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Pharmacometrics, statistics, clinical trials, immunology, and cytometry are my main professional interests. As a modeler, I seek to bring both mechanistic and probabilistic thinking to bear on problems to answer these questions:(1) What are the best inferences we can derive from the available data?(2) How strongly do the available data support these inferences?My training has been experimental, theoretical, and computational. I've worked in the areas of vaccines, clinical trials, relational databases, viral and lymphocyte dynamics, rule based modeling, molecular modeling, automated flow cytometry data analysis, and others. I've had several advanced courses in pharmacokinetics and pharmacodynamics. I believe that a modeler should be very aware of the philosophical issues that lurk just beneath the surface in statistics (= quantitative epistemology), since they directly influence the calculations and (especially) the interpretation of the analysis. I like Richard Royall's three questions as they relate to data analysis:(1) What should I believe?(2) What should I do?(3) What is the evidence for or against some hypothesis?A statistical model allows one to make probabilistic statements concerning data—but all such statements assume the given model. Discriminating between models—model selection—is therefore an essential component of modeling practice. My M.S. research demonstrably improves on current practice in the field of pharmacometrics. Although my methodology is computationally demanding, that is a small price to pay compared to making an expensive clinical or financial decision based on an inferior model.
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Associate Director, Quantitative Pharmacology, PharmacometricsOtsuka Pharmaceutical Companies (U.S.) Aug 2022 - Jan 2024Princeton, Nj, Us -
Pharmacologist / Biopharmaceutical ScientistFda Sep 2020 - Aug 2022Silver Spring, Md, UsContractor to US FDA (formerly with Midnight Sun Technologies, later with Koniag Government Services), in the Quantitative Clinical Pharmacology group, in Division of Quantitative Methods and Modeling (DQMM) | Office of Research and Standards (ORS) | Office of Generic Drugs (OGD) | Center for Drug Evaluation and Research (CDER) | U.S. Food and Drug Administration (FDA)). -
InternCognigen Corporation, A Simulations Plus Company Jan 2016 - Nov 2016Buffalo, Ny, UsI was involved in validation for KIWI, Cognigen's proprietary database for NONMEM output. -
Postdoctoral Research AssociateUniversity Of Rochester Jun 2008 - Sep 2013Rochester, Ny, UsWith collaborators, developed novel approaches for flow cytometry data analysis, both for cases involving a target population (GAFF) and for exploratory analyses (SWIFT). SWIFT can identify extremely rare cell populations and facilitates more rigorous inferences than existing common practice. Publication DOIs: 10.1109/ICASSP.2010.5495653; 10.1002/cyto.a.22446; and 10.1002/cyto.a.22445.Investigated various data transformations for flow cytometry data.Designed an event-level database in PostgreSQL intended to integrate SWIFT, GAFF, and other programs to facilitate consensus clustering and theoretically justified multi-model inferences while providing additional convenience and visualization functionality. Presented poster at ISAC 2013.Initiated close collaboration with Prof. Gregor von Laszewski and served on the educational committee of his masters student, Andrew Pangborn, resulting in the parallelization of the EM algorithm using Nvidia's CUDA technology. Publication DOI: 10.1109/ISPA.2009.29.Co-wrote (with Prof. von Laszewski) two NSF CDI (Cyber-Enabled Discovery and Innovation) grant proposals. These got excellent scores both years.Helped write several NIH grants for principal investigator (Tim R. Mosmann).Made an Access relational database (~ 100 tables) for all Luminex data (XML output) for a multi-year rheumatoid arthritis clinical study, then used R for exploratory analysis for differences between groups.Did various statistical analyses of T cell immunology data in R, and data cleaning in PowerShell.Used logistic regression in a pilot study to show that the best linear combination of laboratory predictors of opportunistic infections in HIV+ patients who may otherwise have normal CD4 counts was RSV net spots (ELISpot assay), background spots, and CD8 T cell count. -
Postdoctoral Research FellowUniversity Of Rochester Jun 2006 - May 2008Rochester, Ny, UsModeled viral growth dynamics in culture using Berkeley Madonna. DOI: 10.1007/s11538-008-9323-4.Participated in other Center for Biodefense Immune Modeling activities, and other research and statistics courses as required by my supervisor (David Oakes) and his training grant; see Education section below. -
Visiting ScientistLos Alamos National Laboratory Apr 2005 - Apr 2006Los Alamos, Nm, UsMade an improved model for JAK-STAT signal transduction after IFN-γ ligand binding using our in-house software BioNetGen, with Drs. James Faeder and William Hlavacek in the Cell Signaling Group. BioNetGen uses rule based modeling to handle the combinatorial complexity arising from multi-subunit stoichiometry. Presented poster at 6th International Conference on Systems Biology (ICSB 2005).Developed an ODE model of lymphocyte and viral dynamics to explain the absence of pathology despite high viremia in SIV-infected sooty mangabeys, with Drs. Ruy Ribiero and Alan Perelson. -
Postdoctoral Cellular ImmunologistMedical Research Council Nov 2004 - Jan 2005Swindon, Gb(This was exactly a continuation of my previous post; I'm splitting it up here for technical accuracy.)I continued to work closely with the data management group on a sophisticated relational database, and did the majority of the data analysis.Publication DOIs: 10.1002/cyto.b.20146 and 10.1371/journal.pone.0014626. -
Postdoctoral Cellular ImmunologistUniversity Of Oxford Jan 2003 - Oct 2004Oxford, Oxfordshire, GbAlthough I was a postdoc for Oxford University, I lived and worked at MRC Laboratories, Fajara, The Gambia as a long term visitor. (I'm splitting it up here for technical accuracy.)Through Oxford University's Nuffield Department of Clinical Medicine, within Prof. Adrian Hill's group, under Dr. Samuel J. McConkey, I worked on a phase II clinical trial investigating a DNA, MVA prime, boost therapeutic vaccine for chronic hepatitis B virus infection. I performed intracellular cytokine staining assays using a four-color FACSCalibur™ flow cytometer, supervised technicians doing IFN-γ ELISpot assays in a biosafety level 2 laboratory, and worked closely with the data management group on a sophisticated relational database.
James Cavenaugh Skills
James Cavenaugh Education Details
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University At Buffalo Pharmacy And Pharmaceutical SciencesPharmacometrics And Personalized Pharmacotherapy -
University Of UtahPharmaceutics And Pharmaceutical Chemistry -
The University Of Texas At AustinChemistry -
The University Of Texas At AustinMolecular Biology
Frequently Asked Questions about James Cavenaugh
What is James Cavenaugh's role at the current company?
James Cavenaugh's current role is Associate Director, Quantitative Pharmacology, Pharmacometrics.
What is James Cavenaugh's email address?
James Cavenaugh's email address is js****@****ail.com
What schools did James Cavenaugh attend?
James Cavenaugh attended University At Buffalo Pharmacy And Pharmaceutical Sciences, University Of Utah, The University Of Texas At Austin, The University Of Texas At Austin.
What are some of James Cavenaugh's interests?
James Cavenaugh has interest in Mathematics, Physics, Kali, Cooking, Theology, Entrepreneurship, Investing, Science, Education, Immunology.
What skills is James Cavenaugh known for?
James Cavenaugh has skills like Clinical Trials, R, Ich Gcp, Pharmacometrics, Cell Biology, Elisa, Berkeley Madonna, Antibodies, Nonmem, Data Analysis, Assay Development, Clinical Research.
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