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DTSTART;VALUE=DATE:20221102
DTEND;VALUE=DATE:20221104
DTSTAMP:20220922T163745Z
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SUMMARY:Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
DESCRIPTION:On November 2\, 2022\, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent\, reliable\, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry\, drug shortages\, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices. \nOn November 3\, 2022\, as part of CDER’s continued effort to provide key updates on modernization of quality assessment\, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20\, 2018\, as an IT system that modernizes FDA’s assessment. Through the development\, testing\, and implementation of various KASA prototypes\, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances\, all generic dosage forms\, new drug and biologics applications\, and post-approval changes. Moreover\, FDA will seek input regarding the need for advancing digitalization in KASA\, including data standardization and mobilization of data from cloud-based servers. \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-1777. \nPlease visit the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/pharmaceutical-science-and-clinical-pharmacology-advisory-committee-meeting/
CATEGORIES:Government Hosted,Webinar-Webcast
LOCATION:
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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:
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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:
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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
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