Co-founder and Vice President, Clinical Research Dr. Ortega brings to INTRIALS, more than 25 years experience in clinical research. His areas of expertise include Oncology, Dermatology, Epilepsy, Cardiovascular, Antibiotics and Women’s Health.

Dr. Ortega has dedicated his career to the clinical research, which started 30 years ago when he conducted a phase IV study with the oral anti-diabetic compound dibenclamide (Daonil). During 1974 and 1975, he was a post-graduate fellow at the New York State University in Syracuse, when he wrote the chapter Mucopolissacaridoses in the textbook “Endocrine and Genetic Diseases of Childhood and Adolescence”, edited by Lytt Gardner. During the 80’s while Medical Assistant at Merrell-DOW, Dr. Ortega coordinated in Brazil several investigations with colestiramine and probucol, both anti-lipemic substances.

As the Medical Director of Schering Brazil, Dr. Ortega structured the clinical research department and brought to the country a number of phase III trials in oral hormonal and injectable contraception, HRT and hiperandrogenicity (hirsutism) with anti-androgen therapy. In 1988 Dr. Ortega jointed PRI RWJ (J & J) in Zurich as Clinical Research Director, with responsibilities in Europe for phase III trials in dermatology and CNS. In 1995, when he returned to Brazil, Dr. Ortega became COVANCE representative in the country, and managed anti-infective studies in Brazil for one of the top 5 global pharmaceutical companies until 1999, when he founded INTRIALS with two other partners. 

At INTRIALS, Dr. Ortega is responsible for planning, directing and supervising clinical research programs, as well as providing consultation for potential safety issues or medical concerns related to the clinical trials. 

Dr. Ortega has a medical degree from Escola de Medicina da Santa Casa de São Paulo, Brazil and a post-graduate degree in Genetics and Endocrinology at New York State University, Syracuse, NY. He is the author of the textbook “Genética Médica” published in Portuguese for Brazilian medical students, and wrote several articles on clinical genetics published in indexed magazines.

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Sergio Lopes, PharmD – Vice President, Regulatory Affairs 

Co-founder and Vice President, Regulatory Affairs, Dr. Lopes brings to INTRIALS, more than 25 years experience in all key areas of product development and marketing with ethical and OTC products, nutritionals and medical devices, having planned, directed and supervised studies in a number of therapeutic areas such as Anti-infectives, Cardiovascular, CNS, Dermatology, Hematology, Infectious Diseases, Ophthalmology, Urology, Oncology, Respiratory, Rheumatology and Vaccines. Prior to founding INTRIALS, Dr. Lopes was General Manager of Bristol-Myers Squibb, Peru, and Marketing Director of Bristol-Myers Squibb, Brazil. His in-depth knowledge of the health care and regulatory environment in Brazil are key contributions to INTRIALS’ successful track record in obtaining quick regulatory approvals and record time in import clinical supplies.

At INTRIALS Dr. Lopes is responsible for all Regulatory Affairs and Drug Supply processes. 

Dr. Lopes received a Degree in Pharmacy and Biochemistry from USP – Universidade de São Paulo, Brazil, a PharmD in Industrial Biochemisty and Pharmacy also from USP – Universidade de São Paulo, Brazil, and have attended several Clinical Research courses and meetings.

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Gizele Thame, BMD, PhD - Vice President, Corporate Development & Administration 

Co-founder and Vice President, Corporate Development & Administration, Dr. Thame brings to INTRIALS 10 years experience in basic research and significant educational background. This expertise supported her to develop the 23 courses in Clinical Research at the INTRIALS Continuing Education Program. These courses had contributed to the outstanding professional level of INTRIALS’ staff. Prior to co-founding INTRIALS, Dr. Thame held several positions as researcher of Sao Paulo State Government. She also held management positions in administration and finance at family-owned businesses, and was Member of the Scientific Commission of Adolfo Lutz Institute, São Paulo, Brazil.

At INTRIALS, Dr. Thame is responsible for Finance and Administration. Her activities also encompass the HR and Personnel Development areas.

Dr. Thame received her Bachelor Degree in Biomedical Science from Universidade Metodista de Piracicaba, Brazil, her Masters Degree in Public Health from USP - Universidade de São Paulo, Brazil, and her PhD in Public Health from USP - Universidade de São Paulo, Brazil. Dr. Thame had 5 papers published on prestigious indexed publications as first author. She has also participated in the “Clinical Research Audit” training program according to FDA rules in Pennsylvania, USA.

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