Director of research
Since 2007
Dr. Ana Maria Abreu Velez is a board certified dermatologist from Colombia, South America with both Ph.D. and Doctor of Science degrees in immunology, and three postdoctoral fellowships; these fellowships included training in all regulatory aspects of clinical trials in the USA and overseas, in autoimmune blistering and rheumatologic diseases and in cancer immunology research. Dr. Abreu is one of the few people in the world with training in basic sciences, clinical trials and the medical field. Dr. Abreu-Velez has a unique expertise combining clinical practice, clinical trials and laboratory research. Dr. Abreu-Velez also has extended experience in developing budgets for new projects, proactively recognizing problems and implementing respective corrective measurements. Dr. Abreu-Velez has the capability to keep regulatory documents up-to-date, she has extensive knowledge in the Bayh-Dole Act and technology transfer. In clinical trials, she has worked with 21 CFR 50.54, and the processes for compliance with Institutional Review Board, informed consent, and medical device, drug and biologic regulations. Dr. Abreu Velez has experience in Phases 1 through 3 of clinical trials. Dr. Abreu Velez is proficient with electronic records, electronic signatures and new drug investigative applications; and also in patient-reported outcome measures, and their use in medical product development and audits. She is also knowledgeable in financial disclosure regulations for clinical investigators.
She has a distinguished national and international record in academic and private practice medical diagnosis, research, journal review, editing, and in all aspect of immunologic medical research. Dr. Abreu-Velez has extensive experience in autoimmune skin diseases. Through her training and experience, she has gained the capability to interpret and evaluate multifaceted, complex scientific research. Her analytic skills are excellent; her extensive experience gives her the aptitude to interact with a variety of populations and organizations. She also has strong strategic planning skills, with extensive experience handling grants, complying with regulations, saving data and providing reports to funding agencies. Dr. Abreu-Velez has experience assisting in the development of budgets, writing laboratory manuals and laboratory portions of clinical protocols, as well as grant applications. Dr. Abreu-Velez has extended experience collecting, analyzing and interpreting data, as well as presenting such data to diverse groups. Dr. Abreu-Velez is able to interact with clinical and research investigators, with communities and with patients. Dr. Abreu-Velez is outstanding at keeping records, managing complaints, generating periodic work reports, and in creating and submitting manuscripts for publication.
Director of Laboratory and Research
Since January 2006
I am physician scientist and expert in clinical trial. I have a PhD in immunology and molecular biology. I have three post-doctoral fellowships. I am a frequent keynote speaker at many academic institutions, professional organization meetings, as well as state, regional, national, and international conferences. I have a scientific leadership background reflected and had authored numerous peer-reviewed articles in professional journals, including 135 first-authored papers. I also have written a book and multiple book chapters. I have 902 citations of my publications and 277 reviews in Publons. I had given presentations across the United States and overseas. I am on the editorial boards of leading journals, and I serve on numerous professional boards. I am an editor and/or a reviewer for renowned medical and scientific journals and have experience on peer review panels. I have created many public health program projects in multiple fields. I have more than 32 years in laboratory expertise management and leadership.
I have expertise working to improve public health surveillance and practice as well as patient outcomes by advancing clinical laboratory quality and safety, data and biorepository science, and workforce competency. I have technical expertise is laboratory safety and risk management. Some of my responsibilities include guidance and oversight for regulatory compliance, environmental health, and safety training, BSL/ABSL-3 containment oversight, safety inspections, hazard identification, hazard monitoring and risk assessments. I have been national leader for emergency diagnostics and the several workgroups on improving diagnostic safety and quality in Health care. I have been responsible for the follow-up and investigations related to student, volunteer and employee injuries and exposures. I developed a new ELISA for this disease. I have experience performing multiple laboratory techniques, immunofluorescence (four colors) and confocal microscopy and bioinformatics. Clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. I have broad expertise in other clinical laboratory techniques, including histology, immunoblotting, immunoprecipitation, ELISA, immunohistochemistry, double color immunohistochemistry, (three colors), molecular biology, affinity chromatography, flow cytometry, among other techniques. I have a PhD in immunology and DSc in biomedical basic science and three post-doctoral fellows as well as clinical trial certification. I hold an MD and dermatologist board certified degrees in Colombia South America. I am considering a leading scientific expert and a dedicated health advocate. I have more than 25 years of experience as leader. Manages the program that provides compliance and regulatory support to the IRB, IACUC, IBC, OSHA, ISO, Radiation Safety Committee and High Hazard Chemical Safety Committees. Strong software and computer skills, including MS Office applications and web-based communication tools for conferences. Management of the Translational Science, and Good Clinical Practices (GCP) requirements.
Extensive knowledge of instructional or multiple clinical and research laboratory operation to include equipment calibration and maintenance, laboratory policies and procedures and lab safety rules and practices. Skills in communication, customer service, work guidance and instruction required as is the use of specialty and general computer applications. Maintain laboratories facility in safe, clean, and organized manner, Coordinate scheduling of lab usage.
I am also responsible for the follow-up and investigations related to student, volunteer and employee injuries and exposures as I have overseen a diverse group of scientific programs, including the laboratory response network for autoimmune, infectious, and parasitic diseases for over 22 years in Colombia South America. This also includes the emerging infections.
Global, public health and large data experience. I serve on several scientific, public health, and health policy national and international committees. I have served as a national and international expert in several areas including autoimmune diseases, sexually transmitted diseases (STDs), tropical and parasitic infections, and acute and chronic diseases. I have worked over 2 decades with Indian communities. I had served as the principal advisor to several Colombian Ministers of Health, Governors, Mayors, community leaders, and University presidents under several administrations in national programs, covering about 50 million people in Colombia, South America. Under my leadership, the country achieved national public health accreditation in autoimmune skin diseases at the national, state, and local levels for several years. I and my colleagues implemented community-based research, prevention, genetic counseling, clinical and laboratory follow-ups. I have overseen a diverse group of scientific programs. Dr Abreu created the public health program studying a disease model endemic pemphigus foliaceus in El Bagre, Colombia South America using among other immunoepidemiologic studies by combing individual- and population-oriented approaches to create new perspectives. This includes working with smart, data-driven styles and intuitive analysis tools that deliver location intelligence.
Compliance and regulatory affairs and research integrity competencies. Extended expertise maintaining fulfillment with institutional, state, federal and international policies. Had extensive expertise directing regulatory assistance and observance services to the wide-ranging research mission of the organizations and leading to carry out research wrongdoing investigations in cooperation with other units and branches. Had led a large groups of professionals responsible for general research compliance oversight and problem improvement. Had created multiple portfolios to handle research regulatory and compliance training; supports, oversight for, problem solving struggles including monitoring and reports on research related activity across multiple jobs and entities.
Scientific, programmatic, and collaborative leadership: I have discovered a new disease, multiple new cell junctions and molecules. I find out the smallest epitope using several techniques such immune absorption, immunoblotting, affinity chromatography and mass spectrograph. Dr Abreu is expert in most blistering disease including those by biological agents as bioterrorism.
Over 32 years of experience designing, implementing medical., scientific and public health interventions programs, projects, and research, and establishing successful collaborations with multiple health partners, including universities, private companies, communities, patients local state, national and international partners. Extensive scientific work in multiple fields with surveillance, intervention effectiveness research, program evaluation and policy. Senior mentorship for U.S. and international doctoral, post-doctoral, medical specialization, masters, and pre-graduate students in immunology, biology, biomedical science, dentist, medicine, genetics among many other as well as Ministry of Health and program staff. Extensive experience establishing groundbreaking programs, monitoring effectiveness, and overseeing enormous expanding and contracting budgets.