J
Jules O'Rear
Researcher at Food and Drug Administration
Publications - 9
Citations - 320
Jules O'Rear is an academic researcher from Food and Drug Administration. The author has contributed to research in topics: Medicine & Surrogate endpoint. The author has an hindex of 6, co-authored 6 publications receiving 256 citations.
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Journal ArticleDOI
Standards for Sequencing Viral Genomes in the Era of High-Throughput Sequencing
Jason T. Ladner,Brett Beitzel,Patrick S. G. Chain,Matthew G Davenport,Eric F. Donaldson,Matthew B. Frieman,Jeffrey R. Kugelman,Jens H. Kuhn,Jules O'Rear,Pardis C. Sabeti,Pardis C. Sabeti,David E. Wentworth,Michael R. Wiley,Guo-Yun Yu,Shanmuga Sozhamannan,Christopher E. Bradburne,Gustavo Palacios +16 more
TL;DR: This work proposes five “standard” categories that encompass all stages of viral genome finishing, and they are defined using simple criteria that are agnostic to the technology used for sequencing.
Journal ArticleDOI
Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis.
Yoichiro Natori,Ali Alghamdi,Mahmood Tazari,Veronica Miller,Shahid Husain,Takashi E. Komatsu,Paul D. Griffiths,Per Ljungman,Ani Orchanian-Cheff,Deepali Kumar,Atul Humar,Rekha Abichandani,Barbara D. Alexander,Robin K. Avery,Fausto Baldanti,Susan Barnett,Paul Baum,M Michelle Berrey,Debra Birnkrant,Emily A. Blumberg,Michael Boeckh,David Boutolleau,Terry Bowlin,Jennifer Brooks,Roy F. Chemaly,Sunwen Chou,Gavin Cloherty,William Cruikshank,Lesia K. Dropulic,Hermann Einsele,Jay Erdman,Gary Fahle,Lynn Fallon,Heather Gillis,Dimitri Gonzalez,Kurt Gunter,Hans H. Hirsch,Aimee Hodowanec,Peter W. Hunt,Filip Josephson,Camille N. Kotton,Philip R. Krause,Frank Kuhr,Christopher Lademacher,Randall Lanier,Tadd Lazarus,John A. D. Leake,Randi Y. Leavitt,Sandra Nusinoff Lehrman,Li Li,Paula Isabelle Lodding,Jens D Lundgren,Francisco Martinez-Murillo,Howard Mayer,Megan McCutcheon,John E. McKinnon,Thomas Mertens,Kevin Modarress,Johann Mols,Sally Mossman,Yoshihiko Murata,David Murawski,Jeffrey C. Murray,Garrett Nichols,Jules O'Rear,Karl S. Peggs,Andreas Pikis,Mark N. Prichard,Raymund R. Razonable,Marcie L. Riches,Jeff Roberts,Wael Saber,Chalom Sayada,Mary Singer,Thomas Stamminger,Anna Wijatyk,Dong Yu,Bernhardt Zeiher +77 more
TL;DR: It is concluded that CMV load is an appropriate surrogate endpoint for CMV trials in organ transplant recipients due to low frequency of disease and several lines of evidence support the validity of viral load.
Journal ArticleDOI
Sequence and Phenotypic Analysis for Resistance Monitoring in Hepatitis C Virus Drug Development: Recommendations From the HCV DRAG
Ann D. Kwong,Isabel Najera,Jill Bechtel,Scott Bowden,Joseph E. Fitzgibbon,Patrick R. Harrington,Dale J. Kempf,Tara L. Kieffer,Diana Koletzki,George Kukolj,Sharlene Lim,Tami Pilot–Matias,Kai Lin,Nina Mani,Hongmei Mo,Jules O'Rear,Michael J. Otto,Neil Parkin,Jean-Michel Pawlotsky,Chris Petropoulos,Gaston Picchio,Robert Ralston,Jacqueline D. Reeves,Robert T. Schooley,Scott Seiwert,David Standring,Lieven J. Stuyver,James C. Sullivan,Veronica Miller +28 more
TL;DR: This research presents a novel and scalable approach called “sequencing-based annotation-based phenotype analysis” (SAWG-PAWG) for HCV Drug Development Advisory Group HCV DRAG, which aims to provide real-time information about the structure and activity of the HCV “spatially aggregating immune checkpoints”.
Journal ArticleDOI
Report of the National Institutes of Health SARS-CoV-2 Antiviral Therapeutics Summit.
Matthew D. Hall,James M. Anderson,Annaliesa S. Anderson,David Baker,Jay Bradner,Kyle R. Brimacombe,Elizabeth A. Campbell,Kizzmekia S. Corbett,Kara Carter,Sara Cherry,Lillian Chiang,Tomas Cihlar,Emmie de Wit,Mark R. Denison,Matthew D. Disney,Courtney V. Fletcher,Stephanie L. Ford-Scheimer,Matthias Götte,Abigail Grossman,Frederick G. Hayden,Daria J. Hazuda,Charlotte A. Lanteri,Hilary D. Marston,Andrew D. Mesecar,Stephanie Moore,Jennifer O. Nwankwo,Jules O'Rear,George R. Painter,Kumar Singh Saikatendu,Celia A. Schiffer,Timothy P. Sheahan,Pei Yong Shi,Hugh D. C. Smyth,Michael J. Sofia,Marla Weetall,Sandra K. Weller,Richard J. Whitley,Anthony S. Fauci,Christopher P. Austin,Francis S. Collins,Anthony J. Conley,Mindy I. Davis +41 more
TL;DR: The 2019 Virtual SARS-CoV-2 Antiviral Summit as discussed by the authors was organized to provide an overview on the status and challenges in developing antiviral therapeutics for coronavirus disease 2019 (COVID-19), including combinations of antivirals.
Journal ArticleDOI
Boceprevir dosing for late responders and null responders: The role of bridging data between treatment-naïve and -experienced subjects
Jeffry Florian,Pravin R. Jadhav,Shashi Amur,Ruben Ayala,Patrick R. Harrington,Poonam Mishra,Jules O'Rear,Michael Pacanowski,Sarah M. Robertson,Mary Singer,Greg Soon,Wen Zeng,Jeffrey Murray +12 more
TL;DR: The rationale to support the BOC dosing recommendations in prior P/R-null responders and treatment-naı̈ve BOC late responders is summarized.