Combined archive search across FBI Vault, SPLC, PHMPT, ACIP, NIH grants, the Federal Writers' Project, and other collections we've ingested.
From: Smith, Michael (CBER) Sent: Wednesday, August 4, 2021 11:00 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE potency assay for determination of IVE by flow cytometry Elisa, The review team has two questions for you regarding the…
ATTACHMENT 1 - Electronic Protocol Page 1 cc: 000000 _0/Lic #/ C or – B or –FC Page 1 of y Lot Number: License Name of Product: Reason For…
From: Smith, Michael (CBER) Sent: Wednesday, August 4, 2021 4:48 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Comments on LRP template submitted to STN 125742/0.14 on 7/20 Elisa, The review team…
From: Smith, Michael (CBER) Sent: Tuesday, August 3, 2021 4:55 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: CMC -related questions Elisa, Our review of the information provided in your BLA STN…
From: Smith, Michael (CBER) Sent: Monday, August 2, 2021 7:05 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura <[email protected]> Subject: STN 125742.0: Questions regarding validation of assay methods and lot release Elisa, The review team…
From: Smith, Michael (CBER) Sent: Tuesday, July 27, 2021 10:01 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: IR RE assessment of vaccine effectiveness Elisa, The review team has the below Information Request for Pfizer and BioNTech…
From: Gottschalk, Laura Sent: Monday, July 26, 2021 7:19 PM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul <[email protected]> Subject: STN 125742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) – Comments regarding manufacturing and equipment Dear Ms.…
Hideki Aihara · UNIVERSITY OF MINNESOTA · 2022 · $619,646 — Abstract Viruses are a major threat to human health. Our laboratory uses various structural biology techniques to dissect molecular mechanisms of how viruses replicate and invade the host cell or its genome. One area of our major interest is retroviral integration, a critical step in the lifecycle o…
ELAN Z EISENMESSER · UNIVERSITY OF COLORADO DENVER · 2022 · $194,375 — PROJECT SUMMARY Coronaviruses (CoVs) have emerged as formidable human pathogens since their detection within human populations only 50 years ago, underlying the need to rapidly characterize their molecular mechanisms in order to thwart their infections through therapeutics. Seven CoVs that infect h…
Matthew Bogyo · STANFORD UNIVERSITY · 2022 · $196,750 — Project Summary Current strategies to overcome virus outbreaks are focused on development of effective vaccines as well as novel treatments that can either block infection or prevent mortality from the resulting disease. One of the strategies that has shown promise is the use of serum from patients …
Nitesh K Kunda · ST. JOHN'S UNIVERSITY · 2022 · $164,000 — Summary Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) is a highly infectious virus known to cause the 2019 coronavirus disease (COVID-19). The disease has been declared as a global pandemic by the World Health Organization. In the United States, as of January 20, 2021, we have more th…
Veronica Villanueva · RUSH UNIVERSITY MEDICAL CENTER · 2022 · $46,752 — Lupus nephritis (LN) and coronavirus disease 2019 (COVID-19) both display myeloid cell dysfunction which can lead to altered signaling resulting in tissue damage, such as kidney injury. Up to 50% of LN patients develop chronic kidney disease (CKD) and 25% of COVID-19 patients are reported to experie…
MICHAEL G ROSENFELD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2022 · $416,540 — ABSTRACT Alzheimer’s disease (AD) presents a formidable therapeutic challenge, as current interventions have failed to slow disease progression. The majority of AD genetic risk variants identified by GWAS reside in non- coding regions of the genome, suggesting that alterations in gene expression con…
Rebecca Michelle DuBois · UNIVERSITY OF CALIFORNIA SANTA CRUZ · 2022 · $379,529 — PROJECT SUMMARY Human astroviruses (HAstV) are a leading cause of viral diarrhea in children. Divergent HAstV strains are associated with fatal human encephalitis. Currently, no vaccines or antiviral therapies exist for HAstV infections. Our goal is to identify sites of vulnerability (Achilles' heel…
MARK L DELL'ACQUA · UNIVERSITY OF COLORADO DENVER · 2022 · $537,331 — Plasticity in the hippocampus leads to persistent changes in synaptic structure and function that underlie learning and memory. Intracellular Ca2+ signaling pathways activated downstream of NMDA receptors (NMDAR) and L-type voltage-gated Ca2+ channels (LTCC) contribute to changes synaptic function t…
Galit Alter · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $26,206 — Since 2002, several coronaviruses have emerged able to cause severe respiratory disease, however no vaccine is available to prevent these rapidly spreading pathogens. Vaccine design has specifically lagged due to our lack of understanding of the correlates of immunity against these pathogens. Both c…
Todd A Wyatt · OMAHA VA MEDICAL CENTER · 2022 — My primary research interests address chronic inflammatory lung disease, and the impact that behavioral and environmental exposures play in the compromise of lung innate defense against pathologic lung infections and injury. Utilizing pre-clinical mouse models and state-of-the-art molecular, biochem…
Yehia Mechref · TEXAS TECH UNIVERSITY · 2022 · $302,855 — Glycosylation is one of the most complex protein modifications; more than 50% of mammalian proteins are glycosylated. The fact that there are 100,000 proteoforms coded by only ~20,300 genes identified in the human genome emphasizes the importance of posttranslational modifications (PTMs) like glycos…
Ricardo Rajsbaum · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · 2022 · $471,011 — The Severe Acute Respiratory Syndrome Coronavirus 2 (CoV-2) belongs to a family of pathogenic enveloped RNA viruses of the family Coronaviridae. The ongoing pandemic has caused a public health emergency worldwide, accompanied by dire health and economic consequences. There is evidence suggesting tha…
GUIRONG WANG · UPSTATE MEDICAL UNIVERSITY · 2022 · $244,500 — More than 4.8 million people have died due to coronavirus disease 2019 (COVID-19) in less than two years. COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Morbidity and mortality following SARS-CoV-2 infection are predominantly due to a robust…