scholarly journals Perspectives on the draft ICH-M10 guidance: an interview with Mark Arnold

Bioanalysis ◽  
2019 ◽  
Vol 11 (15) ◽  
pp. 1379-1382 ◽  
Author(s):  
Mark E Arnold
Keyword(s):  
Immune Cell ◽  
Quantitative Polymerase Chain Reaction ◽  
University Of Pennsylvania ◽  
Clinical Samples ◽  
Indiana University ◽  
Bioanalytical Method Validation ◽  
University Of Pittsburgh ◽  
The Us ◽  
Us Fda ◽  
The University

Biography Mark E Arnold, PhD, is Director of Science for Covance Laboratories. In that role, he develops the bioanalytical strategy for immune-, cell-based, quantitative polymerase chain reaction (qPCR) and LC–MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers in animal and clinical samples for pharmacokinetic and pharmacodynamic assessments. Mark was previously Executive Director of Bioanalytical Sciences at Bristol–Myers Squibb. He received a BS (biology) from Indiana University of Pennsylvania and PhD (pharmacology) from the University of Pittsburgh. For more than 30 years, Mark has been involved in the evolving field of bioanalysis, including the science and the review and interpretation of regulations and guidance. He co-chaired the AAPS Crystal City V and VI Workshops on the US ‘FDA Draft Revised Guidance on Bioanalytical Method Validation’ and ‘Biomarkers’. He is actively involved in the Land O’Lakes Bioanalytical Conference and American Association of Pharmaceutical Scientists (AAPS, named Fellow in 2014). Mark has over 100 peer-reviewed publications, and numerous invited podium presentations. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis.

scholarly journals High Altitude Makes for High Energy

2018 ◽  
Vol XII (1) ◽  
pp. 99-101
Author(s):  
Tin Wegel
Keyword(s):  
High Energy ◽  
Indiana University ◽  
Lifelong Learners ◽  
Conference Room ◽  
Northern Colorado ◽  
The Us ◽  
Language Classrooms ◽  
University Of Northern Colorado ◽  
Performative Pedagogy ◽  
The University

On January 19, 2018 about 80 people sat in an unassuming conference room on the campus of the University of Northern Colorado in Greeley, chatting and signing away cheerfully with their seat neighbors in anticipation of the keynote address by Susanne Even from Indiana University in Bloomington, IN. The lively crowd of students and faculty members from across the country was clearly already in a chatty mood before the official introduction by Erin Noelliste, the lead organizer of the 5th Scenario Symposium on Performative Pedagogy, kicked off an engaging and interactive evening and day ahead. The idea behind this particular symposium was to focus on the use of drama to enhance learning in education and foreign languages, as the program stated. It was the second of its kind held in the US and thus aimed at broadening readership and scope of the Scenario Journal, with the goal of inspiring creativity and improvisation in foreign language classrooms. The keynote speaker Susanne Even took the podium and I dare say she could not have hoped for a more involved group of lifelong learners. Her keynote talk, made accessible to all participants by sign language interpreters, was the first presentation in the 2018 ...

scholarly journals Resecting the Dominant Lesion: Patient Outcomes after Surgery and Radiosurgery vs Stand-Alone Radiosurgery in the Setting of Multiple Brain Metastases

2021 ◽  
Author(s):  
Maria Punchak ◽  
Stephen P Miranda ◽  
Alexis Gutierrez ◽  
Steven Brem ◽  
Donald O'Rourke ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Surgical Resection ◽  
Gamma Knife Radiosurgery ◽  
Median Number ◽  
University Of Pennsylvania ◽  
Multiple Brain Metastases ◽  
The Us ◽  
Median Diameter ◽  
Similar Survival ◽  
The University

Abstract BACKGROUND: Brain metastases are the most common central nervous system (CNS) tumors, occurring in 300,000 people per year in the US. The benefit of surgical resection, over radiosurgery, for dominant lesions remains unclear. METHODS: The University of Pennsylvania Health System database was retrospectively reviewed for patients presenting with multiple brain metastases from 1/1/16 to 8/31/18 with one dominant lesion > 2 cm in diameter, who underwent initial treatment with either resection of the dominant lesion or Gamma Knife radiosurgery (GKS). Inclusion criteria were age > 18, >1 brain metastasis, and presence of a dominant lesion (>2 cm). We analyzed factors associated with mortality. RESULTS: 129 patients were identified (surgery=84, GKS=45). The median number of intracranial metastases was 3 (IQR: 2-5). The median diameter of the largest lesion was 31 mm (IQR: 25-38) in the surgery group vs 21 mm (IQR: 20-24) in the GKS group (p<0.001). Mortality did not differ between surgery and GKS patients (69.1% vs 77.8%, p = 0.292). In a multivariate survival analysis, there was no difference in mortality between the surgery and GKS cohorts (aHR: 1.35, 95% CI: 0.74-2.45 p=0.32). Pre-operative KPS (aHR: 0.97, 95% CI: 0.95-0.99, p=0.004), CNS radiotherapy (aHR: 0.33, 95% CI: 0.19-0.56 p<0.001), chemotherapy (aHR: 0.27, 95% CI: 0.15-0.47, p<0.001), and immunotherapy (aHR: 0.41, 95% CI: 0.25-0.68, p=0.001) were associated with decreased mortality. CONCLUSION: In our institution, patients with multiple brain metastases and one symptomatic dominant lesion demonstrated similar survival after GKS when compared with up-front surgical resection of the dominant lesion.

Perspectives on the draft ICH-M10 guidance: an interview with John Kadavil

Bioanalysis ◽  
2019 ◽  
Vol 11 (22) ◽  
pp. 2027-2028
Author(s):  
John Kadavil
Keyword(s):  
Bachelor's Degree ◽  
Public Consultation ◽  
Baltimore County ◽  
University Of Maryland ◽  
Scientific Investigations ◽  
School Of Medicine ◽  
The Us ◽  
Good Laboratory ◽  
Us Fda ◽  
The University

Biography Dr Kadavil received his bachelor's degree in biochemistry from the University of Maryland, Baltimore County. He then received his PhD in molecular pharmacology and experimental therapeutics from the University of Maryland, Baltimore, School of Medicine. Following his PhD, he joined the US FDA as a pharmacologist. He first worked in the Office of Scientific Investigations – Division of Bioequivalence & Good Laboratory Practice under the Office of Compliance at CDER. During his 8 years at the Office of Scientific Investigations, he conducted foreign and domestic bioanalytical and clinical inspections for bioequivalence, bioavailability, pharmacokinetic and GLP studies. In 2011, he joined the Division of Human Food Safety at CVM as a pharmacologist, where he conducted reviews of residue chemistry studies and directed method trials. In 2014, he returned to CDER to become the team lead for the Collaboration, Risk Evaluation and Surveillance Team under the Office of Study Integrity and Surveillance. In September 2018, he became the Deputy Director for the Division of Generic Drug Bioequivalence Evaluation in Office of Study Integrity and Surveillance. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (MD, USA).

One-Third of a Campus: Ruth Crawford Mitchell and Second-Generation Americans at the University of Pittsburgh

2008 ◽  
Vol 48 (1) ◽  
pp. 94-132 ◽  
Author(s):  
Harold S. Wechsler
Keyword(s):  
World War I ◽  
Social Life ◽  
Second Generation ◽  
University Of Pennsylvania ◽  
Student Body ◽  
University Of Pittsburgh ◽  
College Life ◽  
The Many ◽  
Great Crash ◽  
The University

It was confusing to him. He was in a world which had a set of rules all its own. He knew the other rules—the rules of his own world. But these were different. Men actually lived their four years away at the University, and sent children after them. It was a wild, improbable thing to have fallen into, and the day student looked at his fellows, could distinguish them no differences among them at first, and felt lost. His evenings were spent in the company of old friends and in the old places; his days at the college. And he plunged from past to present; present to past. They told him about loyalty, and he went home to think about it. But at home it became dim and unreal. Then he went back, the next morning, and they told him of loyalty again, of the mighty traditions. If he took it to heart he could only do so above the sickening realization that at four o'clock he must be on Trolley 13 again. And it was hard to take the traditions over the river.Samuel Lipschutz, B.A.University of Pennsylvania, 1929Many of our alumni and some of our students, supported by more than a few of our faculty and corporation, have seriously queried whether or no Brown, in common with other institutions located in a like environment, has in her student body too large a proportion of socially undesirable students. We are most emphatically not concerned with Jew-baiting. I am proud to say that race and creed are still not valid causes for concern in the liberal community founded by Roger Williams. But some of us are worried by the influx of alien blood into what was not so long ago a homogeneous group of students prevailingly Baptist and Anglo-Saxon. Says one alumnus, “A certain type of student is far below the standard we should like to see. I refer to those called carpet-baggers! They live in or near Providence, arrive at the University in the morning in time for their first class, park themselves, their books, and their lunch in the Union, leave the college the minute their last class is over, take no part in college life, absorb all they can, give back nothing of benefit, and probably will prove no credit to the University as alumni.” Surely some of you have heard the same tale.—Kenneth O. MasonDean of Freshmen, Brown University, 1927Were colleges obliged to address the dilemmas faced by the many firstand second-generation Americans who enrolled after World War I? No, replied many administrators who espoused exclusion or assimilation, or who expressed indifference. These attitudes meant that many students would never learn to navigate the turbulent waters of campus social life. Dropout rates were significant even before the Great Crash created insurmountable financial difficulties for numerous undergraduates. The testimony of peers who remained suggested that success often came despite institutional hostility.

scholarly journals The 100 most influential studies in CAR-T: a bibliometric analysis

2020 ◽  
Author(s):  
Beomjun Seo ◽  
Jeeyoon Kim ◽  
Seungwook Kim
Keyword(s):  
Bibliometric Analysis ◽  
Research Field ◽  
University Of Pennsylvania ◽  
Antigen Receptors ◽  
Non Profit ◽  
Funding Agencies ◽  
Car T ◽  
The Us ◽  
Us Government ◽  
The University

Abstract Background: Bibliometric analysis of mainly cited articles is used to provide information on trends in a specific research field and objective indicators of the scientific impact of the publication. With bibliometric and network analysis, we map the scientific landscape of chimeric antigen receptors T-cells (CAR-T) research. Methods: Extract 100 most cited articles published over the last decade (from January 1, 2009 to Dec 31, 2018; 10 years) from the Web of Science Core Collection with bibliographic details; year of publication, country of author, funding agencies, research organization, author information, and keywords. Results: Of the 100 papers identified, most (92%) were written in the US. US government agencies and non-profit organizations provided the most funding, and the papers funded by the NIH had the most citations, followed by those funded by the Alliance for Cancer Gene Therapy (US). 33 papers out of the top 100 most cited papers were published from the University of Pennsylvania. As for authors, Carl H. June participated in 30 papers, followed by Bruce L. Levine who participated in 11 papers. As for journals, Blood (n=20), published the most papers, followed by Science Translational Medicine (n=10). The most frequently used keyword was “adoptive immunotherapy” (n=37), followed by “lymphocytes” (n=27), and “antitumor-activity” (n=25). Conclusion: We performed the quantitative bibliometric analysis of funding bodies, countries, organizations, journals, authors, and keywords for the CAR-T research trends and landscape. Moving forward, Analysis of highly influential CAR-T articles provides insight into areas for future development.

Simultaneous quantification of dexamethasone and 6β-hydroxydexamethasone in rabbit plasma, aqueous and vitreous humor, and retina by UHPLC–MS/MS

Bioanalysis ◽  
2021 ◽  
Author(s):  
Jianghong Gu ◽  
Jiang Wang ◽  
Ashok Krishna ◽  
Lin Xu ◽  
Sharron Stewart ◽  
...  
Keyword(s):  
Rabbit Plasma ◽  
Distribution Profile ◽  
Bioanalytical Method Validation ◽  
Simultaneous Quantification ◽  
In Vivo Release ◽  
The Us ◽  
Fit For Purpose ◽  
Us Fda

Aim: To develop and validate a fit for purpose method for the simultaneous determination of dexamethasone and its major metabolite, 6β-hydroxydexamethasone, in rabbit plasma and ocular matrices to measure the in vivo release and distribution profile of dexamethasone from intravitreal implants. Materials & methods: An UHPLC–MS/MS system was employed to perform the bioanalysis. The method was validated according to the US FDA Bioanalytical Method Validation Guidance for Industry. Results & conclusion: The method was found to be fit-for-purpose for the described biological matrices and had a LLOQ of 0.1 ng/ml.

scholarly journals A veterinary and nursing collaboration to increase access to healthcare

2021 ◽  
Vol 12 (3) ◽  
pp. 84
Author(s):  
Shuzhen Chee ◽  
Sarah Rivera ◽  
Aaron Algren Huntley ◽  
Lauren Lundahl ◽  
Claire Bocage ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Interprofessional Collaboration ◽  
University Of Pennsylvania ◽  
Health Clinic ◽  
Black Communities ◽  
Marginalized Communities ◽  
Schools Of Nursing ◽  
The Us ◽  
The University

Hypertension is associated with almost 25% of US deaths. Philadelphia has the highest prevalence of hypertension of the 6 largest cities in the US, predominantly in non-Hispanic Black communities. Social determinants of health (SDOH) contribute to the development of hypertension and limit access to preventative resources and treatment. This case study describes an interprofessional collaboration between the University of Pennsylvania Schools of Nursing and Veterinary Medicine to offer blood pressure screenings at the annual MLK Day of Service Wellness and Vaccination Clinic. Clients were approached for blood pressure screenings and health education. Sixty-seven clients (48.2%), largely from zip codes with high levels of hypertension, agreed to blood pressure screening; 45 (67.2%) clients were hypertensive. Our One Health clinic could be a model to reach residents in marginalized communities.

Substituted Benzenes: The Garg Synthesis of Tubingensin A

2017 ◽  
Author(s):  
Douglass F. Taber
Keyword(s):  
Organic Chemistry ◽  
University Of Pennsylvania ◽  
Ni Catalyst ◽  
Indiana University ◽  
Aryl Iodide ◽  
Shanghai Institute ◽  
Peking University ◽  
Normal University ◽  
La Jolla ◽  
The University

John F. Hartwig of the University of California, Berkeley devised (Science 2014, 343, 853) conditions for the regioselective silylation of an arene 1 to give 2. The silyl group can directly be converted, inter alia, to halo, amino, alkyl, or hydroxyl. Jin-Quan Yu of Scripps La Jolla effected (Angew. Chem. Int. Ed. 2014, 53, 2683) regioselective alkenylation of the arene 3 with 4 to give 5. Wei-Liang Duan of the Shanghai Institute of Organic Chemistry described (Org. Lett. 2014, 16, 500) a related alkenyl­ation protocol. Deping Wang of Henyang Normal University developed (Eur. J. Org. Chem. 2014, 315) inexpensive conditions for the conversion of an aryl bromide 6 to the corre­sponding phenol 7. Mamoru Tobisu and Naoto Chatani of Osaka University used (J. Am. Chem. Soc. 2014, 136, 5587) a Ni catalyst to convert the lactam 8 to the aryl boro­nate 9. Patrick J. Walsh of the University of Pennsylvania found (Adv. Synth. Catal. 2014, 356, 165) conditions for the clean monoarylation of the amide 11 with 10 to give 12. In an application of the Catellani approach, Zhi- Yuan Chen of Jiangxi Normal University coupled (Chem. Eur. J. 2014, 20, 4237) the aryl iodide 13 with 14 to give the amino ester 15. Frederic Fabis of the Université de Caen-Basse-Normandie used (Chem. Eur. J. 2014, 20, 7507) Pd to catalyze the ortho halogenation (and alkoxylation) of the N-sulfonylamide 16 to give 17. Wen Wan of Shanghai University and Jian Hao of Shanghai University and the Shanghai Institute of Organic Chemistry effected (Chem. Commun. 2014, 50, 5733) ortho azidination of the aniline 18 with 19, leading to 20. Jianbo Wang of Peking University found (Angew. Chem. Int. Ed. 2014, 53, 1364) that the N-aryloxy amide 21 could be combined with the α-diazo ester 22 to give the ortho-alkenyl phenol 23. Silas P. Cook of Indiana University uncovered (Org. Lett. 2014, 16, 2026) remarkably simple conditions for the enantiospecific cyclization of 24 (65% ee) to 25 (63% ee). The development of arynes as reactive intermediates continues unabated. Xiaoming Zeng of Xi’an Jiaotong University developed (Org. Lett. 2014, 16, 314) the reagent 27 for the bis-functionalization of the aryne derived from 26.

scholarly journals Six Noise Type Military Sound Classifier

2012 ◽  
Author(s):  
Christopher Michael Shelton ◽  
Jeffrey S. Vipperman ◽  
Edward T. Nykaza ◽  
Dan Valente
Keyword(s):  
Negative Impact ◽  
Sound Level ◽  
Military Installations ◽  
University Of Pittsburgh ◽  
Us Army ◽  
Additional Signal ◽  
Noise Type ◽  
The Us ◽  
The University ◽  
Development Center

Blast noise from military installations often has a negative impact on the quality of life of residents living in nearby communities. This, in turn, negatively impacts the military’s testing & training capabilities due to restrictions, curfews, or range closures enacted to address noise complaints. In order to more directly manage noise around military installations, accurate noise monitoring around bases has become a necessity. Although most noise monitors are simple sound level meters, more recent ones are capable of discerning blasts from ambient noise with some success. Investigators at the University of Pittsburgh (Pitt) developed a more advanced noise classifier that can discern between wind, aircraft, and blast noise, while simultaneously lowering the measurement threshold. Here, more recent work between Pitt and the US Army Engineer Research and Development Center will be presented from the development of a more advanced classifier that identifies additional classes of noise such as machine gun fire, vehicles, and electronic noise. Additional signal metrics were explored given the increased complexity of the classifier. By broadening the types of noise the system can accurately classify and increasing the number of metrics, a new system was developed with increased blast noise accuracy, decreased number of missed events, and significantly fewer false positives.

Abstract 434: The Majority of Outpatients With Severe Hypercholesterolemia at an Academic Tertiary Centre Have Not Been Screened for FH

2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Ezim Ajufo ◽  
Masako Ueda ◽  
Erik Hossain ◽  
Tracey Sikora ◽  
Scott M Damrauer ◽  
...  
Keyword(s):  
Family History ◽  
Clinical Care ◽  
University Of Pennsylvania ◽  
Family History Information ◽  
Tertiary Centre ◽  
The Us ◽  
Statin Prescription ◽  
History Of ◽  
Ascvd Risk ◽  
The University

Background: National and International guidelines recommend, as a minimum, that individuals with LDL-C ≥190mg/dL are asked about a family history of ASCVD and hypercholesterolemia to screen for familial hypercholesterolemia (FH), a monogenic condition that carries considerable ASCVD risk. However, FH is grossly underdiagnosed and undertreated in the US. One reason for this may be failure to screen severely hypercholesterolemic individuals for FH. Hypothesis: We evaluated the hypothesis that poor identification of FH might be due to inadequate screening for FH among individuals with severe hypercholesterolemia. Methods: An EHR query was used to identify active adult patients in the University of Pennsylvania outpatient EHR database (N=310 802) with LDL-C≥220mg/dL, excluding secondary causes of hypercholesterolemia. The EHR was then systematically reviewed for structured notation of family history information. Result: The query identified 3,475 individuals with severely elevated LDL-C. Among them, only 47.9% (1666) had family history data relating to ASCVD (968), hypercholesterolemia (336) or both (362) in the EHR. The history was positive in 94.2% (1569) of these cases. Overall, patients with LDL-C ≥220mg/dL were more likely to be screened (OR 1.57; 95% CI 1.47-1.68) than those with LDL <220mg/dL. Within the former group, the odds of being screened were higher in Caucasians (OR 1.52; 95% CI 1.33-1.75), with more severe LDL-C elevation or a history of ASCVD (OR 1.36; 95% CI 1.10 - 1.67). Conversely, the presence of diabetes (OR 0.73; 95% CI 0.61-0.86) or hypertension (OR 0.82; 95% CI 0.72-0.94), made screening less likely to occur. Interestingly, the setting of clinical care was also important; individuals seen in secondary care (OR 1.68; 95% CI 1.41-2.26), general (OR 1.69, 95% CI 1.47-1.95) or preventative cardiology (OR 1.82; 95% CI 1.47-2.25) were more likely to be screened. Finally, statin prescription was more common in those screened (OR 1.39; 95% CI 1.16-1.88), but this did not affect LDL-C goal achievement. Conclusion: At a large academic centre, the majority of outpatients with severe hypercholesterolemia had no record of being screened for FH. This report sheds light on factors that might be relevant to the underdiagnosis of FH in the US.

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