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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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1981 to 2006 | Country / Region: Brazil | Summary: 1981 - 1997: Expert's experience in Brazil (she has double citizenship: Brazilian and American) encompasses her MD studies, followed by 5 years of residency in cardiology and internal medicine, and 5 years of work as a physician in hospital settings after residency. 2000-2006: While working for Pfizer, she visited investigators (In their hospitals or medical centers in Sao Paulo and Rio de Janeiro), who were participating in their clinical trials. |
| Years: 2000 to 2004 | Country / Region: Argentina | Summary: While working for Pfizer, she visited investigators (In their hospitals or medical centers in Buenos Aires), who were participating in their clinical trials. |
| Years: 2002 to 2006 | Country / Region: Europe | Summary: While working for Pfizer, She either visited investigators (In their hospitals or medical centers) who were participating in their clinical trials or interacted with them by phone and in person in the US. These investigators were from: Spain, Portugal, UK, France, Germany, Italy. In 2002 she helped to put together and also presented at an Investigator's meeting help by Pfizer (Capravirine project) in Lisbon (to include investigators from Europe and South Africa) for 5 days. She also presented at the International AIDS Conferences in 2002 at Barcelona (posters) and in Vienna in 2010. She has vast experience with Italian culture, specially with Tuscany and Umbian region, as she has lived there for 2 months in 2006; she still has friends who live in the area, to include writer Ingrid Henzler who lives in Assisi, Italy and whose last book she reviewed prior to its publication. She has also visited Italy quite often until recently in 2010. |
| Years: 2004 to 2004 | Country / Region: Thailand | Summary: While working for Pfizer: She attended the International AIDS Conference in Bangkok and also participated of all Pfizer executive activities that happened during the conference. - She also visited the Pfizer facilities in Bangkok with her US colleague, as they were seeking for support and information for prospective clinical trials to be conducted in that country. |
| Years: 2001 to 2005 | Country / Region: South Africa | Summary: While working for Pfizer, Expert worked for large Phase II and Phase III studies that had several sites and investigators in South Africa. Although she has never been in Africa, she had extensive contact with those investigators who were participating in their trials either by phone or in person during meetings in Europe, Thailand and in the USA. |
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). |
| Professional Appointments |
|---|
| Board member of the board of directors at a non-profit that deals with women and families affected by HIV/AIDS. Teacher at a non-profit religious church in Encinitas, CA. Editor reviewer for the last book of writer Tom Crocket; Editorial review: Cercatori di Dio - La vita die francescani oggi by Ingrid Henzler (proficient in written Italian), 2006. TED translator. |
| Medical / Professional |
|---|
| Residency in Internal Medicine and Cardiology; Several trainings, seminars, workshops in Clinical trials and drug development in the last 10 yrs. |
| Publications and Patents Summary |
|---|
| She has 17 papers presented in conferences. |
Additional Experience
| Training / Seminars |
|---|
| Expert developed a pilot education initiative to raise awareness on HIV/AIDS transmission and treatment for youngsters; this project was launched at the XVIII International AIDS Society Conference in Vienna in 2010. She collaborated with the development and teaching of the education program at Shakti Rising, a non-profit organization in San Diego, who deals with social and public health issues related to young women. At SMOC, in Framinham, MA, she collaborated with the development of a public health service to benefit victims of domestic violence. In Brazil, she developed several small work groups for patients who were attended in hospitals, in the areas of: cardiac diseases prevention, breastfeeding, nutrition. |
| Vendor Selection |
|---|
| For over 10 years (until the present date) she has worked in direct association with clinical operations in all US based companies she has worked for. Her collaborations with them have been to help to select vendors to support the implementation of clinical trials: laboratories, clinical sites, devices that are used in the trials, vendors related to services such as electronic data collection, specimen shipping companies, marketing companies, manufacturing companies. She has also helped and reached out for investigators who participate in these trials. |
| Marketing Experience |
|---|
| She has expertise on: Multiple complex trials management Safety and efficacy review Regulatory and clinical strategies Medical Monitoring Clinical development plan Worldwide interface Communication with investigators Implementation of clinical trials The development of educational programs Community-based outreach programs Epidemiology applied to industry |
| Other Relevant Experience |
|---|
| She is a member of the American Translator's Association: she is a translator from English to Portuguese (very helpful when reviewing industry documents); she can also read Spanish, so she has helped with the review of Spanish documents after they have been translated by a 3rd party. Having a degree in Public Health (MPH), She has helped with epidemiological research applied to industry. For example: In 2001, the drug development project she was working on at Pfizer was put on hold by the FDA. Among other required assessments, she helped to prepare an epidemiological evaluation showing that the data did not indicate any additional safety concern - The outcome of this epidemiological assessment was presented at International AIDS conferences in 2002. |
Language Skills
| Language | Proficiency |
|---|---|
| Portuguese | She is a native Portuguese speaker (Brazil); she was raised and educated in Brazil. She had all her school studies up to MD studies and residency, she only immigrated to the US in 1997 |
| Spanish | She can read Spanish well. Sometimes this skill has been used when visiting Spanish-speaking countries and when reviewing Industry documents in Spanish after being translated (to check for their accuracy);she has a proficient understanding of spoken Spanish |
| Italian | She has a beginner to intermediate knowledge of Italian, specially reading skills. she has studied Italian for over a year at Miracosta College in San Diego, CA. |
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