DOCSLIB.ORG

Can Vaccine Development Be Safely Accelerated?

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Can Vaccine Development Be Safely Accelerated? Volume 33 Number 4 BioPharm International INTERNATIONAL BioApril 2020 PharmThe Science & Business of Biopharmaceuticals APRIL 2020 www.biopharminternational.com CAN VACCINE DEVELOPMENT BE SAFELY ACCELERATED? UPSTREAM PROCESSING Pandemic Response I Biosimilars I Audit Preparation OPTIMIZING BIOREACTORS DOWNSTREAM PROCESSING NEW TECHNOLOGIES MANUFACTURING SINGLE-USE SOLUTIONS ANALYTICS CONTAMINATION CONTROL QUALITY/REGULATIONS INTERCHANGEABILITY STANDARDS OPERATIONS SUPPLIER OVERSIGHT COLD-CHAIN PACKAGING PREFILLED SYRINGES BIOBUSINESS FACILITY LOCATION FACTORS Volume Number 33 4 OUTSOURCING ACCELERATING TECH TRANSFER pda.org/bookstore Get the Expert Guidance You Need with PDA Technical Reports PDA Technical Reports (TRs) are peer-reviewed global consensus documents written by subject matter experts on a wide variety of industry-related topics. Long recognized for their quality and relevance to the industry, these documents are used as essential references by industry and regulatory authorities around the world! Best sellers include: TR 26: Sterilization and Filtration of Liquids TR 80: Data Integrity Management System for Pharmaceutical Laboratories TR 13, Revised: Fundamentals of an Environmental Monitoring Program TR 79: Particulate Matter Control in Diffi cult to Inspect Parenterals TR 82: Low Endotoxin Recovery PDA members can download new TRs for free within 30 days of publication and can access electronic versions of all TRs on demand through the PDA TR Portal. All TRs are available for purchase to both members and non-members at any time. Visit the PDA Bookstore to explore the library of more than 80 technical reports and get the expert guidance, opinions, and best practices you need to improve your business! pda.org/bookstore INTERNATIONAL BioPharmThe Science & Business of Biopharmaceuticals ADVERTISING EDITORIAL Publisher Mike Tracey [email protected] Editorial Director Rita Peters [email protected] National Sales Manager Scott Vail [email protected] Senior Editor Agnes M. Shanley [email protected] Managing Editor Susan Haigney [email protected] European Sales Manager Linda Hewitt [email protected] European Editor Felicity Thomas [email protected] European Senior Sales Executive Science Editor Feliza Mirasol [email protected] Stephen Cleland [email protected] Manufacturing Editor Jennifer Markarian [email protected] VP/Managing Director, Pharm/Science Group Dave Esola Assistant Editor Lauren Lavelle [email protected] [email protected] Senior Art Director Marie Maresco C.A.S.T. Data and List Information Graphic Designer Maria Reyes Michael Kushner [email protected] EDITORIAL ADVISORY BOARD AUDIENCE DEVELOPMENT BioPharm International’s Editorial Advisory Board comprises distinguished specialists involved in the biologic manufacture of therapeutic drugs, Audience Development Christine Shappell [email protected] diagnostics, and vaccines. Members serve as a sounding board for the editors and advise them on biotechnology trends, identify potential MJH LIFE SCIENCESTM authors, and review manuscripts submitted for publication. Chairman and Founder Mike Hennessy, Sr K. A. Ajit-Simh Hanns-Christian Mahler Vice Chairman Jack Lepping President, Shiba Associates Head Drug Product Services Lonza AG President and CEO Mike Hennessy, Jr Madhavan Buddha Chief Financial Officer Neil Glasser, CPA/CFE Freelance Consultant Jerold Martin Independent Consultant Executive Vice President, Operations Tom Tolvé Rory Budihandojo Senior Vice President, Content Silas Inman Director, Quality and EHS Audit Hans-Peter Meyer Boehringer-Ingelheim Lecturer, University of Applied Sciences Senior Vice President, I.T. & Enterprise Systems John Moricone and Arts Western Switzerland, Senior Vice President, Audience Generation & Product Fulfillment Edward G. Calamai Institute of Life Technologies Managing Partner Joy Puzzo Pharmaceutical Manufacturing K. John Morrow Vice President, Human Resources & Administration Shari Lundenberg and Compliance Associates, LLC President, Newport Biotech Vice President, Business Intelligence Chris Hennessy Suggy S. Chrai David Radspinner Vice President, Marketing Amy Erdman President and CEO GE Healthcare The Chrai Associates Executive Creative Director, Creative Services Jeff Brown Tom Ransohoff Leonard J. Goren Vice-President and Senior Consultant Global Leader, Human Identity BioProcess Technology Consultants Division, GE Healthcare Uwe Gottschalk Anurag Rathore Vice-President, Biotech CMC Consultant Chief Technology Officer, Faculty Member, Indian Institute of Pharma/Biotech Technology Lonza AG © 2020 MultiMedia Pharma Sciences LLC All rights reserved. No part of this Susan J. Schniepp publication may be reproduced or transmitted in any form or by any means, electronic Fiona M. Greer Executive Vice President of or mechanical including by photocopy, recording, or information storage and retrieval Global Director, Post-Approval Pharma without permission in writing from the publisher. Authorization to photocopy items BioPharma Services Development and Distinguished Fellow for internal/educational or personal use, or the internal/educational or personal use of SGS Life Science Services Regulatory Compliance Associates, Inc. specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other Rajesh K. Gupta users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA Tim Schofield 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For Vaccinnologist and Microbiologist Consultant uses beyond those listed above, please direct your written request to Permission Dept. Alexa Rockenstein, [email protected]. Reprints: Contact Michael Tracey, Denny Kraichely CMC Sciences, LLC [email protected]. Associate Director Johnson & Johnson Paula Shadle MultiMedia Pharma Sciences LLC provides certain customer contact data (such Principal Consultant, as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties Stephan O. Krause Shadle Consulting who wish to promote relevant products, services, and other opportunities that may be of Director of QA Technology interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact AstraZeneca Biologics information available to third parties for marketing purposes, simply email mmhinfo@ Alexander F. Sito mmhgroup.com and a customer service representative will assist you in removing your Steven S. Kuwahara President, name from MultiMedia Pharma Sciences LLC lists. Principal Consultant BioValidation GXP BioTechnology LLC BioPharm International does not verify any claims or other information appearing in Michiel E. Ultee any of the advertisements contained in the publication, and cannot take responsibility for Eric S. Langer Principal any losses or other damages incurred by readers in reliance of such content. President and Managing Partner Ulteemit BioConsulting BioPharm International welcomes unsolicited articles, manuscripts, photographs, BioPlan Associates, Inc. illustrations, and other materials but cannot be held responsible for their safekeeping or return. Thomas J. Vanden Boom Howard L. Levine VP, Biosimilars Pharmaceutical Sciences To subscribe, email [email protected] President Pfizer BioProcess Technology Consultants Hank Liu Krish Venkat Head of Quality Control Managing Partner Sanofi Pasteur Anven Research Herb Lutz Steven Walfish Principal Consulting Engineer Principal Scientific Liaison Merck Millipore USP Table of Contents Volume 33 Number 4 BioPharm International integrates the science and business of biopharmaceutical research, development, and manufacturing. We provide practical, peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively. COVER STORY 10 Can Vaccine Development Be Safely Accelerated? Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe. Cover Design by Maria Reyes Images: BillionPhotos.com FEATURES UPSTREAM PROCESSING QUALITY/REGULATION BIOBUSINESS Bioreactors Redefine Biosimilars Tackle Lower Taxes, More Flexibility Crucial Upstream Productivity Interchangeability Standards to Retaining Pharma Employment Agnes Shanley Feliza Mirasol Agnes Shanley and Lauren Lavelle New bioreactor designs, better media, Demonstrating interchangeability can Biopharmaceutical companies are process intensification, and analytics ensure biosimilar substitutability at the moving to states with lower taxes. �������52 drive improvements. ����������������������������� 14 pharmacy level. �������������������������������������28 COLUMNS AND DEPARTMENTS DOWNSTREAM PROCESSING OPERATIONS What’s New in Being Vigilant in Supplier Oversight FROM THE EDITOR Downstream Technologies? Susan Haigney As the coronavirus pandemic unfolds, Lauren Lavelle Risk assessments, audits, and good pharma must practice science over hype. New chromatography resins and systems, communication are key elements of Rita Peters. .6 valves, and membrane purification supplier oversight. .34 columns are profiled. 18 REGULATORY BEAT Packaging Preserves the Cold Chain FDA is encouraging alternative MANUFACTURING Hallie Forcinio insulins and challenging Seeing Success with More sustainable and functional cold- anticompetitive practices. Single-Use Solutions chain packaging protects temperature- Jill Wechsler ���������������������������������������������8
Load more

Recommended publications
  • Uniqure N.V. Paasheuvelweg 25A 1105BP Amsterdam the Netherlands +1-339-970-7000
    uniQure N.V. Paasheuvelweg 25a 1105BP Amsterdam The Netherlands +1-339-970-7000 NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS To be held on September 14, 2017 To the Shareholders of uniQure N.V.: Notice is hereby given that an Extraordinary General Meeting of Shareholders (the “Extraordinary Meeting”) of uniQure N.V., a public company with limited liability ( naamloze vennootschap ) under the laws of the Netherlands (the “Company,” “uniQure,” and “we”), will be held on September 14, 2017, at 9:30 a.m., Central European Summer Time, at the Company’s principal executive offices located at Paasheuvelweg 25a, 1105BP Amsterdam, the Netherlands, for the following purposes: I. Opening and announcements; II. Appointment of Jeremy P. Springhorn, Ph.D. as a non-executive director (voting proposal no. 1); III. Appointment of Madhavan Balachandran as a non-executive director (voting proposal no. 2); IV Any other business that may properly come before the meeting or any adjournment of the meeting; and V. Closing of the meeting. Each person authorized to attend the Extraordinary Meeting may inspect the Agenda at the office of uniQure. Our Board of Directors (our “Board”) recommends that you vote “FOR” each of the voting proposals noted above. The record date is set at the close of business on August 17, 2017 EST and, therefore, only the Company’s shareholders of record at the close of business on August 17, 2017 EST are entitled to receive this notice (this “Notice”) and to vote at the Extraordinary Meeting and any adjournment thereof. Only shareholders who have given notice in writing to the Company by September 12, 2017 of their intention to attend the Extraordinary Meeting in person are entitled to attend the Extraordinary Meeting in person.
    [Show full text]
  • AMGEN INC. V. SANOFI
    Case: 20-1074 Document: 159 Page: 1 Filed: 06/21/2021 NOTE: This order is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC., Plaintiffs-Appellants v. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC, Defendants-Appellees ______________________ 2020-1074 ______________________ Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv- 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA, Judge Richard G. Andrews. ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for plaintiffs-ap- pellants. Also represented by SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG, STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou- sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott Case: 20-1074 Document: 159 Page: 2 Filed: 06/21/2021 2 AMGEN INC. v. SANOFI Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler Onorato Mead & Sears LLP, Washington, DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff- appellant Amgen Inc. also represented by SARAH CHAPIN COLUMBIA, McDermott, Will & Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA. MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, filed a response for defendants-appellees. Also represented by VICTORIA REINES; DAVID K. BARR, DANIEL REISNER, New York, NY; DEBORAH E.
    [Show full text]
  • Interim Recommendations for Use of the Moderna Mrna-1273 Vaccine Against COVID-19
    Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 Interim guidance First issued 25 January 2021 Updated 15 June 2021 Background This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) at its extraordinary meeting on 21 January 2021 (1) and updated during its extraordinary meeting on 27 May 2021(2). Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Working Group website. The guidance is based on the evidence summarised in the Background document on the Moderna mRNA-1273 vaccine against COVID-19 (3) and the background paper on COVID-19 disease and vaccines (4). Annexes which include GRADE and evidence-to-recommendations (ETR) tables have also been updated to reflect the updated recommendations. All referenced documents are available on the SAGE COVID-19 webpage: https://www.who.int/groups/strategic- advisory-group-of-experts-on-immunization/covid-19-materials. These interim recommendations refer to the mRNA-1273 vaccine, manufactured by Moderna. The vaccine is also known as COVID-19 Vaccine Moderna. In the subsequent text the vaccine will be referred to as mRNA-1273. On 30 April 2021, mRNA-1273 was granted WHO’s Emergency Use Listing (EUL). Methods SAGE applies the principles of evidence-based medicine and has set in place a thorough methodological process for issuing and updating recommendations (5). A detailed description of the methodological processes as they apply to COVID-19 vaccines can be found in the SAGE evidence framework for COVID-19 vaccines (6).
    [Show full text]
  • Moderna Vaccine Day Presentation
    Zika Encoded VLP mRNA(s) RSV CMV + EBV SARS-CoV- RSV-ped 2 Flu hMPV/PIV3 H7N9 Encoded mRNA(s) Ribosome Protein chain(s) First Vaccines Day April 14, 2020 © 2020 M oderna Therapeutics Forward-looking statements and disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning; the impact of the SARS-CoV-2 pandemic on the Company’s clinical trials and operations; the timing and finalization of a dose-confirmation Phase 2 study and planning for a pivotal Phase 3 study for mRNA-1647; the status and outcome of the Phase 1 clinical trial for mRNA-1273 being conducted by NIH; the next steps and ultimate commercial plan for mRNA-1273; the size of the potential market opportunity for mRNA-1273; the size of the potential commercial market for novel vaccines produced by Moderna or others; the potential peak sales for the Company’s wholly-owned vaccines; the probability of success of the Company’s vaccines individually and as a portfolio; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.
    [Show full text]
  • The Covid–19 Pandemic and Haemoglobin Disorders
    THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’.
    [Show full text]
  • Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
    Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S.
    [Show full text]
  • Large Cap Value Fund Q3 Portfolio Holdings
    Putnam Equity Income Fund The fund's portfolio 8/31/20 (Unaudited) COMMON STOCKS (95.5%)(a) Shares Value Aerospace and defense (3.0%) Northrop Grumman Corp. 763,179 $261,472,757 Raytheon Technologies Corp. 1,931,815 117,840,715 379,313,472 Airlines (1.0%) Southwest Airlines Co. 3,596,011 135,138,093 135,138,093 Auto components (0.8%) Delphi Automotive PLC 1,165,950 100,411,614 100,411,614 Automobiles (0.7%) General Motors Co. 2,932,830 86,899,753 86,899,753 Banks (9.9%) Bank of America Corp. 13,888,550 357,491,277 Citigroup, Inc. 6,615,251 338,171,631 JPMorgan Chase & Co. 3,413,635 342,012,091 KeyCorp 3,945,705 48,611,086 PNC Financial Services Group, Inc. (The) 1,279,414 142,270,837 1,228,556,922 Beverages (2.5%) Keurig Dr Pepper, Inc.(S) 3,097,349 92,393,921 Molson Coors Beverage Co. Class B(S) 1,663,844 62,627,088 PepsiCo, Inc. 1,123,779 157,396,487 312,417,496 Biotechnology (4.5%) AbbVie, Inc. 2,005,931 192,108,012 Amgen, Inc. 804,202 203,720,451 Regeneron Pharmaceuticals, Inc.(NON) 262,080 162,471,254 558,299,717 Building products (2.3%) Fortune Brands Home & Security, Inc. 1,681,051 141,342,768 Johnson Controls International PLC 3,432,811 139,818,392 281,161,160 Capital markets (3.5%) Apollo Global Management, Inc. 2,289,153 107,292,601 Charles Schwab Corp. (The) 2,516,793 89,421,655 Goldman Sachs Group, Inc.
    [Show full text]
  • Mark One) (X) QUARTERLY REPORT PURSUANT to SECTION 13 OR 15(D) of the SECURITIES EXCHANGE ACT of 1934
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) (X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 1997 ------------------ OR ( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number 0-19034 ------- REGENERON PHARMACEUTICALS, INC. ------------------------------------------------------ (Exact name of registrant as specified in its charter) New York 13-3444607 ------------------------------- ------------------------------------ (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 777 Old Saw Mill River Road Tarrytown, New York 10591-6707 ---------------------------------------- ---------- (Address of principal executive offices) (Zip code) (914) 347-7000 ---------------------------------------------------- (Registrant's telephone number, including area code) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ----- ----- Indicate the number of shares outstanding of each of the issuer's classes of common stock as of November 3, 1997: Class of Common Stock
    [Show full text]
  • Sigma Spectrum Operator's Manual
    spectrum Operator’s Manual 35700BAX & 35700ABB Generation 2 Operating System Pump Operating Software v6.05 For Use with MDL Editor v6.2.4 SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com Manual 41018- 6.05/6.2.4 Revision D II Pump Operating Software v6.05 For Use With MDL Editor v6.2.4 ©2011 Copyright SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com III Manual 41018- 6.05/6.2.4 Revision D IV Pump Operating Software v6.05 For Use With MDL Editor v6.2.4 TABLE OF CONTENTS Introduction and Safety . 1 Intended Device Use . 1 Related Documents . 1 Regulatory Information . 1 Contacting SIGMA Technical Support . 1 Conventions . 2 Summary of Warnings and Cautions . 2 System Components . 11 Spectrum Pump Illustrations . 12 Hardware Labeling . 13 Battery Compatibility . 14 Setting Up the Pump . 15 Unpack the Pump . 15 AC Power Adaptor . 16 Cleaning the Power Adaptor . 16 Connecting the Power Adaptor . 16 Removing the Power Adaptor . 17 Charging the Battery . 17 Configuring User Options . 18 User Options . 18 Operational Overview . 21 Starting a New Infusion Using the Dose Error Reduction System (DERS) . 24 Starting a New Infusion using the BASIC Mode . 25 Secondary Infusions . 26 Preparing the Pump and IV Sets . 27 Loading an IV Set . 28 Unloading an IV Set . 30 Preparing the Pump for a Secondary Infusion . 30 Programming the Pump . 31 Infusion Programming Modes: . 32 Keys Used to Program and Operate the Pump .
    [Show full text]
  • Biopharma R&D on Treatment and Vaccines
    Biopharma R&D on Treatment and Vaccines Coronavirus: Gilead Readies For Remdesivir Ramp Up, Questions On Profit Motive Demand Could Be High For Antiviral Executive Summary “All of that is at risk in not knowing if the drug If clinical trials prove it effective against COVID-19, works or not – and that is really not with an eye to remdesivir could potentially help millions of commercial,” she added. patients - which raises big questions about funding and access. Mercier said the company was spending more time on considering issues of access to the drug once its safety and efficacy is established – especially in regions of the world with less As vaccines will take around 12 months to developed healthcare systems. develop, companies with antiviral treatments are now been pushed to the front line in the battle Nevertheless, Gilead is contemplating a possible against coronavirus, and Gilead Sciences Inc.’s commercial future for the drug. remdesivir is currently the biggest hope of a drug to treat infected patients. “I have to be honest, commercial opportunity might come if this becomes a seasonal disease The company had big news to talk about on 2 or if stockpiling comes into play, but that is much March at the Cowen Health Care conference, as it later down the line,” concluded Mercier. had announced earlier in the day the acquisition of oncology firm Forty Seven for $4.9bn. (Also see One precedent for a big commercial hit for an “Gilead Calls Forty Seven Buyout Complementary antiviral product is Roche’s Tamiflu (oseltamivir). To Kite, Other IO Efforts” - Scrip, 2 Mar, 2020.) The drug achieved peak revenues of $3bn in 2009, largely down to stockpiling in response to that Speaking at the investor conference, Gilead’s chief year’s H1N1 flu pandemic.
    [Show full text]
  • Sixth Circuit I.O.P
    RECOMMENDED FOR FULL-TEXT PUBLICATION Pursuant to Sixth Circuit I.O.P. 32.1(b) File Name: 15a0199p.06 UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT _________________ DINO RIKOS et al., ┐ Plaintiffs-Appellees, │ │ │ No. 14-4088 v. │ > │ THE PROCTER & GAMBLE COMPANY, │ Defendant-Appellant. │ ┘ Appeal from the United States District Court for the Southern District of Ohio at Cincinnati. No. 1:11-cv-00226—Timothy S. Black, District Judge. Argued: June 16, 2015 Decided and Filed: August 20, 2015 Before: MOORE and COOK, Circuit Judges; COHN, District Judge.* _________________ COUNSEL ARGUED: Brian J. Murray, JONES DAY, Chicago, Illinois, for Appellant. Timothy G. Blood, BLOOD HURST & O’REARDON, San Diego, California, for Appellees. ON BRIEF: Brian J. Murray, JONES DAY, Chicago, Illinois, D. Jeffrey Ireland, FARUKI IRELAND & COX P.L.L., Cincinnati, Ohio, Joanne Lichtman, BAKER & HOSTETLER LLP, Cleveland, Ohio, Chad A. Readler, Rachel Bloomekatz, JONES DAY, Columbus, Ohio, for Appellant. Timothy G. Blood, Leslie E. Hurst, Thomas J. O’Reardon II, BLOOD HURST & O’REARDON, San Diego, California, for Appellees. MOORE, J., delivered the opinion of the court in which COHN, D.J., joined. COHN, D.J. (pg. 37), delivered a separate concurring opinion. COOK, J. (pp. 38–40), delivered a separate dissenting opinion. *The Honorable Avern Cohn, United States District Judge for the Eastern District of Michigan, sitting by designation. 1 No. 14-4088 Rikos et al. v. The Procter & Gamble Co. Page 2 _________________ OPINION _________________ KAREN NELSON MOORE, Circuit Judge. The named plaintiffs-appellees (“Plaintiffs”) are three individuals who purchased Align, Procter & Gamble’s (“P&G”) probiotic nutritional supplement, and found that the product did not work as advertised—that is, it did not promote their digestive health.
    [Show full text]
  • Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
    Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3).
    [Show full text]