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Tarpey TCCC AMEDDJ 2005-2
April-June 2005 Perspective 1 MG George W. Weightman Managing the MC Through a Team Approach and the Balanced Scorecard 3 BG Eric B. Schoomaker The AMEDD Personnel Proponency Directorate/The Structure Models 9 R. Clare Layton AMEDD Continuum of Medical Education 12 COL John M. Powers, MC, USA The Medical Corps Assignment Process 16 COL Jonathan H. Jaffin, MC, USA, et al The Reduction of Unwarranted Clinical Practice Variation in the AMEDD 18 LTC William A. Rice, MC, USA Medical Management of Medical Holdover Patients 24 COL Michael A. Deaton, MC, USA Medical Ethics in Detainee/Enemy Prisoners of War Care 27 COL Gregg Anders, MC, USA The “Intentional” Officer 29 COL Chuck Callahan, MC, USA The Tactical Combat Casualty Care Transition Initiative 33 CAPT Frank K. Butler, Jr, MC, USN/COL John B. Holcomb, MC, USA Tactical Combat Casualty Care in Operation Iraqi Freedom 38 CPT Michael J. Tarpey, MC, USA Battlefield Tourniquets: Modern Combat Lifesavers 42 Thomas J. Walters, PhD, et al Laboratory Evaluation of the U.S. Army One-Handed Tourniquet 44 Joseph C. Wenke, PhD, et al Laboratory Evaluation of Battlefield Tourniquets in Human Volunteers 50 Thomas J. Walters, PhD, et al The Chitosan-Based Hemostatic Dressing: Experience in Current Combat Operations 58 LTC Ian Wedmore, MC, USA, et al Can We Provide Level III Damage Control Surgical Procedures at a Level II Facility? 62 LTC Lorne H. Blackbourne, MC, USA/COL John B. Holcomb, MC, USA GWOT: Assessment, Treatment, and Evacuation of Burn Trauma Casualties 66 LTC Evan M. Renz, MC, USA, et al Also in this issue……. -
Invitrogen Lentiarray Human CRISPR Library, 96-Well Plate User Guide
USER GUIDE Invitrogen™ LentiArray™ Human CRISPR Library, 96-well Plate Catalog Numbers A31931, A31932, A31933, A31934, A31935, A31936, A31937, A31938, A31939, A31940, A31941, A31942, A31943, A31944, A31945, A31946, A31947, A31948, and A31949 Doc. Part No. 100044720 Pub. No. MAN0016075 Rev. B WARNING! Read the Safety Data Sheets (SDSs) and follow the handling instructions. Wear appropriate protective eyewear, clothing, and gloves. Safety Data Sheets (SDSs) are available from thermofisher.com/support. Product description Invitrogen™ LentiArray™ Human CRISPR libraries consist of pre-defined collection of gene families for functional genomics screening in an arrayed format. Each library targets a subset of human genes with up to 4 sequence-verified distinct lentiviral gRNA constructs per gene, pooled in a single well in a 96-well format. The gRNAs are based on the latest research on gRNA design. The gRNAs included in the LentiArray™ libraries are designed to knockout all known isoforms of the target genes and are selected for maximum knockout efficiency without sacrificing specificity. Characteristic Description Product Invitrogen™ LentiArray™ Human CRISPR Lentivirus Library (see Table 1, for details) Amount 4 aliquots of 50 µL/well per gene target (200 µL total per gene target) Viral titer • Libraries are delivered with a range of average titer between 2×107–2×108 TU/mL by puromycin antibiotic selection. • We recommend using 1×108 TU/mL for starting MOI calculations, see “MOI determination for screens“ on page 2 for additional guidance. Lentiviral map • gRNA expression is driven by a U6 promoter. • Includes puromycin resistance gene to allow selection of transduced cells. Plate layout • Refer to the associated PDF file for the plate map of the specific LentiArray™ Human CRISPR library and to the associated Excel files for gRNA target information. -
RNA Isolation and Purification for Every Sample, RNA Type, and Application Isolate and Purify RNA with Confidence
RNA isolation and purification For every sample, RNA type, and application Isolate and purify RNA with confidence RNA isolation is a crucial step in your quest to understand gene expression levels. With all the solutions that Thermo Fisher Scientific has to offer, you can be confident that you’re getting started on the right foot. Go ahead and push the limits of your research. We’ll be there to support you with robust RNA purification kits, trusted RNA tools, and experienced technical support, all backed by nearly 30 years of leadership and innovation in RNA technologies. • Isolate from any sample type, for any application • Obtain high-purity, intact RNA • Achieve high yields, even from small sample quantities Contents Methods of RNA isolation 4 RNA and sample types 5 RNA applications 6 Organic RNA extraction 8 Spin column RNA extraction 10 Lysate-based RNA extraction 11 Automated RNA purification 12 Transcriptome purification 14 mRNA purification 15 MicroRNA and small RNA purification 16 Viral RNA purification 18 RNA from FFPE samples 20 RNA isolation technology guide 22 Avoiding RNA degradation 26 Tips for handling RNA 27 RNA quantitation 28 Gene expression solutions 30 Gene expression research considerations 31 Superior cDNA synthesis for any application 32 Complete kit with flexible priming options 33 Which instrument fits your needs? 34 Which thermal cycler or PCR instrument fits your needs? 35 RNA technical resources 36 Services and support 37 Ordering information 38 Methods of RNA isolation For every application, sample, and RNA type For over three decades, our scientists have developed and professional support. Our RNA isolation products innovative and robust RNA isolation products designed include organic reagents, columns, sample lysate, and to make your job as a scientist easier. -
These Highlights Do Not Include All the Information Needed to Use ANTHIM Safely and Effectively. See Full Prescribing Information for ANTHIM
ANTHIM - obiltoxaximab solution Elusys Therapeutics, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM. ANTHIM® (obiltoxaximab) injection, for intravenous use Initial U.S. Approval: 2016 WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning. Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion (5.1) ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis (1.2, 2.4, 5.1) Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs (2.4, 5.1) INDICATIONS AND USAGE ANTHIM® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. (1.1) Limitations of Use ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. (1.2, 5.1) The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. (1.2, 14) There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. (1.2, 8.4) ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. (1.2) ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. -
Proteomics Tech Note 5802
proteomics tech note 5802 A Practical Approach to Proteomics Sean Taylor, Katrina Academia, Anthony Alburo, Aran Paulus, Kate Smith, and Considering all the possibilities, it is likely that any genome can Tanis Correa, Bio-Rad Laboratories, Inc. 2000 Alfred Nobel Drive, Hercules, CA potentially give rise to an infinite number of proteomes. Because 94547 USA proteins, not genes, are ultimately responsible for the phenotypic Since the completion of the human genome project, changes in cells and tissues, the mechanisms of disease, aging, sequencing technologies have continued to evolve, providing and environmental effects cannot be elucidated solely by tools for the rapid sequencing of most model organism studying the genome. The targets of drugs and chemicals are genomes. Associated genomic and transcriptomic data from proteins, and only through a survey of the proteome can the microarray and real-time PCR technologies have yielded associated mechanisms be understood. Most importantly, the a wealth of new information and deeper understanding of differential expression of mRNA (up or down) can capture at most biological systems. This genomic information has opened 40% of the variation of protein expression (Tian et al. 2004). up the field of proteomics, allowing the identification and The initial goal of most proteomics projects is to identify and comparison of differentially expressed proteins, from bacteria determine differential protein expression between samples. Once to humans. The accumulated data show that changes a list of differentially expressed proteins has been established, the in mRNA levels account for less than half of the relative subsequent step is to perform a detailed analysis of individual expression differences observed between associated proteins. -
Human Cytomegalovirus UL141 Protein Interacts with CELF5 and Affects Viral DNA Replication
MOLECULAR MEDICINE REPORTS 17: 4657-4664, 2018 Human cytomegalovirus UL141 protein interacts with CELF5 and affects viral DNA replication FEI ZOU1,2*, ZHI-TAO LU3*, SHUANG WANG1, SI WU1, YING-YING WU1 and ZHENG-RONG SUN1 1Department of BioBank, Affiliated Shengjing Hospital of China Medical University, Shenyang, Liaoning 110004; 2Department of Pediatrics, First Hospital of Jilin University, Changchun, Jilin 130021; 3Department of Pediatrics, Zhangjiagang First People's Hospital, Zhangjiagang, Jiangsu 215600, P.R. China Received June 14, 2017; Accepted January 5, 2018 DOI: 10.3892/mmr.2018.8419 Abstract. Human cytomegalovirus (HCMV) infection is the regulation of HCMV genomic DNA synthesis, which is a key primary viral cause of congenital abnormalities and mental step during HCMV infection leading to neurological disease. retardation in newborns. The HCMV UL141-encoded glyco- protein has been previously revealed to inhibit the cell-surface Introduction expression of cluster of differentiation (CD)155, CD122, tumor necrosis factor-related apoptosis-inducing ligand death Human cytomegalovirus (HCMV) is a ubiquitous herpes virus (TRAIL)-receptor 1 (R1) and TRAIL-receptor 2 (R2), thus with infection rate of ~50-80% in females of reproductive age protecting virally-infected cells by allowing them to escape from different regions of the world, including Australia, Canada, natural killer cell-mediated cytotoxicity. The present study United States, Sweden, Finland, Spain, United Kingdom and investigated the interaction between HCMV UL141 and Ghana (1). Following an HCMV infection, the primary clinical human fetal brain cDNA to elucidate the possible effects of manifestations in healthy people are asymptomatic reces- UL141 on the nervous system. The findings of the current sive or latent infections. -
Developing Biodefense Ivds Is Still a Priority John Conroy
Beyond Clinical Applications Developing biodefense IVDs is still a priority John Conroy In a scary world, nonclinical diagnostic testing spies a few challenges and many opportunities. s anthrax scares go, this one had that false alerts have become a fact of 1 Environmental and biowarfare. The as benign a beginning and ending life for lawmakers and their staffs. "We report noted that new technologies A as possible in today's terror- get a few of these a day," the spokesman have emerged since the 9/11 attacks to obsessed world. A New York City mu- told the Houston Chronicle. improve the detection, prevention, and sician who returned from Africa in As these stories attest, challenges and surveillance of bioterrorist attacks. February with unprocessed animal skins opportunities abound for IVD firms in a These technologies include rapid tests tested positive for anthrax. The 44-year- world where infectious diseases and for smallpox, anthrax, and salmonella, old man bought the skins, which con- bioterrorism agents are just a plane as well as improved vaccines and in- tained anthrax spores, to make tradi- flight, mail drop, cargo dock, or car ride formation-awareness networks to ex- tional African drums, authorities said. away. Market applications include tests pedite tracking the symptoms of chem- Complaining of flu-like symptoms, the for biodefense, avian flu, West Nile ical and biological events. musician collapsed while on tour with virus, food, animals and pets, water qual- his dance troupe in Pennsylvania, where ity, and genetically modified food. Test- • Food microbiology. In 2003, the glob- he was hospitalized. ing formats include ELISA, rapid later- al market for food microbiology tests Notable for their slightly more prosa- al-flow technology, and real-time was an estimated $864 million with an ic origins, similar stories of viral, toxic, polymerase chain reaction (PCR). -
Superscript® III Platinum® SYBR® Green
Page 4 Troubleshooting Guide Problem Possible Cause Solution ® ® ® No amplification product; cDNA synthesis temperature too Lower incubation temperature. SuperScript III Platinum SYBR Green One-Step qRT-PCR Kit Relative fluorescent high, low priming efficiency Cat. no. 11736-051 Size: 100 reactions signal ≤ background or RT or cDNA primer blocked by Raise incubation temperature. Redesign primer(s). Cat. no. 11736-059 Size: 500 reactions no-template control secondary structure RNA has been damaged/degraded Replace RNA if necessary. Store at -20°C RNase contamination Maintain aseptic conditions; add RNase inhibitor. Description Poor sensitivity Not enough template RNA Increase concentration of template RNA; use 10 ng–1 μg total RNA. The SuperScript® III Platinum® SYBR® Green One-Step qRT-PCR kit a one-step quantitative RT-PCR kit for the detection and Product detected at RNA has been damaged/degraded Replace RNA if necessary. quantification of RNA using real-time detection instruments. This system combines SuperScript® III Reverse Transcriptase higher than expected RNase contamination Maintain aseptic conditions; add RNase inhibitor. ® ® cycle number (RT) and Platinum Taq DNA Polymerase in a single enzyme mix, with SYBR Green I fluorescent dye in a separate 2X RT inhibitors are present in RNA Remove inhibitors in the RNA preparation by an additional 70% reaction mix. Both cDNA synthesis and PCR are performed in a single tube using gene-specific primers and either total RNA ethanol wash. Inhibitors of RT include SDS, EDTA, guanidium or mRNA. Reagents are provided for 100 or 500 amplification reactions of 50 μl each. salts, formamide, sodium phosphate and spermidine. Inefficient cDNA synthesis Adjust cDNA synthesis temperature and/or primer design. -
Pulmonary Delivery of Biological Drugs
pharmaceutics Review Pulmonary Delivery of Biological Drugs Wanling Liang 1,*, Harry W. Pan 1 , Driton Vllasaliu 2 and Jenny K. W. Lam 1 1 Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong, China; [email protected] (H.W.P.); [email protected] (J.K.W.L.) 2 School of Cancer and Pharmaceutical Sciences, King’s College London, 150 Stamford Street, London SE1 9NH, UK; [email protected] * Correspondence: [email protected]; Tel.: +852-3917-9024 Received: 15 September 2020; Accepted: 20 October 2020; Published: 26 October 2020 Abstract: In the last decade, biological drugs have rapidly proliferated and have now become an important therapeutic modality. This is because of their high potency, high specificity and desirable safety profile. The majority of biological drugs are peptide- and protein-based therapeutics with poor oral bioavailability. They are normally administered by parenteral injection (with a very few exceptions). Pulmonary delivery is an attractive non-invasive alternative route of administration for local and systemic delivery of biologics with immense potential to treat various diseases, including diabetes, cystic fibrosis, respiratory viral infection and asthma, etc. The massive surface area and extensive vascularisation in the lungs enable rapid absorption and fast onset of action. Despite the benefits of pulmonary delivery, development of inhalable biological drug is a challenging task. There are various anatomical, physiological and immunological barriers that affect the therapeutic efficacy of inhaled formulations. This review assesses the characteristics of biological drugs and the barriers to pulmonary drug delivery. -
Union Calendar No. 603
Union Calendar No. 603 110TH CONGRESS " ! REPORT 2d Session HOUSE OF REPRESENTATIVES 110–930 ACTIVITIES OF THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM ONE HUNDRED TENTH CONGRESS FIRST AND SECOND SESSIONS 2007–2008 Available via the World Wide Web: http://www.gpoaccess.gov/congress/ index.html http://www.house.gov/reform JANUARY 2, 2009.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed VerDate Aug 31 2005 01:57 Jan 03, 2009 Jkt 046108 PO 00000 Frm 00001 Fmt 6012 Sfmt 6012 E:\HR\OC\HR930.XXX HR930 smartinez on PROD1PC64 with REPORTS congress.#13 ACTIVITIES REPORT OF THE HOUSE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM VerDate Aug 31 2005 01:57 Jan 03, 2009 Jkt 046108 PO 00000 Frm 00002 Fmt 6019 Sfmt 6019 E:\HR\OC\HR930.XXX HR930 smartinez on PROD1PC64 with REPORTS with PROD1PC64 on smartinez 1 Union Calendar No. 603 110TH CONGRESS " ! REPORT 2d Session HOUSE OF REPRESENTATIVES 110–930 ACTIVITIES OF THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM ONE HUNDRED TENTH CONGRESS FIRST AND SECOND SESSIONS 2007–2008 Available via the World Wide Web: http://www.gpoaccess.gov/congress/ index.html http://www.house.gov/reform JANUARY 2, 2009.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed U.S. GOVERNMENT PRINTING OFFICE 46–108 WASHINGTON : 2009 VerDate Aug 31 2005 01:57 Jan 03, 2009 Jkt 046108 PO 00000 Frm 00003 Fmt 4012 Sfmt 4012 E:\HR\OC\HR930.XXX HR930 smartinez on PROD1PC64 with REPORTS congress.#13 COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HENRY A. -
CONGRESS SUMMARY REPORT May 13-16, 2014 | Miami, Florida
CONGRESS SUMMARY REPORT May 13-16, 2014 | Miami, Florida CONVENED BY IN ASSOCIATION WITH CONTENTS Organizing and Program Commitee 1-2 Members 3-4 Overview 2014 Congress 6 Features 2014 Congress 7-8 Statistics Student 9 Reflections Value of 10 ISCMR Partnership 2014 Congress 11 Fact Sheet Plenary 12-26 Sessions Sponsors 29 & Exhibitors All quotations in this summary have been taken from the congress evaluations completed by the attendees. The New Investigator’s Luncheon was one of the most exciting experiences that a trainee could have had, especially for those just starting their careers in this life-long journey of research. The advice of world-renown leading senior researchers was truly helpful and will be remembered in times of hardships that may come in the future. Thank you!!! Organizing Committee Adi Haramati, PhD Mary Jo Kreitzer, PhD, RN Organizing Committee, Co-Chair Fundraising Committee, Co-Chair Georgetown University School of University of Minnesota, USA Medicine, USA Robert Saper, MD, MPH Adam Perlman, MD, MPH Organizing Committee, Co-Chair Fundraising Committee, Co-Chair Boston University School of Medicine, USA Duke University, USA Judith Balk, MD, MPH, FACOG Choi Seung-hoon, PhD, KMD Communications Committee Chair 2015 ICCMR Site Host Temple University School of Medicine, Korea Institute of Oriental Medicine, Korea West Penn Allegheny Health System, USA Margaret Chesney, PhD Samantha Simmons, MPH Vice Chair, Consortium of Academic Local Site Committee, Chair Health Centers, USA Oregon Health Sciences University, USA David -
125509Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125509Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS ACTION PACKAGE CHECKLIST APPLICATION INFORMATION1 If NDA, Efficacy Supplement Type: BLA #125509 BLA Supplement # (an action package is not required for SE8 or SE9 supplements) Proprietary Name: Anthim Applicant: Elusys Therapeutics, Inc. Established/Proper Name: obiltoxaximab Agent for Applicant (if applicable): Dosage Form: injection RPM: Jane A. Dean, RN, MSN Division: Division of Anti-Infective Products For ALL 505(b)(2) applications, two months prior to EVERY action: NDA Application Type: 505(b)(1) 505(b)(2) Efficacy Supplement: 505(b)(1) 505(b)(2) Review the information in the 505(b)(2) Assessment and submit the draft2 to CDER OND IO for clearance. BLA Application Type: 351(k) 351(a) Check Orange Book for newly listed patents and/or Efficacy Supplement: 351(k) 351(a) exclusivity (including pediatric exclusivity) No changes New patent/exclusivity (notify CDER OND IO) Date of check: Note: If pediatric exclusivity has been granted or the pediatric information in the labeling of the listed drug changed, determine whether pediatric information needs to be added to or deleted from the labeling of this drug. Actions Proposed action AP TA CR User Fee Goal Date is 3/20/16 Previous actions (specify type and date for each action taken) None If accelerated approval or approval based on efficacy studies in animals, were promotional materials received? Note: Promotional materials to be used within 120 days after approval must have been Received submitted (for exceptions, see http://www fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/ucm069965.pdf).