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DTSTART;TZID=America/New_York:20221206T100000
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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
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DTSTART;VALUE=DATE:20230724
DTEND;VALUE=DATE:20230729
DTSTAMP:20230421T161848Z
CREATED:20230421T161759Z
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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
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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
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