Welcome to the 2021 Stanford Drug Discovery Symposium
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Janet Woodcock, MD Director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Janet Woodcock, MD Director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The center makes sure that safe and effective drugs are available to improve the health of people in the United States. Dr. Woodcock and her center: • evaluate prescription and over the counter drugs before they can be sold and oversee their testing in clinical trials • provide health care professionals and patients the information they need to use medicines wisely • ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks • take action against unapproved, contaminated, or fraudulent drugs that are marketed illegally "New drugs—and new uses for older drugs—save lives, reduce suffering, and improve the quality of life for millions of Americans," says Dr. Woodcock. "I am continually challenged to make sure that FDA’s regulatory process remains the world's gold standard for drug approval and safety." Dr. Woodcock has led many of FDA's drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the "Pharmaceutical Quality for the 21st Century Initiative," FDA's highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA's "Critical Path" Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently. Most recently, Dr. Woodcock launched the "Safety First" and "Safe Use" initiatives designed to improve drug safety management within and outside FDA, respectively. -
"What Worries Me Is That People Do Trust Vaccines"
Subscribe Past Issues Translate RSS "What Worries Me Is That People Do Trust Vaccines" Interview with Paul A. O¸t, M.D. Professor at the University of Pennsylvania Director Vaccine Education Center Children’s Hospital of Philadelphia Paul O¸t is a widely recognized expert on vaccines and immunology. He is a co-inventor of the rotavirus vaccine known as RotaTeq, manufactured by Merck & Co., and now sits on the US National Institutes of Health’s (NIH) public-private committee known as Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), which is advising on the clinical trials of COVID-19 vaccine candidates. We asked for his thoughts on the clinical trials of COVID-19 vaccine candidates prioritized by Operation Warp Speed. A slightly edited version of our conversation appears below. Are the vaccines that are being prioritized by Operation Warp Speed in the US the most likely to work or just the fastest to produce? I think they’re just the fastest to be produced because for the most part they are all genetic vaccines; mRNA or replication-defective simian or human adenoviruses where you can just sort of plug and play. You know the gene you’re interested in— it’s the gene that codes for the SARS-CoV-2 surface protein, the Spike protein—so you just plug it in. It’s much easier to make than an inactivated viral vaccine, a live- attenuated viral vaccine, or a puriÛed protein vaccine. There is nothing that says these vaccines will be more likely to be safe or e˛ective than existing vaccine strategies. -
HPV Vaccines Efficacy Vs. Effectiveness
HPV Vaccines: Efficacy Vs. Effectiveness, Next Generation Vaccines, and Controversies Laura Koutsky University of Washington Seattle, WA USA Financial Disclosure: The University of Washington receives funds from Merck to support Laura Koutsky’s HPV vaccine research HPV-Related Diseases in the US Estimated Estimated Number Number (%) Related to HPV- Related Disease of Cases HPV-6, -11, -16, or -18 Cervical cancer 11,100 7,800 (~70%) Anal cancer 4,650 3,260 (~70%) Vulvar, vaginal, and penile 6,900 2,070 (~30%) cancers Head and neck cancers 34,000 5,100 (~15%) Recurrent respiratory 1,000 900 (~90%) papillomatosis Precancerous cervical 500,000 200,000 (~40%) lesions (CIN2+) Genital warts 500,000 425,000 (~85%) *ACS 2007, Chesson HW, Persp Repro Health 2004, Saslow D, CA Cancer 2007 Prophylactic HPV Vaccines • Two vaccines based on L1 capsid (shell) protein of HPVs • Bivalent HPV16/18, HPV2 – Cervarix® GlaxoSmithKline – Regulatory approval in 50+ countries – US FDA approval likely based on expert committee approval in September of 2009 • Quadrivalent HPV6/11/16/18, HPV4 – Gardasil® Merck – Regulatory approval in 100+ countries including the US • Recommendations – Prioritize routine vaccination of females 9 to 15 years of age Phase III Randomized Clinical Trials of HPV6/11/16/18 (Merck) or HPV16/18 (GSK) L1 VLP Vaccines in Susceptible Women (~16 to 25 Yrs) Merck Vaccine GlaxoSmithKline Vaccine (NEJM 2007;357:19) Efficacy (Lancet July 7, 2009) Efficacy Vaccine Placebo (95% CI) Vaccine Placebo (96% CI) 5865 5863 8040 8080 HPV 16/18- CIN2+ 3 62 95% 5 91 95% (85-99) (86-98) 2723 2732 HPV6/11/16/18- Genital warts 3 67 96% (86-99) Merck Vaccine: HPV6/11/16/18 L1 VLP with injections 0, 2, 6 mo. -
Pfizer Inc to Discuss Data from an Ongoing Phase 1/2 Study of Mrna-Based Vaccine Candidate Against SARS-Cov-2 Call
THOMSON REUTERS STREETEVENTS EDITED TRANSCRIPT PFE - Pfizer Inc To Discuss Data From An Ongoing Phase 1/2 Study Of mRNA-Based Vaccine Candidate Against SARS-CoV-2 Call EVENT DATE/TIME: JULY 01, 2020 / 6:00PM GMT THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us ©2020 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is prohibited without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JULY 01, 2020 / 6:00PM, PFE - Pfizer Inc To Discuss Data From An Ongoing Phase 1/2 Study Of mRNA-Based Vaccine Candidate Against SARS-CoV-2 Call CORPORATE PARTICIPANTS Charles E. Triano Pfizer Inc. - SVP of IR Kathrin U. Jansen Pfizer Inc. - SVP & Head of Vaccine Research & Development Mikael Dolsten Pfizer Inc. - Chief Scientific Officer and President of Worldwide Research, Development and Medical CONFERENCE CALL PARTICIPANTS David Reed Risinger Morgan Stanley, Research Division - MD in Equity Research and United States Pharmaceuticals Analyst Geoffrey Craig Porges SVB Leerink LLC, Research Division - Director of Therapeutics Research & Diversified Biopharma and Senior Research Analyst Louise Alesandra Chen Cantor Fitzgerald & Co., Research Division - Senior Research Analyst & MD Navin Cyriac Jacob UBS Investment Bank, Research Division - Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic Scott Daniel Puckhaber -
Welcome to FDA's Rare Disease Day 2021 Virtual Event
Welcome to FDA’s Rare Disease Day 2021 Virtual Event Webcast link: https://fda.yorkcast.com/webcast/Play/84f0dfdc2c1444679516d9f73d690b351d In this packet you will find: - Agenda - Conference Speaker and Moderator Brief Biographies 1 Agenda for FDA Rare Disease Day 2021: Friday, March 5, 2021 (virtual) 9:00-9:10am Welcome Janet Maynard, MD, MHS, Director, Office of Orphan Products Development (OOPD) FDA 9:10-9:15am Meeting Overview Lewis Fermaglich, MD, MHA, Acting Senior Clinical Advisor, OOPD, FDA 9:15-9:30am Orphan Products Grants Program Katherine Needleman, PhD, Director, Clinical Trials and Natural History Grant Program, OOPD, FDA 9:30-9:40am Opening Remarks Amy Abernethy, MD, PhD, Principal Deputy Commissioner of Food and Drugs, Acting Chief Information Officer, FDA 9:40-10:35am Panel 1: Rare Disease Partnerships, Collaborations, and Scientific Advancements Session Goal/Overview: Provide perspectives on successful partnerships to support rare disease product development. Outline the importance of working with rare disease stakeholders to ensure scientific advancements support the development of rare disease products. Mr. Kroslowitz and Dr. McCormack will provide presentations at the start of the panel followed by a facilitated discussion with all panel members. Moderator: Susan McCune, MD, Director, Office of Pediatric Therapeutics, FDA Panelists: • Robert Kroslowitz, President and CEO of Berlin Heart Inc. • Frank McCormack, MD, Professor of Medicine; Director, Division of Pulmonary, Critical Care, and Sleep Medicine, University -
The Administrative Law Review Is ACCEPTING SUBMISSIONS for Recent Developments
ADMINISTRATIVE LAW REVIEW Volume 63 Summer 2011 Number 3 REPORT Lobbying Law in the Spotlight: Challenges and Proposed Improvements ................................................... 419 ARTICLES An Inductive Understanding of Separation of Powers ............................................................. Jack M. Beermann 467 An Empirical Study of Judicial Review of Agency Interpretations of Agency Rules ........................ Richard J. Pierce, Jr. 515 Joshua Weiss Rule by Reasonableness ................................................... David Zaring 525 COMMENTS The Department of Veterans Affairs’ Entitlement Complex: Attorney Fees and Administrative Offset After Astrue v. Ratliff .............................................. Stacy L.Z. Edwards 561 The Illusion of Interchangeability: The Benefits and Dangers of Guidance-Plus Rulemaking in the FDA’s Biosimilar Approval Process ............... Jonathan Stroud 599 RECENT DEVELOPMENT Fees From Mars: Why the FTC Needs to Regulate Mortgage Assistance Relief Services (MARS) Fees .................. Alexander Lutch 645 ADMINISTRATIVE LAW REVIEW Volume 63 Summer 2011 Number 3 Editor in Chief Stacy L.Z. Edwards Executive Editor Managing Editor Keeley McCarty Brittany Ericksen Senior Recent Senior Senior Note & Senior Developments Editor Articles Editors Comment Editor Symposia Editor Emily Baver Aaron M. Moore Shannon L. Cain Jonathan Stroud Tom Rath Articles Editors Note & Comment Editors Sarah Fech Christina Andreen Carolyn Lindley David Van Fleet Bloys Amanda Lutz Aaron V. Gleaton Gregory M. Reyes Ted Uliassi Michael T. Vasquez Katherine A. Weatherford Topics and Trends Managers Jessica Buonaccorsi Kimberly Payne Senior Staff Katherine Aljinovic Brenda A. González Sapna Mehta Patrick Schultz Alexander Bard Elizabeth F. Jackson Diana M. Pak Yi Elizabeth S. Shen Kristan Callahan Harrison Kang Amanda K. Patton Ann Slacter Lauren Caplan Maanasa Kona Chris Pepe Sarah V. Stanley Robert D. Cardina Erin Kuhls Ricardo L. Piereck Dennis Tristani Sarah Chiang Priya Lamba Jennifer Ponder Sean S. -
August 8, 2018 Guidance Document Submission Dr. Janet Woodcock Dr
August 8, 2018 Guidance Document Submission Dr. Janet Woodcock Dr. Richard Pazdur Center for Drug Evaluation and Research Oncology Center of Excellence Food and Drug Administration Food and Drug Administration 10903 New Hampshire Ave 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Silver Spring, MD 20993-0002 Dear Drs. Janet Woodcock and Richard Pazdur, and colleagues at the FDA, The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) formally submit the following draft guidance documents for consideration by the Food and Drug Administration (FDA). The content and strategies to modernize eligibility criteria for oncology clinical trials build upon recommendations developed by a consortium of stakeholders composed of patient advocates, drug/biotech manufacturers, investigators, and regulators. In 2016, ASCO and Friends began a joint project to develop and advance specific strategies to change the exclusionary nature of cancer clinical trial eligibility criteria on the following topics: 1) Brain Metastases, 2) HIV/AIDS, 3) Organ Dysfunction, 4) Prior and Concurrent Malignancies, and 5) Minimum Age for Enrollment. An ASCO-Friends joint research statement and four supporting manuscripts containing consensus recommendations based on the review of evidence, consideration of the patient population, and consultation with the research community were published in the Journal of Clinical Oncology on October 2, 2017. Since the publication of these recommendations, ASCO and Friends have been working to advance their broad implementation. To further bolster that effort, recommendations outlined in the published manuscripts have been adapted to serve as the foundation for the five FDA draft guidance documents enclosed in this submission. The recommendations aim to maximize the generalizability of clinical trial results while also maintaining the safety of clinical trial participants. -
Review of the Proposed Generic Drug and Biosimilars User Fees and Further Exam- Ination of Drug Shortages
REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS USER FEES AND FURTHER EXAM- INATION OF DRUG SHORTAGES HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS SECOND SESSION FEBRUARY 9, 2012 Serial No. 112–114 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 81–517 PDF WASHINGTON : 2013 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Aug 31 2005 15:22 Jul 01, 2013 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 F:\112-11~1\112-11~1 WAYNE COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman JOE BARTON, Texas HENRY A. WAXMAN, California Chairman Emeritus Ranking Member CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky Chairman Emeritus JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York MARY BONO MACK, California FRANK PALLONE, JR., New Jersey GREG WALDEN, Oregon BOBBY L. RUSH, Illinois LEE TERRY, Nebraska ANNA G. ESHOO, California MIKE ROGERS, Michigan ELIOT L. ENGEL, New York SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas Vice Chairman DIANA DEGETTE, Colorado JOHN SULLIVAN, Oklahoma LOIS CAPPS, California TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas BRIAN P. BILBRAY, California JAY INSLEE, Washington CHARLES F. -
Messenger RNA (Mrna) – a Forgotten Molecule; Its Past, Present and Future for Therapeutics Melin J
Clinical Microbiology and Infectious Diseases Review Article ISSN: 2398-8096 Messenger RNA (mRNA) – A forgotten molecule; its past, present and future for therapeutics Melin J. Khandekar1 and Janardan D. Khandekar2* 1Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, USA 2Department of Medicine, Northshore University Health System, University of Chicago, USA Abstract The COVID-19 pandemic began in Wuhan, China in December of 2019. The disease rapidly disseminated, affecting at least 167 million people worldwide with a minimum of 3.4 million deaths. In the United States alone, close to six hundred thousand deaths can be attributed to Covid. (Johns Hopkins University Center for Systems Science and Engineering – My 24th 2020) The pandemic has caused worldwide economic recession and hardships to millions, if not billions, of people. Amongst this gloom, one molecule stands out as a shining light; messenger RNA-based (mRNA) vaccines. Rapid development and deployment of these vaccines in the community has resulted in decreasing infection rates, transmission of infections in the community, and reduced death rates in the countries that have been able to distribute them. Here, we briefly review the advances in molecular biology that led to the development of mRNA-based vaccines at lightning speed. We briefly discuss mechanisms by which these vaccines produce B and T cell immunity, as well as outstanding questions, including the duration of the protective effect of vaccines and the efficacy of vaccines in immuno-compromised people. We also briefly discuss other applications of mRNA-based technology in management of cancer and other diseases. The development of these vaccines show the amazing power of science to save lives and economic livelihoods, and how forgotten aspects of science can be redeveloped to great therapeutic effect. -
Food and Drug Law Journal
FOOD AND DRUG LAW JOURNAL EDITOR IN CHIEF Judy Rein EDITORIAL ADVISORY BOARD CHAIR VICE CHAIR FACULTY ADVISOR Laurie Lenkel Robert Giddings Joseph A. Page FDA – OC Hutchison PLLC Georgetown University Law Center _______________________________ Anthony Anscombe Kimberly Gold Sandra Retzky Sedgwick LLP Norton Rose Fulbright FDA – CTP LLP Peter Barton Hutt Jessica Ringel Covington & Burling John Johnson King & Spalding LLP FDA Imports Barbara Binzak Joan Rothenberg Blumenfeld Alan Katz FDA - CFSAN Buchanan Ingersoll & toXcel, LLC Jodi Schipper Rooney PC Sara Koblitz FDA – CDER Kellie Combs Hyman, Phelps & Christopher van Gundy Ropes & Gray LLP McNamara, PC Keller and Heckman Nathan Cortez Valerie Madamba Southern Methodist Blue Apron James Woodlee University Kleinfeld Kaplan & Becker LLP Alan Minsk Brian Dahl Arnall Golden Gregory Emily Wright Dahl Compliance LLP Pfizer Consulting LLC Nicole Negowetti Kimberly Yocum Sandra dePaulis Harvard Law School TC Heartland LLC FDA – CVM James O’Reilly Lowell Zeta University of Ian Fearon Cincinnati Hogan Lovells British American Tobacco Francis Palumbo Patricia Zettler Abraham Gitterman University of Maryland Georgia State Arnold & Porter LLP School of Pharmacy University Law School OFFICERS OF THE FOOD AND DRUG LAW INSTITUTE CHAIR: Jeffrey N. Gibbs, Hyman, Phelps & McNamara, P.C. TREASURER: Frederick R. Ball, Duane Morris LLP GENERAL COUNSEL/SECRETARY: Joy J. Liu, Vertex Pharmaceuticals IMMEDIATE PAST CHAIR: Allison M. Zieve, Public Citizen Litigation Group PRESIDENT & CEO: Amy Comstock Rick GEORGETOWN UNIVERSITY LAW CENTER GEORGETOWN LAW STUDENT EDITORS EDITOR IN CHIEF Erik Rynko MANAGING EDITORS Meaghan Jerrett Tiffany Weston ARTICLES & NOTES EDITOR SYMPOSIUM EDITOR Allison Parr Laura Higbee EXECUTIVE EDITORS Natalie Camastra Nicholas Hill Thomas Sanford Lacey Henry Daniel Krisch SENIOR STAFF EDITORS Seth Appiah-Opoku Daniel Elkus Nicholas Prust Emma Chapman Adam Harris GEORGETOWN LAW FACULTY FACULTY ADVISOR Joseph A. -
EDITED TRANSCRIPT PFE.N - Pfizer Inc Virtual Investor Day: Day 1
REFINITIV STREETEVENTS EDITED TRANSCRIPT PFE.N - Pfizer Inc Virtual Investor Day: Day 1 EVENT DATE/TIME: SEPTEMBER 14, 2020 / 5:00PM GMT REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us ©2020 Refinitiv. All rights reserved. Republication or redistribution of Refinitiv content, including by framing or similar means, is prohibited without the prior written consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 14, 2020 / 5:00PM, PFE.N - Pfizer Inc Virtual Investor Day: Day 1 CORPORATE PARTICIPANTS Albert Bourla Pfizer Inc. - Chairman of the Board & CEO Alexander Rod MacKenzie Pfizer Inc. - Chief Development Officer & Executive VP, Global Product Development Angela Hwang Pfizer Inc. - Group President of Biopharmaceuticals Group Charles E. Triano Pfizer Inc. - SVP of IR James Rusnak Pfizer Inc. - Chief Development Officer, Internal Medicine Kathrin U. Jansen Pfizer Inc. - SVP & Head of Vaccine Research & Development Luis Jodar Pfizer Inc. - Chief Medical & Scientific Affairs Officer, Vaccines Michael Gladstone Pfizer Inc. - Global President, Internal Medicine Mikael Dolsten Pfizer Inc. - Chief Scientific Officer and President of Worldwide Research, Development & Medical Morris J. Birnbaum Pfizer Inc. - Chief Scientific Officer of Internal Medicine Nanette Cocero Pfizer Inc. - Global President, Vaccines William Gruber Pfizer Inc. - Senior Vice President, Vaccine Clinical Research & Development CONFERENCE CALL PARTICIPANTS Christopher Thomas Schott JPMorgan -
Dr. Janet Woodcock
An ocial website of the United States government Here’s how you know " # Search $ Menu ! Home / About FDA / FDA Organization / Janet Woodcock Janet Woodcock M.D. ACTING COMMISSIONER OF FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION % Share & Tweet ' Linkedin ( Email ) Print FDA Organization Follow Dr. Woodcock @DrWoodcockFDA * Content current as of: 03/03/2021 OEce of the Commissioner Janet Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021. Center for Biologics As Acting Commissioner, Dr. Woodcock oversees the Evaluation and Research (CBER) full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other Center for Devices and applicable laws. This includes assuring the safety, Radiological Health effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human Center for Drug Evaluation use, and medical devices; the safety and security of our and Research | CDER nation's food supply, cosmetics, dietary supplements, Janet Woodcock M.D. products that give off electronic radiation; and the Center for Food Safety and Applied Nutrition (CFSAN) regulation of tobacco products. Dr. Woodcock began her FDA career in 1986, joining the agency’s Center for Biologics Center for Tobacco Evaluation and Research (CBER) as Director of the Division of Biological Investigational Products New Drugs, as well as serving as CBER’s Acting Deputy Director for a period of time. She later became Director of the Office of Therapeutics Research and Review in CBER, which Center for Veterinary Medicine included the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.