DOCSLIB.ORG

Implications for Patients and Health Policy Speaker Biographies

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Implications for Patients and Health Policy Speaker Biographies What Evidence is Essential for New Medical Products? Implications for Patients and Health Policy June 13, 2014 AAAS Headquarters Washington, DC Speaker Biographies Jerry Avorn, M.D. Harvard Medical School Jerry Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital. An internist and drug epidemiologist, he studies the intended and adverse effects of prescription drugs, physician prescribing practices, and medication policy. The division he founded and leads comprises physicians, epidemiologists, health policy analysts, statisticians, and computer scientists who work together to analyze patterns of utilization and outcomes of prescription drugs in numerous settings. Dr. Avorn pioneered the “academic detailing” approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the U.S., Canada, Australia, and Europe. Dr. Avorn did his undergraduate work at Columbia University in 1969, received the M.D. from Harvard Medical School in 1974, and completed a residency in internal medicine at the Beth Israel Hospital in Boston. He has served as a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 400 papers in the medical literature on medication use and its outcomes, and of the book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, now in its 11th printing. Robert Ball, M.D., M.P.H, Sc.M. Office of Surveillance and Epidemiology, FDA Robert Ball is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for planning, managing, and directing the work of OSE staff evaluating drug risks and promoting the safe use of drugs by the American people. From 2008 to 2013, Dr. Ball served as the Director, Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER), FDA. In this role, Dr. Ball provided overall leadership and scientific direction to OBE and served as the principal advisor to the CBER director on all matters pertaining to statistical and epidemiological evaluation of regulated biological products. Dr. Ball led CBER post-marketing safety programs for vaccines and blood in the FDA’s Sentinel Initiative and with the Centers for Medicare and Medicaid Services. Dr. Ball began his FDA career in 1998 as a medical epidemiologist and was Chief, Vaccine Safety Branch, CBER from 2001 to 2007 where he oversaw the pharmacovigilance planning and evaluation of post-marketing safety for all vaccines licensed in the US. Dr. Ball received his BS in Mathematics and MD from Georgetown University, where he was elected to the Alpha Omega Alpha Honor Medical Society. He interned at the US Naval Hospital Bethesda, completed his MPH and residency in Occupational Medicine at the Uniformed Services University of the Health Sciences, and received the ScM degree in Infectious Disease Epidemiology and Vaccine Science and Policy from Johns Hopkins School of Public Health. Prior to joining the FDA, Dr. Ball served as a US Navy Medical Officer. Gregory Curfman, M.D. New England Journal of Medicine Gregory Curfman’s career as a professional medical editor at the New England Journal of Medicine spans 27 years. He is currently the executive editor of the Journal, a position that he has held for 13 years. Prior to being appointed executive editor, he served as deputy editor of the Journal for 14 years. The New England Journal of Medicine is an international medical journal that has been published continuously for over 200 years. Dr. Curfman is a board-certified internal medicine physician and cardiologist, and he holds two academic appointments at Harvard Medical School: assistant professor in the Department of Medicine and lecturer in the Department of Health Care Policy. He graduated magna cum laude from Princeton University, and cum laude from Harvard Medical School. He joined the editorial staff of the New England Journal of Medicine in 1986, where he now serves as the principal editor for cardiovascular disease. He also has a longstanding interest in health policy, and he founded and directs the Perspective section of the Journal. Dr. Curfman has authored 60 editorials and Perspective articles for the New England Journal of Medicine on a variety of topics in medicine and health care, including health policy, health law, and the regulation of drugs and medical devices. Congresswoman Rosa DeLauro (D-CT) Rosa DeLauro represents Connecticut’s Third Congressional District, which stretches from the Long Island Sound and New Haven to the Naugatuck Valley and Waterbury. Rosa serves in the Democratic leadership as co-chair of the Steering and Policy Committee, and she is the ranking member on the Labor, Health, Human Services, and Education Appropriations Subcommittee, where she oversees our country’s investments in education, health, and employment. From that position, Rosa works to increase support for education and innovation, to fully implement the Affordable Care Act, to protect the rights of employees and unions, and raise living standards. She also serves on the subcommittee responsible for funding the FDA and Agriculture Department, where she oversees drug and food safety. Rosa has long been a champion for drug and device safety to improve health and wellness, and has fought to ensure that women and minorities are represented and analyzed in clinical trial research. She has also led the fight in Congress to achieve full pay equity for women, and to ensure that all employees have access to paid sick days and family leave. Soon after earning degrees from Marymount College and Columbia University, Rosa followed her parents’ footsteps into public service, serving as the first Executive Director of EMILY'S List, a national organization dedicated to increasing the number of women in elected office, Executive Director of Countdown '87, the national campaign that successfully stopped U.S. military aid to the Nicaraguan Contras, and as Chief of Staff to U.S. Senator Christopher Dodd. In 1990, Rosa was elected to the House of Representatives, and she has served as the Congresswoman from Connecticut’s 3rd District since. Mark S. Frankel, Ph.D. American Association for the Advancement of Science Mark Frankel is director of the Scientific Responsibility, Human Rights and Law Program at the American Association for the Advancement of Science (AAAS), the largest multidisciplinary scientific society in the world. There he develops and manages AAAS’s activities related to the ethical, human rights, and legal aspects of science and technology. At AAAS, he has directed projects on research integrity and scientific misconduct; advocacy in science; personalized medicine; mobile health, and the implications of advances in neuroscience research for the legal system. Since 2006, he has organized nearly 20 seminars for federal and state judges on how advances in neuroscience may affect the courts. Dr. Frankel is a former member of the Boards of Directors of the National Patient Safety Foundation and the Food and Drug Law Institute and currently sits on the Board of the Center for Law, Science and Innovation at Arizona State University and the International Neuroethics Society. He serves on the editorial boards of Science and Engineering Ethics and the Journal of Empirical Research on Human Research Ethics. He is a Fellow of AAAS. Curt Furberg, M.D., Ph.D. Wake Forest University Curt Furberg received his medical training and a Ph.D.-equivalent at the University of Umea, Sweden. From 1974 through 1985 he was employed at the National Heart, Lung, and Blood Institute in Bethesda, MD. In 1986 he was appointed Director of the Center for Prevention Research and Biometry at Wake Forest University School of Medicine in Winston-Salem, NC. In 1989 he became department chair. He is currently Professor Emeritus. He has four decades of experience in the areas of epidemiology and clinical trials. He is considered a national leader in these fields. As Project Officer or Principal Investigator he served on a large number of primarily cardiovascular trials that documented the efficacy and safety of various interventions that led to improvements in the care for millions of patients with coronary heart disease, heart failure, hypertension and other vascular conditions. He served as charter member of the U.S. FDA Drug Safety and Risk Management. He was recently invited to serve on the United States Medicare Evidence Development and Coverage Advisory Committee. He has published about 450 scientific articles and co-authored four books including Fundamentals of Clinical Trials. C. Bernie Good, M.D., M.P.H. University of Pittsburgh C. Bernie Good is an internist and faculty member of the Center for Health Equity Research and Promotion at the VA Pittsburgh Healthcare System; he is a Professor of Medicine and Pharmacy at the University of Pittsburgh. Dr. Good serves numerous national roles with the Department of Veterans Affairs, including serving as the chair of the Medical Advisory Panel for Pharmacy Benefits Management, and Co-Director for the VA Center for Medication Safety. As a recognized expert in drug safety and formulary management, Dr. Good
Load more

Recommended publications
  • Breast Implants: Choices Women Thought They Made
    NYLS Journal of Human Rights Volume 11 Issue 1 Article 5 Fall 1993 BREAST IMPLANTS: CHOICES WOMEN THOUGHT THEY MADE Zoe Panarites Follow this and additional works at: https://digitalcommons.nyls.edu/journal_of_human_rights Part of the Law Commons Recommended Citation Panarites, Zoe (1993) "BREAST IMPLANTS: CHOICES WOMEN THOUGHT THEY MADE," NYLS Journal of Human Rights: Vol. 11 : Iss. 1 , Article 5. Available at: https://digitalcommons.nyls.edu/journal_of_human_rights/vol11/iss1/5 This Notes and Comments is brought to you for free and open access by DigitalCommons@NYLS. It has been accepted for inclusion in NYLS Journal of Human Rights by an authorized editor of DigitalCommons@NYLS. BREAST IMPLANTS: CHOICES WOMEN THOUGHT THEY MADE Nearly two million women- received breast implants between 1962 and 1991: eighty percent for cosmetic purposes, and twenty percent for reconstructive surgery following mastectomies. 1 From their inauspicious beginnings as a tool for Japanese prostitutes during World War II to enlarge their breasts for American servicemen, 2 implants have now been deemed crucial to post-mastectomy recipients3 and other women seeking self-improvement." Implants are © Copyright 1993 by the New York Law School Journalof Human Rights. 'John R. Easter ct al., Medical "State of the Art"for the Breast Implant Litigation, in BREAST IMPLANT Lrrio. 1, 12 (Law Journal Seminars-Press 1992). This Note will focus primarily on silicone-filled implants. Food and Drug Administration ("FDA") estimates released in 1988 indicate that only 15% of implant surgeries were for reconstructive purposes, while 85% were for cosmetic purposes. Teich v. FDA, 751 F. Supp. 243, 245-46 (D.D.C.
    [Show full text]
  • Spring/Summer 2019
    34 We are dedicated to improving the health and How Can We Cut the Cost of Medical Care? safety of adults and children by using research to develop Everyone agrees that health insurance is too Our own research on cancer drugs found that expensive and prescription drugs cost much too many that were recently approved based on their more effective treatments and much – some cost more than patients’ annual success at shrinking tumors provided zero benefit income! The amount Americans spend on to the average patient in terms of living longer or policies. The Cancer prescription drugs has nearly doubled since the having a better quality of life. Since cancer drugs Prevention and Treatment 1990s, and today the most expensive drugs cost so often cause nausea, vomiting, exhaustion, and $500,000 or more per year. other debilitating side effects, it is unconscionable Fund is our major program. that these drugs are being approved without clear What’s the solution? evidence that they work – or which patients have at least some chance of benefitting even if most This article isn’t about Medicare for All, Medicaid don’t. for All, or other major legislation, all of which face enormous political and corporate opposition. Instead, this article focuses on the issues that would be easier to fix in the near term. How to Spend Less on Drugs and Medical Tests Too many patients are being priced out of the Our Cancer Prevention and medical treatment that they need – or think they Treatment Fund helps adults need. As prices have risen, companies have broken one record after another, so that it seems there is and children reduce their risk no limit on what they will charge.
    [Show full text]
  • Fall 2018/Winter 2019
    ISSUE ISSUE 2433 TheTheVoice Voice FALL/WINTER 2018 FOR PREVENTION, TREATMENT, AND POLICY SPRING/SUMMER 2014 FOR PREVENTION, TREATMENT, AND POLICY National WHAT’S INSIDE We’re in the Headlines…2 Center Brain Stimulation as a Treatment for Depression?...3 What are the Implant Files?...4 for Health Is the Affordable Care Act Still at Risk?....4 What is Breast Implant Illness?...5 Research Honoring Foremothers….6 Dietary Supplements...7 We are dedicated to improving the health and safety of adults and children by Can Sleeping Pills Cause Cancer? Can Avoiding using research to develop more Them Improve Your Health? effective treatments and policies. The Cancer Americans spend more than $41 billion each year on prescription sleeping pills, and that doesn’t Prevention and Treatment count the popular over-the-counter sleep aids such Fund is our major program. as Tylenol PM and Benadryl. If you are one of the many Americans that needs help sleeping, you’ll want to know about a study showing that people who take these drugs are significantly more likely to be diagnosed with cancer or to die within the next The Cancer two and a half years than people who don’t take Even before this study, there were at least 18 other them. Published in the prestigious British Medical studies showing an increased risk of death for Prevention Journal, author Dr. Daniel Kripke estimates that people taking sleeping pills, and several also and Treatment sleep medications could be causing more than showed an increased risk of cancer. However, this Fund 300,000-500,000 deaths every year.
    [Show full text]
  • Implications for Patients and Health Policy Conference Agenda
    What Evidence is Essential for New Medical Products? Implications for Patients and Health Policy June 13, 2014 AAAS Headquarters Washington, DC Conference Agenda 8:00 am Registration 8:30 am Welcome Remarks: Mark S. Frankel American Association for the Advancement of Science 8:40 am Keynote Addresses Introductions: Diana Zuckerman National Center for Health Research 8:45 am Remarks: Congresswoman Rosa L. DeLauro (D-CT) 9:05 am Remarks: Margaret R. Hamburg (via live video) Food & Drug Administration 9:15 am Panel I. Evidence-Based Policy: Opportunities and Challenges Moderator: Susan F. Wood George Washington University Speakers: Aaron S. Kesselheim Brigham and Women’s Hospital/Harvard Medical School Robert Yarchoan National Cancer Institute Gregory D. Curfman New England Journal of Medicine Rita F. Redberg JAMA Internal Medicine 10:45 am Panel II. Speed vs. Safety: Implications for Public Health of Changing Standards for Getting Products to Market Moderator: Kim Witczak Patient Safety Advocate Speakers: Bernard Lo Greenwall Foundation Lisa M. Schwartz & Steven Woloshin Dartmouth Medical School Michael Rosenblatt Merck 12:00 pm Lunch 1:00 pm Panel III. Biomarkers, Surrogate Endpoints and Other Shortcuts that May or May Not Predict Health Outcomes Moderator: Thomas J. Moore Institute for Safe Medication Practices Speakers: Jerry Avorn Brigham and Women’s Hospital/Harvard Medical School Joseph S. Ross Yale School of Medicine Diana Zuckerman National Center for Health Research Ann de Velasco WomenHeart of Miami 2:30 pm Panel IV. Post-Market Surveillance and Comparative Effectiveness Research Moderator: Tianjing Li Johns Hopkins University Speakers: Robert Ball Food & Drug Administration Sebastian Schneeweiss Brigham and Women’s Hospital/Harvard Medical School Patrick Ryan Janssen Research and Development 3:45 pm Break 4:00 pm Panel V.
    [Show full text]
  • Jerry Avorn, MD Is Professor of Medicine at Harvard Medical
    Promoting Biomedical Innovation and Economic Value: New Models for Reimbursement and Evidence Development Participant Biographies Jerry Avorn, MD is professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital. An internist, geriatrician, and drug epidemiologist, he studies the intended and adverse effects of prescription drugs, physician prescribing practices, and medication policy. The division he founded and leads comprises physicians, epidemiologists, health policy analysts, statisticians, and computer scientists who work together to analyze the utilization and outcomes of prescription drugs in numerous settings. Dr. Avorn pioneered the “academic detailing” approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the United States, Canada, Australia, and Europe. Dr. Avorn completed his undergraduate training at Columbia University in 1969, received the MD from Harvard Medical School in 1974, and completed a residency in internal medicine at the Beth Israel Hospital in Boston. He is a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 275 papers in the medical literature on medication use and its outcomes, and of the book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, now in its 11th printing. Robert Epstein, MD is Medco’s president of advanced clinical science and research, and chief clinical research and development officer. Dr. Epstein is responsible for all of Medco’s clinical research initiatives, including the Medco Research Institute™ and the United BioSource Research Divisions.
    [Show full text]
  • Long Term Effects of Dab Pens
    Long Term Effects Of Dab Pens Heavy-handed Corrie louts indestructibly. Is Woodrow culicid or semiparasitic after cotemporaneous mimicsTheo automobiles very vaingloriously so sycophantically? and spryly? Is Cole always theism and geochemical when cooperated some In design and long term This field is created when you smoked, also find the aerosol is the pipe and general categories: an fda approval that a breakdown in. But, the truth no the felt is that individuals would not recover the symptoms of withdrawal if there now nothing to disperse from. What boss a cannabis dab pen Leafly. Is Vaping Bad play You Vaping vs Smoking Side Effects and. Weed vapes What you need to make about marijuana CNET. Learn learn the research. Like many vaping products, different batteries provide varying functions and are compatible with disease other products. Another person realized he is dabbing temperatures needed a long run low and effects that cbd and dependence: which contains no. Publications and Reports of the Surgeon General. Early reactions to dab pens. Dna damage to list of? This includes the script as async. Are and aware, has there enough people, companies and bloggers who override their entire days unraveling these lies and exposing the truth lend them? Very friendly but helpful ready with vast product knowledge. Our comments here to not intended it a diatribe against vaping or the legalization of cannabis. It whereas Black Note. The Mighty is no portable powerhouse. Diana zuckerman and. You could probably do consent better. Medical staff revise the depth in Miami, where she as been airlifted, struggled to keep anyone alive.
    [Show full text]
  • INSTITUTION Congress of the US, Washington, DC. House Committee
    DOCUMENT RESUME ED 303 136 IR 013 589 TITLE Commercialization of Children's Television. Hearings on H.R. 3288, H.R. 3966, and H.R. 4125: Bills To Require the FCC To Reinstate Restrictions on Advertising during Children's Television, To Enforce the Obligation of Broadcasters To Meet the Educational Needs of the Child Audience, and for Other Purposes, before the Subcommittee on Telecommunications and Finance of the Committee on Energy and Commerce, House of Representatives, One Hundredth Congress (September 15, 1987 and March 17, 1988). INSTITUTION Congress of the U.S., Washington, DC. House Committee on Energy and Commerce. PUB DATE 88 NOTE 354p.; Serial No. 100-93. Portions contain small print. AVAILABLE FROM Superintendent of Documents, Congressional Sales Office, U.S. Government Printing Office, Washington, DC 20402. PUB TYPE Legal/Legislative/Regulatory Materials (090) -- Viewpoints (120) -- Reports - Evaluative/Feasibility (142) EDRS PRICE MFO1 /PC15 Plus Postage. DESCRIPTORS *Advertising; *Childrens Television; *Commercial Television; *Federal Legislation; Hearings; Policy Formation; *Programing (Broadcast); *Television Commercials; Television Research; Toys IDENTIFIERS Congress 100th; Federal Communications Commission ABSTRACT This report provides transcripts of two hearings held 6 months apart before a subcommittee of the House of Representatives on three bills which would require the Federal Communications Commission to reinstate restrictions on advertising on children's television programs. The texts of the bills under consideration, H.R. 3288, H.R. 3966, and H.R. 4125 are also provided. Testimony and statements were presented by:(1) Representative Terry L. Bruce of Illinois; (2) Peggy Charren, Action for Children's Television; (3) Robert Chase, National Education Association; (4) John Claster, Claster Television; (5) William Dietz, Tufts New England Medical Center; (6) Wallace Jorgenson, National Association of Broadcasters; (7) Dale L.
    [Show full text]
  • Introduction Fact Checking
    Innovative Health Solutions’ Response to NPR Story: Questions Raised About Study of Device to Ease Opioid Withdrawal Introduction Jake Harper’s NPR story, Questions Raised About Study of Device to Ease Opioid Withdrawal, presented a biased and misleading view of the NSS-2 BRIDGE device. To address his story’s factual inaccuracies, this document provides a comparison to many of Harper’s claims with facts backed by the IHS team and its research. Fact Checking Inaccuracy: Innovative Health Solutions (IHS), the device maker, has marketed the BRIDGE for opioid withdrawal for more than a year, even before it had clearance for that use from the Food and Drug Administration. Fact: IHS did not market the BRIDGE for opioid withdrawal prior to FDA clearance. The original 510(k)-cleared BRIDGE device was indicated for use in the acute and chronic pain population. Pain is highly prevalent in this patient population, which led some clinicians to adopt in their treatment of patients. Subsequently, IHS received clearance for a next generation product – the NSS-2 BRIDGE – with a claim that it could reduce the symptoms of opioid withdrawal. What Mr. Harper may be referring to, and what he asked IHS about previously, were conversations with policymakers in a non-promotional setting about future applications for IHS technology. In that context, as we explained to Mr. Harper, IHS has every right to discuss ongoing development and future activities, but Mr. Harper chose to ignore our input. Inaccuracy: An investigation by Side Effects Public Media and NPR reveals that researchers working with Innovative Health Solutions, maker of the BRIDGE, submitted to a medical journal a study that wasn't what it appeared to be.
    [Show full text]
  • Videx® Expanding Possibilities: a Case Study
    Videx® Expanding Possibilities: A Case Study Acquired Immune Deficiency Syndrome (AIDS) has long-standing and effective choice for building the dual- devastated millions of lives worldwide. The virus that NRTI foundation. causes AIDS, the human immunodeficiency virus (HIV), attacks immune system cells, leaving the body vulnerable to Development of Videx® illnesses that would otherwise pose little threat. In the worldwide AIDS pandemic, there are 5 million new HIV Role of NIH i infections and over 3 million deaths each year. By 1993, AIDS was the leading cause of death among persons 25 - 44 A well-established research program R & D TIMELINE years old in the United States. The hope brought by the first at the National Cancer Institute (NCI) drug approved by the Food and Drug Administration (FDA) gave it a unique capacity to screen Synthesis of ddA to attack the HIV, zidovudine, dissolved as patients rapidly compounds for anti-viral activity. Reported -- 1964 developed resistance to its therapeutic effect. The use of ddI to treat AIDS was discovered by NCI scientists Drs. ® Conversion of ddA The second anti-HIV drug approved by the FDA, Videx Robert Yarchoan, Hiroaki Mitsuya, to ddI Reported -- 1980 (didanosine, ddI), developed by Bristol-Myers Squibb in and Sam Broder, who also collaboration with the NIH, offered hope for people when spearheaded the early clinical NCI Scientists Identify zidovudine was not effective. It also helped usher in a new development of ddI. Using capacities Activity of ddI Against way of thinking about suppressing HIV infection as it developed in the “War on Cancer,” HIV -- 1985 became possible to test whether and how anti-viral drugs the NCI was able to do preclinical could be combined to obtain lasting benefits.
    [Show full text]
  • Differential Phosphorylation of Azidothymidine, Dideoxycytidine, and Dideoxyinosine in Resting and Activated Peripheral Blood Mononuclear Cells
    Differential phosphorylation of azidothymidine, dideoxycytidine, and dideoxyinosine in resting and activated peripheral blood mononuclear cells. W Y Gao, … , S Broder, H Mitsuya J Clin Invest. 1993;91(5):2326-2333. https://doi.org/10.1172/JCI116463. Research Article The antiviral activity of azidothymidine (AZT), dideoxycytidine (ddC), and dideoxyinosine (ddI) against HIV-1 was comparatively evaluated in PHA-stimulated PBM. The mean drug concentration which yielded 50% p24 Gag negative cultures were substantially different: 0.06, 0.2, and 6 microM for AZT, ddC, and ddI, respectively. We found that AZT was preferentially phosphorylated to its triphosphate (TP) form in PHA-PBM rather than unstimulated, resting PBM (R-PBM), producing 10- to 17-fold higher ratios of AZTTP/dTTP in PHA-PBM than in R-PBM. The phosphorylation of ddC and ddI to their TP forms was, however, much less efficient in PHA-PBM, resulting in approximately 5-fold and approximately 15- fold lower ratios of ddCTP/dCTP and ddATP/dATP, respectively, in PHA-PBM than in R-PBM. The comparative order of PHA-induced increase in cellular enzyme activities examined was: thymidine kinase > uridine kinase > deoxycytidine kinase > adenosine kinase > 5'-nucleotidase. We conclude that AZT, ddC, and ddI exert disproportionate antiviral effects depending on the activation state of the target cells, i.e., ddI and ddC exert antiviral activity more favorably in resting cells than in activated cells, while AZT preferentially protects activated cells against HIV infection. Considering that HIV-1 proviral DNA synthesis in resting lymphocytes is reportedly initiated at levels comparable with those of activated lymphocytes, the current data should have practical relevance in the design of anti-HIV chemotherapy, particularly combination chemotherapy.
    [Show full text]
  • Workshop 2: Practical Approaches
    Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series Workshop 2: Practical Approaches Workshop Briefing Materials Table of Contents 1. Workshop Information 2. Real-World Evidence Workshop Series Background Document 3. Workshop Agenda 4. Workshop Series Planning Committee Member Biographies 5. Workshop Speaker and Discussant Biographies 6. Literature Informing the Use Cases Being Discussed at the Workshop a. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation (Patel et al. for the ROCKET-AF Investigators, 2011) b. Prospective Surveillance Pilot of Rivaroxaban Safety Within the US Food and Drug Administration Sentinel System (Chrischilles et al., 2017) c. Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study (Go et al., 2017) d. Lithium for Suicidal Behavior in Mood Disorders (Li+) (ClinicalTrials.gov record) e. Can Lithium Help Stem Suicide Rate? VA Study Aims to Find Out (VA Research Currents article) f. Use of Health Care Databases to Support Supplemental Indications of Approved Medications (Fralick et al., 2018) g. Comparison of Observational Data and the ONTARGET Results for Telmisartan Treatment of Hypertension: Bull’s-Eye or Painting the Target Around the Arrow? (Califf, 2018) Workshop Information Dates: March 6-7, 2018 Time: Day 1: 8:30am – 5:00pm Day 2: 8:30am – 12:30pm Location: National Academy of Sciences Building Room 120 2101 Constitution Ave NW Washington, DC 20418 Examining the Impact of Real-World Evidence on Medical Product Development: A Three-Part Workshop Series Washington, D.C. Background and Objectives Workshop Topics and Flow Workshop One (September 19-20, 2017) focused on Randomized, controlled clinical trials (RCTs) have how to align incentives to support collection and use traditionally served as the gold standard for evidence of real-world evidence in health product review, generation in support of medical product development and payment, and delivery.
    [Show full text]
  • Use of Pembrolizumab with Or Without Pomalidomide in HIV-Associated Non-Hodgkin's Lymphoma
    Open access Original research J Immunother Cancer: first published as 10.1136/jitc-2020-002097 on 19 February 2021. Downloaded from Use of pembrolizumab with or without pomalidomide in HIV- associated non- Hodgkin’s lymphoma 1 1 1 1 Kathryn Lurain , Ramya Ramaswami, Ralph Mangusan, Anaida Widell, Irene Ekwede,1 Jomy George,2 Richard Ambinder,3 Martin Cheever,4 5 1 6 James L Gulley , Priscila H Goncalves, Hao- Wei Wang, 1,7 1 Thomas S Uldrick , Robert Yarchoan To cite: Lurain K, ABSTRACT INTRODUCTION Ramaswami R, Mangusan R, Background Non- Hodgkin’s lymphoma (NHL) is With current combination antiretroviral et al. Use of pembrolizumab currently the most common malignancy among people therapy (ART), the most common cancer with or without pomalidomide in living with HIV (PLWH) in the USA. NHL in PLWH is more HIV- associated among people living with HIV (PLWH) in the frequently associated with oncogenic viruses than NHL in 1 non- Hodgkin’s lymphoma. USA is non-Hodgkin's lymphoma (NHL). immunocompetent individuals and is generally associated Journal for ImmunoTherapy There is an 11- fold to 17- fold increased life- of Cancer 2021;9:e002097. with increased PD-1 expression and T cell exhaustion. An effective immune-based second-line approach that is less time risk of NHL in PLWH compared with doi:10.1136/jitc-2020-002097 + immunosuppressive than chemotherapy may decrease the general population, due in part to CD4 T cell lymphopenia but also to immune ► Additional material is infection risk, improve immune control of oncogenic published online only. To view, viruses, and ultimately allow for better lymphoma control.
    [Show full text]