FLAB 2018

Palestrantes Internacionais Confirmados

DR. CRISTIAN FLÓREZ TRAINED FOR HIS MEDICAL DEGREE AT THE UNIVERSIDAD AUTÓNOMA DE BUCARAMANGA, COLOMBIA. HE STUDIED CLINICAL EPIDEMIOLOGY AT THE UNIVERSIDAD INDUSTRIAL DE SANTANDER, COLOMBIA, AND SPECIALISED IN INTERNAL MEDICINE AND GASTROENTEROLOGY AT THE HOSPITAL MILITAR CENTRAL DE BOGOTÁ, AND ENDOSCOPIC ULTRASOUND AT THE INSTITUTO NACIONAL DE CANCEROLOGÍA IN MEXICO. DR FLÓREZ WENT ON TO STUDY IN INFLAMMATORY BOWEL DISEASE AT THE BETH ISRAEL DEACONESS MEDICAL CENTER, HARVARD MEDICAL SCHOOL. DURING HIS TRAINING HE RECEIVED RECOGNITION AND AWARDS FOR EXCELLENCE IN INTERNAL MEDICINE AND GASTROENTEROLOGY.
HE CURRENTLY WORKS AS A PROFESSOR OF GASTROENTEROLOGY AND DIGESTIVE ENDOSCOPY AT THE UNIVERSIDAD MILITAR NUEVA GRANADA, BOGOTÁ COLOMBIA. HE IS ALSO DIRECTOR OF GASTROENTEROLOGY AND INFLAMMATORY BOWEL DISEASE AT GASTROADVANCED IPS, BOGOTÁ AND IS CURRENTLY DIRECTING MULTIPLE STUDIES IN ULCERATIVE COLITIS IN THE LATIN AMERICAN POPULATION, FOCUSED ON POLYMORPHISMS AND BIOMARKERS. HE HAS BEEN A NATIONAL AND INTERNATIONAL LECTURER FOCUSED ON INFLAMMATORY BOWEL DISEASE AND THE DEVELOPMENT OF NEW APPLIED TECHNOLOGIES, PROMOTING CLINICAL EXCELLENCE FOR THESE PATIENTS
CO-DIRECTOR OMI REUMATÓLOGO EN ORGANIZACIÓN MÉDICA DE INVESTIGACIÓN (OMI) - URUGUAY 725 PB, CAPITAL FEDERAL, BUENOS AIRES, ARGENTINA INVESTIGADOR PRINCIPAL EN PROTOCOLOS PARA EMPRESAS FARMACÉUTICAS NACIONALES E INTERNACIONALES. SUB-INVESTIGADOR EN PROTOCOLOS DE FASE II, III Y IV PARA EMPRESAS FARMACÉUTICAS NACIONALES E INTERNACIONALES INCLUYEN PROTOCOLOS DE ARTRITIS REUMATOIDE, ARTRITIS PSORIÁSICA, DOLOR LUMBAR, OSTEOPOROSIS
DR CASTAÑEDA-HERNÁNDEZ IS CURRENTLY THE SENIOR INVESTIGATOR AT THE DEPARTMENTO DE FARMACOLOGÍA (DEPARTMENT OF PHARMACOLOGY), CENTRO DE INVESTIGACIÓN Y ESTUDIOS AVANZADOS DEL INSTITUTO POLITÉCNICO NACIONAL (CENTRE FOR RESEARCH AND ADVANCED STUDIES OF THE NATIONAL POLYTECHNIC INSTITUTE), MÉXICO CITY, MEXICO.
HIS PAST PUBLICATIONS INCLUDE 185 RESEARCH AND REVIEW ARTICLES IN SCIENTIFIC JOURNALS AND A TEXTBOOK ON BIOAVAILABILITY AND BIOEQUIVALENCE.
DR CASTAÑEDA-HERNÁNDEZ'S QUALIFICATIONS INCLUDE A PHD IN PHARMACOLOGY FROM FACULTÉ DE MÉDECINE, UNIVERSITÉ CATHOLIQUE DE LOUVAIN, BELGIUM, AND A BSC IN BIOLOGY FROM DIVISIÓN DE CIENCIAS BIOLÓGICAS Y DE LA SALUD, UNIVERSIDAD AUTÓNOMA METROPOLITANA, MEXICO CITY, MEXICO.
HEAD REGULATORY AFFAIRS POLICY AT SANDOZ.
BETWEEN 2001 AND 2017 INGRID WAS HEAD GLOBAL REGULATORY AFFAIRS FOR SANDOZ BIOPHARMACEUTICALS. UNDER HER RESPONSIBILITY AS HEAD THE GLOBAL REGULATORY AFFAIRS TEAM, WHICH IS DEDICATED TO BIOSIMILAR APPLICATIONS WORLDWIDE, NUMEROUS PIONEERING MILESTONES IN THE HISTORY OF BIOSIMILARS WERE ACHIEVED:
- APPROVALS OF OMNITROPE® (SOMATROPIN) - THE FIRST BIOSIMILAR PRODUCT APPROVED EVER - IN EUROPE, AUSTRALIA, USA, JAPAN, AND CANADA AS WELL AS IN MANY OTHER COUNTRIES GLOBALLY
- SUCCESSFUL REGISTRATIONS OF BINOCRIT® (EPOETIN ALFA), THE FIRST COMPLEX BIOSIMILAR PRODUCT APPROVED EVER, AND OF ZARZIO® (FILGRASTIM) IN THE EU
- APPROVAL FOR THE FIRST BIOSIMILAR PRODUCT EVER IN THE US: ZARXIO® (FILGRASTIM)
- APPROVAL OF THE SANDOZ FIRST MORE COMPLEX BIOSIMILAR IN THE US, ERELZI® (ETANERCEPT)
- APPROVALS OF TWO MORE BIOSIMILAR IN THE EU: ERELZI® (ETANERCEPT) AND RIXATHON® (RITUXMAB)
- SUCCESSFUL MAINTENANCE OF MORE THAN 200 APPROVALS IN OVER 90 COUNTRIES IN THE WORLD
FARMACOLOGISTA, PROFESSOR E INVESTIGADOR DA FACULDADE DE FARMÁCIA DA UNIVERSIDADE DE LISBOA.
DR. MELANIE ROYCE RECEIVED HER PHD (IN CELL BIOLOGY) AND MD DEGREES AT THE UNIVERSITY OF CINCINNATI IN OHIO, USA AND COMPLETED HER INTERNAL MEDICINE RESIDENCY AT YALE UNIVERSITY-NEW HAVEN HOSPITAL IN CONNECTICUT. SHE THEN OBTAINED HER MEDICAL ONCOLOGY FELLOWSHIP AT THE M.D. ANDERSON CANCER CENTER IN HOUSTON, TEXAS WHERE SHE SUBSEQUENTLY JOINED THE BREAST DEPARTMENT AS JUNIOR FACULTY UNTIL HER MOVE TO ALBUQUERQUE. AT THE UNIVERSITY OF NEW MEXICO, SHE ESTABLISHED A BREAST CANCER CLINICAL PROGRAM WHICH CARES FOR ALL STAGES OF BREAST CANCER PATIENTS IN A MULTI-DISCIPLINARY FASHION. DR. ROYCE'S OTHER RESPONSIBILITIES AT UNM INCLUDED OVERSEEING BREAST CANCER RESEARCH AS THE PRINCIPAL INVESTIGATOR FOR SEVERAL BREAST CANCER CLINICAL TRIALS. BEYOND BREAST CANCER, DR. ROYCE HAD A WIDER INVOLVEMENT IN CLINICAL RESEARCH AS THE DIRECTOR OF THE CLINICAL PROTOCOL AND DATA MANAGEMENT AND THE PRINCIPAL INVESTIGATOR OF THE U01-NCI GRANT ENTITLED NEW MEXICO MINORITY/ UNDERSERVED COMMUNITY ONCOLOGY RESEARCH PROGRAM. DR. ROYCE HAS BEEN A TENURED PROFESSOR AT UNM FOR SEVERAL YEARS BUT CHOSE TO LEAVE ACADEMIA, THOUGH REMAINING ACADEMICALLY CONNECTED THROUGH HER CONTINUED SERVICE AS A FACULTY MENTOR, A REVIEWER FOR NIH STUDY-SECTION, AND A MEMBER OF SWOG BREAST CANCER COMMITTEE. SHE IS ALSO PURSUING HER INTEREST IN DRUG DEVELOPMENT WORKING WITH COMPANIES LIKE CELLTRION TO ADVANCE NOVEL OR COST-EFFECTIVE THERAPIES FOR PATIENTS.
OLIVER ROSERO GRADUATED FROM SECONDARY SCHOOL IN QUITO, ECUADOR, AND WENT ON TO FURTHER TRAIN FOR HIS MEDICAL DEGREE AT SEMMELWEIS UNIVERSITY IN BUDAPEST, HUNGARY. HE SPECIALIZED IN ABDOMINAL SURGERY AT THE FIRST DEPARTMENT OF SURGERY OF SEMMELWEIS UNIVERSITY. DURING HIS YEARS AS RESIDENT SURGEON-TRAINEE HE ACHIEVED A PHD DEGREE ON HIS RESEARCH FOR THE ATTENUATION OF SMALL INTESTINAL INFLAMMATION WITH CHEMICAL AND SURGICAL TECHNIQUES. HE CONTINUED RESEARCHING IN A PHASE 1 UNIT AS RESEARCH PHYSICIAN AND LATER AS A CLINICAL RESEARCH ASSOCIATE. HE CURRENTLY WORKS AS REGIONAL MEDICAL ADVISOR AT CELLTRION HEALTHCARE AND IS LOOKING FORWARD TO CULTIVATING STRONG LINKS BETWEEN LATIN AMERICAN DOCTORS AND KOREA.
DOCTOR EN BIOQUÍMICA (UNIVERSIDAD NACIONAL DE ROSARIO, ARGENTINA), POSTDOCTORADO EN ONCOLOGÍA MOLECULAR (BARCELONA, ESPAÑA). INVESTIGADOR DEL CONSEJO NACIONAL DE INVESTIGACIONES CIENTÍFICAS Y TÉCNICAS (CONICET). DOCENTE DE GENÉTICA Y ONCOLOGÍA DE LA FACULTAD DE CIENCIAS MÉDICAS Y PROFESOR INVITADO EN LA CARRERA DEL DOCTORADO EN CIENCIAS BIOMÉDICAS, UNIVERSIDAD NACIONAL DE ROSARIO. DIRECCIÓN DE PROYECTOS DE INVESTIGACIÓN EN ONCOLOGÍA E INMUNOLOGÍA, EN TEMAS DE INMUNOTERAPIA DEL CÁNCER, TERAPIAS DIRIGIDAS A BLANCOS MOLECULARES E IDENTIFICACIÓN DE BIOMARCADORES. INMUNOTERAPIAS COMBINADAS. INVESTIGACIÓN TRASLACIONAL. PUBLICACIONES EN REVISTAS INTERNACIONALES CON REFERATO, LIBROS Y PRESENTACIONES EN CONGRESOS INTERNACIONALES. EXPERTO Y ASESOR EXTERNO DE LA INDUSTRIA FARMACÉUTICA EN BIOTECNOLOGÍA Y MEDICAMENTOS BIOTECNOLÓGICOS. ORGANIZACIÓN Y EXPOSICIÓN EN PROGRAMAS DE FORMACIÓN PROFESIONAL MÉDICA CONTINUA DIRIGIDA A MÉDICOS ESPECIALISTAS EN ONCOLOGÍA, REUMATOLOGIA, HEMATOLOGÍA Y NEUROLOGÍA. PLANIFICACIÓN, ORGANIZACIÓN Y EXPOSICIÓN EN JORNADAS, CURSOS, SIMPOSIOS Y FOROS CIENTÍFICOS EN TEMAS DE BIOTECNOLOGÍA, MEDICAMENTOS BIOTECNOLÓGICOS Y MEDICINA PERSONALIZADA. ASESORAMIENTO DE AGENCIAS REGULATORIAS DE LATINOAMÉRICA SOBRE MEDICAMENTOS BIOTECNOLÓGICOS. EX-BECARIO DE LA AMERICAN ASSOCIATION FOR CANCER RESEARCH, FUNDACIÓN CAROLINA Y AGENCIA ESPAÑOLA DE COOPERACIÓN INTERNACIONAL, Y LIGA ARGENTINA DE LUCHA CONTRA EL CÁNCER (LALCEC).
DR. THOMAS FELIX IS A MEDICAL DIRECTOR IN AMGEN'S GLOBAL REGULATORY AND R&D (GRR&D) POLICY ORGANIZATION. HE HAS BEEN AT AMGEN SINCE 2006 AND IS CURRENTLY BASED IN WASHINGTON, DC, USA.
DR. FELIX SERVES IN A TECHNICAL POLICY ROLE IN THE UNITED STATES, AMGEN'S JAPAC AND INTERCONTINENTAL REGIONS (I.E., ASIA, AUSTRALIA, CANADA, LATIN AMERICA, TURKEY, AND THE MIDDLE EAST). HE HAS EXPERIENCE WORKING IN MEDICAL AFFAIRS ON BOTH SMALL MOLECULE AND BIOLOGIC THERAPEUTICS. THE SCIENTIFIC DIFFERENCES BETWEEN THESE MEDICINES SERVE AS THE UNDERPINNING FOR THE ESTABLISHMENT OF SEPARATE STANDARDS AND REGULATORY APPROVAL PATHWAYS. DR. FELIX CONTRIBUTES TO A CROSS-FUNCTIONAL, GLOBAL MULTIDISCIPLINARY TEAM COMMITTED TO ADVANCING SCIENCE, POLICY AND MANUFACTURER ACCOUNTABILITY FOR A SUCCESSFUL, PATIENT-FOCUSED BIOSIMILAR IMPLEMENTATION. DR. FELIX MEETS WITH REGULATORY AUTHORITIES AROUND THE WORLD TO SHARE SCIENTIFIC CONSIDERATIONS FOR BIOLOGIC AND BIOSIMILAR APPROVAL STANDARDS AND POST-APPROVAL IMPLEMENTATION CONSIDERATIONS. DR. FELIX ALSO WORKS TO ADVANCE PHARMACOVIGILANCE (PV) SYSTEMS TO MORE ACCURATELY IDENTIFY ADVERSE EVENTS AND ASSOCIATED MANUFACTURERS IN A TIMELY MANNER. HE PARTNERS WITH PHARMACOVIGILANCE EXPERTS AND ELECTRONIC HEALTH INFORMATION STAKEHOLDERS TO EVOLVE ADVERSE EVENT TRACEABILITY CAPABILITIES FOR MULTISOURCE BIOLOGICS IN VARIOUS TREATMENT SETTINGS AND REGIONS. DR. FELIX ALSO SERVES AS A SUBJECT MATTER EXPERT, INFORMING U.S. STATE GOVERNMENTS ON NECESSARY LEGISLATIVE PROVISIONS TO ALLOW FOR SCIENCE-BASED SUBSTITUTION OF BIOSIMILARS IN THE RETAIL PHARMACY SETTING. HE REPRESENTS AMGEN AS A CORPORATE MEMBER TO THE FOLLOWING ORGANIZATIONS: AMERICAN MEDICAL INFORMATICS ASSOCIATION (AMIA), NATIONAL PATIENT SAFETY FOUNDATION (NPSF), AND THE PHARMACY HIT COLLABORATIVE. HE ALSO SERVES AS AMGEN'S REPRESENTATIVE ON THE ACADEMY OF MANAGED CARE PHARMACY'S BIOLOGICS & BIOSIMILARS COLLECTIVE INTELLIGENCE CONSORTIUM (AMCP BBCIC) PLANNING COMMITTEE. HE ALSO HAS INTERESTS IN ADVANCING POLICY IN THE AREAS OF PATIENT PREFERENCE INCLUSION IN DRUG DEVELOPMENT, BIOPHARMACEUTICAL RISK MANAGEMENT, INNOVATIVE CLINICAL TRIAL DESIGN AND THE USE OF REAL-WORLD EVIDENCE FOR REGULATORY DECISION MAKING.
DR. FELIX EARNED HIS MEDICAL DEGREE AT THE PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH (INDIA). PRIOR TO AMGEN, DR. FELIX WAS VICE PRESIDENT OF MEDICAL AFFAIRS AT AN NBC UNIVERSAL HEALTH MEDIA COMPANY (HEALTHOLOGY, INC., NEW YORK, NY, USA), AN ORGANIZATION DEDICATED TO THE DEVELOPMENT OF PHYSICIAN-LED EDUCATIONAL PROGRAMS ON DISEASE MANAGEMENT ACROSS THERAPEUTIC AREAS.