Expert Details
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
ID: 729771
California, USA
Her work includes:
* Extensive experience for over 10 years in drug development: Clinical and medical monitoring, safety assessment, the writing of INDs and supplementary NDA; the development of clinical protocols and clinical development plan design and implementation, study safety reports writing for biotech/pharmaceutical industries, site selection, experienced with building relationships with investigators and health centers during clinical trials management in the US and internationally. She is knowledgeable of epidemiology applied to pharmaceutical industry for risk assessment. Adept at collaborating with various multi-departmental and cultural groups.
* In biotech and pharmaceutical companies: Skilled in drug development Phase I - IV in various therapeutic areas including: AIDS, Flu, CMV and cardiology.
* Substantial experience in HIV/AIDS research and epidemiology: At Pfizer, Expert worked for 6 1/2 years as clinical lead and medical monitor in clinical trials Phase I-III, for the development of a protease inhibitor and a non-nucleoside reverse transcriptor inhibitor. She also collaborated with a Phase IV program and marketing research.
Currently Expert is a board member at a San Diego based non-profit organization that gives support to women and families affected by HIV/AIDS.
Also, in 2010, Expert launched a pilot educational initiative at the XVIII International AIDS Conference in Vienna. During the conference Expert shared a space with a non-profit organization from Amsterdam where she could not only present her program but also support other similar initiatives. This educational activity is being developed to raise awareness on HIV/AIDS transmission and prevention among young audiences.
* Experience with biologics clinical trials: Expert is currently working for a biotech company where sIgA is isolated from breast milk and whose immune properties are being studied for the prevention of serious diseases in premature babies and potential use in adults with selected cancers.
* Experience with vaccine development: For almost 2 years, Expert worked for a San Diego based company, Vical, as a clinical lead and medical monitor for the development of Flu and CMV DNA vaccines.
* Experience with Safety assessment, immunology principles, clinical medicine: Expert has a combined experience of over 20 years in clinical medicine and diagnosis due to her experience in hospitals as a provider and as a clinical researcher/medical monitor in industry. Immunology knowledge has been applied and further developed during her work in HIV/AIDS research, vaccine development and current work with the isolation of immunoglobulins.
Expertise includes:
- Multiple complex trials management
- Communication skills with international & domestic stakeholders
- Outreach capacity
- Medical monitoring
- Safety & efficacy data review
- Strategic planning
- Clinical development plan & general project strategy in drug development
- Worldwide interface
- Operational and team player skills
- Leadership skills
- Development of clinical programs in multiple therapeutic areas at hospital settings
- Educational program development in the areas of health, women & family issues
- Clinical project leadership & strategic planning in clinical trials
Since 2009, Expert has consulted for a biotech located in Southern California. She has consulted in the capacity of medical director and helped to build the clinical group in this start-up company. In 2009 she collaborated with the educational program of a non-profit based in San Diego, called Shakti Rising. Since 2010, Expert has collaborated as a board member and HIV/AIDS expert to a non-profit based in San Diego.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2006 | Degree: MBA | Subject: MBA - Health Care Executive Management | Institution: University of California, Irvine |
| Year: 1999 | Degree: MPH | Subject: Public Health - Major: International Health | Institution: Harvard School of Public Health |
| Year: 2000 | Degree: Professional Certificate Program | Subject: Clinical Trials Design and Management | Institution: University of California, San Diego, CA |
| Year: 1987 | Degree: MD | Subject: Medicine | Institution: University of Brasilia (Universidade de Brasilia) ; Brasilia, Brazil |
| Year: 1992 | Degree: Residency certificates | Subject: Cardiology and Internal Medicine | Institution: Hospital de Base de Brasilia, Brasilia, DF |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2009 to Present | Employer: Undisclosed | Title: Medical director | Department: Clinical Development Dept |
Responsibilities:To help with the implementation of the new clinical development group, and with the writing/execution of the new clinical development plan. The company is a start-up biotech specialized in the isolation of secretory IgA from breast milk for the prevention and treatment of necrotising enterocolitis (NEC) |
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| Years | Employer | Title | Department |
| Years: 2008 to 2008 | Employer: Arena | Title: Medical Director | Department: |
Responsibilities:• Medical lead for the cardiovascular program/Collaborator for the obesity program.• Participated in the re-evaluation of priorities for cardiovascular program by providing and presenting data from which senior management was able to make better business decision. • Redesigned Phase IIa coronary disease study for discussion with advisors to evaluate feasibility of the cardiovascular program. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2008 | Employer: Vical, Inc | Title: Director, clinical research | Department: |
Responsibilities:• Medical monitor and manager of early development projects for the development of a pDNA vaccine.• Worked as the primary medical monitor for the Pandemic Influenza program (flu) resulting in successful management of sites and efficient data collection. • Conceived and implemented safety monitoring plan for Flu studies which addressed FDA requirements and concerns. • Acted as the medical monitor for the CMV program (bone marrow transplant population). • Co-authored two IND regulatory submissions: CMV-EP (electroporation) project and flu program. • Collaborated in the writing of Clinical Study Reports for CMV, Anthrax and West Nile Virus programs in addition to helping with the preparation of annual reports and other seasonal reports. • Contributed with discussion and research to the immunology aspects related to pDNA vaccine development which helped with protocol design and data interpretation. • Coordinated activities with the operational and the biostatistician groups resulting in productive communication across groups and diligent group management. • Interaction with the FDA to discuss the clinical development plan and safety concerns as needed. • Mentored direct reports: two project managers and a clinical research coordinator. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2006 | Employer: Pfizer, Inc | Title: Associate Medical Director | Department: Clinical Development |
Responsibilities:• Clinical project lead, medical monitor and safety and efficacy data reviewer in various HIV studies.• Led early stage development of a Protease Inhibitor program (main compound and two backups) including the preparation of clinical development plan and protocols design. • Worked as the primary medical monitor and safety data reviewer in a worldwide phase IIb/III Clinical Trial where Capravirine (CPV) was evaluated in 200 HIV+ patients naïve to treatment. • Collaborated as Medical Monitor and safety data reviewer in a worldwide Phase IIb/III Clinical trial in the CPV Project involving 300 HIV+ patients that had failed a second anti-retroviral therapy. • Acted as the Medical Monitor in approximately 10 small Pharmacokinetic studies including drug-drug interaction, bioequivalence and bioavailability studies to support the late stage studies. • Participated in QT studies for risk assessment of QT prolongation in various in-house projects which helped to rule out potential cardiovascular risks in the capravirine project. • Collaborated with NDA submissions: as a Safety data reviewer for an Oncology NDA filing (Sutent) and for s-NDA for Viracept 625mg tablet. • Collaborated actively with medical affairs for marketing strategy, marketing research, preparation of label and insert package, clarification of safety parameters, and other activities as needed • Interaction with the FDA as needed. • Team member of the clinical development group involved with the implementation of clinical trials. • Assisted with the preparation of clinical development plans, protocol design, safety reports, laboratory and site selection, budget discussions and case report forms design. • Supported a Phase III Cardiovascular project to evaluate Zithromax in the prevention of the development of plaques of atherosclerosis. • Collaborated with the elaboration, implementation and data review of a clinical monitoring plan and epidemiological assessment of the risk of vasculitis, in the capravirine project, which resulted in the successful lift of a partial clinical hold imposed by the FDA to the project in 2001. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1999 | Employer: Several Hospital settings in Brazil and Public health sector in Massachusetts | Title: Physician and public health educator - | Department: |
Responsibilities:• Held progressively responsible clinical positions as a physician in hospital settings and private office in internal medicine and cardiology areas in the city of Brasilia, Brazil.• Concomitant responsibility as a clinical leader in public health programs at the hospital in the areas of breastfeeding, cardiovascular disease prevention, diabetes management and prevention. • Collaborated with a public health program at SMOC in Framingham, MA while attending a MPH program (97-99) • Domestic and international experience as a researcher and/or consultant in various academic or public health sectors: |
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Career Accomplishments
| Associations / Societies |
|---|
| American Public Health Association International AIDS Society International Association of Physicians in AIDS care University of California, Irvine, Alumni Association Harvard School of Public Health Alumni Association American Translator's Association |
| Licenses / Certifications |
|---|
| Clinical Trials Design and Management Professional Certification; Board certified in Brazil (MD). |
| Publications and Patents Summary |
|---|
| She has 17 papers presented in conferences. |
Fields of Expertise
AIDS, biologic (product), clinical protocol, clinical research, clinical research management, clinical study, clinical trial, clinical trial design, clinical trial documents generation, disease, drug, drug clinical trial, drug development, Drug Information Association, drug safety testing, drug screening, Food and Drug Administration, Good Clinical Practice, investigational drug procedures, medical lexicon, medical record, integrated medicine, medication risk assessment survey, clinical diagnostics, biocompatibility testing, Current Good Manufacturing Practice, urinalysis, drug validation, medical laboratory, immunosuppression, medical device clinical research, infection prevention, disease control, clinical virology, medical diagnosis, autoimmune disease, medical diagnostics, documentation process, clinical immunology, internal medicine, immunology, clinical medicine, cardiovascular system, cardiology, blood, biostatistics, antibody