PSII-B-21 Development of an industry relevant graduate certificate for regulatory affairs in animal health

2021 ◽  
Vol 99 (Supplement_3) ◽  
pp. 501-501
Author(s):  
Haley E Larson ◽  
Alison P Adams ◽  
Rebekkah Stuteville
Keyword(s):  
Vaccine Development ◽  
Animal Health ◽  
Educational Background ◽  
Advisory Panel ◽  
Strong Interest ◽  
Regulatory Affairs ◽  
Health Products ◽  
Regulatory Development ◽  
Assessment Of Student Learning ◽  
Graduate Certificate

Abstract Seven years of data collection and industry collaboration identified a longstanding need from the animal health corridor for educational offerings focused on regulatory affairs for animal health products. The animal health corridor, anchored by Manhattan, Kansas and Columbia, Missouri, is home to more than 300 animal health companies, representing the largest concentration in the world. When surveying industry needs, Kansas State University received 446 responses from individuals in this area and found 40% indicated interest in “policy and regulations,” with 64% of interested respondents showing strong interest with programming at the graduate level. Meetings with industry representatives further confirmed results of the survey by highlighting a need for educational programming focused on animal health product license requirements with USDA, FDA, and EPA. At a roundtable with 22 Animal Health organizations, 64% of attendees had strong interest in a program focused on “regulatory aspects of drug and vaccine development in animal health.” In response to these findings, a graduate certificate was launched in 2019 encompassing regulatory development and management of animal health products. Curriculum was crafted in close collaboration with an industry advisory panel, because comparable academic models were not available. Interests to maintain industry contacts within the courses have led to integration of notable engagement techniques as the course format moves toward asynchronous delivery. Curriculum encompasses regulatory development of animal pharmaceuticals, pesticides, biologics, and diagnostics from pre- to post- licensure. The presentation will explain objectives of the certificate, data gathered regarding industry need, process of certificate design and curriculum co-creation with industry partners, and resulting curriculum. Additionally, since the new courses in the regulatory affairs certificate have been offered since spring 2020, the presentation will examine strategies for working with subject matter experts in the online classroom, plans for assessment of student learning, and educational background of enrolled students.

Industry Watch

2003 ◽  
Vol 07 (22) ◽  
pp. 1391-1406
Keyword(s):  
Drug Discovery ◽  
Animal Health ◽  
Biotech Company ◽  
Discovery Research ◽  
Fda Approval ◽  
Drug Discovery Research ◽  
Medical Facilities ◽  
Us Government ◽  
Health Products ◽  
Us Fda

Alliance between AGT Biosciences and Starpharma. First Australian Biotech Company to List on HKSE. Breakthrough in Transdermal Drug Discovery Technology. Acrux Licenses MDTS Technology to Eli Lilly got Animal Health Products. Biota Secures SARS Testing Agreement with US Government Research Agencies. SysArris in Bio Partnering Europe 2003. Shantha Bio to Launch Streptokinase by Year-end. Lupin Receives US FDA Approval to Launch Ceftriaxone. MerLion Pharma Collaborates with Schering-Plough in Drug Discovery Research. Quest Pharmaceutical Sets up Taiwanese Subsidiary. BenQ to Invest in Nanjing's Medical Facilities.

scholarly journals The Intriguing Interaction of Escherichia coli with the Host Environment and Innovative Strategies To Interfere with Colonization: a Summary of the 2019 E. coli and the Mucosal Immune System Meeting

2020 ◽  
Vol 86 (24) ◽  
Author(s):  
Eric Cox ◽  
Meryem Aloulou ◽  
James M. Fleckenstein ◽  
Christina Schäffer ◽  
Åsa Sjöling ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Immune System ◽  
Vaccine Development ◽  
Animal Health ◽  
Mucosal Immune System ◽  
Periodontal Pathogen ◽  
Content Type ◽  
Innovative Strategies ◽  
E Coli ◽  
Health And Disease

ABSTRACT The third E. coli and the Mucosal Immune System (ECMIS) meeting was held at Ghent University in Belgium from 2 to 5 June 2019. It brought together an international group of scientists interested in mechanisms of colonization, host response, and vaccine development. ECMIS distinguishes itself from related meetings on these enteropathogens by providing a greater emphasis on animal health and disease and covering a broad range of pathotypes, including enterohemorrhagic, enteropathogenic, enterotoxigenic, enteroaggregative, and extraintestinal pathogenic Escherichia coli. As it is well established that the genus Shigella represents a subspecies of E. coli, these organisms along with related enteroinvasive E. coli are also included. In addition, Tannerella forsythia, a periodontal pathogen, was presented as an example of a pathogen which uses its surface glycans for mucosal interaction. This review summarizes several highlights from the 2019 meeting and major advances to our understanding of the biology of these pathogens and their impact on the host.

scholarly journals Bovine Babesiosis in Turkey: Impact, Current Gaps, and Opportunities for Intervention

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1041
Author(s):  
Sezayi Ozubek ◽  
Reginaldo G. Bastos ◽  
Heba F. Alzan ◽  
Abdullah Inci ◽  
Munir Aktas ◽  
...  
Keyword(s):  
Vaccine Development ◽  
Point Of Care ◽  
Animal Health ◽  
Current Control ◽  
Diagnostic Methods ◽  
Control Measures ◽  
Bovine Babesiosis ◽  
Research Programs ◽  
The Impact

Bovine babesiosis is a global tick-borne disease that causes important cattle losses and has potential zoonotic implications. The impact of bovine babesiosis in Turkey remains poorly characterized, but several Babesia spp., including B. bovis, B. bigemina, and B. divergens, among others and competent tick vectors, except Rhipicephalus microplus, have been recently identified in the country. Bovine babesiosis has been reported in all provinces but is more prevalent in central and highly humid areas in low and medium altitude regions of the country housing approximately 70% of the cattle population. Current control measures include acaricides and babesicidal drugs, but not live vaccines. Despite the perceived relevant impact of bovine babesiosis in Turkey, basic research programs focused on developing in vitro cultures of parasites, point-of-care diagnostic methods, vaccine development, “omics” analysis, and gene manipulation techniques of local Babesia strains are scarce. Additionally, no effective and coordinated control efforts managed by a central animal health authority have been established to date. Development of state-of-the-art research programs in bovine babesiosis to address current gaps in knowledge and implementation of long-term plans to control the disease will surely result in important economic, nutritional, and public health benefits for the country and the region.

scholarly journals Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel

2020 ◽  
Vol 5 ◽  
pp. 139 ◽  
Author(s):  
Emily R. Adams ◽  
Mark Ainsworth ◽  
Rekha Anand ◽  
Monique I. Andersson ◽  
Kathryn Auckland ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Vaccine Development ◽  
Detection Threshold ◽  
Negative Control ◽  
Antibody Detection ◽  
Advisory Panel ◽  
Antibody Testing ◽  
Highly Sensitive ◽  
History Of ◽  
The Uk

Background: The COVID-19 pandemic caused >1 million infections during January-March 2020. There is an urgent need for reliable antibody detection approaches to support diagnosis, vaccine development, safe release of individuals from quarantine, and population lock-down exit strategies. We set out to evaluate the performance of ELISA and lateral flow immunoassay (LFIA) devices. Methods: We tested plasma for COVID (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) IgM and IgG antibodies by ELISA and using nine different LFIA devices. We used a panel of plasma samples from individuals who have had confirmed COVID infection based on a PCR result (n=40), and pre-pandemic negative control samples banked in the UK prior to December-2019 (n=142). Results: ELISA detected IgM or IgG in 34/40 individuals with a confirmed history of COVID infection (sensitivity 85%, 95%CI 70-94%), vs. 0/50 pre-pandemic controls (specificity 100% [95%CI 93-100%]). IgG levels were detected in 31/31 COVID-positive individuals tested ≥10 days after symptom onset (sensitivity 100%, 95%CI 89-100%). IgG titres rose during the 3 weeks post symptom onset and began to fall by 8 weeks, but remained above the detection threshold. Point estimates for the sensitivity of LFIA devices ranged from 55-70% versus RT-PCR and 65-85% versus ELISA, with specificity 95-100% and 93-100% respectively. Within the limits of the study size, the performance of most LFIA devices was similar. Conclusions: Currently available commercial LFIA devices do not perform sufficiently well for individual patient applications. However, ELISA can be calibrated to be specific for detecting and quantifying SARS-CoV-2 IgM and IgG and is highly sensitive for IgG from 10 days following first symptoms.

scholarly journals Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel

2020 ◽  
Author(s):  
◽  
Emily R Adams ◽  
Mark Ainsworth ◽  
Rekha Anand ◽  
Monique I Andersson ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Vaccine Development ◽  
Detection Threshold ◽  
Negative Control ◽  
Antibody Detection ◽  
Advisory Panel ◽  
Antibody Testing ◽  
Highly Sensitive ◽  
History Of ◽  
The Uk

ABSTRACTBackgroundThe COVID-19 pandemic caused >1 million infections during January-March 2020. There is an urgent need for reliable antibody detection approaches to support diagnosis, vaccine development, safe release of individuals from quarantine, and population lock-down exit strategies. We set out to evaluate the performance of ELISA and lateral flow immunoassay (LFIA) devices.MethodsWe tested plasma for COVID (SARS-CoV-2) IgM and IgG antibodies by ELISA and using nine different LFIA devices. We used a panel of plasma samples from individuals who have had confirmed COVID infection based on a PCR result (n=40), and pre-pandemic negative control samples banked in the UK prior to December-2019 (n=142).ResultsELISA detected IgM or IgG in 34/40 individuals with a confirmed history of COVID infection (sensitivity 85%, 95%CI 70-94%), vs. 0/50 pre-pandemic controls (specificity 100% [95%CI 93-100%]). IgG levels were detected in 31/31 COVID-positive individuals tested ≥10 days after symptom onset (sensitivity 100%, 95%CI 89-100%). IgG titres rose during the 3 weeks post symptom onset and began to fall by 8 weeks, but remained above the detection threshold. Point estimates for the sensitivity of LFIA devices ranged from 55-70% versus RT-PCR and 65-85% versus ELISA, with specificity 95-100% and 93-100% respectively. Within the limits of the study size, the performance of most LFIA devices was similar.ConclusionsCurrently available commercial LFIA devices do not perform sufficiently well for individual patient applications. However, ELISA can be calibrated to be specific for detecting and quantifying SARS-CoV-2 IgM and IgG and is highly sensitive for IgG from 10 days following first symptoms.

scholarly journals Antibody Response against SARS-CoV-2 and Seasonal Coronaviruses in Nonhospitalized COVID-19 Patients

mSphere ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Natalia Ruetalo ◽  
Ramona Businger ◽  
Karina Althaus ◽  
Simon Fink ◽  
Felix Ruoff ◽  
...  
Keyword(s):  
Antibody Response ◽  
Vaccine Development ◽  
Neutralizing Antibody ◽  
Cross Protection ◽  
Antibody Dependent Enhancement ◽  
Strong Interest

There is strong interest in the nature of the neutralizing antibody response against SARS-CoV-2 in infected individuals. For vaccine development, it is especially important which antibodies confer protection against SARS-CoV-2, if there is a phenomenon called antibody-dependent enhancement (ADE) of infection, and if there is cross-protection by antibodies directed against seasonal coronaviruses.

EFFECT OF MONENSIN AND A DEAMINASE INHIBITOR ON FEED UTILIZATION BY LAMBS

1980 ◽  
Vol 60 (1) ◽  
pp. 169-172 ◽  
Author(s):  
G. M. J. HORTON
Keyword(s):  
Fatty Acids ◽  
Propionic Acid ◽  
Feed Efficiency ◽  
Volatile Fatty Acids ◽  
Control Diet ◽  
Animal Health ◽  
Feed Utilization ◽  
Feedlot Performance ◽  
Gain Ratio ◽  
Health Products

Lambs were fed monensin (Rumensin®, monensin sodium, Eli Lilly and Co., Greenfield, Ind.) and a deaminase inhibitor 4,4’-dimethyldiphenyliodonium chloride (SmithKline Animal Health Products, West Chester, Pa.) (DAI) at 33 and 25 mg/kg of diet, respectively. Digestibility and ruminal volatile fatty acids were measured using five yearling lambs per treatment. There were no treatment effects on digestibility. Molar proportions of propionic acid were 93% higher when monensin plus DAI were fed than when lambs were offered the nonmedicated control diet. Feedlot performance was measured using eighty 18-kg crossbred lambs, with two pens of 10 lambs per treatment. Lambs fed DAI consumed 8% less feed than controls, though feed to gain ratio was not affected. Gains and feed efficiency with monensin were 8% and 5% higher (P < 0.05), respectively, than control values, though feed was utilized most efficiently when both monensin and DAI were fed.

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