products site to register.
URL:https://globalbiodefense.com/event/capturing-post-approval-safety-and-efficacy-data-on-cell-and-gene-therapy-products/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230504T080000
DTEND;TZID=America/New_York:20230504T120000
DTSTAMP:20230501T154445Z
CREATED:20230501T153634Z
LAST-MODIFIED:20230501T154445Z
UID:57174-1683187200-1683201600@globalbiodefense.com
SUMMARY:Prioritizing Actions for Epidemic and Pandemic Preparedness
DESCRIPTION:The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 4 May and 18 May 2023. \nThis first session will be held from 8:00am-12:00pm ET on 4 May 2023 and the second session from 8:00 am-12:00pm ET on 18 May 2023. \nThe purpose of this symposium is to convene global health planning stakeholders\, including those in government and academia\, and across health- and non-health sectors\, to strengthen the capacity for evidence-based prioritization of global health capabilities. Objectives of this meeting are the following: \n\nReview assessment tools and how\, independently and together\, they relate to national action planning.\nGain insight into how countries and organizations currently select priorities in funding for epidemic prevention\, detection\, and response.\nAssess evidence for effective prioritization approaches to building disease surveillance and risk communication capabilities.\nIdentify governance structures that can support robust and reliable systems for global health investments.\n\nAGENDA\nPolitical and Economic Context for Sustainable International Epidemic Preparedness: International Governance and Finance (Session 1)\nThe goal of this forward-looking discussion is to highlight critical needs\, challenges\, and gaps in international and national governance and financing for developing and maintaining critical capabilities needed to prevent\, detect\, and respond to future epidemics. \nModerator: Dr. Mercy Mwangangi\, AMREF Kenya \nSpeakers:\nRaj Panjabi\, White House National Security Council\nSara Hersey\, World Health Organization Health Emergencies\nPriya Basu\, Pandemic Fund Secretariat\, World Bank Group\nSaul Walker\, Coalition for Epidemic Preparedness Innovations (CEPI) \nPolitical and Economic Context for Sustainable International Epidemic Preparedness: Regional and Country Efforts and Building Trust (Session 2)\nThe goal of this forward-looking discussion is to highlight critical needs\, challenges\, and gaps in science\, public health\, and health security for strengthening and maintaining critical capabilities needed to prevent\, detect\, and respond to future epidemics. \nModerator: Dr. Mercy Mwangangi\, AMREF Kenya \nSpeakers:\nAyoade Alakija\, African Vaccine Delivery Alliance\, Pre-recorded Video\nIrma Makaliano\, University of the Philippines\nDuncan Selbie\, International Association of National Public Health Institutes\nJailson Correia\, Instituto de Medicina Integral Professor Fernando Figueira\nWessam Mankoula\, Africa Centers for Disease Control \nAction Groups Preview \n\nSituational Awareness in the Context of Health and Diseases: Larry Brilliant\, Pandefense Advisory\nBuilding Trust\, Transparency\, and Risk Communication Capabilities: Richard Garfield\, US Centers for Disease Control and Prevention\nStrengthening Global Health Security through Strong Country-Level Infrastructure for Effective Governance\, Financing\, and Accountability: Julie Wahl\, Resolve to Save Lives\nGlobal Health Capacity and Functionality Assessment: Jessica Petrillo\, US Agency for International Development\nCountries’ and Organizations’ Experiences in Preparedness and Response Planning: Erwin Calgua\, Universidad de San Carlos de Guatemala\n\nPlease visit the National Academies’ Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium page for more information and to register for virtual attendance.
URL:https://globalbiodefense.com/event/prioritizing-actions-for-epidemic-and-pandemic-preparedness/
LOCATION:
CATEGORIES:Webinar-Webcast,Workshop
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230507
DTEND;VALUE=DATE:20230511
DTSTAMP:20230422T170026Z
CREATED:20230421T232418Z
LAST-MODIFIED:20230422T170026Z
UID:57016-1683417600-1683763199@globalbiodefense.com
SUMMARY:ABRF 2023 Annual Meeting | Association of Biomolecular Resource Facilities
DESCRIPTION:The Annual Meeting of the Association of Biomolecular Resource Facilities (ABRF 2023) will be held 7-10 May 2023 in Boston\, Massachusetts. \nHighlighted topics and presentations include: \n\nBusiness Skills for Core Facility Directors\, Managers and Administrators\nAdvancing Single Cell in Core Laboratories\nImplementing Spatial Transcriptomics in Core Facilities\nUsing R/R-Studio for reproducible data analysis and visualization\nSpatial Biology for Shared Research Laboratories\nGenome Editing Cores and Best Practices\nSample Preparation for Single Cell Genomics\nNon-Biological Core Facilities and Their Place within ABRF\nDigital PCR–applications\, challenges\, and use in a core setting\nNew Sequencers and Evolving Next Generation Sequencing Landscape\nWhat Do We Hand Over When an Analysis Is Finished? A spectrum-style discussion\nCell Sorting Technology Acquisition in the SRL: Evaluation\, Integration and Deployment to Users\nUpdates from the Microbiome and Metagenomics\, Genome Engineering\, and Genomics Research Groups\n\nPlease visit the ABRF 2023 Annual Meeting site for more information and to register.
URL:https://globalbiodefense.com/event/abrf-2023-annual-meeting-association-of-biomolecular-resource-facilities/
LOCATION:Sheraton Boston Hotel\, 39 Dalton Street\, Boston\, MA\, 02199\, United States
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230511T154500
DTEND;TZID=America/New_York:20230511T170000
DTSTAMP:20230421T195422Z
CREATED:20230421T195422Z
LAST-MODIFIED:20230421T195422Z
UID:56995-1683819900-1683824400@globalbiodefense.com
SUMMARY:Collaborating on Culture in the New Era of Smarter Food Safety
DESCRIPTION:Live from the Food Safety Summit: Measure What You Treasure\nMay 11\, 2023\, from 3:45 pm 5:00 pm ET \nThe upcoming webinar will focus on the importance of assessing food safety culture in an organization. \nGuest speakers include: \n\nDonald A. Prater\, DVM\, Acting Director\, Office of Food Policy and Response\, FDA\nConrad Choiniere\, PhD\, Director\, Office of Analytics and Outreach\, Center for Food Safety and Applied Nutrition\, FDA\nLone Jespersen\, Principal and Founder\, Cultivate SA\nVanessa Coffman\, Director\, Alliance to Stop Foodborne Illness\nBrian Perry\, Executive Food Safety & Quality Leader\, TreeHouse Foods\, Inc\nKarleigh Bacon\, Director of U.S. Supply Chain Food Safety\, Science & Regulatory\, McDonald’s Corporation\nPhilip Bronstein\, Ph.D.\, Assistant Administrator\, Office of Field Operations\, Food Safety and Inspection Service\, Food Safety and Inspection Service\, USDA\n\nThe U.S. Food and Drug Administration and Stop Foodborne Illness\, a non-profit public health organization\, are collaborating on a webinar series that explores food safety culture\, one of the core elements in FDA’s New Era of Smarter Food Safety initiative. \nThe New Era of Smarter Food Safety blueprint states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs\, attitudes\, and\, most importantly\, the behaviors of people and the actions of organizations. \nPlease visit the FDA’s Collaborating on Culture in the New Era of Smarter Food Safety event page for more information and to register to attend this virtual event.
URL:https://globalbiodefense.com/event/collaborating-on-culture-in-the-new-era-of-smarter-food-safety/
LOCATION:https://zoom.us/webinar/register/WN_uMaG_U92TLGqb-2bTozXSw#/registration
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230518T080000
DTEND;TZID=America/New_York:20230518T120000
DTSTAMP:20230501T154139Z
CREATED:20230501T153817Z
LAST-MODIFIED:20230501T154139Z
UID:57177-1684396800-1684411200@globalbiodefense.com
SUMMARY:Prioritizing Actions for Epidemic and Pandemic Preparedness
DESCRIPTION:The Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium will be held 18 May 2023. \nThis is the second of two sessions. The purpose of this symposium is to convene global health planning stakeholders\, including those in government and academia\, and across health- and non-health sectors\, to strengthen the capacity for evidence-based prioritization of global health capabilities. \nObjectives of this meeting are the following: \n\nReview assessment tools and how\, independently and together\, they relate to national action planning.\nGain insight into how countries and organizations currently select priorities in funding for epidemic prevention\, detection\, and response.\nAssess evidence for effective prioritization approaches to building disease surveillance and risk communication capabilities.\nIdentify governance structures that can support robust and reliable systems for global health investments.\n\nAGENDA\nHealth Security Action Areas: Issues and Opportunities\nThe goals of these discussions are to review success and failures\, use of assessment tools\, identify outstanding gaps and determine critical areas for action to sustainably improve capabilities in three areas. \nSituational Awareness in the Context of Health and DiseasesThe goal of this discussion is to re-set expectations at a higher-level of what can be done to keep both public health and the general public aware of changes in disease risks as early as possible by combining many current surveillance systems with new sources of disease data to form near real time awareness of constantly changing disease risks. \nTopics covered in this discussion include: \n\nCurrent tools for disease surveillance and the international tools used to evaluate the effectiveness of these systems\nRoutine methods and genetic surveillance for assessing situational awareness\nRecent innovations in detection in detection of novel diseases and use of closer-to-real-time monitoring of critical changes in endemic disease\nRecent experience including new types of disease surveillance and combinations of traditional and new methods to improve situational awareness\nIntegration of surveillance tools to realize near-real-time situational awareness\n\nModerator: Larry Brilliant\, Pandefense Advisory \nDiscussants:Mark Smolinski\, Ending PandemicsPatipat Keng Susumpow\, Opendream CoChanne Suy\, Co–Founder\, Kawsang \nBuilding Trust\, Transparency\, and Risk Communication Capabilities\nThe goal of this discussion is to review existing guidance and frameworks for risk communication\, highlighting approaches that are particularly effective for communicating risk about epidemics and describing approaches that have been demonstrated to be less effective or ineffective in communicating risks. \nModerator: Richard Garfield\, U.S. Centers for Disease Control and Prevention \nDiscussants:\nKatelyn Jetelina\, Your Local Epidemiologist\nRania Elessawi\, UNICEF\nBaruch Fischhoff\, Carnegie Mellon University \nStrengthening Global Health Security through Strong Country-Level Infrastructure for Effective Governance\, Financing\, and Accountability\nA country’s performance during an infectious disease outbreak is only as strong as its ability to leverage multisectoral partnerships; coordinate at national\, subnational and community levels; and continuously develop and strengthen health and public health system capacity to prevent and respond to outbreaks. \nThe goal of this discussion is to examine how improving global health security begins at the country-level and how countries can strengthen their public health architecture for epidemic preparedness and response through effective mechanisms for governance\, financing\, and accountability. This group will focus on the following questions: \n\nHow might countries /organizations ensure effective multisectoral governance at country-level?\nHow might countries /organizations foster accountability among partners and stakeholders that drives continuous quality improvement and well-prioritized investments?\n\nModerators\nJulie Wahl\, Resolve to Save Lives\nGisela Scaglia\, Former Member of Parliament Argentina \nDiscussants\nAminu Magashi Garba\, Africa Budget Network\nImmaculate Nabukenya\, Makerere University\nAbrham Ejigu – Senior Project Manager\, Resolve to Save Lives\, Ethiopia \nCross-Cutting Action Areas: Issues and Opportunities\nThe goals of these discussions are to review success and failures\, use of assessment tools\, identify outstanding gaps and determine critical areas for action to sustainably improve capabilities in three overarching areas \nGlobal Health Security Capacity and Functionality Assessment\nTimely access to quality\, actionable data underpins effective prioritization of investments to address GHS capacity and functionality gaps. The goal of this session is to discuss and identify critical needs\, challenges\, gaps\, and\nopportunities to improve GHS capacity and functionality assessment tools\, their use\, and the use of the data they generate to inform decision making on strengthening and maintaining critical capabilities needed to prevent\, detect\, and respond to any future epidemics. Participants will discuss the following issues: \n\nIdentify challenges in the use of existing tools (including accessibility) and opportunities to improve them.\nIdentify opportunities to improve interoperability\, interconnectedness\, and integration of assessment tools and data.\nIdentify opportunities to improve linkages between capacity/capability guidance and assessment tools.\nParticipants will have a worksheet to contribute to prior to and following the discussion.\nParticipants will use Jamboard to add suggested actions for addressing identified gaps.\n\nModerators\nAamer Ikram\, National Institutes of Health Pakistan\nJessica Petrillo\, U.S. Agency for International Development \nDiscussants:\nAnne Liu\, Gates Ventures\nDr. Magda Robalo Correia e Silva\, Institute for Global Health and Development\nCharles Bebay\, ECTAD Regional Manager for Eastern and Southern Africa\,\nFood and Agriculture Organization \nCountries’ and Organizations’ Experiences in Preparedness and Response Planning\nThe goal of this discussion is to identify lessons and best practices for preparedness and response at the national level\, and identify actions on policy and practice for improving preparedness and planning for the next pandemic by learning from what went well and what went less well in national contexts. \nExamples exist of countries on good planning practices to address the SARS-CoV-2 pandemic. These countries have observed strong and weak points in the national system through systematic monitoring and evaluation (M&E) tools (e.g.\, IHR\, Joint External Evaluation\, Universal Health and Preparedness Review). Before engaging in discussion about these topics\, participants will hear from two examples of countries from different perspectives. This discussion will focus on the following questions: \n\nWhat are the actual practices in a term of multisectoral approach that the country is adopting as a result of learning in this symposium from the M&E tool?\nWhat’s the nature of the reinforcement process of preparedness and response planning at the national level?\n\nParticipants will be asked to suggest approaches and actions to guide each country’s decision to implement and strengthen the use of their preparation and response plans with academia\, donors\, and private partners. \nModerators\nSoawapak Hinjoy\, Department of Disease Control\, Ministry of Health\, Thailand\nErwin Humberto Calgua Guerra\, Universidad de San Carlos de Guatemala\nArminder Kaur Deol\, Coalition of Epidemic Preparedness Innovations \nDiscussants:\nJeffery Cutter\, Ministry of Health Singapore\nAli Ardalan\, Health Systems in Emergencies Lab\, World Health Organization\nRegional Officer for the Eastern Mediterranean \nPlease visit the National Academies’ Prioritizing Actions for Epidemic and Pandemic Preparedness Virtual Symposium page for more information and to register for virtual attendance.
URL:https://globalbiodefense.com/event/prioritizing-actions-for-epidemic-and-pandemic-preparedness-2/
LOCATION:
CATEGORIES:Webinar-Webcast,Workshop
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230518T083000
DTEND;TZID=America/New_York:20230518T173000
DTSTAMP:20230421T194600Z
CREATED:20230421T194600Z
LAST-MODIFIED:20230421T194600Z
UID:56993-1684398600-1684431000@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Pfizer's ABRYSVO Respiratory Syncytial Virus Vaccine
DESCRIPTION:Vaccines and Related Biological Products Advisory Committee May 18\, 2023 Meeting Announcement \nOn 18 May 2023\, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine)\, manufactured by Pfizer Inc.\, with a requested indication\, in Biologics License Application (BLA) 125768 (STN 125768/0)\, for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals. \nAdvisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA\, which generally follows the recommendations but is not legally bound to do so. Please see\, “Advisory Committees Give FDA Critical Advice and the Public a Voice\,” for more information. \nMeeting Materials\nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nThe meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. \nPublic Participation Information\nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2023-N-1338 \nComments received on or before May 11\, 2023\, will be provided to the committee. Comments received after May 11\, 2023\, and by May 17\, 2023\, will be taken into consideration by FDA. In the event the meeting is canceled\, FDA will continue to evaluate any relevant applications or information\, and consider any comments submitted to the docket\, as appropriate. \nPlease visit the VRBPAC Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-pfizers-abrysvo-respiratory-syncytial-virus-vaccine/
LOCATION:https://www.youtube.com/watch?v=NXVMILYvocM
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230524T090000
DTEND;TZID=America/New_York:20230524T140000
DTSTAMP:20230421T193224Z
CREATED:20230421T193224Z
LAST-MODIFIED:20230421T193224Z
UID:56991-1684918800-1684936800@globalbiodefense.com
SUMMARY:Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
DESCRIPTION:FDA CDER Office of Pharmaceutical Quality is offering a five-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and how they support risk-based decisions in a variety of contexts. These reports provide an early warning signal to the agency that a marketed product may harm patients due to a deviation or incident that has occurred. \nThis webinar will present FDA expectations for conducting root cause analysis and then implementing and assessing effectiveness of corrective action and preventive action plans (CAPAs) to mitigate the severity and probability of harm. Attendees will learn how the agency is integrating advanced analytics (e.g.\, machine learning and natural language processing) to innovate processes and facilitate proactive approaches to quality risk management. FDA will also share some common reporting errors as well as best practices for report submission. \nTOPICS COVERED\n\nPost-market reporting (FARs and BPDRs) requirements and expectations – who is responsible for reporting\, how do you report\, and what happens if they are not reported\nFDA’s use of post-market quality defect reports to support risk-based decisions\nThe parameters of OPQ’s assessment for FARs and BPDRs (i.e.\, how are they assessed and what is the overall business process OPQ manages\nThe integration of advanced analytics into OPQ’s post-market quality defect report program\n\nLEARNING OBJECTIVES\n\nWhat are the post-market reporting requirements and expectations for application holders and manufacturers.\nHow does FDA manage and assess the reports.\nWhat to expect regarding follow-ups and engagement from FDA after submitting a report.\nHow does FDA utilize FARs/BPDRs to support regulatory decisions (e.g.\, surveillance inspection prioritization\, pre-approval/pre-license inspections\, regulatory flexibility\, etc.).\nHow does FDA integrate FARs/BPDRs into their overall assessment on the state of pharmaceutical quality.\nHow is FDA innovating processes for managing FARs/BPDRs with the integration of advanced analytics.\n\nINTENDED AUDIENCE\n\nNDA\, ANDA\, BLA applicant holders\nGeneric and New Drug Pharmaceutical manufacturers (including CDMOs)\nContract Testing Laboratories\nRegulatory Affairs professionals supporting post-marketing reporting requirements\nQuality Assurance and Quality Control professionals\nConsultants supporting pharmaceutical manufacturers\nForeign Regulators\n\nFDA RESOURCES\n\n21 CFR 314.81\n21 CFR 600.14\nField Alert Reports\nCDER – Biological Product Deviations\n\nCONTINUING EDUCATION\nReal-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. \nThis webinar has been: \n\npre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.\npre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations\, operations or management\, or to the candidate’s clinical research therapeutic area.\npre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration\napproved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.\n\nPlease visit the FDA’s Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) meeting page for more information and to register to attend virtually.
URL:https://globalbiodefense.com/event/update-on-field-alert-reports-far-and-biological-product-deviation-reports-bpdr/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230611
DTEND;VALUE=DATE:20230616
DTSTAMP:20230422T155708Z
CREATED:20230422T155251Z
LAST-MODIFIED:20230422T155708Z
UID:57028-1686441600-1686873599@globalbiodefense.com
SUMMARY:The Protein Phosphorylation Conference
DESCRIPTION:The Protein Phosphorylation Conference will be held 11-15 June 2023 in Steamboat Springs\, Colorado. This Federation of American Societies for Experimental Biology (FASEB) Science Research Conference (SRC) focuses on new discoveries and techniques regarding the role of protein phosphorylation in health and disease. \nThe conference brings together an interdisciplinary group of scientists representing academia and industry who study and conduct research on protein phosphorylation. \nProgram Details \nThe program focuses on kinase signaling through canonical and non-canonical modes and network regulation of signaling outputs. We will explore how they provide insight critical to our understanding of kinases and kinase pathways underlying normal physiology and disease progression\, and the translation of this information in the design of improved therapeutic strategies. \nConference sessions will present the latest research findings and foster engaging discussion on: \n\nStructural regulation of kinases\nOptogenetic and chemical genetic approaches to kinase and phosphatase networks\nConcepts in drug resistance\nKinase allostery and molecular scaffolds\nSignaling dynamics\nSystems and mathematical biology of phosphorylation networks\n\nThe conference covers eight sessions\, with 16 talks selected from abstracts\, and two poster sessions. \nPlease visit FASEB’s Protein Phosphorylation Conference site for more information and to register.
URL:https://globalbiodefense.com/event/the-protein-phosphorylation-conference/
LOCATION:The Steamboat Grand Resort\, 2300 Mt Werner Circle\, Steamboat Springs\, CO\, 80487\, United States
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230611
DTEND;VALUE=DATE:20230616
DTSTAMP:20230422T163234Z
CREATED:20230422T163234Z
LAST-MODIFIED:20230422T163234Z
UID:57038-1686441600-1686873599@globalbiodefense.com
SUMMARY:Signal Transduction in the Immune System Conference 2023
DESCRIPTION:The Signal Transduction in the Immune System Conference will be held 11-15 June 2023 in Palm Springs\, California. \nFirst convened in 2000\, this FASEB Science Research Conference (SRC) showcases recent advances in the understanding of signal transduction mechanisms that control immune responses in both health and disease. \nThe conference provides a forum for a diverse community of scientists across all career stages to share and discuss their research and to develop new cross-disciplinary collaborations. It is also recognized as one of the best meetings in the immunology field for trainees to present their work and network. \nProgram Details\nThe conference catalyzes new ideas and the use of interdisciplinary approaches for the development of novel therapeutics to treat inflammatory and autoimmune disorders\, cancer\, and immunodeficiency. \nConference sessions will present the latest research and foster discussion on: \n\nInnate Immune Cell Sensing\nLeukocyte Adhesion and Migration\nLymphocyte Signaling\nSignaling and Effector Function\nImmune Signaling in Health and Disease\n\nThe conference features 35 talks with ten short talks selected from submitted abstracts. New this year are two Lightning Sessions – 20 one-minute talks – that will allow trainees to highlight their poster session presentations selected from abstracts. \nThe program also includes a Meet-The-Expert session\, “Networking in Academia and Industry; When\, What\, How?” and a Career Development Workshop\, “Science Policy and Community Engagement.” \nPlease visit FASEB’s Signal Transduction in the Immune System Conference site for more information and to register.
URL:https://globalbiodefense.com/event/signal-transduction-in-the-immune-system-conference-2023/
LOCATION:Omni Rancho Las Palmas Resort and Spa\, 41000 Bob Hope Drive\, Palm Springs\, CA\, 92270\, United States
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230618
DTEND;VALUE=DATE:20230621
DTSTAMP:20230422T165944Z
CREATED:20230422T165728Z
LAST-MODIFIED:20230422T165944Z
UID:57043-1687046400-1687305599@globalbiodefense.com
SUMMARY:AMP 2023 Europe Congress | Association for Molecular Pathology
DESCRIPTION:The Association for Molecular Pathology (AMP) 2023 Europe Congress will take place 18-20 June 2023 in Milan\, Italy. \nThe AMP Europe Congress will bring together a network of more than 300+ molecular professionals and representatives of the diagnostics industry to educate healthcare practitioners and to advance the value of molecular laboratories in providing high quality patient care around the world. This multi-disciplinary scientific program will showcase molecular diagnostics with clinical applications in infectious diseases\, oncology (solid tumors\, hematopathology)\, genetics (congenital\, heritable)\, and informatics. \nHighlighted presentations include: \n\nThe Role of the -omics in Microbiology and in Infectious Disease Control (SIPMeT)\nEvaluation of SARS-CoV-2 genomic mutations potentially conferring resistance to antiviral drugs in viral populations isolated from untreated SARS-CoV-2-infected subjects\nArtificial Intelligence in Genomic Diagnostics\nLaboratory Strategies for Survival during the Pandemic\nMind the Gap: Advances in Immunology and Diseases\nNavigating the EU’s In Vitro Diagnostic Regulation\nKeeping pace with the homologous recombination deficiency testing landscape\nEvaluation of a Meta-Genomics Next-Generation sequencing (MNGS) assay with novel host Depletion Method for Pathogen Identification in Sepsis patients\n\nPlease visit the AMP 2023 Europe Congress website for more information and to register.
URL:https://globalbiodefense.com/event/amp-2023-europe-congress-association-for-molecular-pathology/
LOCATION:Hotel NH Milano Congress Centre\, Strada 1 Milanofiori\, Assago MI\, Italy
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230624
DTEND;VALUE=DATE:20230629
DTSTAMP:20230422T161944Z
CREATED:20230422T161944Z
LAST-MODIFIED:20230422T161944Z
UID:57033-1687564800-1687996799@globalbiodefense.com
SUMMARY:Worm23 - International C. elegans Conference
DESCRIPTION:The premier meeting for C. elegans researchers will be held 24-28 June 2023 in Glasgow\, Scotland. \nHundreds of presentations cover the full diversity of C. elegans investigations\, including genetics\, molecular biology\, cell biology\, development\, immunology\, physiology\, neuroscience\, evolution\, and more. \nA virtual attendance option is available in addition to the in-person meeting. Virtual participant registration fees will be waived for scientists who are full-time residents of countries with low- and middle-income economies. \nPlease visit the Genetics Society of America 24th International C. elegans Conference website for more information and to register.
URL:https://globalbiodefense.com/event/worm23-international-c-elegans-conference/
LOCATION:Scottish Event Campus\, Exhibition Way\, Glasgow\, Scotland\, G3 8YW\, United Kingdom
CATEGORIES:Conference
ORGANIZER;CN="Genetics Society of America":MAILTO:society@genetics-gsa.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20230628T120000
DTEND;TZID=Europe/Paris:20230628T133000
DTSTAMP:20230622T143901Z
CREATED:20230622T143901Z
LAST-MODIFIED:20230622T143901Z
UID:57247-1687953600-1687959000@globalbiodefense.com
SUMMARY:One Health Priority Research Agenda for AMR
DESCRIPTION:The One Health Priority Research Agenda for AMR Report launch event will take place on 28 June 2023. This is a joint initiative to assist in directing and catalyzing scientific interest and financial investments for the priority research agenda across sectors for countries and funding bodies. \nThe lead organizations working in the multilateral system on human\, animal\, plant and environmental health\,  the UN Environment Programme (UNEP)\, the Food and Agriculture Organization of the United Nations (FAO)\, the World Health Organization (WHO) and the World Organisation for Animal Health (WOAH) joined forces to advance international co-operation for a One Health response on AMR. \nThese Quadripartite organizations have developed the One Health Priority Research Agenda for AMR report\, this is a joint initiative to assist in directing and catalysing scientific interest and financial investments for the priority research agenda across sectors for countries and funding bodies. The research agenda also serves as a guide to mitigate One Health AMR that will help policymakers\, researchers\, and a multidisciplinary scientific community work together on solutions to prevent and mitigate AMR within the One Health approach. \nAGENDA \n12:00-12:05 Welcome and scene setting\, Sarah Nehrling Moderator \n12:05-12:20 Presentation of the One Health Priority Research Agenda for Antimicrobial Resistance\, Haileyesus Getahun\, Director\, Quadripartite Joint Secretariat on AMR\, WHO \n12:20-13:15 Moderated panel discussion on the implications of the One Health Priority Research Agenda for Antimicrobial Resistance for the different sectors and stakeholders Speakers (3-5 minutes) \n\nMaria Helena Semedo\, Deputy Director General\, Food and Agriculture Organization of the United Nations (FAO)\nJacqueline Álvarez\, Chief\, Chemicals and Health Branch\, Economy Division\, United Nations Environment Programme (UNEP)\nHanan H Balkhy\, Assistant Director General for Antimicrobial Resistance\, World Health Organization (WHO)\nMontserrat Arroyo Kuribreña\, Deputy Director General\, International Standards and Science\, World Organisation for Animal Health (WOAH)\nRobert Skov\, Scientific Director at the International Center for Antimicrobial Resistance Solutions (ICARS)\nScott Weese\, Professor in the Department of Pathobiology\, Director of the Centre for Public Health and Zoonoses\, University of Guelph\, Global Leaders Group member on AMR\nSabiha Essack\, Professor in the South African Research Chair (SARChI) in Antibiotic Resistance and One Health and Professor in Pharmaceutical Sciences at the University of KwaZulu Natal (UKZN)\n\n13:15-13:25 Qs&As with the audience \nParticipate virtually in the webinar to launch the One Health Priority Research Agenda for AMR due to take place on 28 June 2023 from 12:00 to 13:30 CET. Please visit UN Environment Programme’s One Health Priority Research Agenda for AMR Report launch event to register.
URL:https://globalbiodefense.com/event/one-health-priority-research-agenda-for-amr/
LOCATION:https://who.zoom.us/webinar/register/WN_YgvxO3sgQvmdNYfZERfscQ#/registration
CATEGORIES:Webinar-Webcast
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230723
DTEND;VALUE=DATE:20230728
DTSTAMP:20220923T160919Z
CREATED:20220923T155814Z
LAST-MODIFIED:20220923T160919Z
UID:56482-1690070400-1690502399@globalbiodefense.com
SUMMARY:2023 AACC Annual Scientific Meeting and Clinical Lab Expo
DESCRIPTION:The American Association for Clinical Chemistry will gather for the 2023 AACC Annual Scientific Meeting & Clinical Lab Expo from 23-27 July 2023 in Anaheim\, California. \nThe world’s largest gathering of laboratory medicine professionals connects with stakeholders in clinical chemistry\, molecular diagnostics\, mass spectrometry\, translational medicine\, lab management\, and other areas of breaking science in laboratory medicine. Learn about cutting edge technology at the AACC Clinical Lab Expo featuring 800+ exhibitors and 200+ new products/services. \nCall for Proposals: Deadline is 4 November 2022. \nPlease visit AACC’s 2023 Annual Scientific Meeting & Clinical Lab Expo website for more information and registration.
URL:https://globalbiodefense.com/event/2023-aacc-annual-scientific-meeting-and-clinical-lab-expo/
LOCATION:Anaheim Convention Center\, 800 West Katella Avenue\, Anaheim\, CA\, 92802-3415\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230724
DTEND;VALUE=DATE:20230729
DTSTAMP:20230421T161848Z
CREATED:20230421T161759Z
LAST-MODIFIED:20230421T161848Z
UID:56962-1690156800-1690588799@globalbiodefense.com
SUMMARY:Just Breathe: ARDS Therapeutics Pitch Event
DESCRIPTION:A BARDA-Sponsored Phase 2 ARDS Platform Clinical Trial \nBARDA will host ‘Just Breathe – An ARDS Therapeutics Pitch Event’ on July 24-28\, 2023 to support development of threat-agnostic and host-directed therapeutic candidates to address acute respiratory distress syndrome (ARDS). The event will be held in a virtual format. \nThe Biomedical Advanced Research and Development Authority Influenza & Emerging Infectious Diseases Division plans to support a randomized\, double-blinded\, placebo-controlled\, multi-center U.S. Phase 2 platform clinical trial that investigates multiple immune modulators or other host-directed therapeutics in hospitalized adult patients with acute respiratory distress syndrome (ARDS). In this trial\, BARDA will evaluate the safety and efficacy of novel threat-agnostic and host-directed therapeutics that could address ARDS caused by known or unknown health security threats such as pandemic influenza\, COVID-19\, other emerging infectious diseases\, and chemical\, biological\, radiological\, and nuclear (CBRN) incidents. \nMore information about the design of the phase 2 ARDS platform clinical trial is available in the draft protocol synopsis under the BAA Area of Interest (AOI) 9.7 (closed March 14\, 2023). \nTo participate in the Just Breathe Pitch Event\, drug sponsors will need to submit the following: \n\nSlide deck containing the required information about the proposed therapeutic candidate\nA current Investigator’s Brochure (IB) for the proposed therapeutic candidate\nSubmission cover page form\n\nInterested drug sponsors will have the opportunity to submit questions and receive feedback from BARDA on their initial slide deck submissions for revision and submit the updated slide deck for for the event. \nThe final (revised) slide deck submission and the IB will be evaluated by a scientific review process based on pre-specified criteria outlined in the presentation template. Drug sponsors with most competitive submissions will be invited to present virtually about their products and attend a live Q&A in front of an interagency review panel. \nUp to three phase 2-ready therapeutic candidates representing different mechanisms of action will be selected for inclusion in the planned BARDA-sponsored phase 2 ARDS platform clinical trial. \nPlease visit BARDA’s Influenza & Emerging Infectious Diseases Division website for additional program information and visit the Just Breathe – An ARDS Therapeutics Pitch Event page for submission instructions\, provided templates\, evaluation criteria\, and a detailed timeline. All pre-submission inquiries and submissions should be submitted to IEIDD_Tx@hhs.gov. Critical due dates for this pitch event are listed below: \n\nFinal day to submit questions: May 26\, 2023\, by 5 p.m. EDT\nInitial slide deck submission: June 2\, 2023\, by 5 p.m. EDT\nFinal (revised) slide deck submission: June 30\, 2023\, by 5 p.m. EDT\nPitch event presentation invitations to drug sponsors with the most competitive therapeutic candidates: July 10\, 2023\nJust Breathe – An ARDS Therapeutics Pitch Event: July 24-28\, 2023\n\nSource: Biomedical Advanced Research and Development Authority
URL:https://globalbiodefense.com/event/just-breathe-ards-therapeutics-pitch-event/
LOCATION:
CATEGORIES:Government Hosted,Industry Day,Innovation Challenge
ATTACH;FMTTYPE=image/png:https://globalbiodefense.com/wp-content/uploads/2023/04/barda-just-breathe-ards-clinical-trial-therapeutics.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230824
DTEND;VALUE=DATE:20230826
DTSTAMP:20230802T184221Z
CREATED:20230802T184151Z
LAST-MODIFIED:20230802T184221Z
UID:57441-1692835200-1693007999@globalbiodefense.com
SUMMARY:NIAID Review of BAA Proposals for Development of Diagnostics for Biodefense\, AMR\, and Emerging Infectious Diseases
DESCRIPTION:A closed meeting of the National Institute of Allergy and Infectious Diseases (NIAID) Special Emphasis Panel will be held August 24-25\, 2023 to review and evaluate contract proposals for the NIAID 2023 DMID Omnibus BAA (HHS–NIH–NIAID–BAA2023–1)\, Research Area 004—Development of In Vitro Diagnostics for Biodefense\, Antimicrobial Resistant Infections\, and Emerging Infectious Diseases (N01). \nThe meeting will be closed to the public in accordance with U.S. policies as the contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material\, and personal information concerning individuals associated with the contract proposals\, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. \nThe proposals support the development of promising diagnostics technologies for detection of signatures from biothreat pathogens and pathogens causing emerging\, reemerging\, and AMR infectious diseases\, and for pandemic preparedness. \n\nNext-generation Nucleic Acid Sequencing on Portable Systems\nRapid Protein Detection\nBacterial Identification and Phenotypic Antimicrobial Resistance Characterization.\n\nFederal Register announcement
URL:https://globalbiodefense.com/event/niaid-panel-review-of-baa-proposals-for-development-of-in-vitro-diagnostics-for-biodefense-amr-and-emerging-infectious-diseases/
LOCATION:DC
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230828T130000
DTEND;TZID=America/New_York:20230828T150000
DTSTAMP:20230713T151512Z
CREATED:20230713T150933Z
LAST-MODIFIED:20230713T151512Z
UID:57316-1693227600-1693234800@globalbiodefense.com
SUMMARY:National Biodefense Science Board (NBSB) Public Meeting
DESCRIPTION:The National Biodefense Science Board (NBSB) will convene for a virtual meeting on 28 August 2023. \nThe NBSB provides expert advice and guidance to the U.S. Department of Health and Human Services and the Assistant Secretary of Preparedness and Response regarding current and future chemical\, biological\, radiological\, and nuclear threats\, as well as other matters related to disaster preparedness and response. ASPR manages and convenes the NBSB on behalf of the Secretary of HHS. \nThe public and expert stakeholders are invited to observe the meeting. Pre-registration (Zoom) is required. Anyone may submit questions and comments to the NBSB by email before the meeting. \nRepresentatives from industry\, academia\, health professions\, health care consumer organizations\, non-Federal Government agencies\, or community-based organizations may request up to seven minutes to speak directly to the Board. Requests to speak to the Board will be approved in consultation with the Board Chair and based on time available during the meeting. \nAbout the National Biodefense Science Board\nThe National Biodefense Science Board (NBSB) is a federal advisory committee that provides advice and guidance to assistant secretary for preparedness and response within the U.S. Department of Health and Human Services (HHS)\, and to the HHS secretary on preventing\, preparing for\, and responding to adverse health effects of emergencies. \nThe committee was formerly known as the National Preparedness and Response Science Science Board. The new title more accurately reflects the board’s work\, expertise\, and contributions to the HHS and to the nation’s health resilience. \nThe board was created and given authorities under the Pandemic and All-Hazards Preparedness Act of 2006 and chartered in 2007. The Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) amended the board’s authorities by broadening membership to include a representative with pediatric expertise and a state\, tribal\, territorial\, or local public health official and expanding the board’s duties to consist of providing specified information to appropriate committees of Congress. These changes\, as well as the board’s new name\, are reflected in the September 2016 charter. \nThe board has 13 voting members with a broad range of expertise in science\, medicine\, and public health. \nPlease visit the NBSB website to register to attend.
URL:https://globalbiodefense.com/event/national-biodefense-science-board-nbsb-public-meeting/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230901T090000
DTEND;TZID=America/New_York:20230901T180000
DTSTAMP:20230805T164510Z
CREATED:20230805T164510Z
LAST-MODIFIED:20230805T164510Z
UID:57510-1693558800-1693591200@globalbiodefense.com
SUMMARY:NIAID Review of BAA Proposals for Vaccine Candidates for Biodefense and Emerging Infectious Diseases
DESCRIPTION:A closed meeting of the National Institute of Allergy and Infectious Diseases (NIAID) Special Emphasis Panel will be held September 1\, 2023 to review and evaluate contract proposals for the NIAID 2023 DMID Omnibus BAA (HHS–NIH–NIAID–BAA2023–1)\, Research Area 001—Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases. \nThe meeting will be closed to the public in accordance with U.S. policies as the contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material\, and personal information concerning individuals associated with the contract proposals\, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. \nThe proposals advancing vaccine candidates\, technologies\, and platforms that could be deployed against agents that include category A\, B\, and C NIAID Emerging Infectious Diseases and Pathogens. \nFederal Register announcement
URL:https://globalbiodefense.com/event/niaid-review-of-baa-proposals-for-vaccine-candidates-for-biodefense-and-emerging-infectious-diseases/
LOCATION:DC
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230907
DTEND;VALUE=DATE:20230909
DTSTAMP:20230905T152717Z
CREATED:20230805T152440Z
LAST-MODIFIED:20230905T152717Z
UID:59045-1694044800-1694217599@globalbiodefense.com
SUMMARY:Genomics and Precision Public Health Issues Enrichment Event
DESCRIPTION:The Oak Ridge Institute for Science and Education (ORISE) will host a Genomics and Precision Public Health Issues Enrichment Event from 7-8 Sep 2023 in Atlanta\, Georgia. \nIn the past decade\, genomics\, and precision health approaches such as big data science and machine learning have emerged as important tools for public health. Those entering the public health and medical workforces must keep pace with these evolving fields to maximize the benefit to public health. Recognizing this need\, ORISE is partnering with the Office of Genomics and Precision Public Health at the Centers for Disease Control and Prevention to offer a two-day in-person enrichment event covering the latest developments in these fields. \nThe course will consist of a series of 15-60 minute lectures\, grouped by topic\, with learning objectives for each lecture. The course will be freely available to all ORISE fellows and will also be available for online viewing after the event. Online materials will include a video recording of each lecture\, a slide presentation\, and\, for some lectures\, recommended readings and questions for discussion and knowledge assessment. \nHighlighted topics include: \n\nGenomics in the Practice of Medicine and Public Health\nPathogen Genomics and new Precision Public Health Tools for Infectious Diseases and Outbreak Response\nPharmacogenomics – Because Every Person in the Population is Important and Unique\nEffective Use of Behavioral\, Communication and Social Sciences for Precision Public Health\nHarnessing Big Data and Precision Medicine – Intelligent & Integrative Data Analysis for Health Impact\nPrecision Public Health Surveillance and Machine Learning – Better Tools to Tackle Old and New Challenges\nPopulation Based Genomic Screening – Are We Ready?\nImplementation Science – A Critical Element of Precision Public Health\nGenomic Epidemiology: Linking Precision Health and Populations\nMeasurement of Health Equity in Public Health Investigations\nPrecision Public Health as a Primary Strategy for Reaching Health Equity\nEffective Educating of Providers in Precision Public Health\n\nRegistration for the in-person event is capped at 200 attendees\, with preference given to the order in which registrations are received. There is no cost to register. Travel to and from the event is the responsibility of the attendee and their program. \nPlease visit ORISE’s Genomics and Precision Public Health Issues Enrichment Event to register.
URL:https://globalbiodefense.com/event/genomics-and-precision-public-health-issues-enrichment-event/
LOCATION:Atlanta Marriott Buckhead Hotel\, 3405 Lenox Road NE\, Atlanta\, GA\, 30326\, United States
CATEGORIES:Government Hosted,Webinar-Webcast
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230909
DTEND;VALUE=DATE:20230914
DTSTAMP:20230421T213031Z
CREATED:20230421T211951Z
LAST-MODIFIED:20230421T213031Z
UID:56998-1694217600-1694649599@globalbiodefense.com
SUMMARY:EMGS Annual Meeting 2023 - Environmental Mutagenesis and Genomics Society
DESCRIPTION:The 54th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS 2023) will be held 9-13 September 2023 in Chicago\, Illinois. \nHighlighted topics and presentations include: \n\nIn Vivo-Like Testing Strategies for Genotoxicity Risk Characterization\nEnhancing chemical hazard screening with epigenetic measurements\nError-corrected sequencing for mutation detection in male germ cells: progress opportunities and challenges\nEvaluating Genotoxic and Tumorigenic Potential of Gene Therapies\nMechansims of mutagenesis\nAdvancing the battery of in vivo testing assays in genetic toxicology\nSingle cell sequencing insights into adverse outcome development due to environmental exposure\nAdductomics: an approach to explore the health effects of the exposome\nFinding de novo structural mutations in germ cells or offspring Germline\nHigh throughput gene expression and cell state dynamics in tissues: a new way of understanding the biological impacts of environmental exposures\nOngoing validations of TGR tech transfer and bridging studies from TGR to ecNGS\n\nPlease visit EMGS’ Environmental Mutagenesis and Genomics Society 54th Annual Meeting page for more information and to register.
URL:https://globalbiodefense.com/event/emgs-annual-meeting-2023/
LOCATION:Palmer House Hilton\, 17 East Monroe Street\, Chicago\, IL\, 60603\, United States
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230909
DTEND;VALUE=DATE:20230914
DTSTAMP:20230422T173826Z
CREATED:20230422T173826Z
LAST-MODIFIED:20230422T173826Z
UID:57056-1694217600-1694649599@globalbiodefense.com
SUMMARY:ECP 2023 - 35th European Congress of Pathology
DESCRIPTION:The 35th European Congress of Pathology will be held 9-13 September 2023 in Dublin\, Ireland. A virtual attendance option is available. \nThe event provides an opportunity to meet pathologists from more than 100 countries around the globe and to meet your peers and evaluate research in front of leading world experts. \nHighlighted sessions include: \n\nPaediatric and perinatal infections\nStandardisation of molecular pathology at the European level\nEvaluation and reporting of complex biomarkers with big panels\nDigital pathology solutions in pulmonary pathology\nThe “I”s have it: infectious\, iatrogenic and ischaemic injury to the GI tract\nDiagnostic challenges in pulmonary vascular pathology\n\nPlease visit the European Society of Pathology’s 35th European Congress of Pathology event page for more information and to register.
URL:https://globalbiodefense.com/event/ecp-2023-35th-european-congress-of-pathology/
LOCATION:The Convention Centre Dublin\, Spencer Dock\, North Wall Quay\, Dublin 1\, D01 T1W6\, Ireland
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230912
DTEND;VALUE=DATE:20230914
DTSTAMP:20230421T193322Z
CREATED:20230421T192700Z
LAST-MODIFIED:20230421T193322Z
UID:56989-1694476800-1694649599@globalbiodefense.com
SUMMARY:Scientific Computing for Public Health Solutions
DESCRIPTION:2023 Scientific Computing Days \n Sharing and Collaboration in the Data Multiverse:Scientific Computing for Public Health Solutions\n \nThe 11th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies. The event’s goal is to help FDA improve the application of technology and scientific computing in support of the FDA’s public health mission. \nThis year’s theme is “Sharing and Collaboration in the Data Multiverse: Scientific Computing for Public Health Solutions.” \nPlease visit the FDA’s 2023 Scientific Computing Days site for more information.
URL:https://globalbiodefense.com/event/scientific-computing-for-public-health-solutions/
LOCATION:
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230919
DTEND;VALUE=DATE:20230922
DTSTAMP:20230916T170739Z
CREATED:20230116T175259Z
LAST-MODIFIED:20230916T170739Z
UID:59216-1695081600-1695340799@globalbiodefense.com
SUMMARY:GeoVet 2023: Interdisciplinary Geospatial Research for the One Health Era
DESCRIPTION:The GeoVet conference\, held every 3 years\, will next convene from 19-21 September 2023 in Silvi Marina\, Teramo\, Italy. \nThis event brings together a diverse group of international experts in spatial epidemiology\, spatial statistics and Geographical Information Systems applied to animal health\, public health and food safety. Don’t miss this gathering of thought leaders to exchange ideas and perspectives. \nHighlighted presentations include: \n\nImpact of climate change on soil-borne and vector-borne diseases\nInfectious water-associated diseases: the role of the environment\nThe challenges of real-time science communication and decision support in a pandemic context: building the plane instruments after take-off\nEmergent infection disease problems under environmental land management\nMapping Global Bushmeat Activities to Improve Zoonotic Spillover Surveillance\nChoice of Landscape Discretisation Affects the Rate of Spread in Wildlife Disease Models\nLandscape phylogeography — using viral gene sequences to compare and explain the heterogeneous spatial dynamics of virus epidemics\nMapping global coldspots of veterinary capacity\nDecision-support tools to track and predict climate-sensitive infectious diseases at cascading spatial scales\nLandscape Connectivity and travel corridors routes for predicting the spread of ASF in European wild boar\n\nPlease visit the GeoVet 2023 website for more information and to register.
URL:https://globalbiodefense.com/event/geovet-2023-interdisciplinary-geospatial-research-for-the-one-health-era/
LOCATION:Centro Congressi Abruzzo\, Via della Marina\, Silvi TE\, Italy
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230920
DTEND;VALUE=DATE:20230921
DTSTAMP:20230918T174503Z
CREATED:20230718T173326Z
LAST-MODIFIED:20230918T174503Z
UID:59243-1695168000-1695254399@globalbiodefense.com
SUMMARY:First WHO/Europe Indoor Air​ Conference 2023
DESCRIPTION:The First WHO/Europe Indoor Air​ Conference will be held 20 September 2023 in Bern\, Switzerland and via virtual participation. \nThe COVID-19 pandemic demonstrated the importance of ventilation to mitigate the transmission of respiratory disease. \nBeyond COVID-19 there is growing awareness that exposure to pollutants in indoor environments has a substantial impact on health\, productivity and performance. Large numbers of buildings do not have good ventilation or good indoor air quality\, and there are multiple other considerations including climate change\, energy\, comfort\, noise and security. \nHighlighted presentations include: \n\nThe indoor environment as a determinant for health\nInfection risk and IAQ in Swiss schools\nWhat do we need to achieve in buildings? What is realistic vs what is ideal?\nWhat do we know about the current state of IAQ in buildings?\nPandemic management through indoor pathogen transmission suppression – EU innovation funding\nChallenge and opportunity for Indoor Air – Learning from the pandemic\nImproving ventilation in Swiss buildings – IAQ as part of sustainability\nCompliance through information sharing in Belgium\nPriorities for improving indoor air in Switzerland\n\nThe event will be held in English and simultaneously translated in French\, German and Russian. \nPlease visit the WHO and Geneva Health Forum’s First WHO/Europe Indoor Air Conference website to register.
URL:https://globalbiodefense.com/event/first-who-europe-indoor-air-conference-2023/
LOCATION:Hotel Schweizerhof Bern & Spa\, Bahnhofpl. 11\, Bern\, 3001\, Switzerland
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230927
DTEND;VALUE=DATE:20230929
DTSTAMP:20230816T010636Z
CREATED:20230815T173825Z
LAST-MODIFIED:20230816T010636Z
UID:57610-1695772800-1695945599@globalbiodefense.com
SUMMARY:Government Biotechnology Innovation Summit
DESCRIPTION:Join government leaders at the forefront on how biotechnology is transforming the economic\, agricultural\, healthcare and security landscape of the U.S. \nThe 2023 Government Biotechnology Innovation Summit will be held 27-28 September 2023 in the DC Capitol Region. \nBe part of the discussion of the advancement of innovative biotechnology and biomanufacturing solutions across agencies and sectors as a means of furthering and securing U.S. National Interests. \nIn September 2022\, the White House announced an Executive Order launching a National Biotechnology and Bio-manufacturing Initiative with a $2 billion funding plan to further drive a national strategy for expanding the domestic bioeconomy and biomanufacturing capacity. \nThe Government Biotechnology Innovation Summit will offer a forum for leaders to discuss how the government employs biotechnology for national security purposes\, including biodefense initiatives\, surveillance of infectious diseases\, and the prevention and response to biological threats. \nHighlighted speakers include: \n\nRenee Wegrzyn\, PhD – Director\, Advanced Research Projects Agency for Health (ARPA-H)\nKerri Dugan\, PhD – Director\, Biological Technologies Office\, Defense Advanced Research Projects Agency (DARPA)\nPeter Marks\, MD\, PhD – Director\, Center for Biologics Evaluation and Research\, Food and Drug Administration (FDA)\nDeirdra Chester\, PhD – Director\, Office of the Chief Scientist\, US Department of Agriculture (USDA)\nCari Young\, ScM – Acting Division Director\, Biosafety\, Biosecurity\, and Emerging Biotechnology\, National Institutes of Health (NIH)\nSimon Malcomber\, PhD – Deputy Assistant Director\, Directorate for Biological Sciences\, National Science Foundation (NSF)\n\nThe Summit will also explore investing in research and development\, establishing regulations and guidelines\, and collaborating with academia and industry to harness the potential of biotechnology for the benefit of society as a whole. By harnessing the power of biotechnology through cooperation\, the government can improve public health outcomes through advanced diagnostics\, therapies\, and personalized medicine. Biotech innovations can also revolutionize sustainable agriculture by increasing crop yields\, developing drought and pest-resistant varieties\, and reducing environmental impact. \nPlease visit DSI’s Government Biotechnology Innovation Summit to register to attend. \nDefense Strategies Institute is an official partner of Global Biodefense
URL:https://globalbiodefense.com/event/government-biotechnology-innovation-summit/
LOCATION:The Sunset Room\, 165 Waterfront Street\, National Harbor\, MD\, 20754\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2023/08/biotechnology-innovation-1200x630-1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230929T100000
DTEND;TZID=America/New_York:20230929T113000
DTSTAMP:20230920T192004Z
CREATED:20230820T191510Z
LAST-MODIFIED:20230920T192004Z
UID:59298-1695981600-1695987000@globalbiodefense.com
SUMMARY:The Long Journey to Eliminate the Deadly U.S. Chemical Weapons Stockpile
DESCRIPTION:The CWC Coalition will host a webinar entitled ‘The End of an Era: The Long Journey to Eliminate the Deadly U.S. Chemical Weapons Stockpile’ on 29 September 2023. \nWhen the United States ratified the Chemical Weapons Convention (CWC) in 1997\, it took on the legal obligation and the complex technical and engineering task of destroying its massive Cold War-era chemical weapons stockpile\, which consisted of some 31\,500 tons (63\,000\,000 pounds) of deadly chemical agents much of which were loaded in various forms of munitions. \nAfter years of delay\, all U.S. declared chemical weapons stockpiles were irreversibly and verifiably destroyed in July 2023\, two months ahead of the Sept. 2023 deadline set by the Organization for the Prohibition of Chemical Weapons (OPCW). \nThe event is a major milestone in disarmament: the United States was the last declared stockpile possessor state to complete its safe and permanent demilitarization of chemical weapons. \nOn Sept. 29\, this webinar will feature perspectives from a senior Defense Department official on the long path to successfully eliminate the U.S. chemical arsenal\, and the experiences of two local leaders who worked to reshape the government’s original plans for chemical weapons destruction to reduce the risks to local communities where the U.S. stockpiles were once stored. \nSpeakers: \n\nKingston Reif\, deputy assistant secretary of defense for threat reduction and arms control\nIrene Kornelly\, chair of the Colorado Citizens’ Advisory Commission\nCraig Williams\, co-chair of the Kentucky Citizens’ Advisory Commission\nDaryl Kimball\, executive director\, Arms Control Association\, moderating\n\nThis discussion will be on the record. The webinar is organized by the Arms Control Association and the Chemical Weapons Convention Coalition. \nRSVP via Zoom
URL:https://globalbiodefense.com/event/the-long-journey-to-eliminate-the-deadly-u-s-chemical-weapons-stockpile/
LOCATION:https://us02web.zoom.us/webinar/register/7416946160158/WN_N3yOaJhBTaOPVD9IB80z-g#/registration
CATEGORIES:Webinar-Webcast
END:VEVENT
END:VCALENDAR