Chief Medical Officer
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Drug Safety Oversight Board Members
April 29, 2021 Drug Safety Oversight Board (DSOB) Roster Chair • Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs Center for Drug Evaluation and Research Executive Director • Terry Toigo, R.Ph, MBA Associate Director for Drug Safety Operations, Center for Drug Evaluation and Research Food and Drug Administration Center for Drug Evaluation and Research (CDER) Office of the Center Director (OCD) Primary Member: • Robert Temple, M.D., Deputy Director for Clinical Science Office of New Drugs (OND) Primary Member: • Mary Thanh Hai, M.D., Deputy Director, Office of New Drugs Alternate Members: • Peter Stein, M.D., Director, Office of New Drugs • Ellis Unger, M.D., Director, Office of Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) Office of Medical Policy (OMP) Primary Member: • Jacqueline Corrigan-Curay, Director Alternate Member: • Leonard V. Sacks, Mgr. Supervisory Medical Officer Office of Generic Drugs (OGD) Primary Member: • Linda Forsyth, M.D., Division of Clinical Review Alternate Member: • Vacant Office of Surveillance and Epidemiology (OSE) Primary Members: • Mark I. Avigan, M.D., Associate Director for Critical Path Initiatives • Judy Zander, M.D., Director, Office of Pharmacoviligance and Epidemiology (OPE) Alternate Members: • Gerald DalPan, M.D., M.H.S., Director, OSE • S. Chris Jones, Deputy Director, Division of Pharmacovigilance (DPV) II • Judy Staffa, Ph.D., R.Ph., Associate Director for Public Health Initiatives -Page 1 of 4- April 29, 2021 • Cynthia LaCivita, R.Ph, Director, Division -
When Mentoring Matters
careers & recruitment People Recent moves of note in and around the biotech and pharma industries. over 20 years of experience in the pharma Clinical-stage biopharma Humanigen has announced the industry, including significant gene therapy appointment of Adrian Kilcoyne (photo) to the newly created translational and development expertise. role of chief medical officer. He brings leadership experience Reape was most recently chief medical from multinational pharma and biotech companies and a officer at Spark Therapeutics. strong clinical background in internal medicine and public health medicine, having recently served as vice president of Clinical-stage precision medicine oncology global medical affairs, head of evidence generation company Relay Therapeutics has named and external alliances at AstraZeneca. Patrick Riley senior vice president of “Dr. Kilcoyne’s experience and knowledge in multiple areas, including COVID-19, artificial intelligence. Riley has over a CAR-T and other oncology clinical development areas, medical affairs, regulatory affairs, decade of data science and machine learning evidence generation, health economics and partnering, gives him a unique insight that can experience from Google, initially in web be leveraged towards Humanigen’s COVID-19, acute GvHD, CAR-T and other oncology search and user behavior analysis and programs with lenzilumab and ifabotuzumab,” said Humanigen CEO Cameron Durrant. later as a principal engineer and senior “In addition, Adrian’s leadership in the external alliances arena will be instrumental in researcher on the Google Accelerated helping guide the progress of Humanigen’s pipeline and potential commercialization.” Science team. In addition, Relay has appointed Charles Ferté, formerly AstraZeneca’s senior director and global project leader of oncology R&D, as its Laura Carter has been appointed CSO of Precision metagenomics company vice president and lead for RLY-4008, a Gossamer Bio, succeeding Luisa Salter-Cid. -
Public Health Act
Province of Alberta PUBLIC HEALTH ACT Revised Statutes of Alberta 2000 Chapter P-37 Current as of June 17, 2021 Office Consolidation © Published by Alberta Queen’s Printer Alberta Queen’s Printer Suite 700, Park Plaza 10611 - 98 Avenue Edmonton, AB T5K 2P7 Phone: 780-427-4952 Fax: 780-452-0668 E-mail: [email protected] Shop on-line at www.qp.alberta.ca Copyright and Permission Statement Alberta Queen's Printer holds copyright on behalf of the Government of Alberta in right of Her Majesty the Queen for all Government of Alberta legislation. Alberta Queen's Printer permits any person to reproduce Alberta’s statutes and regulations without seeking permission and without charge, provided due diligence is exercised to ensure the accuracy of the materials produced, and Crown copyright is acknowledged in the following format: © Alberta Queen's Printer, 20__.* *The year of first publication of the legal materials is to be completed. Note All persons making use of this consolidation are reminded that it has no legislative sanction, that amendments have been embodied for convenience of reference only. The official Statutes and Regulations should be consulted for all purposes of interpreting and applying the law. Amendments Not in Force This consolidation incorporates only those amendments in force on the consolidation date shown on the cover. It does not include the following amendments: RSA 2000 cP-37 s77 repeals ss1(1)(e.1) and (2), 33(2.1) and (2.2), 52.6(1.1)(c) and (1.2), 52.61, 52.92 to 52.992, 53(4.2) to (4.4), 53.1 to 53.4, 66(2)(r), 76. -
April 7, 2021 Message from Chief Medical Officer on COVID-19
From: Chief Medical Officer Subject: Message from Chief Medical Officer on COVID-19 Vaccine Availability Date: Wednesday, April 7, 2021 6:08:49 PM Attachments: image001.png April 7, 2021 Message from Chief Medical Officer on COVID-19 Vaccine Availability Dear Colleagues, Earlier this week, President Biden announced the timeline for all U.S. adults to be eligible for the COVID-19 vaccine was moved up to April 19, from the original goal of May 1. That means that in just over a week, any adult in our country who wants a vaccine will be eligible to register for one. This news brings us hope and encouragement that we are on the right path to defeat the pandemic. I want to provide as many resources as possible to help you navigate the various pathways for getting the vaccine. As a DHS employee, there are several roads to vaccination. Mission-essential, location-dependent (1A/1B) employees were provided an opportunity to receive the vaccine through our partnership with the Veterans Health Administration (VHA). Currently, 163 VA Medical Centers (VAMCs) across the country are scheduling and vaccinating those 1A/1B employees who opted in. DHS employees also have several options to locate vaccine opportunities in their communities through VaccineFinder.org or local retail pharmacies. NEW: All non-1A/1B DHS employees may present this designation letter to their local vaccine provider immediately as proof of priority eligibility to receive the COVID-19 vaccine as part of the Centers for Disease Control and Prevention’s Phase 1C (essential workforce) recommendation. Note: This designation letter is not for use as part of our VHA partnership, as the VAMCs are completing vaccinations for DHS 1A/1B colleagues only. -
Global Health, Epidemiology and Genomics
global health, epidemiology and genomics HEALTH CARE SYSTEMS ORIGINAL RESEARCH ARTICLE Competency of peripheral health workers in detection & management of common syndromic conditions under surveillance, North 24 Parganas, West Bengal, India, 2016: a cross-sectional study F. Debnath1,2*, T. Bhatnagar3, L. Sundaramoorthy3 and M. Ponnaiah3 1 Division of Epidemiology, ICMR-National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India 2 Masters of Public Health Scholar, ICMR-National Institute of Epidemiology, Chennai, India 3 ICMR School of Public Health, ICMR-National Institute of Epidemiology, Chennai, India Global Health, Epidemiology and Genomics (2017), 2, e15, page 1 of 8. doi:10.1017/gheg.2017.13 Background Competency of peripheral health workers in the detection and management of common syndromic condi- tions is crucial as they are the first point of contact for the majority of the Indian population. Methods We measured the competency of auxiliary nurse midwives (ANMs), and factors associated with inadequate competency, in the detection and management of common conditions diarrhoea,̶ acute respiratory tract infection, fever, malaria through̶ a cross-sectional study using condition specific validated clinical vignettes and structured questionnaires. Results Out of 272 selected ANMs, 68% (95% CI 62–74%) were adequately competent. Factors independently associated with inadequate competency were unavailability of essential drugs in preceding month [adjusted odds ratio (AOR) = 1.95; 95% CI 1.1–3.5] and ever trained in integrated management of childhood illness (AOR = 2.4; 95% CI 1.4–4.1). Conclusion More than two third of the peripheral health workers were adequately competent to detect and manage com- mon conditions. -
From the Chief Medical Officer Dr Michael Mcbride by EMAIL To: All
From the Chief Medical Officer Dr Michael McBride BY EMAIL Castle Buildings Stormont Estate To: All NI Departments through the Civil BELFAST Contingencies Group, for onward distribution to BT4 3SQ all public authorities Tel: 028 9052 0563 Email: [email protected] Your Ref: Our Ref: Date: 26 February 2020 Dear Colleagues CORONAVIRUS: (A) KEY PUBLIC HEALTH ADVICE (B) ACTION TO BE TAKEN BY PUBLIC AUTHORITIES 1 This letter updates the advice given in my letter of 6 February to all NI Departments and their public authorities, to reflect the recent changes in the case definition including reference to northern Italy. This letter supersedes the letter of 6 February. The purpose is to enable all NI Executive Departments and public authorities to prepare to respond to any and all potential eventualities arising from the current novel coronavirus (COVID-19) outbreak. It is essential that all Departments are assured that proportionate, appropriate and efficient arrangements are in place that are consistent with the key public health messages about novel coronavirus. 2 Each NI Department is asked to ensure that the letter is distributed to each public authority that they sponsor, including schools. Coronavirus: key facts 3 Coronaviruses are a large family of viruses, some of which cause illness in people, ranging from the common cold to more severe diseases such as MERS and SARS. As a group, coronaviruses are common across the world. The 2019 novel Coronavirus strain, now officially designated COVID-19 by the World Health Organisation, is a strain not previously seen in humans. On 31 December 2019 Chinese authorities notified the WHO of an outbreak of viral pneumonia in Wuhan City. -
From the Chief Medical Officer Dr Michael Mcbride HSS(MD)93/2020
From the Chief Medical Officer Dr Michael McBride HSS(MD)93/2020 Castle Buildings Stormont Estate FOR ACTION BELFAST Chief Executives, Public Health Agency/Health and Social BT4 3SQ Care Board/HSC Trusts/ NIAS Tel: 028 9052 0563 GP Medical Advisers, Health & Social Care Board Email: [email protected] All General Practitioners and GP Locums (for onward distribution to practice staff) OOHs Medical Managers (for onward distribution to staff) Our Ref: HSS(MD)93/2020 RQIA Date: 30 December 2020 PLEASE SEE ATTACHED FULL CIRCULATION LIST Dear Colleague DEPLOYMENT OF THE ASTRAZENECA COVID-19 VACCINE IN NORTHERN IRELAND AND UPDATED JCVI ADVICE ON COVID-19 VACCINES ACTION REQUIRED Chief Executives must ensure this information is drawn to the attention of all staff involved in the COVID-19 vaccination programme. The PHA must ensure this information is cascaded to their staff working on COVID-19 vaccine deployment and the health protection team. The HSCB must ensure this information is cascaded to all General Practitioners and practice managers for onward distribution to all staff involved in the COVID-19 vaccination programme. INTRODUCTION 1. You will be aware that on 30 December the COVID-19 vaccine developed by AstraZeneca/Oxford, was granted approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). In addition to this announcement the Joint Committee on Vaccination and Immunisation (JCVI) have also issued further updated advice in relation to the COVID-19 vaccination programme. 2. This letter sets out a broad overview of how the AstraZeneca vaccine will be deployed and highlights some of the updated advice from JCVI, particularly in relation to the intervals between doses of the Pfizer/BioNTech or AstraZeneca vaccines. -
Open Letter to the ICO, Cmos and UK Data Providers: Reducing Barriers to Data Access for Research in the Public Interest – Lessons from COVID-19
Open letter to the ICO, CMOs and UK data providers: Reducing barriers to data access for research in the public interest – lessons from COVID-19 Dear Ms Elizabeth Denham CBE, Prof Sir Chris Whitty, Dr Frank Atherton, Dr Gregor Smith, Dr Michael McBride, Ms Sarah Wilkinson, Rt Hon. Gavin Williamson MP, Sir Ian Diamond, Prof David Ford, Prof Kerina Jones, Prof Ronan Lyons, Ms Siobhan Carey CBE, Mr Roger Halliday, Mr Frank Hester OBE, Dr Janet Valentine, and Mr Duncan Selbie, Letter sent by email on 6th July 2020 The COVID-19 outbreak has sparked increased awareness of the importance of timely, system-wide data for examining trends and modelling different scenarios to inform policy response.1-5 The scale and speed of data access and use has been unprecedented in public health history. Pre-print articles sharing results before peer review have proliferated (with implications for research quality6 7) and over 500 vaccine and treatment clinical trials have been initiated in record time.8 The entire economy of knowledge production related to COVID-19 has been accelerated, with the understanding that, if we wait for perfect information before acting, we will be too late. COVID-19 is providing valuable lessons on improving data access and the importance of using data for efficient and effective service response. This situation contrasts sharply with the cumbersome processes usually faced by researchers using administrative (or routinely-collected) health data to inform policy-making on other topics, resulting from systems that are not purpose-built for research and summarised by four key obstacles. First, the cost of using administrative data is prohibitive. -
MEI Pharma Announces the Retirement of Chief Medical Officer
MEI Pharma Announces the Retirement of Chief Medical Officer Robert Mass and Promotion of Richard Ghalie to Chief Medical Officer SAN DIEGO, April 30, 2021 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced the retirement of Robert Mass, M.D., MEI's chief medical officer. Dr. Mass joined the company in 2010 and will retire on May 3, 2021, after which he will continue to serve as a strategic advisor to the company. The Company also announced that Richard Ghalie, M.D., MEI's senior vice president, clinical development, has been promoted to chief medical officer. "Bob's contributions to MEI over his more than ten years at the company have been invaluable across our drug candidate pipeline, particularly in guiding the strategy and broad clinical development program for zandelisib, which will best be measured by the benefit these programs may ultimately provide to patients. I want to thank Bob for his dedication to MEI and his friendship over these past 10 years. We wish him the very best in his retirement and look forward to continued interaction through his advisory role," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "I also welcome Richard stepping into his role as our new chief medical officer, a role for which he is very well suited, as evidenced by the significant progress in our zandelisib program under Richard's guidance and its progress with our partners at Kyowa Kirin towards zandelisib's planned new drug application for consideration by FDA for approval under the accelerated approval pathway." Dr. -
Medical Research Council Annual Report and Accounts 2006/07 HC 93
06/07 Annual Report and Accounts © Crown Copyright 2006 The text in this document (excluding any Royal Arms and departmental logos) may be reproduced free of charge in any format or medium providing that it is reproduced accurately and not used in a misleading context. The material must be acknowledged as Crown copyright and the title of the document specified. Any queries relating to the copyright in this document should be addressed to The Licensing Division, HMSO, St Clements House, 2-16 Colegate, Norwich, NR3 1BQ. Fax: 01603 723000 or e-mail: licensing@cabinet-office.x.gsi.gov.uk 2 MRC Annual Report and Accounts 2006/07 Medical Research Council Annual Report and Accounts 2006/07 Presented to Parliament by the Secretary of State, and by the Comptroller and Auditor General in pursuance of Schedule I, Sections 2(2) and 3(3) of the Science and Technology Act 1965. Sir John Chisholm Chairman Professor Sir Leszek Borysiewicz Deputy Chairman and Chief Executive Ordered by and printed on London: The Stationery Office 6 February 2008 Price: £18.55 HC 93 The Medical Research Council The MRC RCUK The Medical Research Council (MRC) was set up in 1913 to administer Research Councils UK (RCUK) is a partnership of the seven (formerly public funds for medical research. It was incorporated under its eight) UK Research Councils – public bodies funded mainly by the UK present title by Royal Charter in 1920. A supplemental charter was Government via OSI. granted in 1993 describing the MRC’s new mission following the 1993 government white paper on science and technology. -
Directory of State and Local Government
DIRECTORY OF STATE AND LOCAL GOVERNMENT Prepared by RESEARCH DIVISION LEGISLATIVE COUNSEL BUREAU 2020 Table of Contents TABLE OF CONTENTS Please refer to the Alphabetical Index to the Directory of State and Local Government for a complete list of agencies. NEVADA STATE GOVERNMENT ORGANIZATIONAL CHART ............................................. D-9 CONGRESSIONAL DELEGATION ............................................................................................. D-13 DIRECTORY OF STATE GOVERNMENT CONSTITUTIONAL OFFICERS: Attorney General ........................................................................................................................ D-15 State Controller ........................................................................................................................... D-19 Governor ..................................................................................................................................... D-20 Lieutenant Governor ................................................................................................................... D-27 Secretary of State ........................................................................................................................ D-28 State Treasurer ............................................................................................................................ D-30 EXECUTIVE BOARDS ................................................................................................................. D-31 NEVADA SYSTEM OF HIGHER EDUCATION -
Supporting Doctors Throughout the COVID-19 Pandemic
12 January 2021 Supporting doctors throughout the COVID-19 pandemic Dear Colleagues This year has started in a way we could all have barely imagined 12 months ago, and we wanted to write to thank all of you for your immense efforts. After the long ordeal of last year, we enter the New Year with the real hope that vaccination offers to control COVID and the very substantial impact that it has had on health, lives and livelihoods but with a significant surge in cases to deal with before that begins to take effect. There are many weeks ahead that are likely to be among the most challenging of all our professional lives. Doctors will be faced with many professional dilemmas and some may be pushed to the limits of physical and mental endurance. Please look after your colleagues - protracted, relentless crises are often much more draining than short intense ones. We wrote to you during the first wave of COVID-19 last Spring and again in the Autumn when infections once again began to rise. Those letters contained important advice concerning the application of clinical decisions in extreme circumstances and we would encourage you to read them if you have not already done so. We also append them for your information. Our view remains that clinical decision making must remain anchored in the principles of Good Medical Practice. This means it must also rightly take into account the realities of the situation in which we find ourselves. We would emphasise once again that a rational approach to varying practice in an emergency is part of a doctor’s professional response, and we would expect you to be professionally supported to do this.