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X-WR-CALDESC:Events for Global Biodefense
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T083000
DTEND;TZID=America/New_York:20221109T161500
DTSTAMP:20220922T162918Z
CREATED:20220922T162826Z
LAST-MODIFIED:20220922T162918Z
UID:56465-1667982600-1668010500@globalbiodefense.com
SUMMARY:Considerations and Approaches for Obese Patient Populations in Drug Development Studies
DESCRIPTION:Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. \nThe U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a one-day virtual public workshop entitled “Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches” on November 9\, 2022. The purpose of this workshop is to review the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition. \nBesides the major health and socioeconomic implications of obesity\, there are great challenges in ensuring the optimal use and development of drugs for the growing population of obese persons. Obese patients are a large segment of the U.S. population and should be included in drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. Although smaller clinical studies have begun to examine drug pharmacokinetics in obese pediatric patients\, the relationship between pediatric obesity and drug response\, including efficacy and safety\, has not been thoroughly elucidated. Advancing this field requires identifying key knowledge gaps and barriers to the conduct of such studies and potential innovative solutions to improve data generation and analysis. \nThe workshop aims to: \n\nReview the implications of obesity in adult and pediatric patients on safety\, efficacy\, drug dosing and disposition.\nDiscuss whether adult and pediatric patients should be identified and studied as a special population in new drug development programs\nAddress when it may be appropriate to include obese patients in drug development studies to develop specific dosing guidelines for obese patients\n\nThe workshop which is jointly sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA\, will be open to the public. \nPlease visit the FDA’s Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches event page for more information.
URL:https://globalbiodefense.com/event/considerations-and-approaches-for-obese-patient-populations-in-drug-development-studies/
CATEGORIES:Government Hosted,Workshop
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221109T090000
DTEND;TZID=America/New_York:20221109T170000
DTSTAMP:20220922T161453Z
CREATED:20220922T161453Z
LAST-MODIFIED:20220922T161453Z
UID:56463-1667984400-1668013200@globalbiodefense.com
SUMMARY:FDA Review: EUA for Oral Sabizabulin for High-Risk COVID-19 Patients
DESCRIPTION:The FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule\, a tubulin polymerization inhibitor\, submitted by Veru Inc.\, for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. \nSabizabulin is an oral\, novel microtubule disruptor that has dual antiviral and anti-inflammatory activities in preclinical models. \nA focus of the discussion will include the treatment effect size in the context of the high placebo mortality rate\, the limited size of the safety database\, and identifying the proposed population. \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. The docket number is FDA-2022-N-2107. \nPlease visit the FDA’s Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement for more information.
URL:https://globalbiodefense.com/event/fda-review-eua-for-oral-sabizabulin-for-high-risk-covid-19-patients/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20221115
DTEND;VALUE=DATE:20221117
DTSTAMP:20220621T165636Z
CREATED:20220621T164935Z
LAST-MODIFIED:20220621T165636Z
UID:55684-1668470400-1668643199@globalbiodefense.com
SUMMARY:BARDA Industry Day 2022 - BID22
DESCRIPTION:The Biomedical Advanced Research and Development Authority (BARDA) 2022 Industry Day virtual event will be held 15-16 November 2022. \nBARDA\, a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR)\, invites you to participate in the annual conference to learn about U.S. Government medical countermeasure priorities\, interact with the BARDA and ASPR teams\, and network with public and private sector colleagues. \nThis year’s lineup will have an assortment of BARDA program briefings\, featured speakers\, special sessions\, and breakout sessions addressing efforts towards four strategic goals of enhancing preparedness\, response\, and partnerships against future threats. There will be a renewed focus on strengthening connections\, networking\, and collaboration within the virtual event environment. \n \nAt last year’s BARDA Industry Day event\, BARDA Director Dr. Gary Disbrow delivered a strategic overview of BARDA’s mission\, priorities and engagement during welcoming remarks. \nPlease visit the BARDA website for the latest updates.
URL:https://globalbiodefense.com/event/barda-industry-day-2022-bid22/
CATEGORIES:Government Hosted
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/06/barda-industry-day-2022-bid-november.jpg
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221206T100000
DTEND;TZID=America/New_York:20221206T170000
DTSTAMP:20220921T172133Z
CREATED:20220921T171951Z
LAST-MODIFIED:20220921T172133Z
UID:56410-1670320800-1670346000@globalbiodefense.com
SUMMARY:FDA BAA Industry Day 2022
DESCRIPTION:The U.S. Food and Drug Administration FDA will host an Industry Day on 6 December 2022 to discuss a Broad Agency Announcement (BAA) for state of the art advancements in technology\, materials\, processes\, methods\, devices\, and techniques in pharmaceutical regulatory science. \nFDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join the event to learn more about the FY 2023 BAA\, and how to apply. \nThe FDA BAA Industry Day 2022 will be held in virtual webcast format and is open to all responsible sources. Small businesses are strongly encouraged to participate. BAA Offerors may include single entities or teams from private sector organizations\, Federally Funded Research and Development Centers (FFRDCs)\, and academic institutions. \nThe FY 2023 FDA BAA has not yet been released at the time of this event listing (21 Sep 22). The FY 2022 FDA BAA is available here for reference.
URL:https://globalbiodefense.com/event/fda-baa-industry-day-2022/
CATEGORIES:Government Hosted,Industry Day
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/09/fda-baa-2022-industry-day-broad-agency-announcement.jpg
LOCATION:
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/
CATEGORIES:Government Hosted
LOCATION:
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/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09#success
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/
CATEGORIES:Government Hosted
LOCATION:https://fda.zoomgov.com/meeting/register/vJIsd-GvrDgqGKQjMEzpDtzTCvGTY4xmZxk
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/
CATEGORIES:Government Hosted
LOCATION:
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/
CATEGORIES:Government Hosted
LOCATION:https://zoom.us/webinar/register/WN_uMaG_U92TLGqb-2bTozXSw#/registration
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/
CATEGORIES:Government Hosted
LOCATION:https://www.youtube.com/watch?v=NXVMILYvocM
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/
CATEGORIES:Government Hosted
LOCATION:
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/
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
LOCATION:
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/
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/
CATEGORIES:Government Hosted
LOCATION:
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/
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: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/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231003
DTEND;VALUE=DATE:20231006
DTSTAMP:20230916T150439Z
CREATED:20230916T150439Z
LAST-MODIFIED:20230916T150439Z
UID:59214-1696291200-1696550399@globalbiodefense.com
SUMMARY:OneLab Summit 2023
DESCRIPTION:The CDC will host the OneLab Summit 2023 from 3-5 October 2023 online. This free\, three-day virtual summit connects laboratory professionals in real time to support a unified response to laboratory training needs. \nAttendance is open to anyone interested or involved in the laboratory profession. OneLab Summit programming is most relevant to people who provide education or training to clinical and public laboratory professionals. \nHighlighted topics include: \n\nMaximizing Lessons Learned from Past Outbreaks to Develop a Sustainable Laboratory Cross-training Program\nBiosafety Plan: Preparing Your Laboratory to Handle Emerging and Re-Emerging Pathogens\nHow Laboratories Should Prepare for Future Responses\nEvaluating Your Laboratory’s Risk Management Process Or Quality Improvement Process\nThe Role and Importance of DEIAB in Public Health Workforce Development to Advance Health Equity\nInterconnecting People for Planning and Preparedness\nOneLab REACH – What’s New and What’s Ahead\nUnderstanding CLIA and CAP Regulations to Advance Your Laboratory Career\nCreating a Training Needs Assessment For Your Laboratory\nLaboratory Staffing and Retention\nInnovative Student Recruitment to MLS and MLT Programs\n\nThis year\, OneLab Summit will feature a Virtual Exhibit Hall. Attendees can use this online space to highlight their organization’s programs\, resources\, success stories\, and more. \nPlease visit CDC’s OneLab Summit 2023 website to register.
URL:https://globalbiodefense.com/event/onelab-summit-2023/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:https://cdc.zoomgov.com/webinar/register/WN_tANOotpLSduPLwmczNXDVA#/registration
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231113
DTEND;VALUE=DATE:20231115
DTSTAMP:20231017T165957Z
CREATED:20231016T173338Z
LAST-MODIFIED:20231017T165957Z
UID:59385-1699833600-1700006399@globalbiodefense.com
SUMMARY:BARDA Industry Day - BID2023
DESCRIPTION:The annual BARDA Industry Day (BID) conference will be held 13-14 November 2023 in Washington DC and via virtual participation. \nBID2023: Driving Innovation for Preparedness & Response will feature presentations from BARDA leadership\, U.S. government partners\, and industry on medical countermeasure (MCM) priorities and public health innovation. Attendees will also have an informal opportunity to interact with BARDA and ASPR teams and identify areas of potential collaboration in the field of MCM research and development. \nThe event lineup will have an assortment of BARDA program briefings\, guest speakers\, networking opportunities\, and specialized breakout sessions. Content will focus on BARDA’s efforts to collaborate across government and industry to continually innovate MCMs to address current and future health security threats. \nBARDA’s Influenza and Emerging Infectious Diseases Division (IEIDD) will give a broad ranging presentation on BARDA’s strategy for vaccine development through licensure including harmonized clinical trials\, centralized immune endpoint assays\, determination of correlates of protection\, lessons learned from the COVID-19 vaccine portfolio\, and assay-generated data for accelerated decision making. \nBARDA’s Division of Chemical\, Biological\, Radiological\, And Nuclear (CBRN) Countermeasures will provide an overview of its strategic priorities for branch and division level efforts. Among these priorities include CBRN’s plans to expand the nation’s capabilities to respond to any CBRN health security incident\, whether naturally occurring or intentional. Following the presentations\, a moderated Q&A panel will provide a deeper dive into how division-level priorities can shape medical countermeasure development going forward. \nBARDA program representatives\, industry partners\, and developers will provide an overview of animal models developed in laboratories of network performers funded through the Biological\, Chemical\, and Radiological Indefinite Delivery/Indefinite Quantity (ID/IQ) contract. In addition\, selected product developers funded by BARDA’s nonclinical network will share information on the use of animal models in efforts to license products for use against biodefense threats. \nBARDA’s Biopharmaceutical Manufacturing Preparedness (BioMaP) program has a three-pronged approach to address key vaccine manufacturing gaps to bring the nation up to the speed and scale required for future public health emergencies. In this session\, the BioMaP team will discuss these three components: the BioMaP-Consortium\, the Exercise (BioMaP-X)\, and the BioMaP Workforce Development (BioMaP-W). Join BARDA’s Pharmaceutical Countermeasures Infrastructure Division (PCI) to learn about these different aspects of the BioMaP program. \nSpeakers from the U.S. Food and Drug Administration’s (FDA) Medical Countermeasures Initiative will also address the coordination of emergency activities involving products regulated by the FDA’s Center for Drug Evaluation and Research (CDER)\, Center for Biologics Evaluation and Research (CBER)\, and Center for Devices and Radiological Health (CDRH). \nThe Division of Chemical\, Biological\, Radiological and Nuclear (CBRN)\, Division of Research\, Innovation and Ventures (DRIVe)\, and Division of Nonclinical Development (DNCD) will discuss microphysiological systems (MPS)/organ chips and how it aligns with BARDA’s portfolio. \nLearn more about BARDA Ventures – Global Health Investment Corporation (GHIC) partnership and join a discussion with GHIC on investment focus\, priorities\, and the landscape of venture investment in global health security. In addition\, learn more about the case study with Cytovale and Endpoint Health demonstrating how BARDA Ventures complements BARDA’s other investment vehicles to support MCM development and commercialization. \nA session on host-based diagnostics in sepsis will illuminate the strategic value of Host-Based Diagnostics (HBDs) in the infectious disease space and how to build a community around demonstrating the clinical utility of HBDs and streamlining their adoption and integration into practice. \nUncover BARDA’s latest initiative in clinical trial innovation pertaining to decentralized trials – the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) strategic partnership. Topics include information on D-COHRe and BARDA’s fundamental interagency work towards advancing pandemic preparedness. \nPlease visit Medicalcountermeasures.gov to register. \n 
URL:https://globalbiodefense.com/event/barda-industry-day-bid2023/
LOCATION:Grand Hyatt Washington\, 1000 H St NW\, Washington DC\, 20001\, United States
CATEGORIES:Government Hosted,Industry Day
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2023/10/barda-industry-day-2023.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20240222T090000
DTEND;TZID=America/New_York:20240222T160000
DTSTAMP:20240202T211124Z
CREATED:20240202T210750Z
LAST-MODIFIED:20240202T211124Z
UID:59861-1708592400-1708617600@globalbiodefense.com
SUMMARY:PACCARB Public Meeting
DESCRIPTION:The 24th Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) public meeting will be held virtually on February 22\, 2024. \nThis will be the second of two meetings to address the task provided to the PACCARB by the Secretary of HHS to address antimicrobial resistance globally. The focus of the meeting will be on international implementers and the gaps\, challenges\, and opportunities they see to combat AMR globally – specifically focusing on low- and middle-income countries. \nMeetings of the PACCARB are open to the public\, and virtual meetings can be accessed through the webcast. Registration to attend is not required but is encouraged. Attendees may also directly address the council on topics of antimicrobial resistance during public meetings. To provide written comments\, please e-mail your comments to CARB@hhs.gov. Written comments must be sent in by midnight February 15\, 2024 and should be limited to no more than one page. All public comments received prior to the deadline will be provided to the PACCARB council members. \nMeeting times are tentative and subject to change. Please visit HHS’ PACCARB website for the most current information.
URL:https://globalbiodefense.com/event/paccarb-public-meeting/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240223
DTEND;VALUE=DATE:20240224
DTSTAMP:20240218T175243Z
CREATED:20240218T174811Z
LAST-MODIFIED:20240218T175243Z
UID:60021-1708646400-1708732799@globalbiodefense.com
SUMMARY:Rapid Access to Products in Development (RAPID) Virtual Industry Day
DESCRIPTION:A Joint Industry Day for the Rapid Access to Products in Development (RAPID) program to be held virtually on 23 Feb 2024. \nThe Joint Program Executive Office for Chemical\, Biological\, Radiological\, and Nuclear Defense\, Enabling Biotechnologies (JPEO-CBRND-EB)\, develops\, manufactures and delivers safe and effective Medical Countermeasures (MCMs) for preparedness\, prevention\, protection\, response\, and recovery from CBRN threats. \nThe Rapid Access to Products in Development (RAPID) program is an integrated defense system composed of both physical MCM storage and fielding capabilities and a readily accessible information warehouse and sharing system (the RAPID Database). \nThe purpose of this Industry Day is to identify industry partners and capabilities to develop a RAPID Database capable of storing and organizing complex data and information related to CBRN MCMs such that it is intuitively accessible by a variety of end users during urgent planning and response situations. \nThe Database is intended to provide actionable information to assist CCMD-level decision makers when evaluating a RAPID MCM for potential administration to US warfighters; and JPEO- and CBDP-level decision makers when determining portfolio investment strategies or rapid response adjustments based on changing circumstances. \nThis Industry Day will include presentation by JPL EB as well as opportunities for industry partners to present their capabilities in one-on-one breakout sessions with representatives from the Government agencies. Industry partners will update Government stakeholders\, partners\, and end users on current efforts and capabilities. \nCompanies that wish to attend must register no later than 19 Feb 2024. More information is available at SAM.gov Notice ID W911SR-24-S-RAPID.
URL:https://globalbiodefense.com/event/medical-countermeasures-rapid-access-to-products-in-development-rapid-virtual-industry-day/
CATEGORIES:Government Hosted
LOCATION:
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240228
DTEND;VALUE=DATE:20240301
DTSTAMP:20240226T215053Z
CREATED:20240226T215042Z
LAST-MODIFIED:20240226T215053Z
UID:60125-1709078400-1709251199@globalbiodefense.com
SUMMARY:Meeting of the Advisory Committee on Immunization Practices (ACIP)
DESCRIPTION:The CDC’s Advisory Committee on Immunization Practices (ACIP) will convene 28-29 February 2024 in Atlanta\, GA and via webcast. \nThe ACIP develops recommendations for U.S. immunizations\, including ages when vaccines should be given\, number of doses\, time between doses\, and precautions and contraindications. \nThe agenda will include the following: \n\nUpdate on chikungunya vaccine licensure and review of proposed policy options for chikungunya vaccine use among U.S. adults traveling abroad\, laboratory workers\, and pregnant and breastfeeding persons\nGuidance to use Td vaccine for those instances when receipt of the pertussis component is contraindicated\nCOVID-19 vaccination coverage\, effectiveness and economic analysis of additional dose recommendations\nNext steps for the COVID-19 vaccine program\nInterim estimates of 2023-24 seasonal influenza vaccine effectiveness\nSafety of LAIV4 in children with asthma\nInfluenza B/Yamagata update\nPolio Work Group deliberations on potential use of nOPV2 as an outbreak control measure in the US\nClinical considerations for children who received fractional dose inactivated polio vaccine (fIPV) in other countries\nPost-marketing safety surveillance of older adult RSV vaccination\nPreliminary Analysis of Guillain-Barré Syndrome (GBS) following RSV vaccination among adults 65 years and older\nOverview of Moderna’s investigational RSV Vaccine (mRNA-1345) in adults ≥60 years of age\nRevising the adolescent Meningococcal vaccine schedule\nCurrent epidemiology of invasive pneumococcal disease and pneumococcal vaccine coverage in adults\nPreliminary findings of the Pneumococcal pNeumonia Epidemiology\, Urine serotyping\, and Mental Outcomes (PNEUMO) US study\nBackground on invasive Hib disease and vaccination among American Indian and Alaska Native Populations\n\nThe meeting will be held on February 28\, 2024\, from 8 a.m. to 5 p.m.\, EST and February 29\, 2024\, from 8 a.m.\nto 3 p.m.\, EST (times subject to change). \nPlease visit the CDC’s Advisory Committee on Immunization Practices for the latest information. No registration is required to watch the webcasts.
URL:https://globalbiodefense.com/event/meeting-of-the-advisory-committee-on-immunization-practices-acip/
CATEGORIES:Government Hosted
LOCATION:https://video.ibm.com/channel/VWBXKBR8af4
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240411
DTEND;VALUE=DATE:20240413
DTSTAMP:20240302T211201Z
CREATED:20240302T211201Z
LAST-MODIFIED:20240302T211201Z
UID:60496-1712793600-1712966399@globalbiodefense.com
SUMMARY:NIST Rapid Microbial Testing Methods Consortium Workshop
DESCRIPTION:The NIST-led Rapid Microbial Testing Methods (RMTM) Consortium is hosting the 4th annual workshop 11-12 April 2024 to update the community on RMTM Consortium efforts and to work on Consortium deliverables. \nOver the course of two days\, independent working sessions will be hosted\, with Day 1 open to the public and Day 2 for Consortium members only. \nThis open\, virtual workshop is free of charge. All interested parties are invited to Day 1\, including advanced therapy producers\, rapid microbial testing assay/instrument developers\, and cell reference material producers. \nNew members are being accepted into the Consortium. \nPlease visit NIST’s 2024 NIST Rapid Microbial Testing Methods Consortium Workshop website for more information. \nABOUT THE RMTM \nThe NIST Rapid Microbial Testing Methods (RMTM) Consortium addresses the need for measurements and standards\, including reference materials\, to increase confidence in the use of rapid testing for microbial contaminants in regenerative medicine and advanced therapy products. \nThe safety and quality of advanced therapies\, including cell therapy\, gene therapy\, and tissue engineered products\, must be maintained prior to patient administration. The culture-based compendial methods currently used to assess product purity (specifically to ensure absence of microbial contamination) typically take weeks\, which is inadequate for patients in urgent need of life-saving therapies. These methods are also incompatible with products that have a limited shelf-life and cannot meet good manufacturing practices required in process control and release testing. Alternative rapid microbial testing methods are needed to ensure fit for purpose safety assessments for this broad class of advanced therapeutics. \nThe NIST RMTM Consortium brings together experts across the regenerative medicine field including stakeholders in industry\, academia and government to address this need.
URL:https://globalbiodefense.com/event/nist-rapid-microbial-testing-methods-consortium-workshop/
CATEGORIES:Government Hosted
LOCATION:
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20240603
DTEND;VALUE=DATE:20240606
DTSTAMP:20240528T155500Z
CREATED:20240528T153434Z
LAST-MODIFIED:20240528T155500Z
UID:61289-1717372800-1717631999@globalbiodefense.com
SUMMARY:Spring 2024 NSF Grants Conference
DESCRIPTION:Join the National Science Foundation (NSF) for the Spring 2024 Grants Conference from June 3 – 5\, 2024\, in Philadelphia\, PA. The event offers virtual attendance as well. \nThe NSF Grants Conference will provide up-to-date information about policies and procedures\, specific funding opportunities\, and answer attendee questions on topics including: \nResearch.gov and SciENcv Session \nNSF staff will highlight updates to NSF Research.gov. Staff from the National Institutes of Health will demonstrate SciENcv for the preparation of the biographical sketch and current and pending (other) support information. \nSciENcv is a grant application tool that helps proposers reduce administrative burden with time-saving features. This portion of the session will delve into the evolution of SciENcv\, showcase how it empowers researchers to access vital data for grant applications\, and demonstrate the enhancements added to help you generate needed forms faster than ever! \nDirectorate for Biological Sciences (BIO) \nThe mission of the Directorate for Biological Sciences (BIO) is to enable discoveries for understanding life. BIO-supported research advances the frontiers of biological knowledge\, increases our understanding of complex systems\, and provides a theoretical basis for original research in many other scientific disciplines. \nPlease visit NSF’s Grants Conference website for more information.
URL:https://globalbiodefense.com/event/spring-2024-nsf-grants-conference/
LOCATION:Philadelphia Mariott Old City\, One Dock St\, Philadelphia\, 19106\, United States
CATEGORIES:Government Hosted
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20240606T130000
DTEND;TZID=America/New_York:20240606T140000
DTSTAMP:20240528T155815Z
CREATED:20240528T155815Z
LAST-MODIFIED:20240528T155815Z
UID:61299-1717678800-1717682400@globalbiodefense.com
SUMMARY:Modernized ClinicalTrials.gov Update
DESCRIPTION:ClinicalTrials.gov is the world’s largest database of privately and publicly funded clinical trials. NLM is in the final phases of a multi-year effort to modernize ClinicalTrials.gov delivering an improved user experience on an updated platform that will accommodate growth and enhance efficiency. \nDuring this webinar\, ClinicalTrials.gov staff will: \n\nShare updates on the overall modernization effort\,\nHighlight features of the modernized website\, and\nHelp users prepare for the retirement of the classic ClinicalTrials.gov.\n\nYou’ll also have an opportunity to submit questions to the speakers. \nPlease REGISTER in advance for this webinar. \nThis webinar is intended for the general public\, patients\, patient advocates\, data researchers\, data providers\, and anyone who accesses and uses the information found on ClinicalTrials.gov.
URL:https://globalbiodefense.com/event/modernized-clinicaltrials-gov-update/
CATEGORIES:Government Hosted
LOCATION:
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20240625T120000
DTEND;TZID=America/New_York:20240625T130000
DTSTAMP:20240624T175704Z
CREATED:20240521T200752Z
LAST-MODIFIED:20240624T175704Z
UID:61246-1719316800-1719320400@globalbiodefense.com
SUMMARY:What's in the RADx Data Hub?
DESCRIPTION:The NIH RADx Data Hub is one of the largest NIH COVID data collections available to researchers\, allowing them to explore\, access\, and analyze COVID-related data developed from over 150 studies through NIH RADx Initiative programs. \nThe NIH RADx Data Hub relaunched with an entirely new look and feel and exciting new analysis features. Join a virtual presentation on 25 June 2024 on the NIH RADx® study data collections accessible via the RADx Data Hub. \nIn this presentation\, representatives from RADx program Collection and Data Coordinating Centers ((C)DCCs) will highlight unique scientific domain areas. Presenters will discuss challenges\, illustrate their diverse study landscapes\, and overview impactful studies. RADx Data Hub Partners will then provide an overview of RADx data access requests for secondary analysis. \nPresenters and RADx Data Hub developers will be available for a live Question and Answer session\, and a recording of the event will be sent to all registrants.
URL:https://globalbiodefense.com/event/whats-in-the-radx-data-hub/
CATEGORIES:Government Hosted
LOCATION:
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20241114T093000
DTEND;TZID=America/New_York:20241114T170000
DTSTAMP:20241107T191142Z
CREATED:20241107T191142Z
LAST-MODIFIED:20241107T191142Z
UID:61954-1731576600-1731603600@globalbiodefense.com
SUMMARY:Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral Vectors
DESCRIPTION:The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on the clinical use of integration site analysis (ISA) during long term follow-up following administration of gene therapies with integrating viral vectors. \nIn this workshop\, FDA will convene a panel of external experts to discuss the risk of insertional mutagenesis and best practices for ISA method design\, data analysis\, and clinical interpretation. The workshop participants will include research scientists with experience in vector design and ISA\, as well as clinician-scientists with expertise in clinical interpretation of ISA data. \nFocus for this Workshop\nAs of 2024\, twelve approved and hundreds of investigational cell-based gene therapies use integrating viral vectors. While stable integration may have considerable therapeutic benefits\, integration into genomic DNA can alter host gene expression and may contribute to secondary malignancies via insertional mutagenesis. Additionally\, the choice of vector (e.g.\, lentivirus versus gammaretrovirus) and cell substrate (e.g.\, T cells versus CD34+ cells) may also contribute to this risk. \nISA is the established approach to identify vector insertion sites. However\, ISA method design and data interpretation are highly complex and product-specific. Moreover\, ISA methods may be costly and challenging to perform. There is a critical need to understand the best practices for product design and ISA method design\, execution\, and interpretation to facilitate efficient evaluation of complex gene therapy products and protect the public from potential serious adverse events. \nThis workshop will include discussions on the following topics: \n\nEffects of Cell Substrate and Vector Design on the Risk of Vector Insertion-Related Adverse Events\nISA Methodology\, Assay Design\, and Analytical Capabilities\nISA Analysis\, Quality Control\, and Data Reporting\nClinical Follow-Up for Integrating Viral Vectors\nUsing ISA to Inform Clinical Decisions\n\nFor current guidance on the role of ISA in clinical follow-up\, please refer to section V.F “Special Considerations Regarding Integrating Vectors” of the FDA Guidance for Industry “Long Term Follow-Up After Administration of Human Gene Therapy Products” dated January 2020 (https://www.fda.gov/media/113768/download). \n Registration is required.
URL:https://globalbiodefense.com/event/integration-site-analysis-during-long-term-follow-up-for-gene-therapies-with-integrating-viral-vectors/
CATEGORIES:Conference,Government Hosted
LOCATION:
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250401T090000
DTEND;TZID=America/New_York:20250401T100000
DTSTAMP:20250320T183753Z
CREATED:20250320T183753Z
LAST-MODIFIED:20250320T183753Z
UID:62253-1743498000-1743501600@globalbiodefense.com
SUMMARY:USDA HPAI Poultry Innovation Grand Challenge
DESCRIPTION:U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS) is offering a webinar on April 1\, 2025 to discuss a newly released HPAI Poultry Innovation Grand Challenge. \nThe event will assist interested applicants in learning more about the funding opportunity and how to submit a proposal. \nThe funding will support projects that will explore vaccines\, therapeutics\, research and other strategies to combat highly pathogenic avian influenza (HPAI) in poultry. \nAdvanced registration is required.
URL:https://globalbiodefense.com/event/usda-hpai-poultry-innovation-grand-challenge/
CATEGORIES:Government Hosted
LOCATION:
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250930T140000
DTEND;TZID=America/New_York:20250930T170000
DTSTAMP:20250925T170137Z
CREATED:20250925T170053Z
LAST-MODIFIED:20250925T170137Z
UID:63188-1759240800-1759251600@globalbiodefense.com
SUMMARY:Strengthening and Modernizing Biosafety Oversight: Region 1 Listening Session
DESCRIPTION:On September 30\, 2025\, the National Institutes of Health (NIH)\, in collaboration with the New England Biological Safety Association\, the Northeast Biological Safety Association\, the Mid-Atlantic Biological Safety Association\, and the Chesapeake Area Biological Safety Association\, will host the first in a series of public regional listening sessions aimed at strengthening and modernizing biosafety oversight. \nThis Region 1 session will take place virtually from 2:00–5:00 PM ET and will prioritize participation from stakeholders located in Maine\, New Hampshire\, Vermont\, Massachusetts\, Connecticut\, Rhode Island\, New York\, Pennsylvania\, New Jersey\, Delaware\, West Virginia\, Maryland\, and Washington\, D.C.. \nPurpose and Objectives\nThe initiative reflects NIH’s commitment to updating its biosafety framework in light of evolving research practices and new challenges in global health security. The listening session is designed to: \n\nGather Stakeholder Input: Solicit feedback on the scope of NIH’s biosafety policy\, including whether it should continue to focus on recombinant and synthetic nucleic acids or expand to encompass wild-type biological agents\, proteins (e.g.\, toxins\, prions)\, infectious microbes\, and other hazardous biological materials.\nAssess Oversight Needs: Identify categories of research that may warrant reduced local or NIH oversight\, such as non-biomedical research under USDA or EPA purview\, FDA-regulated clinical research\, or low-risk projects involving RG1 agents or certain transgenic organisms.\nPromote Transparency and Engagement: Provide a platform for scientists\, biosafety professionals\, and other stakeholders to share their perspectives on creating a more modern\, risk-based biosafety oversight system.\n\n \nFormat and Participation\nThe session will be webcast live via NIH Videocast\, ensuring accessibility for participants across the region. Pre-registration is required\, and attendees are encouraged to indicate if they wish to provide oral comments. Requests to make comments must be submitted by September 29\, 2025. \nAll oral contributions\, as well as written feedback\, will be considered as NIH and its partners refine the direction of biosafety modernization. Importantly\, the session is free and open to the public\, reinforcing the initiative’s emphasis on inclusivity and diverse stakeholder engagement. \nWho Should Attend\nThis session is particularly relevant to: \n\nPublic health and global health security professionals\nBiosafety officers and laboratory managers\nAcademic and government researchers conducting life sciences or biomedical research\nRegulatory and compliance officials working with NIH\, USDA\, EPA\, or FDA frameworks\nEpidemiologists and infectious disease experts interested in policy intersections with research oversight\n\nLooking Ahead\nThe Region 1 event represents just the beginning of NIH’s nationwide effort. By engaging local and regional stakeholders\, NIH aims to shape a modern\, flexible biosafety oversight framework that balances scientific innovation with safety and public trust. \nFor more information\, including the draft agenda\, registration link\, and participation details\, please visit the NIH Office of Science Policy’s event webpage.
URL:https://globalbiodefense.com/event/nih-strengthening-and-modernizing-biosafety-oversight-region-1-listening-session/
CATEGORIES:Government Hosted
LOCATION:
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