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Clinical research / Clinical pharmacology / Pharmaceutical industry / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Drug discovery / Generic drug / Biologic / Dermatologic and Ophthalmic Drugs Advisory Committee / Pharmaceutical sciences / Food and Drug Administration / Pharmacology


MARRIOTT CRYSTAL GATEWAY • 1700 JEFFERSON DAVIS HIGHWAY • ARLINGTON, VA, USA Co-sponsored by ARLINGTON, VA &
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City

ARLINGTON / Washington / DC / /

Company

Preclinical / NOVARTIS / DURAMED RESEARCH INC. / BARR LABORATORIES INC. / NOVO NORDISK A/S / TLG Consulting Inc. / CENTOCOR INC. / Genentech Inc. / AMGEN INC. / BIOGEN IDEC INC. / ZYMOGENETICS / PhD / TEKGENICS INC. / CBER/FDA / TEVA PHARMACEUTICAL INDUSTRIES LTD. / Clinical Development Sciences / CDER/FDA / PHARMACOKINETICS/ PHARMACODYNAMICS (PK/PD) STUDIES / IMMUNOGENICITY STUDIES / GOALS & OBJECTIVES At / /

Continent

America / /

Country

Denmark / /

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EntertainmentAwardEvent

the AMA Physician's Recognition Award / /

Event

FDA Phase / /

Facility

INSTITUTE TECHNOLOGY Keith Webber / Pharmacy Education / CDER/FDA UTRECHT UNIVERSITY / JEFFERSON DAVIS HIGHWAY / Laboratory of Plasma Derivatives / /

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IndustryTerm

risk products / clinical research pharmaceutical manufacturers regulatory authorities / similar products / ameliorative products / manufacturing / follow-on protein products / recombinant and natural protein products / reference product / analytical tools / to protein products / life saving products / follow-on product / lower risk products / /

MedicalCondition

hypersensitivity / MS / /

Organization

Drug Information Association / office of Biotechnology Products CDER / office of Biotechnology Products / Division of Metabolic and Endocrine Drugs / Massachusetts Institute of Technology / International Association for Continuing Education and Training / FDA / office of New Drug Chemistry / Biotechnology Industry Organization / office of Pharmaceutical Science / office of Generic Drugs / FDA UTRECHT UNIVERSITY / Division of Immunology and Endocrinology / Accreditation Council for Continuing Medical Education / Food and Drug Administration / Accreditation Council for Pharmacy Education / CDER Advisory Committee for Pharmaceutical Science / Interested / Laboratory of Plasma Derivatives / Generic Pharmaceutical Association / Institute of Technology Acting / Center for Drug Evaluation and Research / /

Person

Late Stages / KATHLEEN A. CLOUSE / Jay P. Siegel / William Hancock / Dorothy Scott / Steve Kozlowski / FDA BLAIR FRASER / FDA FRANK HOLCOMBE / Dena Hixon / THERESA L. GERRARD / Barry Cherney / Stephen Moore / William Schwieterman / Raja B. Velagapudi / Marc Walton / James D. Green / Andrea Weir / FDA DENA HIXON / FDA MARILYN WELSCHENBACH / FDA STEPHEN MOORE / Amy Rosenberg / Blair Fraser / Mercedes Serabian / FDA AMY ROSENBERG / Alexandra Worobec / Joy Cavagnaro / Janice Brown / FDA BARRY CHERNEY / Chi-Wan Chen / MARIE A. VODICKA / Kathryn Stein / FDA STEVE KOZLOWSKI / Inger Mollerup / Mark Rogge / ANTHONY S. LUBINIECKI / GORDON JOHNSTON / Charles Cooney / Christopher Joneckis / Hae-Young Ahn / Yafit Stark / Hong Zhao / Reed Harris / FDA CHRISTOPHER JONECKIS / Jay Lozier / SARA RADCLIFFE / Robin Thorpe / Andrew Chang / KEITH WEBBER / David Orloff / Ajaz Hussain / Dave Parkinson / Charles Diliberti / Carole Ben-Maimon / GENE MURANO / Joerg Windisch / /

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Position

Director / Division of Metabolic and Endocrine Drug Products / Advisor / PHYSICAL CHEMICAL CHARACTERIZATION Supervisory Pharmacologist / President / MS Pharmacologist / Vice President / Global Development Head / Vice President / Director / Scientific and Regulatory Affairs / Professor of Biological Engineering / Vice President of Development / physician / Senior Program Management Officer / Vice President / Scientific Affairs / Director for Medical Affairs / Acting Deputy Director / Division of Hematology / Chemistry Team Leader / Acting Director / Division of Monoclonal Antibodies / Acting Director / Global Head / Technical Development / Managing Director / Scientific and Regulatory Affairs / Senior Advisor / LUNCHEON Head / CHAIRPERSON / CHEMICAL AND BIOLOGICAL CHARACTERIZATION AM CHAIRPERSON / Director / Biologics & Biotechnology / Pharmaceutical Research / Senior Director / Pharmacologist / IMPURITIES Pharmacologist / Branch Chief / Director / Scientific Affairs / PhD AND EFFICACY STUDIES CHAIRPERSON Vice President / Vice President / Product Development and Regulatory Affairs / President / Research & Development / Toxicologist / Director / Division of Therapeutic Proteins / Director / Division of Therapeutic Internal Medicine Products / Acting Deputy Director / RECEPTION PM / AMA Physician / Vice President / Technology Transfer & Project Planning / Vice President / Regulatory Affairs / Director for The focus / Deputy Director / Director / Deputy Director / This workshop / Deputy Director / Division of Therapeutic Proteins / President and COO / Director / Global Clinical Research / Professor of Chemical and Biochemical Engineering Co-Director / Chair / Medical Officer / Associate Director for Chemistry / Deputy Division Director / Director / Division of Monoclonal Antibodies / Vice President / Regulatory Affairs / Head / Deputy Director / Division of Hematology / /

Product

L04 / /

ProgrammingLanguage

DC / /

ProvinceOrState

Massachusetts / /

RadioStation

CHARACTERIZATION AM / BREAK AM / AM 8 / AM AM / AM-12 / /

SportsLeague

International Association / /

Technology

MASSACHUSETTS INSTITUTE TECHNOLOGY / WAN / in vitro diagnostics / Antibodies / Biotechnology / PHARMACOKINETICS / PHARMACODYNAMICS / /

URL

www.diahome.org / /

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