EXHIBIT 33 AR 600-110 Identification

Total Page:16

File Type:pdf, Size:1020Kb

EXHIBIT 33 AR 600-110 Identification Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 1 of 64 PageID# 10157 EXHIBIT 33 AR 600-110 Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus (current version) Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 2 of 64 PageID# 10158 TRIAL EXHIBIT PX023 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 3 of 64 PageID# 10159 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 4 of 64 PageID# 10160 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 5 of 64 PageID# 10161 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 6 of 64 PageID# 10162 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 7 of 64 PageID# 10163 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 8 of 64 PageID# 10164 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 9 of 64 PageID# 10165 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 10 of 64 PageID# 10166 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 11 of 64 PageID# 10167 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 12 of 64 PageID# 10168 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 13 of 64 PageID# 10169 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 14 of 64 PageID# 10170 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 15 of 64 PageID# 10171 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 16 of 64 PageID# 10172 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 17 of 64 PageID# 10173 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 18 of 64 PageID# 10174 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 19 of 64 PageID# 10175 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 20 of 64 PageID# 10176 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 21 of 64 PageID# 10177 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 22 of 64 PageID# 10178 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 23 of 64 PageID# 10179 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 24 of 64 PageID# 10180 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 25 of 64 PageID# 10181 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 26 of 64 PageID# 10182 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 27 of 64 PageID# 10183 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 28 of 64 PageID# 10184 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 29 of 64 PageID# 10185 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 30 of 64 PageID# 10186 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 31 of 64 PageID# 10187 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 32 of 64 PageID# 10188 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 33 of 64 PageID# 10189 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 34 of 64 PageID# 10190 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 35 of 64 PageID# 10191 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 36 of 64 PageID# 10192 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 37 of 64 PageID# 10193 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 38 of 64 PageID# 10194 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 39 of 64 PageID# 10195 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 40 of 64 PageID# 10196 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 41 of 64 PageID# 10197 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 42 of 64 PageID# 10198 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 43 of 64 PageID# 10199 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 44 of 64 PageID# 10200 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 45 of 64 PageID# 10201 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 46 of 64 PageID# 10202 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 47 of 64 PageID# 10203 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 48 of 64 PageID# 10204 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 49 of 64 PageID# 10205 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 50 of 64 PageID# 10206 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 51 of 64 PageID# 10207 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 52 of 64 PageID# 10208 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 53 of 64 PageID# 10209 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 54 of 64 PageID# 10210 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 55 of 64 PageID# 10211 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 56 of 64 PageID# 10212 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 57 of 64 PageID# 10213 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 58 of 64 PageID# 10214 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 59 of 64 PageID# 10215 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 60 of 64 PageID# 10216 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 61 of 64 PageID# 10217 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 62 of 64 PageID# 10218 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 63 of 64 PageID# 10219 Case 1:18-cv-01565-LMB-IDD Document 270-33 Filed 05/04/20 Page 64 of 64 PageID# 10220 Case 1:18-cv-01565-LMB-IDD Document 270-34 Filed 05/04/20 Page 1 of 7 PageID# 10221 EXHIBIT 34 Declaration of Lt. Col. Lisa Lute CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 12 of 67 PageID# 45110222 CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 23 of 67 PageID# 45210223 CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 34 of 67 PageID# 45310224 CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 45 of 67 PageID# 45410225 CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 56 of 67 PageID# 45510226 CaseCase 1:18-cv-01565-LMB-IDD 1:18-cv-00641-LMB-IDD Document Document 270-34 40-1 Filed 08/16/1805/04/20 Page 67 of 67 PageID# 45610227 Case 1:18-cv-01565-LMB-IDD Document 270-35 Filed 05/04/20 Page 1 of 12 PageID# 10228 EXHIBIT 35 Excerpts from the January 9, 2019 Deposition of Lt. Col. Lisa Lute Case 1:18-cv-01565-LMB-IDD Document 270-35 Filed 05/04/20 Page 2 of 12 PageID# 10229 Page 1 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA 2 ALEXANDRIA DIVISION 3 _______________________ 4 : NICHOLAS HARRISON and : 5 OUTSERVE-SLDN, INC., : : 6 Plaintiffs, : : No.
Recommended publications
  • Philip M. Cox January 27, 2017
    CURRICULUM VITAE Philip M. Cox January 27, 2017 Educational History: Ph.D. 2016 Program in Pharmacology Johns Hopkins University School of Medicine Mentor: Namandjé N. Bumpus, Ph.D. B.S. 2010 Biology-Chemistry Southern Nazarene University Professional Experience Assistant Professor 2017 - Azusa Pacific University, Azusa, CA Department of Biology and Chemistry Graduate Student 2012-2016 Lab of Namandje Bumpus, Ph.D. Johns Hopkins University School of Medicine, Baltimore, MD Research Technician 2010-2012 Lab of Darise Farris, Ph.D. Oklahoma Medical Research Foundation, OKC, OK Summer Student 2009 Lab of Kenneth Kaye, Ph.D. Harvard Medical School, Boston, MA Summer Student 2008 Lab of John Iandolo, Ph.D. University of Oklahoma Health Sciences Center, OKC, OK Summer Student 2007 Lab of Swapan Nath, Ph.D. Oklahoma Medical Research Foundation, OKC, OK External Funding: National Science Foundation Graduate Research Fellowship, September 2013-December 2016 Peer-Reviewed Publications: Cox PM, Bumpus NN. (2016) Single Heteroatom Substitutions in the Efavirenz Oxazinone Ring Impact Metabolism by CYP2B6. ChemMedChem. doi:10.1002/cmdc.201600519 Cox PM, Bumpus NN. (2014) Structure-Activity Studies Reveal the Oxazinone Ring Is a Determinant of Cytochrome P450 2B6 Activity Toward Efavirenz. ACS Med Chem Lett. 10:1156- 1161. PMCID: PMC4191608 Dumas EK, Nguyen ML, Cox PM, Rodgers H, Peterson JL, James JA, Farris AD. (2013) Stochastic humoral immunity to Bacillus anthracis protective antigen: identification of anti-peptide IgG correlating with seroconversion to Lethal Toxin neutralization. Vaccine. 14:1856-63. PMCID: PMC3614092 Garman L, Dumas EK, Kurella S, Hunt JJ, Crowe SR, Nguyen ML, Cox PM, James JA, Farris AD. (2012) MHC class II and non-MHC class II genes differentially influence humoral immunity to Bacillus anthracis lethal factor and protective antigen.
    [Show full text]
  • Investigating the Biological Role of O-Acyl ADP Ribose
    Investigating the Biological Role of O-Acyl ADP Ribose by Elyse Blazosky A thesis submitted to Johns Hopkins University in conformity with the requirements for the degree of Master of Science Baltimore, Maryland November, 2018 © Elyse Blazosky All Rights Reserved Abstract Sirtuins are an ancient family of deacetylase enzymes found in all three domains of life, where they have diverse biological roles. These widely studied enzymes are popular drug targets for treating diseases associated with aging, neurological disorders, cardiovascular disorders, metabolic disorders and even cancer. Unlike most deacetylase enzymes which use water to hydrolyze the amide bond linking the acetyl group to a lysine side chain, sirtuins catalyze a unique NAD+-dependent reaction that yields O-acetyl ADP ribose, nicotinamide and the deacetylate lysine. This seemingly wasteful use of NAD+ has led some to hypothesize that sirtuin activity is coupled to NAD+ levels in the cell. While sirtuin activity does rely on NAD+ biosynthesis and salvage pathways, it is unclear whether NAD+ levels fluctuate to a level that could affect sirtuin activity in-vivo. More recent studies have revealed new roles for sirtuins which suggests a more complex role of the sirtuin and a re-evaluation of the current hypothesis for why sirtuins uses NAD+. It has been shown that some sirtuins preferentially remove a variety of acyl lysine groups such as malonyl, succinyl, and butyryl, forming the corresponding O-acyl ADP ribose product. Mass spectrometry studies have revealed an abundance of these acyl modifications on cellular proteins, some of which are thought to result from non-enzymatic reaction with metabolites such as acyl-CoAs.
    [Show full text]
  • Efavirenz and Efavirenz-Like Compounds Activate Human, Murine, and Macaque Hepatic Ire1α-XBP1 Carley J.S
    Molecular Pharmacology Fast Forward. Published on November 15, 2018 as DOI: 10.1124/mol.118.113647 This article has not been copyedited and formatted. The final version may differ from this version. Efavirenz and Efavirenz-like Compounds Activate Human, Murine, and Macaque Hepatic IRE1α-XBP1 Carley J.S. Heck, Allyson N. Hamlin, and Namandjé N. Bumpus Department of Pharmacology & Molecular Sciences (C.J.S.H. and N.N.B.) and Department of Medicine – Division of Clinical Pharmacology (A.N.H and N.N.B.), Johns Hopkins University School of Medicine, Baltimore, MD, USA Downloaded from molpharm.aspetjournals.org at ASPET Journals on September 28, 2021 1 Molecular Pharmacology Fast Forward. Published on November 15, 2018 as DOI: 10.1124/mol.118.113647 This article has not been copyedited and formatted. The final version may differ from this version. Running title: EFV activates hepatic IRE1α-XBP1 Corresponding Author: Dr. Namandjé Bumpus, Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, 725 N Wolfe Street, Biophysics Building 307A, Baltimore, MD 21205, USA Email: [email protected] Phone: 410-955-0562 Document statistics: Text Pages: 38 Tables: 0 Downloaded from Figures: 11 References: 52 Abstract: 245 words Introduction: 749 words Discussion: 1470 words molpharm.aspetjournals.org Abbreviations: 8-hydroxyefavirenz (8-OHEFV) Acridine Orange (AcrO) c-Jun N-terminal kinase (JNK) cytochrome P450 (CYP) at ASPET Journals on September 28, 2021 DNAJ heat shock protein family member 9 (DNAJB9) Efavirenz (EFV) Endoplasmic reticulum (ER) Ethidium Bromide (EtBr) Inositol requiring enzyme 1α (IRE1α) Pregnane X receptor (PXR) Reverse transcriptase- polymerase chain reaction (RT-PCR) Spliced XBP1 (sXBP1) Tunicamycin (TM) Unspliced XBP1 (uXBP1) X-box-binding protein 1 (XBP1) 2 Molecular Pharmacology Fast Forward.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,463,173 B2 Bumpus Et Al
    USOO94631 73B2 (12) United States Patent (10) Patent No.: US 9,463,173 B2 Bumpus et al. (45) Date of Patent: Oct. 11, 2016 (54) COMPOSITIONS AND METHODS FOR OTHER PUBLICATIONS TREATING OBESITY AND OBESTY-RELATED CONDITIONS Ghodke-Puranik, et. al., “Valproic acid pathway: pharmacokinetics and pharmacodynamics' Pharmacogenetics and genomics (2013). (71) Applicant: THE JOHNS HOPKINS Silva, M., et al., “Differential effect of valproate and its Delta2- and Delta4-unsaturated metabolites, on the beta-Oxidation rate of long UNIVERSITY, Baltimore, MD (US) chain and medium-chain fatty acids' Chem Biol Interact. (Sep. 28. 2001) vol. 137, No. 3, pp. 203-212. (72) Inventors: Namandje Bumpus, Washington, DC Zhang, L, et al., “Combined effects of a high-fat diet and chronic (US); Lindsay Avery, S. Hamilton, MA valproic acid treatment on hepatic Steatosis and hepatotoxicity in (US) rats'. Acta Pharmacol Sin. (Mar. 2014) vol. 35. No. 3, pp. 363-372. Meral, C., et al., “New adipocytokines (vaspin, apelin, visfatin, (73) Assignee: THE JOHNS HOPKINS adiponectin) levels in children treated with valproic acid” Eur UNIVERSITY, Baltimore, MD (US) Cytokine Netw. (Jun. 2011) vol. 22, No. 2, pp. 118-122. Acheampong, A., et al., “Identification of valproic acid metabolites *) Notice: Subject to anyy disclaimer, the term of this in human serum and urine using hexadeuterated valproic acid and patent is extended or adjusted under 35 gas chromatographic mass spectrometric analysis'. Biomed Mass U.S.C. 154(b) by 0 days. Spectrom (1983) vol. 10, No. 11, pp. 586-595. Becker, C., et al., “Influence of valproic acid on hepatic carbohy drate and lipid metabolism”, Arch Biochem Biophys (1983) vol.
    [Show full text]
  • Benzodiazepines Sixty Years Of
    A Publication by The American Society for the Pharmacology and Experimental Therapeutics Pharmacologist Vol. 61 • Number 1 • March 2019 INSIDE 2019 Election Results Sixty Years of 2019 Award Winners Benzodiazepines 2019 Annual Meeting Program The Pharmacologist is published and distributed by the American Society for Pharmacology and Experimental Therapeutics THE PHARMACOLOGIST PRODUCTION TEAM Rich Dodenhoff Catherine L. Fry, PhD Contents Tyler Lamb Judith A. Siuciak, PhD Suzie Thompson COUNCIL Message from the President 1 President Edward T. Morgan, PhD President Elect 2019 Election Results 3 Wayne L. Backes, PhD Past President John D. Schuetz, PhD 2019 Award Winners 4 Secretary/Treasurer Margaret E. Gnegy, PhD Secretary/Treasurer Elect 2019 Annual Meeting Program 11 Jin Zhang, PhD Past Secretary/Treasurer John J. Tesmer, PhD Feature Story – Councilors 26 Sixty Years of Benzodiazepines Carol L. Beck, PharmD, PhD Alan V. Smrcka, PhD Kathryn A. Cunningham, PhD Science Policy News Chair, Board of Publications Trustees 38 Mary E. Vore, PhD Chair, Program Committee Education News Michael W. Wood, PhD 42 FASEB Board Representative Brian M. Cox, PhD AMSPC News Executive Office 44 Judith A. Siuciak, PhD Journals News The Pharmacologist (ISSN 0031-7004) 45 is published quarterly in March, June, September, and December by the American Society for Pharmacology Membership News and Experimental Therapeutics, 1801 48 Rockville Pike, Suite 210, Rockville, MD Obituary: Brian Sorrentino 20852-1633. Annual subscription rates: $25.00 for ASPET members; $50.00 for U.S. nonmembers and institutions; Members in the News $75.00 for nonmembers and institutions 52 outside the U.S. Single copy: $25.00. Copyright © 2019 by the American Division News Society for Pharmacology and 54 Experimental Therapeutics Inc.
    [Show full text]
  • Semi-Solid Prodrug Nanoparticles for Long-Acting Delivery of Water-Soluble Antiretroviral Drugs Within Combination HIV Therapies
    ARTICLE https://doi.org/10.1038/s41467-019-09354-z OPEN Semi-solid prodrug nanoparticles for long-acting delivery of water-soluble antiretroviral drugs within combination HIV therapies James J. Hobson1, Amer Al-khouja2, Paul Curley3, David Meyers2, Charles Flexner2,4, Marco Siccardi3, Andrew Owen 3, Caren Freel Meyers2 & Steve P. Rannard 1 fi 1234567890():,; The increasing global prevalence of human immunode ciency virus (HIV) is estimated at 36.7 million people currently infected. Lifelong antiretroviral (ARV) drug combination dosing allows management as a chronic condition by suppressing circulating viral load to allow for a near-normal life; however, the daily burden of oral administration may lead to non- adherence and drug resistance development. Long-acting (LA) depot injections of nanomilled poorly water-soluble ARVs have shown highly promising clinical results with drug exposure largely maintained over months after a single injection. ARV oral combinations rely on water- soluble backbone drugs which are not compatible with nanomilling. Here, we evaluate a unique prodrug/nanoparticle formation strategy to facilitate semi-solid prodrug nanoparticles (SSPNs) of the highly water-soluble nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine (FTC), and injectable aqueous nanodispersions; in vitro to in vivo extrapolation (IVIVE) modelling predicts sustained prodrug release, with activation in relevant biological environments, representing a first step towards complete injectable LA regimens containing NRTIs. 1 Department of Chemistry, University of Liverpool,CrownStreet,LiverpoolL697ZD,UK.2 Department of Pharmacology and Molecular Sciences, The Johns Hopkins University School of Medicine, 725 North Wolfe St., Baltimore, MD 21205, USA. 3 Department of Molecular and Clinical Pharmacology, University of Liverpool, Block H, 70 Pembroke Place, Liverpool L69 3GF, UK.
    [Show full text]
  • Divergence of Anti-Angiogenic Activity and Hepatotoxicity of Different Stereoisomers of Itraconazole
    Author Manuscript Published OnlineFirst on January 22, 2016; DOI: 10.1158/1078-0432.CCR-15-1888 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Divergence of Anti-angiogenic Activity and Hepatotoxicity of Different Stereoisomers of Itraconazole Joong Sup Shim1,2,3, Ruo-Jing Li1,3, Namandje N. Bumpus1,4, Sarah A. Head1, Kalyan Kumar1, Eun Ju Yang2, Junfang Lv2, Wei Shi1,5, Jun O. Liu1,6 1Department of Pharmacology and Molecular Sciences, 4Department of Medicine and 6Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA 2Faculty of Health Sciences, University of Macau, Taipa, Macau SAR, China 5Department of Chemistry and Biochemistry, University of Arkansas, Fayetteville, AR 72701, USA 3These authors contributed equally to this study. Correspondence to: Jun O. Liu, Ph.D, Department of Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, 725 N Wolfe St, Hunterian Building 516, Baltimore, MD 21205 (e-mail: [email protected]) Running title: Distinct activity and toxicity of itraconazole stereoisomers Keywords: itraconazole, stereoisomers, drug repositioning, angiogenesis, hepatotoxicity Financial support: This work was supported in part by R01CA184103, the Flight Attendant Medical Research Institute (J. O. L.), the Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 001079 and the PhRMA foundation fellowship in Pharmacology/Toxicology (S. A. H.). Conflict of interest: Patents covering itraconazole and its stereoisomers as angiogenesis and hedgehog pathway inhibitors have been licensed from Johns Hopkins to Accelas Pharmaceuticals, of which J.O.L. is a cofounder and owns equity.
    [Show full text]
  • 40-Perkowski-Declaration-Iso-Pi
    Case 1:18-cv-01565-LMB-IDD Document 40 Filed 01/11/19 Page 1 of 8 Page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²VHUYLFHPHPEHUV YHWHUDQVFLYLOLDQ'HSDUWPHQWRI'HIHQVHDQGWKHLUVSRXVHVDQGIDPLOLHV²ZRUOGZLGH7KH RUJDQL]DWLRQ¶VPLVVLRQLVWRDGGUHVVDQGHQG²WKURXJKOLWLJDWLRQSROLF\DGYRFDF\DQG HGXFDWLRQ²DOOIRUPVRIXQHTXDORUXQIDLUWUHDWPHQWDJDLQVWPHPEHUVRILWVFRPPXQLW\EDVHGRQ VH[XDORULHQWDWLRQJHQGHULGHQWLW\RU+,9VWDWXV 2XW6HUYH6/'1LVLQSDUWDPHPEHUVKLSRUJDQL]DWLRQRUWKHIXQFWLRQDO HTXLYDOHQWRIDPHPEHUVKLSRUJDQL]DWLRQ,WKDVZHOORYHUPHPEHUV²YHWHUDQVDFWLYHGXW\ Case 1:18-cv-01565-LMB-IDD Document 40 Filed 01/11/19 Page 2 of 8 PageID# 221 DQGUHVHUYHFRPSRQHQWVHUYLFHPHPEHUVDQGFLYLOLDQ'HSDUWPHQWRI'HIHQVHZRUNHUV WKURXJKRXWWKHZRUOGZKRLGHQWLI\DV/*%74RUDUHOLYLQJZLWK+,9²DQGPRUHWKDQ VXSSRUWHUV2XW6HUYH6/'1DOVRKDVPRUHWKDQFKDSWHUVZRUOGZLGHLQFOXGLQJLQWKH 8QLWHG6WDWHVDQGDGGLWLRQDOVSHFLDOJURXSIRUXPVRQHRIZKLFKLVWKH³3RVLWLYH)RUXP´IRU SHRSOHOLYLQJZLWK+,97KHVHFKDSWHUVDUHQRWMXVWVRFLDOJURXSVEHFDXVHVHUYLFHPHPEHUVZKR DUH/*%74DQGRUOLYLQJZLWK+,9DUHPLQRULW\JURXSVWKDWDUHVWLOOVRPHWLPHVPDUJLQDOL]HG
    [Show full text]
  • ISSX President's Message
    Volume 40 Issue 4, 2017 ISSX President’s Message By Geoff Tucker, ISSX President The North American Meeting in or European regions were successful Finally, the time Providence, Rhode Island at the in the last round of elections. This for me to step end of September attracted 630 may reflect the current make-up of down as attendees, and Meeting Chairs ISSX membership, being 61% from President is Jash Unadkat and Alan Rettie are to North America and 19% from both approaching be congratulated on their excellent Asia Pacific and Europe, and is rapidly. In organization of a well-balanced clearly not sustainable for an Providence I program. For me, a highlight of international society. Accordingly, already passed the meeting was the outstanding Council agreed that the by-laws the chain of Geoff Tucker, Ph.D. presentations by the recipients should be modified to rectify the office (a rather ISSX President. of the North American Scientific situation. How exactly to assure attractive Achievement Awards, Kathy global representation is under accessory engraved with the names Giacomini and Namandje Bumpus. discussion and, in due course, of all previous Presidents that Steve members will be asked to ratify a Kemp keeps under lock and key) A face-to-face meeting of Council proposed change to the statutes. to my successor, Tom Baillie. in Providence allowed time for a Serving ISSX in the role of President reflective and productive discussion Meanwhile, programming plans for over the last two years has been on strategic issues, with focus the upcoming 2018 meetings in an interesting and enjoyable particularly on membership benefits, Montreal and China are proceeding experience.
    [Show full text]
  • Case 1:18-Cv-00641-LMB-IDD Document 26-5 Filed 07/19/18 Page 1 of 113 Pageid# 244
    Case 1:18-cv-00641-LMB-IDD Document 26-5 Filed 07/19/18 Page 1 of 113 PageID# 244 Exhibit E Case 1:18-cv-00641-LMB-IDD Document 26-5 Filed 07/19/18 Page 2 of 113 PageID# 245 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA Alexandria Division NICHOLAS HARRISON and OUTSERVE-SLDN, INC. Plaintiffs, v. Case No. 1:18-cv-641 (LMB/IDD) JAMES N. MATTIS, in his official capacity as Secretary of Defense; MARK ESPER, in his official capacity as the Secretary of the Army; and the UNITED STATES DEPARTMENT OF DEFENSE, Defendants. EXPERT DECLARATION OF CRAIG W. HENDRIX, M.D., IN SUPPORT OF PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION 1 Case 1:18-cv-00641-LMB-IDD Document 26-5 Filed 07/19/18 Page 3 of 113 PageID# 246 I. INTRODUCTION 1. My name is Craig W. Hendrix. I have been retained by counsel for Plaintiffs as an expert in connection with this litigation. 2. I am offering this declaration to provide my expert opinions regarding the U.S. Department of Defense and U.S. Army policies with respect to people living with HIV, including the purported medical justifications for preventing individuals living with HIV from joining the United States military, from being commissioned as officers, and—if already in the military— from deploying outside the United States. 3. As detailed below, it is my opinion that there are no medical justifications for excluding individuals from serving in any capacity in the military or from being deployed outside of the United States based solely on their HIV-positive status.
    [Show full text]
  • Efavirenz Is Predicted to Accumulate in Brain Tissue
    AAC Accepted Manuscript Posted Online 31 October 2016 Antimicrob. Agents Chemother. doi:10.1128/AAC.01841-16 Copyright © 2016, American Society for Microbiology. All Rights Reserved. 1 Efavirenz is predicted to accumulate in brain tissue: an in silico, in vitro and in vivo 2 investigation 3 4 Paul CURLEY1, Rajith K R RAJOLI1, Darren M MOSS1, Neill J LIPTROTT1+2, Scott Downloaded from 5 LETENDRE3, Andrew OWEN1+2 # and Marco SICCARDI1 6 7 1 Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, 8 Liverpool, UK 9 10 2 European Nanomedicine Characterisation Laboratory, Molecular and Clinical Pharmacology, http://aac.asm.org/ 11 Institute of Translational Medicine, University of Liverpool, Liverpool, UK 12 13 3 Departments of Medicine and Psychiatry, University of California San Diego, 220 Dickinson 14 Street, Suite A, San Diego, CA 92103, USA. 15 on November 7, 2016 by University of Liverpool Library 16 * Author for correspondence and reprints: Prof A Owen, Molecular and Clinical Pharmacology, 17 Institute of Translational Medicine, University of Liverpool, UK 18 Tel: +44 (0) 151 794 8211 19 Fax: + 44 (0) 151 794 5656 20 E-mail: [email protected] 21 Word Count: 3439 22 References: 34 23 Figures: 3 24 Tables: 2 25 Key words: efavirenz, PBPK, CNS and toxicity 26 Running (short) Title: Efavirenz Accumulation in Brain Tissue 27 28 Abbreviations: cisterna magna (CM), extra cellular fluid (ECF), intracellular space (ICS), left 29 ventricle (LV), nevirapine (NVP), permeability surface area product (log PS), physiologically based 30 pharmacokinetic (PBPK), rapid equilibrium dialysis (RED), sub arachnoid space (SAS), third and 31 fourth ventricles (TFV), van der Waals polar surface area (TPSA) and van der Waals surface area of 32 the basic atoms (vasbase).
    [Show full text]
  • Dosage of HIV Drug May Be Ineffective for Half of African-Americans 27 August 2014
    Dosage of HIV drug may be ineffective for half of African-Americans 27 August 2014 Many African-Americans may not be getting bloodstream, the Johns Hopkins team predicted. effective doses of the HIV drug maraviroc, a new And since 85 percent of participants in the study from Johns Hopkins suggests. The initial maraviroc dosing study were European-Americans, dosing studies, completed before the drug was who typically lack functional CYP3A5, the licensed in 2007, included mostly European- researchers surmised that the recommended dose Americans, who generally lack a protein that is key for maraviroc could be too low for anyone with two to removing maraviroc from the body. The current functional copies of the gene—including 45 percent study shows that people with maximum levels of of African-Americans. the protein—including nearly half of African- Americans—end up with less maraviroc in their To test this idea, the research team grouped 24 bodies compared to those who lack the protein healthy volunteers according to how many even when given the same dose. A simple genetic functional copies of the CYP3A5 gene they test for the gene that makes the CYP3A5 protein had—zero, one or two. They were each given a could be used to determine what doses would single dose of maraviroc in the recommended dose achieve effective levels in individuals, the of 300 milligrams, and each participant's blood was researchers say. taken at 10 time points over 32 hours. The results of the small study were published At almost all time points, the concentrations of online on Aug.
    [Show full text]