DOCSLIB.ORG

Request ID Organization FOIA Log Description Received Date Stanford John S

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Request ID Organization FOIA Log Description Received Date Stanford John S Request ID Organization FOIA Log Description Received Date Stanford John S. Knight Journalism Digital copies of all financial conflict of interest (FCOI) reports submitted to NIH in 1/3/2020 51073 fellowship accordance with the Federal regulation at 42 CFR Part 50 Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought Skid Row Housing Trust Grant application and associated summary statement for project 1P50MH115846-01A1 , 10/2/2019 52818 sub-project ID 7132. (Date Range for Record Search: From 05/18/2018 To 05/10/2019) 52875 Washington state university A copy of the following contract, HHSN271201100027C. 10/2/2019 52876 The Washington Post Copies of various correspondence and attachments. 10/8/2019 Being Patient A copy of the following: 1) 1R43AG059520-01A1, 2) 1R43AG058357-01 and 3) 10/1/2019 52906 4R44AG055319-02. University of South Carolina Correspondence (including emails and meeting/phone call notes) regarding the animal 10/1/2019 52907 care program at the University of South Carolina, Columbia SC and the Office of Laboratory Animal Welfare (OLAW) employees self Any and all report and documents related to NIH wide internal control assessment of the 10/7/2019 52908 clinical center pharmacy conducted by the office of management assessment and executed by a senior management analyst at the national institutes of health. University of Alabama - Birmingham A copy of the records related to grant #1U01CA224151-01 which were released in NCI 10/2/2019 52909 FOIA Case #19-114. Nathan Kline Institute Abstract, project narrative, specific aims, and research strategy for R01MH101307, plus 10/3/2019 52910 budget info for all years. n/a Copies of any type of correspondence sent to or from principal investigator Cora E Lewis 10/2/2019 52911 at the University of Alabama at Birmingham regarding the mercury leaks that were reported to the Office for Human Research Protections. 52912 Individual A copy of grant application 5R01CA218306. 10/2/2019 Baker & Hostetler LLP 1. All grant proposals or applications, research proposals or applications, and other 10/3/2019 52913 project proposals or applications submitted to the NCI by or on behalf of Ritu Aneja from September 1, 2015 to present. 2. All supporting documentation submitted in conn 52914 Case Western Reserve University A copy of: 1) R03AG057838-01, and 2) R03AG054705-01A1. 10/3/2019 The University of Michigan All of the information that NIH and/or OLAW provided to the organizations for the 10/3/2019 52915 following FOIA requests - Request ID: 48530, 48585, 50345, 51001, 47124, 47558, 47788, 48169. National Association for Biomedical Most up to date FOIA Log as of 10/2019. 10/3/2019 52916 Research The Washington Post Emails that address the funding and any restrictions on projects involving self-organizing 10/3/2019 52917 human embryo models. Specifically emails from program officers regarding proposed or ongoing projects in the labs of several researchers. National Association for Biomedical All congressional correspondence, both electronic and not-electronic, to and from NIH 10/3/2019 52918 Research Director Francis Collins from July 18, 2019 to current date. National Association for Biomedical All communication, both electronic and non-electronic, regarding September 16-17, 2019 10/3/2019 52919 Research NIH Workshop on Optimizing Reproducibility in Non-human Primate Research Studies by Enhancing Rigor and Transparency, announced on June 28, 2019. New England Anti-Vivisection Grant notification and proposal document and 2) awardee's yearly progress report that 10/4/2019 52920 Society has been previously released via FOIA since January 1, 2015, for 11 projects. New England Anti-Vivisection Copies of the 2017 and 2018 APHIS Form 7023 materials, reports of exceptions to the 10/4/2019 52921 Society Animal Welfare Act regulations and standards, supplemental NIH IRP reporting submitted by all NIH IC's, and other records submitted. Arbor Research Collaborative for Copies of the following pertaining to 5U01DK106786-05 : grant application, budget, 10/4/2019 52922 Health budget justification, notice of grant award, and summary statement. Regenerative Medicine A copy of the official NIH research grant policy on maintaining the confidentiality of the 10/4/2019 52923 Minnesota/University of Minn reviewers in regards to the exact grants they have reviewed. North Carolina A&T State University A copy of the following: 1) MD012393, 2) MD007586, 3) MD012392, 4) MD012388, 5) 10/4/2019 52924 MD007585, 6) MD007601, and 7) MD007600. 52926 Green Haven Correctional Facility Information regarding neck pain from damaged discs in back. 10/4/2019 52927 MuckRock News Information about, R01 NS099348. 10/4/2019 Premiere Lignes All emails and records to NIH employees from Curt Ellison ([email protected]) or to Curt 10/7/2019 52928 Ellison ([email protected]) by NIH employees and from numerous entities and domains. Premiere Lignes Any and all records of grants, donations, endowments, and funding received by Prof. Curt 10/7/2019 52929 Ellison of Boston University from the NIH from 2007 - 2013 including all records of donations, endowments, and funding with numerous entities. Premiere Lignes All emails sent to NHLBI employees from Curt Ellison ([email protected]) or to Curt Ellison 10/7/2019 52930 ([email protected]) by NHLBI employees from 2007 - 2013 and to and from numerous domains. Premiere Lignes Any and all records of grants, donations, endowments, and funding received by Prof. Curt 10/7/2019 52931 Ellison of Boston University from the NHLBI from 2007 - 2013 including other financial records. Premiere Lignes Copy of records of grant funds awarded by NIAAA to Curt Ellison of Boston University and 10/7/2019 52932 gift funds from various alcohol industry donors to NIAAA 2007-2013. Premiere Lignes Copy of emails between NIAAA employees and [email protected] or various listed domains 10/7/2019 52933 2007-2013. The Humane Society of the United All records and documents created or received by NIH, on or after August 12, 2019 10/7/2019 52935 States regarding the health classification of individual chimpanzees; a full census of the remaining NIH-owned or -supported chimpanzees in facilities other than Chimp Haven. Individual January 1, 2015 to February 5, 2015, I am writing to request copies of all written 10/8/2019 52937 correspondence between the University of North Carolina at Chapel Hill (UNC; PHS Assurance # D16-00256) and the OLAW documenting noncompliance items The Lambert Firm Requesting documents related to the NIH Gulf Study (NIEHS Gulf Long-term Follow-up 10/8/2019 52938 Study). 52939 NHAssociates A copy of the SOW for HHSN316201200110W-HHSN27100001. 10/8/2019 52940 NHAssociates A copy of the SOW for HHSN316201200070W-HHSN26900001. 10/8/2019 52941 Hendall Inc. Contract HHSN275201600271U under GSA contract GS00F083CA. 10/8/2019 52942 Tucker Ellis LLP NIDA meeting minutes from 1974-1996. 10/8/2019 University of Missouri Sinclair some examples of funded F32 that have been funded by NINR including at least one of 10/8/2019 52943 School of Nursing the following: 5F32NR017322-02, 1F32NR017322-01, 1F32NR018585-01 and 1F32NR012389-01. People for the Ethical Treatment of Most recent PHS Assurance and all correspondence between OLAW and 10 institutions for 10/9/2019 52944 Animals the period of 1/1/2018 to 9/1/2019. Stop Animal Exploitation NOW! All correspondence between OLAW and 19 Colorado institutions for the period of 10/1/2019 52946 6/30/2019 to 9/30/2019. Stop Animal Exploitation NOW! All correspondence between OLAW and 12 Arizona institutions for the period of 10/1/2019 52947 6//30/2019 to 9/30/2019. Stop Animal Exploitation NOW! All correspondence between OLAW and 10 New Mexico, 7 Nevada, 7 Utah, and 4 Hawaii 10/1/2019 52948 institutions for the period of 6/30/2019 to 9/30/2019. Stop Animal Exploitation NOW! All correspondence between OLAW and 179 California institutions for the period of 10/1/2019 52949 6/30/2019 to 9/30/2019. Stop Animal Exploitation NOW! All correspondence between OLAW and 37 institutions for the period of 7/31/2019 to 10/1/2019 52950 9/30/2019. Buzzfeed Investigative files at OER that mention NIH funds and/or grants to Mark Kay of Stanford 10/9/2019 52951 University for research about gene therapy and/or RNA interference (also known as “RNA,” “RNAi”) from 2011 through 2012 People for the Ethical Treatment of Most recent PHS Assurance and all correspondence between OLAW and 10 institutions for 10/1/2019 52952 Animals the period of 1/1/2018 to 9/1/2019. Knowledge Ecology International Copy of all NIH U.S. manufacturing requirement waiver requests and determinations, 10/4/2019 52953 from 2009 to present. Adelphi University A copy of previously released version-secondary data analysis using medicare data (Date 10/10/2019 52954 Range for Record Search: From 01/01/2018 To 10/09/2019). 52955 Private Individual A copy of grant #1R01GM117324-01A1 and grant# 1R01GM099514-01. 10/9/2019 52956 Private Individual A copy of grant# 1R01GM099514-01. 10/9/2019 52957 Private Individual A copy of the grant#1R01DE026186-01. 10/9/2019 Duke University School of Medicine A copy of the following grants: 1) 1K01AG061260-01A1, 2) 1K01AG059831-01A1, 10/10/2019 52958 3)1K99AG059947-01A1, 4) 5K01AG057820-02, 5) 1K23AG055668-01, 6) 1K23AG062613- 01, and 7) 5K01AG042450-05. 52959 Duke University School of Medicine A copy of, 1K01AG059831-01A1. 10/10/2019 52960 Duke University School of Medicine A copy of, 1K99AG059947-01A1. 10/10/2019 52961 Duke University School of Medicine A copy of, 5K01AG057820-02. 10/10/2019 52962 Duke University School of Medicine A copy of, 1K23AG055668-01. 10/10/2019 52963 Duke University School of Medicine A copy of, 1K23AG062613-01.
Load more

Recommended publications
  • A Multicenter, Multi-Outbreak, Randomized, Controlled Safety And
    2018 Ebola MCM RCT Protocol Page 1 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease Short Title: 2018 Ebola MCM RCT Protocol Sponsored by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20892 NIH Protocol Number: 19-I-0003 Protocol IND #: 125530 ClinicalTrials.gov Number: NCT03719586 Date: 4 October 2019 Version: 7.0 CONFIDENTIAL This document is confidential. No part of it may be transmitted, reproduced, published, or used by other persons without prior written authorization from the study sponsor and principal investigator. 2018 Ebola MCM RCT Protocol Page 2 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 KEY ROLES DRC Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD Director-General, DRC National Institute for Biomedical Research Professor of Microbiology, Kinshasa University Medical School Kinshasa Gombe Democratic Republic of the Congo Phone: +243 898949289 Email: [email protected] Other International Investigators: see Appendix E Statistical Lead: Lori Dodd, PhD Biostatistics Research Branch, DCR, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Phone: 240-669-5247 Email: [email protected] U.S. Principal Investigator: Richard T. Davey, Jr., MD Clinical Research Section, LIR, NIAID, NIH Building 10, Room 4-1479, Bethesda,
    [Show full text]
  • Coronavirus Preparedness and Response Hearing
    CORONAVIRUS PREPAREDNESS AND RESPONSE HEARING BEFORE THE COMMITTEE ON OVERSIGHT AND REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTEENTH CONGRESS SECOND SESSION MARCH 11–12, 2020 (A TWO DAY HEARING) Serial No. 116–96 Printed for the use of the Committee on Oversight and Reform ( Available on: http://www.govinfo.gov, oversight.house.gov or docs.house.gov U.S. GOVERNMENT PUBLISHING OFFICE 40–428 PDF WASHINGTON : 2020 COMMITTEE ON OVERSIGHT AND REFORM CAROLYN B. MALONEY, New York, Chairwoman ELEANOR HOLMES NORTON, District of JIM JORDAN, Ohio, Ranking Minority Member Columbia PAUL A. GOSAR, Arizona WM. LACY CLAY, Missouri VIRGINIA FOXX, North Carolina STEPHEN F. LYNCH, Massachusetts THOMAS MASSIE, Kentucky JIM COOPER, Tennessee MARK MEADOWS, North Carolina GERALD E. CONNOLLY, Virginia JODY B. HICE, Georgia RAJA KRISHNAMOORTHI, Illinois GLENN GROTHMAN, Wisconsin JAMIE RASKIN, Maryland JAMES COMER, Kentucky HARLEY ROUDA, California MICHAEL CLOUD, Texas RO KHANNA, California BOB GIBBS, Ohio DEBBIE WASSERMAN SCHULTZ, Florida CLAY HIGGINS, Louisiana JOHN P. SARBANES, Maryland RALPH NORMAN, South Carolina PETER WELCH, Vermont CHIP ROY, Texas JACKIE SPEIER, California CAROL D. MILLER, West Virginia ROBIN L. KELLY, Illinois MARK E. GREEN, Tennessee MARK DESAULNIER, California KELLY ARMSTRONG, North Dakota BRENDA L. LAWRENCE, Michigan W. GREGORY STEUBE, Florida STACEY E. PLASKETT, Virgin Islands FRED KELLER, Pennsylvania JIMMY GOMEZ, California ALEXANDRIA OCASIO-CORTEZ, New York AYANNA PRESSLEY, Massachusetts RASHIDA TLAIB, Michigan KATIE PORTER, California DEB HAALAND, New Mexico DAVID RAPALLO, Staff Director DANIEL REBNORD, Subcommittee Staff Director ALEXANDRA GOLDEN, Chief Health Counsel RICHARD TRUMKA, Subcommittee Staff Director AMY STRATTON, Clerk CHRISTOPHER HIXON, Minority Staff Director CONTACT NUMBER: 202-225-5051 (II) CONTENTS MARCH 11 AND 12, 2020 (DAY 1 AND DAY 2) Page WITNESSES Dr.
    [Show full text]
  • Administration of Donald J. Trump, 2020 Remarks on Coronavirus
    Administration of Donald J. Trump, 2020 Remarks on Coronavirus Vaccine Development November 13, 2020 The President. Thank you very much. Thank you. It's beautiful out here this time of year. In the past 9 months, my administration has initiated the single greatest mobilization in U.S. history, pioneering, developing, and manufacturing therapies and vaccines in record time. Numbers like nobody has seen before. No medical breakthrough of this scope and magnitude has ever been achieved this rapidly, this quickly. And we're very proud of it, and I had tremendous help from the military—generals, admirals—and many of the great people at the White House. Operation Warp Speed is unequaled and unrivaled anywhere in the world, and leaders of other countries have called me to congratulate us on what we've been able to do, and we've helped many countries with their ventilators and all of the problems they were having. And I'd like to congratulate everyone involved in this effort. It's been an incredible effort. As a result of Operation Warp Speed, Pfizer announced on Monday that its "China virus" vaccine is more than 90-percent effective. This far exceeds any and all expectations. Nobody thought they'd get to that level. And we have others coming which we think will be at equal level—maybe more, if that's possible. In July, my administration reached an agreement with Pfizer to provide $1.95 billion to support the mass manufacturing and distribution of 100 million doses, with the option to purchase a total of 600 million doses shortly thereafter.
    [Show full text]
  • COVID-19 UPDATE November 23, 2020 Global Total Cases – 59,025,871 Total Deaths – 1,393,889
    COVID-19 UPDATE November 23, 2020 Global Total cases – 59,025,871 Total deaths – 1,393,889 United States Total cases – 12,369,978 Total deaths – 257,415 On Wednesday, the United States surpassed 250,000 coronavirus deaths. The total number of patients hospitalized with COVID-19 in the United States has reached new highs every day since November 11, when hospitalizations first surpassed the April peak. One week before the end of the month, the United States has already recorded its highest monthly case total in November, reporting more than 3,075,000 cases. The number of November cases could exceed four million, more than double the total in October. Trump Administration • The Centers for Disease Control and Prevention urged Americans against traveling for Thanksgiving and to limit gatherings to people in the same household as Covid-19 rages in the U.S. o “Celebrating virtually or with the people you live with is the safest choice this Thanksgiving,” the agency said on its website on Thursday. “Travel may increase your chance of getting and spreading COVID-19.” o For people considering traveling for the holiday, the agency offered a checklist of risks and standard advice such as wearing a face covering and staying 6 feet away from people “who don’t live with you.” People hosting Thanksgiving guests at home should observe precautions that could include having an outdoor meal with family and friends, have people bring their own food and drink, and opening windows if the gathering is indoors. • In a call last week, Centers for Disease Control and Prevention Director Robert Redfield and Health and Human Services Secretary Alex Azar encouraged governors to help build confidence in vaccines and stressed the importance of wearing masks.
    [Show full text]
  • 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27
    Case 2:20-cv-04074 Document 1 Filed 05/04/20 Page 1 of 27 Page ID #:1 1 Mary E. Alexander, Esq. (State Bar No. 104173) Brendan D.S. Way, Esq. (State Bar No. 261705) 2 MARY ALEXANDER & ASSOCIATES, P.C. 44 Montgomery Street, Suite 1303 3 San Francisco, California 94104 Telephone: (415) 433-4440 4 Facsimile: (415) 433-5440 5 Elizabeth J. Cabraser (State Bar No. 083151) [email protected] 6 Jonathan D. Selbin (State Bar No. 170222) [email protected] 7 LIEFF CABRASER HEIMANN & BERNSTEIN, LLP 8 275 Battery Street, 29th Floor San Francisco, CA 94111-3339 9 Telephone: 415.956.1000 Facsimile: 415.956.1008 10 11 Attorneys for Plaintiff 12 UNITED STATES DISTRICT COURT 13 CENTRAL DISTRICT OF CALIFORNIA 14 15 CHRISTOPHER WEIDNER, Case No. 2:20-cv-4074 Individually and as Personal 16 Representative of the Decedent, PLAINTIFF’S COMPLAINT FOR CARL WEIDNER, DAMAGES 17 Plaintiff, 1. NEGLIGENCE – WRONGFUL 18 DEATH, 46 U.S.C. § 30301 et seq. v. 19 2. NEGLIGENCE - WRONGFUL CARNIVAL CORPORATION, DEATH 20 CARNIVAL PLC, and PRINCESS CRUISE LINES LTD., 3. GROSS NEGLIGENCE – 21 WRONGFUL DEATH Defendants. 22 23 COMPLAINT 24 Plaintiff CHRISTOPHER WEIDNER, Individually and as Personal 25 Representative of the Decedent, his father, CARL WEIDNER, brings this action 26 against Defendants, PRINCESS CRUISE LINES LTD. ("PRINCESS"), 27 CARNIVAL CORPORATION, and CARNIVAL PLC (collectively, 28 “CARNIVAL”) and allege: PLAINTIFF'S COMPLAINT FOR DAMAGES -1- CASE NO. _______________ Case 2:20-cv-04074 Document 1 Filed 05/04/20 Page 2 of 27 Page ID #:2 1 THE PARTIES 2 1.
    [Show full text]
  • So Many People Are Perplexed with the Covid-19 Lockdowns, Mask Requirements, Social Distancing, Loss of Jobs, Homes, and Their Very Sanity
    So many people are perplexed with the Covid-19 lockdowns, mask requirements, social distancing, loss of jobs, homes, and their very sanity. What lies behind all of this? There have been so many conflicting reports that one has to ask the question, Is there even a pandemic at all? Was there ever one? Let’s have a look. ======================== Strange advance hints (predictive programming) – A 1993 Simpsons episode called “Marge in Chains” actually accurately predicted the coronavirus outbreak. One scene depicted a boardroom meeting between government officials and major media moguls. The chairman opened with these words: “I’d like to call to order this secret conclave of America’s media empires. We are here to come up with the next phony baloney crisis to put Americans back where they belong…” Suddenly a delegate from NBC chimed in: “Well I think…” Then the chairman interrupted him, saying: “NBC, you are here to listen and not speak!” He then said: “I think we should go with a good old fashioned health scare.” Everyone then nodded in approval. Next, a female delegate remarked: “A new disease–no one’s immune–it’s like The Summer of the Shark, except instead of the shark, it’s an epidemic.” – Another Simpsons episode called “A Totally Fun Thing that Bart will Never Do Again,” first aired on April 29, 2012, featured an emergency broadcast announcing the outbreak of the deadly “Pandora Virus,” and how it was “spreading rapidly.” The announcer then said: “This unprecedented threat requires a world-wide quarantine. All ships must remain at sea until further notice.
    [Show full text]
  • T1 Emails Received
    Miller, Roger From: J & J Schroeder <[email protected]> Sent: Friday, March 06, 2020 5:07 PM To: Kesarwani, Rashi; Miller, Roger; T1 Cc: [email protected] Subject: Follow up question after 1600 block Curtis St. 3/5/20 meeting Hello Rashi, Roger and Andrew, Thank you very much for the time you gave us last night to discuss T1 Bond Phase 1 & 2 infrastructure improvement projects. You very patiently and attentively listened to our concerns, feedback and questions regarding the T1 Bond infrastructure improvement projects. I sincerely appreciate your diligence and efforts of outreach to the Berkeley community to make this T1 Phase 1 & 2 planning process transparent and accessible to the public for input. After speaking with my neighbors, we would like clarification regarding the email Director of Public Works Phil Harrington sent to Joan Hamilton and me on February 7, 2020. Mr. Harrington's email was in response to an email both Joan and I sent regarding the unsafe, degraded condition of the 1600 block of Curtis St. This is the email I sent 1/29/20: City of Berkeley Department of Public Works 2180 Milvia St. Berkeley, CA 94704 January 29, 2020 Department of Public Works Director Phil Harrington: I am here tonight to strongly urge the Department of Public Works to have the second phase of Measure T1 (infrastructure bond money) go towards paving more streets. I have lived at 1610 Curtis St. for the past 41 years. According to Beth Gerstein, District 1 Council member Rashi Kesarwani’s Legislative Aide, the 1600 block of Curtis St.
    [Show full text]
  • Officials Call on States to Expand Groups Getting COVID-19 Vaccines
    Officials call on states to expand groups getting COVID-19 vaccines by Melissa Jenco, News Content Editor Editor's note:For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19. Federal health officials are releasing COVID-19 vaccine doses they had been withholding and are encouraging states to open vaccination to broader groups of people. "This next phase reflects the urgency of the situation we face," Health and Human Services Secretary Alex M. Azar II, J.D., said Tuesday. "Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied." Azar said states should start vaccinating everyone 65 years and older and people ages 16 or 18 to 64 (depending on the vaccine) who have documented underlying conditions. The recommendation is a change from the initial recommendations on priority groups made by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices last month. "We are telling states today they should open vaccination to all of their most vulnerable people," Azar said. "That is the most effective way to save lives now." Administration of vaccines from Pfizer-BioNTech and Moderna started in December among health care workers and residents of long-term care facilities, and roughly 9 million people have received at least one dose. However, that is significantly behind the 20 million officials predicted by the end of December. Azar blamed reporting lags and states micromanaging who could get a dose. He noted nearly 38 million doses, including 25 million first doses, have been distributed to states.
    [Show full text]
  • Supreme Court of the United States
    No. 15-____ IN THE Supreme Court of the United States IN RE: AVANDIA MARKETING, SALES PRACTICES & PRODUCTS LIABILITY LITIGATION: GLAXOSMITHKLINE LLC, Petitioner, v. ALLIED SERVICES DIVISION WELFARE FUND, UFCW LOCAL 1776 AND PARTICIPATING EMPLOYERS HEALTH AND WELFARE FUND, AND UNITED BENEFIT FUND, Respondents. On Petition For A Writ Of Certiorari To The United States Court of Appeals For the Third Circuit PETITION FOR A WRIT OF CERTIORARI Nina M. Gussack John H. Beisner Anthony C.H. Vale Counsel of Record Yvonne M. McKenzie Jessica D. Miller PEPPER HAMILTON LLP Geoffrey M. Wyatt 3000 Two Logan Square SKADDEN, ARPS, SLATE, Eighteenth & Arch Streets MEAGHER & FLOM LLP Philadelphia, PA 19103 1440 New York Ave., NW (215) 981-4000 Washington, DC 20005 (202) 371-7000 [email protected] Attorneys for Petitioner i QUESTIONS PRESENTED This case involves claims by third-party payors (“TPPs”) that they overpaid for Avandia, a prescrip- tion diabetes medication manufactured by petitioner, GlaxoSmithKline (“GSK”). The TPPs claim that GSK failed to disclose risk information, entitling them to recovery under the Racketeer Influenced and Corrupt Organizations Act, even though they do not allege that Avandia was ineffective; that it injured any one of their plan participants; or that they stopped cover- ing it after learning about the drug’s alleged risks. The Third Circuit nevertheless held that the TPPs could plausibly allege that GSK’s representations had an “inflationary effect” on the drug’s price. In so ruling, the Third Circuit expressly declined to follow the Eleventh Circuit, which had previously rejected similar claims, and also departed from several other appellate decisions rejecting similar “fraud on the market” theories.
    [Show full text]
  • Recent Zoonotic and Vector-Borne Viral Threats NIAID Vaccine
    4/1/2020 PROTOTYPE PATHOGEN APPROACH TO PANDEMIC PREPAREDNESS HIV→PNEUMOVIRUS→PARAMYXOVIRUS→CORONAVIRUS ADVAC Alumni 2 April 2020 Barney S. Graham, MD, PhD Deputy Director Vaccine Research Center, NIAID, NIH 1 Recent Zoonotic and Vector-borne Viral Threats • Hanta virus • Nipah/Hendra • West Nile virus • SARS • Influenza • Chikungunya • Ebola • MERS • Zika • EV‐D68 • SARS‐CoV‐2 2 NIAID Vaccine Research Center Basic Research Process Development Nucleic acid Vectors VLPs • AIDS/HIV • Influenza Proteins and cGMP Manufacturing nanoparticles • Ebola/Marburg • RSV • Malaria Monoclonal antibodies • Tuberculosis • EID GLP Analysis • West Nile virus, Zika • Chikungunya • W/E/V equine encephalitis viruses • MERS‐CoV, SARS, and other CoV • Nipah and other paramyxoviruses • EV‐D68 and other picornaviruses Clinical Trials • Smallpox 3 1 4/1/2020 Public health burden of re-emerging & emerging viruses Traditional Approaches • Licensed vaccines/antibiotics Vaccine • Passive surveillance Challenges • Contact tracing • Quarantine • Vaccines for unmet needs • Emerging viruses • Improving licensed vaccines 4 4 New Technologies are Transforming Vaccinology • Structure-based vaccine design Structural analysis of antigenic sites on viral • Single-cell sorting, sequencing, and bioinformatics surface glycoproteins – Rapid isolation of human mAbs Isolation of human monoclonal – Definition of antibody lineages antibodies from single B cells – Analysis of immune responses • Protein engineering of self-assembling nanoparticles • Rapid DNA synthesis • Recombinant
    [Show full text]
  • Administration of Donald J. Trump, 2020 Remarks on Coronavirus
    Administration of Donald J. Trump, 2020 Remarks on Coronavirus Vaccine Development and an Exchange With Reporters May 15, 2020 The President. Thank you very much. It's very hot today. Please, sit down. This is going to be a very hot one, and we apologize to everybody out there that's going to suffer through it. But you know what? It's better than bad weather. And it's great to be in the Rose Garden. I want to especially thank this group for joining us as we announce a historic, groundbreaking initiative in our ongoing effort to rapidly develop and manufacture a coronavirus vaccine. We're joined by Secretary Steven Mnuchin, Secretary Mark Esper, Secretary Alex Azar, Chairman of the Joint Chiefs of Staff General Mark Milley, FDA Director Dr. Stephen Hahn, Director of the National Institute of Health Dr. Francis Collins, Dr. Fauci, Dr. Birx. We're joined by a very terrific group of professionals. Tomorrow will mark 30 days since we released the White House guidelines for a safe and phased opening of America. That's what we're doing. It's the opening of America. We're going to have an amazing year next year. We're going to have a great transition into the fourth quarter. As of this morning, almost every State has taken steps to begin reopening, and the American people are doing an extraordinary job of continuing to take precautions while, at the same time, wanting to start—and they will be starting—to resume their American way of life. We will be reigniting our economic engines.
    [Show full text]
  • Kizzmekia S. Corbett
    KIZZMEKIA S. CORBETT, PHD Senior Research Fellow National Institutes of Health | National Institute of Allergy and Infectious Diseases | Vaccine Research Center 40 Convent Drive, Building 40 - Room 2608, Bethesda MD 20892 [email protected] | phone: 301.761.7610 | fax: 301.480.2771 EDUCATION Doctor of Philosophy in Microbiology and Immunology 2014 University of North Carolina at Chapel Hill (UNC) Director’s Scholar Bachelor of Science in Biological Sciences | Secondary Major in Sociology 2008 University of Maryland – Baltimore County (UMBC) Robert and Jane Meyerhoff Scholar RESEARCH EXPERIENCE Research Fellow 10/14 - present National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: mechanisms of viral immunity to inform influenza and coronavirus vaccine development Graduate Research Assistant 08/09 – 10/14 University of North Carolina at Chapel Hill | Microbiology and Immunology | PI: Aravinda de Silva, MPH PhD Research Interest: human antibody responses to dengue virus infection Visiting Scholar 04/14 – 05/14 Genetech Research Institute | PI: Aruna Dharshan de Silva, PhD Research Interest: immunological relevance of dengue virion maturation Postbaccalaureate Research Fellow 05/08 – 08/09 National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: novel vaccine platform design for respiratory syncytial virus antigens NIH Undergraduate Scholarship Program Summer Intern 06/07 – 08/07 National Institutes of Health | Vaccine Research Center
    [Show full text]