Quality Control Management Human Resources Clinical Research
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|LUIS SZYFRES, M.P.H.
INTERNATIONAL EXPERT ON PHARMACEUTICAL PRODUCTS
A. GLOBAL EPIDEMIOLOGY
B. GLOBAL CLINICAL RESEARCH
C. GLOBAL PHAMACOEPIDEMIOLOGY/SAFETY/RISK MANAGEMENT & REG. AFFAIRS.
(941) ***-**** email@example.com
SUMMARY/Unique Professional Value Offered to the Employer
Training & Experience (extensive, multidisciplinary & integrated):
sMPH Degree sThree Accredited Training Programs sOne Postdoctoral Fellowship.
-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), NY University (Mt. Sinai Medical Ctr.), IT&E International Corporation, US.DHHS, Dpt. of Health of DC, World Health Organization
Core Competencies (multidisciplinary & integrated):
Global Knowledge, Skills, & Abilities:
Global Epidemiology, Laboratory Medicine, Genetic Engineering & Molecular Biology, Bioinformatics, R&D, IT applied to Clinical Research & Drug Monitoring, Global Pharmacoepidemiology, Pharmacovigilance, Benefit-Risk Assessment, Risk Management, International Regulatory Affairs, Global Quality Control & Assurance Standards, Global Medical Liaison, Global Medical Affairs.
National Institutes of Health (NIH)/St. Elizabeths Campus. Washington, DC 1989-1993
Accredited Training Program: Psych Social- Behavioral Sc. applied to:
1.Community health research status/identification and characterization of markets in the different population groups (in recognition of the interplay between social-economic factors and health).
2.Human resources development and management; outcomes evaluation (patients-reported outcomes)
3.Field studies on products under development or new in the marketplace according to the characteristics of the consumers (age, sex, race, ethnicity, and social, cultural, educational, and economic levels), to develop efficient and realistic marketing strategies
4.Evidence based models and development of realistic and effective social-marketing strategies
5.Health economics research and modeling to develop communication strategies of the value message for new products; development and distribution of products information adapted to the professional community and the general public
6.Mathematical modeling to forecast market performance, cost-benefit, and cost-production, of new pharmaceutical products and healthcare services.
7.Development of data mining techniques and methodologies.
8.Public affairs and analytical consumer relationship management
9.Programs/projects management and evaluation.
The Johns Hopkins University, Hospital and School of Medicine. Baltimore, MD 1986-1987
Postdoctoral Fellowship: Biotechnology, applied to:
a.Development of research protocols
b.Writing, submitting, and securing grants, contracts, and cooperative agreements.
c.Medical technology assessment
e.Medical affairs, medical liaison, quality affairs, validation, regulatory affairs, global affairs.
f.Human resources development
City University of NY. Mt. Sinai Medical Center. Manhattan, NY 1984-1985
Accredited Training Program: Clinical Pathology – Clinical Research, Pharmacology, Phamacodynamics, Pharmacokinetics, Toxicology, and Pharmacoepidemiology applied to:
1.Feasibility studies and business plans,
2.Preclinical studies, clinical studies (Phases I-II-II), and Phase IV
3.Laboratory/clinical epidemiology research
4.Policy research and analysis, economics research and modeling, & outcomes evaluation research
5.Developing treatment guidelines and decision trees
6.Designing and evaluating evidence based models
7.Human resources development and management
8.Research projects management and evaluation.
The Johns Hopkins University. Department of Epidemiology. Baltimore. MD 1979-1980
Master of Public Health (M.P.H.). Clinical Epidemiology, applied to:
a.Research and evaluation of the health and pharmaceutical products status in the community including: magnitude, trends, patterns, and frequency and distribution of medical conditions and associated factors, according to the different population groups (age, sex, race, ethnicity, geography, social, educational, and economic) and population dynamics, for the identification of new markets for biopharmaceutical products and services.
b.Epidemiological Community Health Studies, for the evaluation of the national and international needs assessment of the population for biopharmaceutical products and healthcare services.
c.Evidence based models, to develop effective marketing strategies
d.Surveillance/monitoring/tracking systems for Phase IV (Pharmacoepidemiology and Risk Management)
e.Human resources development and management
f.Policy research and analysis
g.Economics research, modeling, and evaluation, for development of efficient communication strategies on the value message for new pharmaceutical products and healthcare services
h.Outcomes evaluation research
i.Development and implementation of evidence based models, for the development of effective marketing strategies
PROFESSIONAL EXPERIENCE: CHRONOLOGICAL
World Health Organization. Strategic Center for Epidemiology, Bioinformatics, Research, and Publications. Washington, DC
Director 06/09 – 07/11(Present: Scientific advisor)
Participating, coordinating, and evaluating:
1. “The WHO Program of Vaccines & Biologicals” (International Regulatory and Technical Guidance, Norms and Standards on the Production and Control of Biological Medicines and related in vitro diagnostic tests). My functions included:
=Quality Assurance and Safety of Biologicals (QSB): to ensure the quality and safety of vaccines and other biological medicines through the development and establishment of global norms and standards, including: (1) International (physical standards for vaccines and other biologicals (cytokines, hormones, biotechnology products) (2) Guidelines on production and quality control (3) International consensus on safety and quality issues (4) Technical advice to national regulatory authorities and national control laboratories (5) Methods, requirements, provision of international standards and reference preparations and advice on how to use them
=Access to Technologies (ATT): to reduce financial and technical barriers to the introduction of new and existing vaccines and immunization-related technologies.
=Vaccine Assessment and Monitoring (VAM): to assess the strategies and activities for reducing morbidity and mortality of vaccine-preventable diseases (VPDs).
=Expanded Program on Immunization (EPI): for the development of policies and strategies for maximizing the use of vaccines of public health importance and their delivery. Supporting regions and countries in acquiring the necessary skills, competence and infrastructure to implement these policies and strategies and achieve disease control/elimination and eradication objectives.
=Initiative for Vaccine Research (IVR): guide, provide vision, enable, support, and facilitate the development, clinical evaluation and world-wide access to safe, effective and affordable vaccines against infectious diseases of public health importance, especially in developing countries.
2.‘The WHO Expert Committee on Specifications for Pharmaceutical Preparations”. My functions included:
=Development of norms, standards and guidelines to promote quality assurance and quality control
=Establishing guidelines relating to quality assurance, prepared in consultation with the “WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations”, with specialists from Pharmaceutical Industry and National Institutions. The draft guidelines are evaluated during the “WHO Expert Committee on Specifications for Pharmaceutical Preparations” and if found suitable adopted as international standards.
3.“Good Manufacturing Practices for pharmaceutical products”. I participated in the development and evaluation of this guidelines, norms, and standards
4.“The WHO Program for International Drug Monitoring”. My functions included:
=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. A data-mining approach (BCPNN) is used at the UMC to support the clinical analysis made by a panel of signal reviewers
=Provision of the WHO database as a reference source for signal strengthening and ad hoc investigations. Web-based search facilities and customized services are available
=Information exchange between WHO and National Centers, mainly through 'Vigimed', an e-mail information exchange system
=Publication of periodical newsletters, (WHO Pharmaceuticals Newsletter and Uppsala Reports), guidelines and books in the pharmacovigilance and risk management area
=Supply of tools for management of clinical information including ADRs case reports.
=Provision of training and consultancy support to National Centers and countries establishing pharmacovigilance systems
=Computer software for case report management designed to suit the needs of National Centers (Vigibase Online)
=Annual meetings for representatives of National Centers at which scientific and organizational matters are discussed
=Methodological research for the development of pharmacovigilance as a science
NIH-Funded Partnership: Center for epidemiology, research, and training.
Professor of Epidemiology and Researcher 2005- 2009
Main Functions: developing regional center for epidemiological research, conducting epidemiological research studies, grant writing, developing health registry, teaching and training students and faculty in epidemiology and research.
Appointed Member of the Legislature, by the Speaker of the House, creating
a commission to deal with the main health problems in the population.
IT&E International Corporation. Headquarters: San Jose, CA
• IT&E works with the major Pharmaceutical Industry
• Main functions
1. Information Technology & Engineering applied to the design and development of business plans based in various parameters (i.e.: market studies, cost-benefit, risk assessment, evaluation of competition) for biopharmaceutical products and healthcare services, policy modeling, health research studies, outcomes evaluations, economic research, medical technology assessment, policy research and modeling, data management, validation, regulatory affairs, quality control, operational data modeling, data mining, information and surveillance systems, computerized tools for statistical analysis, developing strategies for public relations/networking (analytical consumer relationship management systems), data mining systems..
2. IT&E is also a CRO, conducting advance Clinical Research (Phases I-II-II), and Pharmacovigilance))
US-Department of Health and Human Services (FDA, NIH, HRSA). WDC
Member Scientific Advisory Committee, Office of the Secretary of US-DHHS. Part-time.
Department of Health (DOH). Government of the District of Columbia
Coordinator, Division of Epidemiology, Bioinformatics, & Clinical Research.
• Main functions:
1.Federal Regulatory Affairs (FDA):
Monitoring and performing Outcomes Evaluation of ongoing research projects, grants, cooperative agreements, and contracts, to ensure that the projects are consistent with current Federal Policies, Statues, and Regulations, and are progressing as planned towards their stated objectives, and preparing bids consistent with HHS procurement regulations, to ensure that they are meeting the needs of identified populations, are improving their services, are consistent with national policies and procedures, and that they are operating within current statute and regulations
2.Technical Cooperation and Assistance to research projects:
Providing technical assistance in all matters affecting health clinical research, including: policies, strategic planning, regulations, finances, human resources, operational modalities, administration, and evaluation.
3.Technical Management of clinical research projects:
=I prepared NOFAs, RFAs, RFPs, RFCs, and scopes of work for new research grants, contracts, or cooperative agreements
=I participated in the selection of research contracts, directing and monitoring contractor performance, evaluating quality and acceptability of work products, evaluating progress and financial reports.
=I provided technical assistance to grantees of research projects, and recommended performance improvements.
=I conducted the outcome evaluation and impact assessment of Grant-funded health research
=I developed technical guidelines to assist grantees and/or contractors in determining the most effective methods for the operation of health programs.
4. Fiscal Management of clinical research projects:
•I prepared analytical documents on budget evaluation, justification, and support, for the proper allocation of funds according to priorities, and monitored the selection process for the adjudication of new grants, or after performance evaluation, re-issuance of existing Grants.
•I participated in the selection of research grants and contracts to be funded according to health priorities, evaluation of grant proposals, quality control, and outcomes evaluation
•I designed strategies for the continuous redefinition of the health system relationships and communication with contractors and grantees, to be able to respond quickly to the changing needs on the health sector
•I prepared policy and operational instructions and guidance for the fiscal management of research projects, and for the implementation of new fiscal initiatives or systems.
Awarded Letter of recognition by the Deputy Secretary of US.HHS
•Large program of the Department of Health, that consists of twenty-eight hospitals and clinics of all levels of complexity.
1.In charge of all aspects related to epidemiology applied to health research studies for the analysis and evaluation of projects’ policies, economics, and outcomes.
2.Community health research status/identification and characterization of markets in the different population groups:
a.Designing and implementing epidemiological community studies, aimed at identifying the causes, incidence, prevalence, and economic impact of diseases, accidents/injuries, and health disability.
b.Assessing the frequency, distribution, trends, and patterns of diseases and associated factors
c.Synthesizing data sources and methods for assessing the scope of diseases
d.Identifying risk factors in the different population groups.
e.Designing reliable measures of morbidity and mortality, and indices of community health
f.Analyzing clinical data from community health studies that are inconsistent with the current statistical diagnostic criteria, by testing hypothesis about a set of parameters and evaluation of clinical versus statistical significance
g.Evaluating health programs through, outcome evaluation and impact assessment studies
Awarded Certificate of Recognition for an Outstanding
Performance Rating, by the Major of Washington, D.C.
World Health Organization / United Nations. Washington, DC 1981-1983; 1988; 1994
Epidemiologist, Division Epidemiology, Clinical Research, & Program Management
• Clarification: I worked for the World Health Organization/United Nations in three different periods: 1981-1983; 1988; 1995. The interruptions were to obtain further medical training.
• Successfully directed this program of the highest complexity and very difficult logistics, as it operated in 35 WHO member countries (including the US), with a large budget and staff.
• Main functions:
In charge of all activities involving epidemiological research studies for medical technology assessment, health policy analysis, health economics research and modeling, and outcomes evaluation.
1.Evidence and Information for Health Policy
Participated actively in the “WHO Statistical Information System (WHOSIS)”. The WHO Statistical Information System is the guide to health and health-related epidemiological and statistical information available from the World Health Organization.
2.Burden of Disease Statistics: (statistical measures relating to the burden of disease).
Worked in the development and evaluation of “WHO’s Healthy Life Expectancy (HALE)” It summarizes the expected number of years to be lived in what might be termed the equivalent of full health. Making annual life tables for all Member States. These life tables have several uses and form the basis of all WHO's estimates about mortality patterns and levels worldwide. A key use of these life tables is in the construction of healthy life expectancy (HALE), which is the basic indicator of population health levels used by WHO
3.Other WHO worldwide disease Information Systems: participated in the following information and surveillance systems:
• Statistical information by disease
• Disability statistics
• Environmental information, by health topic
• Essential drugs electronic tools and computerized information systems
• Health Indicators: database
• Physicians, nurses, dentists, and pharmacists (WHO estimates)
• Weekly Epidemiological Record
•WHO Model List of Essential Drugs (EDL)
•World Health Report: statistics
4.Pharmacoepidemiology/Vigilance and Risk Management:
=Collecting and analyzing reports of adverse drug reactions from worldwide members of the Program for International Drug Monitoring and to issue international signals of drug safety concerns arising from the data.
=Supporting and providing training for both aspirant countries in establishing their own national drug safety surveillance systems, and for current members in maintaining and developing their systems
=Developing the science of pharmacovigilance, in theory, methodology, practice and research
The Johns Hopkins University. Dept. of Clinical Epidemiology & Research. Baltimore.MD
Faculty Member/ResearchAssociate 1987
Design, implementation, evaluation, of epidemiological research studies for health projects’ policy analysis, economic modeling, and outcomes evaluation.
a. Research: design, implementation, evaluation, and management of epidemiological research projects.
b. Teaching and training: students and professionals of various categories (MDs, DVMs, PhDs, RNs, MPHs, MSCs), on the principles, theories, and methodologies used to analyze health data from epidemiological surveys, including:
=Designing and implementing clinical and field/community epidemiological studies
=Preparing research protocols and grants
=Planning and implementing observational and experimental studies
=Formulating hypotheses regarding health status and health outcomes
=Assessing health research needs in the different population groups, and geographical areas
=Providing broad knowledge of computer systems and statistical applications
=Developing mathematical models to predict the possible outcome of research projects.
=Teaching communication methods sufficient to present findings to diverse audiences.
=Studying the magnitude, profiles, patterns, and trends of diseases in the community
=Designing epidemiological studies of disease-related attributes of human populations
=Conducting quality control of ongoing research studies.
=Selecting the most appropriate epidemiological techniques for quality control analysis.
Awarded Letter of Recognition for “Research of the
Highest Caliber“, by the Chairman of the Dept.
Mt. Sinai Medical Centers, City University of NY. Manhattan, New York 1984-1985
Accredited Training Program: Clinical Pathology – Clinical Research, Pharmacology, Phamacodynamics, Pharmacokinetics, Toxicology, and Pharmacoepidemiology
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