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DR. LUIS SZYFRES, MD, MPH
INTERNATIONAL EXPERT IN EPIDEMIOLOGY AND DRUG SAFETY
PHARMACOEPIDEMIOLOGY/VIGILANCE, BENEFITRISK ASSESSMENT & MANAGEMENT
Telephone: Email: _________________________________________________________________________________________________________________________________________________________
SUMMARY/Unique Professional Value Offered to the Employer
Physician with Unique, Extensive, Multidisciplinary, & Integrated scientific background at the National & International levels. Uncommon knowledge, skills, and abilities to analyze and manage the most complex methodological issues, and to find the most effective way to design and implement Global Epidemiology and International Drug Safety projects.
Training extensive, multidisciplinary & integrated:
Two Degrees MD & MPH Three Medical Specialties Medical Epidemiology/Clinical Research; Laboratory Medicine; Social Epidemiology One Postdoctoral Fellowship Genetic Engineering.
Experience worked at multiple Settings and levels:
* Years: extensive professional experience with progressive responsibility and documented success in areas of expertise. Last twelve years in managerial positions.
* Settings: Private, Public, State, Federal, Academic, and International organizations, including: the Johns Hopkins University Hospital and SPH, City University of New York Mt. Sinai Medical Center, IT&E International Corporation, US.DHHS, Dpt. of Health of DC, World Health Organization/United Nations.
Core Competencies multidisciplinary & integrated:
Global Epidemiology, Global Drug Safety, Laboratory Medicine, Genetic Engineering & Molecular Biology, R&D, IT applied to Drug Monitoring, Global Pharmacoepidemiology, Pharmacovigilance, BenefitRisk Assessment, Risk Management, International Regulatory Affairs, Global Quality Control.
PROFESSIONAL EXPERIENCE: CHRONOLOGICAL
World Health Organization WHO.Ctr. for Epidemiology, Drug Safety, & Publications, WDC
Founder and Director / / Present: Scientific Advisor
* Working with the: "WHO Program for International Drug Monitoring". Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centers and from them to the WHO database.
* Evaluating Adverse Reaction Signals, using a datamining approach BCPNN to support clinical analysis.
* Developing & updating tools for management of clinical information including adverse drug reaction case reports WHO Drug Dict. and WHO Adverse Reaction Terminology.
* Information exchange between WHO and National Centers, mainly through &;Vigimed&;.
* Writing & reviewing the WHO Pharmaceuticals Newsletter, Uppsala Reports, and guidelines in pharmacovigilance and risk management.
* Establishing pharmacovigilance systems and training personnel in several countries.
* Conducting methodological research for development of pharmacovigilance as a science
National Institutes of Health NIHFundedMedical Research Center.
Director Epidemiology, Clinical Research, & D.Safety //
IT&E International. Private Corporation. San Jose, CA.
Worldwide Medical Director // /
Working with the Major Pharmaceutical Companies, in the development of clinical research protocols, clinical trials, pharmacoepidemiology, pharmacovigilance, benefitrisk assessment & management, clinical data management, validation, regulatory affairs, quality control, operational data modeling, laboratory standards, data mining, information, surveillance, and tracking systems, computerized tools for the analysis of files and documentation of statistical analysis for submission to the FDA.
Joint Appointment: //
US. DHHS: Member Scientific Advisory Committee, Office of the Secretary of US.DHHS.
Development, evaluation, operating, and administering epidemiology and drug safety programs FDA, NIH, CDC, and Dept. of Health of DC: Director, Division of Epidemiology, Research, and Bioinformatics.
The Johns Hopkins University. Dpt. of Clinical Epidemiology & Research. Baltimore, MD.
Faculty Member/Research Associate //
Design, implementation, evaluation, and management of clinical research projects.
World Health Organization / United Nations. Washington, DC
Director, Division of Epidemiology, Research & Drug safety / /
Clarification: I worked for the World Health Organization/United Nations in three different periods: ; ; . The interruptions were either to obtain further medical training i.e., MPH at the Johns Hopkins University.
* Collecting and analyzing reports of adverse drug reactions from worldwide members of the Program for International Drug Monitoring and issuing international signals of drug safety concerns arising from the data.
* Supporting and providing training to countries in establishing their own national drug safety surveillance systems
* Communicating the drug safety message throughout the world to all Member Countries of WHO&;s Program for International Drug Monitoring.
PROFESSIONAL EXPERIENCE: FUNCTIONAL
* Designing Phase IV protocols for epidemiological safety studies.
* Conducting surveillance on the safety/adverse reactions to drugs both, types A & B
* Implementing epidemiological studies on DARs, and evaluating studies results.
* Performing evaluation and Risk Assessment of drugs in the postmarketing environment
* Obtaining new information that supplements that available from premarketing studies for a better quantification of the incidence of known adverse effects, studying: patients not evaluated prior to marketing the elderly, children, pregnant women, etc, interaction with other drugs, effect on other illnesses, comparison with other drugs used for the same indication
* Obtaining new types of information not available from premarketing studies: discovery of previously undetected adverse, uncommon, and delayed effects, patterns of drug utilization, effects of drug overdose, economic implications of drug use, reassurances about drug safety, fulfillment of ethical and legal obligations
* Developing new methodologies for PostMarketing Surveillance, focusing in:
The limitations of PhaseIII Trials i.e.: study population too small, length of trial too short, case/controls too healthy
The population of users expands after drug approval to other age groups children/elderly, other ethnic groups, and to use in pregnancy.
* Evaluating Risk Assessment componentsSignals from adverse drug reactions ADRs:
Reviewing Process of ADRs expediting Day; preparing direct and periodic reports; analyzing patterns of ADRs over time
Preparing signal reports MARs
Evaluating medically significant events
Labeling changes and promote safe use of drugs
* Working with large recordlinked databases:
Reporting Systems on drug use IMS America, Ltd., National Disease & Therapeutic IndexNDTI, National Prescription AuditNPA, Audatrex, US Pharmaceutical MarketHospitals & Drugstores, Medicaid Management Systems, COMPASS, DURbase, etc
Spontaneous reporting systems
Industry screening for unknown effects of newly marketed drugs
Health data bases
FDA&;s AERS Adverse Event Reporting System
* Working with extramural drug data sources
IMS Health: a Prescribing practices; b Drug exposure data; c Reporting rate estimates
Cooperative Agreements: a Incidence studies; b Risk factor identification; c Labeling compliance studies; d Off label use
* Coordinating and conducting DataMining:
Evaluating its utility to target and refine signal detection and evaluation
Analyzing its utility in the assessment of risk factors age and sex adverse events, and identification of drugdrug interactions
* Monitoring the quality and timeliness of adverse drug reaction reports by manufacturers to the FDA, as required by regulation, and in compliance with the international safety reporting guidance ICH EB issued by the International Conference on Harmonization, and properly coded using the standardized international terminology, MedDRA the Medical Dictionary for Regulatory Activities.
* Monitoring the quality and timeliness of adverse drug reaction reports by health care professionals and consumers through the MedWatch program.
* Providing technical advice, and participating in ADRs&; Active Surveillance, including the:
Acute, Severe, Hepatotoxicity Active Surveillance Program ASH. United Network for Organ Sharing Program: determining drug exposure history among liver transplant candidates
Death Certificate Active Surveillance Project. NCHS Death Certificates: obtaining an annual data tape to determine death rates and demographic data of deaths due to drugs
National Electronic Adverse Event Surveillance System. National Electronic Injury Surveillance System funded by the Consumer Product Safety Commission: determining incidence of ADRs among emergency room patients
Drug Use and Pregnancy Outcomes in RecordLinked Databases: a developing linkage of maternal and infant records in existing databases; b validating the linkage through medical records and vital records
Centralized Registry of Drug Exposure during Pregnancy: participating in the development of a single registry of prospective drug exposures during pregnancy with collection of infant outcomes.
Active Postmarketing Surveillance Methods in Hospitals: a analyzing methodologies to establish a system for identification of device and drug ADRs; b collaborating with CDRH
Providing technical assistance for the development of databases and mechanisms tailored for ADRs: a Soliciting ideas; b Identifying funding sources; c Identifying collaborators
Conducting Epidemiological Studies on Drug Interactions: a Evaluating the natural history of the indication population to determine the most common possible interactions, plus pharmacological /pharmacokinetic assessment of the likelihood of those interactions; b Designing adverse reaction collection protocols, and training of investigators.
PROFESSIONAL EXPERIENCE: INTERNATIONAL
Working with the World Health Organization, developed and managed multicenter and international epidemiological research, ADRs studies, and surveillance systems, in more than fifty member countries of the World Health Organization.
National Institutes of Health NIH/St. Elizabeths Campus/. Washington, DC
Medical Specialty: accredited Medical Residency Training Program: SocialBehavioral Sc, applied to Epidemiological Research and Drug Safety.
The Johns Hopkins University, Hospital and School of Medicine. Baltimore, MD
Postdoctoral Fellowship: Biotechnology: Genetic Engineering/Molecular Biology Research
NY University. Mt. Sinai Medical Center, Manhattan, NYC
Medical Specialty: accredited Medical Residency Training Program: Laboratory Medicine Pharmacology, Pharmacokinetics, Pharmacodynamics Pharmacoepidemiology, Microbiology, Toxicology, Immunology, Hematology, and DiagnosticsClinicalLab. Correlation applied to Epidemiology & Drug Safety.
The Johns Hopkins University. Dpt. of Epidemiology. Baltimore. MD
Master of Public Health M.P.H. in Epidemiology applied to Drug Safety.
School of Medicine.NatUnivBsAs/ECFMG Diploma.Philadelphia, PA
Medical Doctor M.D.