Death of a Sales Model, Or Not: Perspectives on The
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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. -
Medicine Safety “Pharmacovigilance” Fact Sheet
MINISTRY OF MEDICAL SERVICES MINISTRY OF PUBLIC HEALTH AND SANITATION PHARMACY AND POISONS BOARD MEDICINE SAFETY “PHARMACOVIGILANCE” FACT SHEET What is medicine safety? Medicine safety, also referred to as Pharmacovigilance refers to the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines. It aims at identifying new information about hazards, and preventing harm to patients. What is an Adverse Drug Reaction? The World Health Organization defines an adverse drug reaction (ADR) as "A response to a drug which is noxious and unintended, and which occurs at doses normally used or tested in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function". Simply put, when the doctor prescribes you medicines, he expects the desirable effects of them. The undesired effects of the medicines is the ADR or, commonly known as “side effects”. An adverse drug reaction is considered to be serious when it is suspected of causing death, poses danger to life, results in admission to hospital, prolongs hospitalization, leads to absence from productive activity, increased investigational or treatment costs, or birth defects. Age, gender, previous history of allergy or reaction, race and genetic factors, multiple medicine therapy and presence of concomitant disease processes may predispose one to adverse effects. Why monitor adverse drug reactions? Before registration and marketing of a medicine, its safety and efficacy experience is based primarily on clinical trials. Some important adverse reactions may not be detected early or may even be rare. -
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. -
AVANDIA (Rosiglitazone Maleate Tablets), for Oral Use Ischemic Cardiovascular (CV) Events Relative to Placebo, Not Confirmed in Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION ----------------------- WARNINGS AND PRECAUTIONS ----------------------- These highlights do not include all the information needed to use • Fluid retention, which may exacerbate or lead to heart failure, may occur. AVANDIA safely and effectively. See full prescribing information for Combination use with insulin and use in congestive heart failure NYHA AVANDIA. Class I and II may increase risk of other cardiovascular effects. (5.1) • Meta-analysis of 52 mostly short-term trials suggested a potential risk of AVANDIA (rosiglitazone maleate tablets), for oral use ischemic cardiovascular (CV) events relative to placebo, not confirmed in Initial U.S. Approval: 1999 a long-term CV outcome trial versus metformin or sulfonylurea. (5.2) • Dose-related edema (5.3) and weight gain (5.4) may occur. WARNING: CONGESTIVE HEART FAILURE • Measure liver enzymes prior to initiation and periodically thereafter. Do See full prescribing information for complete boxed warning. not initiate therapy in patients with increased baseline liver enzyme levels ● Thiazolidinediones, including rosiglitazone, cause or exacerbate (ALT >2.5X upper limit of normal). Discontinue therapy if ALT levels congestive heart failure in some patients (5.1). After initiation of remain >3X the upper limit of normal or if jaundice is observed. (5.5) AVANDIA, and after dose increases, observe patients carefully for signs • Macular edema has been reported. (5.6) and symptoms of heart failure (including excessive, rapid weight gain; • Increased incidence of bone fracture was observed in long-term trials. dyspnea; and/or edema). If these signs and symptoms develop, the heart (5.7) failure should be managed according to current standards of care. -
Pharmaceutical Sales Representatives
[Chapter 4, 28 April] Chapter 4 Pharmaceutical sales representatives Andy Gray, Jerome Hoffman and Peter R Mansfield The presence of pharmaceutical industry sales representatives almost seems a fact of life at many modern medical centres and universities around the world. Many medical and pharmacy students come into contact with pharmaceutical industry sales representatives during their training. Later on in the careers of many health professionals, encounters with sales representatives can occur on a daily basis, taking up a substantial portion of a busy health professional s time. However, health professionals have a choice in the matter - they may choose not to see pharmaceutical sales representatives at all or they may attempt to manage such interactions.’ This chapter aims to provide information to help you make up your own mind on this issue. This choice has important consequences for health professionals practice and patients, so requires careful consideration. ’ Aims of this chapter By the end of the session based on this chapter, you should be able to answer a series of questions on your interactions with sales representatives: In what ways, if any, might I hope to benefit from meeting with sales representatives? How are sales representatives selected, trained, supported and managed? What information do sales representatives provide? How might contact with sales representatives influence me in a positive or negative way? Should I have contact with sales representatives at all? Is it possible, if I choose to have contact with sales representatives, to minimise the potential harm and maximise the potential benefit for my professional development and practice? This chapter presents evidence that we believe can be helpful in addressing these questions, and ends with a series of activities that will allow students to work on the issue in more depth. -
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. -
Alison Bass Curriculum Vitae Current Affiliations • Associate Professor Of
Alison Bass Curriculum Vitae Current Affiliations Associate Professor of Journalism, West Virginia University 2012-present Author, Freelance Writer and Blogger 2008-present Journalism Experience Author of forthcoming book, Getting Screwed: Sex Workers and the Law (Fall 2015) Getting Screwed takes a wide-ranging historic look at prostitution in the United States. It weaves the true stories of sex workers (past and present) together with the latest research in exploring the advisability of decriminalizing adult prostitution. To read more about this project, visit www.sexworkandthelaw.com/. Author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial Side Effects won the NASW Science in Society Award and garnered critical acclaim from many quarters, including The New York Review of Books, The Boston Globe and The Washington Post. Published by Algonquin Books in 2008, Side Effects tells the true story of three people who exposed the deception behind the making of a bestselling drug. To read more about the book, visit www.alison-bass.com. Journalist-Blogger 2008-present My blog, at http://www.sexworkandthelaw.com/blog/ is an ongoing discussion about sex work and public health. I have also written blogs for The Huffington Post and opinion pieces for The Boston Globe about various topics including scientific misconduct and sex work. Alicia Patterson Foundation 2007-2008 Won a prestigious Alicia Patterson Fellowship to write Side Effects, a book about scientific fraud and conflicts of interest in the medical/pharmaceutical industry. CIO magazine, Executive Editor 2000-2006 Wrote and edited feature-length articles and columns for CIO, an award-winning business magazine that covers information 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 -
Side Effects in Education
What works may hurt: Side effects in education Yong Zhao Journal of Educational Change ISSN 1389-2843 J Educ Change DOI 10.1007/s10833-016-9294-4 1 23 Your article is protected by copyright and all rights are held exclusively by Springer Science +Business Media Dordrecht. This e-offprint is for personal use only and shall not be self- archived in electronic repositories. If you wish to self-archive your article, please use the accepted manuscript version for posting on your own website. You may further deposit the accepted manuscript version in any repository, provided it is only made publicly available 12 months after official publication or later and provided acknowledgement is given to the original source of publication and a link is inserted to the published article on Springer's website. The link must be accompanied by the following text: "The final publication is available at link.springer.com”. 1 23 Author's personal copy J Educ Change DOI 10.1007/s10833-016-9294-4 What works may hurt: Side effects in education Yong Zhao1 Ó Springer Science+Business Media Dordrecht 2017 Abstract Medical research is held as a field for education to emulate. Education researchers have been urged to adopt randomized controlled trials, a more ‘‘scien- tific’’ research method believed to have resulted in the advances in medicine. But a much more important lesson education needs to borrow from medicine has been ignored. That is the study of side effects. Medical research is required to investigate both the intended effects of any medical interventions and their unintended adverse effects, or side effects.