Dr. H. James Williams Holds a Hearing On Actemra
Political Transcript Wire › August 27, 2009
Linked as:
Extract
Dr. H. James Williams Holds a Hearing On Actemra
DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION'S CENTER FOR DRUG EVALUATION AND RESEARCH, ARTHRITIS DRUGS ADVISORY COMMITTEE HOLDS A HEARING ON ACTEMRA
JULY 29, 2008SPEAKERS: H. JAMES WILLIAMS, M.D., PROFESSOR OF MEDICINE, DIVISION OF RHEUMATOLOGY, UNIVERSITY OF UTAH NICOLE VESLEY DESIGNATED FEDERAL OFFICIAL OSTEOARTHRITIS ADVISORY COMMITTEEDIANE ARONSON, CONSUMER REPRESENTATIVE, CONSUMER ADVOCACY CHRISTY SANDBORG, M.D., DIVISION CHIEF OF PEDIATRIC RHEUMATOLOGY STANFORD UNIVERSITY SCHOOL OF MEDICINE ROBERT STINE, PH.D., PROFESSOR, DEPARTMENT OF STATISTICS, THE WHARTON SCHOOL OF PENNSYLVANIA DENNIS TURK, PH.D., JOHN AND EMMA BONICA PROFESSOR OF ANESTHESIOLOGY AND PAIN RESEARCH, DEPARTMENT OF ANESTHESIOLOGY, UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE MARK FLETCHER, M.D, INDUSTRY REPRESENTATIVE, EXECUTIVE DIRECTOR HEAD, CLINICAL IMMUNO-VACCINOLOGY CONSULTING GROUP, PFIZER GLOBAL RESEARCH AND DEVELOPMENT DAVID BLUMENTHAL, M.D., RHEUMATOLOGY/INTERNAL MEDICINE, METROHEALTH MEDICAL CENTER DAVID PISETSKY, M.D., PH.D., PROFESSOR, MEDICINE AND IMMUNOLOGY, DUKE UNIVERSITY MEDICAL CENTER GARY HOFFMAN, M.D., M.S., HAROLD C. SCHOTT PROFESSOR OF MEDICINE, DEPARTMENT OF RHEUMATIC AND IMMUNOLOGIC DISEASES, LERNER COLLEGE OF MEDICINE, DIRECTOR, PHYSICIAN VOLUNTEER PROGRAMS, CLEVELAND CLINIC DAVID FELSON, M.D., MPH, PROFESSOR, MEDICINE AND EPIDEMIOLOGY CHIEF, CLINICAL EPIDEMIOLOGY UNIT, BOSTON UNIVERSITY SCHOOL OF MEDICINE MICHAEL WEISMAN, M.D., DIVISION OF RHEUMATOLOGY, DEPARTMENT OF MEDICINE, CEDARS-SINAI MEDICAL CENTER LEONA MALONE, LCSW, PATIENT REPRESENTATIVECURTIS J. ROSEBRAUGH, M.D., DIRECTOR, OFFICE OF DRUG EVALUATION II, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATIONBOB A. RAPPAPORT, M.D., DIRECTOR, DIVISION OF ANESTHESIA, ANALGESIA AND RHEUMATOLOGY PRODUCTS, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATIONJEFFREY SIEGEL, M.D., CLINICAL TEAM LEADER, DIVISION OF ANESTHESIA, ANALGESIA AND RHEUMATOLOGY PRODUCTS, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATIONSARAH OKADA, M.D., CLINICAL TEAM LEADER, DIVISION OF ANESTHESIA, ANALGESIA AND RHEUMATOLOGY PRODUCTS, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATIONJONATHAN LEFF, VICE PRESIDENT INFLAMMATION CLINICAL DEVELOPMENT, HOFFMANN-LA ROCHEPHILIPPE VAN DER AUWERA, GLOBAL HEAD OF ANAEMIA MANAGEMENT HOFFMAN-LA ROCHEKENNETH BAHRT, M.D. GLOBAL MEDICAL DIRECTOR FOR AUTOIMMUNITY HOFFMAN-LA ROCHEJOEL KRASNOW, M.D. HOFFMAN-LA ROCHECLARE DAVIS HOFFMAN-LA ROCHEPAUL WATKINS UNIVERSITY OF NORTH CAROLINANAVEED SATTAR, MBCHB, MRCP UNIVERSITY OF GLASGOW[*] WILLIAMS: Reminder, individuals will be allowed to speak into the record only if recognized by the chair. We look forward to a productive meeting.In the spirit of the Federal Advisory Committee Act and the Government in the Sunshine Act, we ask that that the advisory committee members take care that their conversations about the topic at hand take place in the open forum for the meeting. We are aware that members of the media are anxious to speak with the FDA about these proceedings. However, if the FDA will refrain from discussing the details of this meeting with the media until its conclusion.Also, the committee is reminded to please refrain from discussing the meeting topic during breaks or lunch. Thank you.We'd like to introduce the members of the committee. I will ask them to introduce themselves with their name and institution. I'll begin with Mark Fletcher.FLETCHER: Good morning. I'm Mark Fletcher. I'm the industry representative for this advisory committee. My background training is in allergy, immunology, and rheumatology. And I presently work for Pfizer in an internal consulting function as an immunovaccinology consultant. Thank you.MALONE: Hi. I'm Leona Malone and the patient rep...See the full content of this document
