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CURRICULUM VITAE

PAOLA TAPIA, BSc, CCRA

Clinical Research Expertise in the following Therapeutic Areas Gastroenterology Pregnancy Rheumatoid Arthritis Hematology Endocrinal Metabolic Diseases Oncology Infectology (AIDS, Respiratory diseases, Pediatric Diarrhea) Cardiology EDUCATION Secondary school: Bachelor Colegio Nacional de Buenos Aires - Universidad de Buenos Aires, Buenos Aires, Argentina, Graduate Studies: Biologist Facultad de Ciencias Exactas y Naturales Universidad de Buenos Aires, Buenos Aires, Argentina Post-Graduate Studies: Clinical Research Associate. Facultad de Biología - Universidad Bar Ilan, Buenos Aires, Argentina ADDITIONAL EDUCATIONAL DETAILS Languages: English - Reads, Speaks, Writes. Level 11 (11 of 15), continue studying. Language Lab Certification of University of Buenos Aires. French - Reads Computer Skills: Microsoft Office

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SEMINARS/COURSE WORK: 2015. ACRP Annual Meeting at Salt Lake City, Utah, US. 2013. ISO 14155 versus ICH GCP Training at B&A. 2013. Useful Genetics. University of British Columbia. Center for Teaching and Learning Technologies. 2013. Professional Communications in English. Languages Lab. University of Buenos Aires. 2013. GCP Refresher Training and Test at B&A. 2012. Institute Curie – Institute Leloir Collaboration Workshop about Biobanks 2011. Argentine Regulations in Clinical Research. Internal B&A Training. 2011. Investigator Responsibilities as per ICH GCP. Internal. 2010. DIA 46th Annual Meeting in Washington DC, US. 2010. Actualization in Clinical Research Regulations- CAOIC- Buenos Aires- Argentina 2010. Seminar on New regulation of Clinical Research in the City of Bs As. 2007. Certified CRA by ACRP (Association of Clinical Research Professionals) 2006. Administration and Management of Investigational Sites. March – April. FEFyM. Buenos Aires. Argentina 2005. CRAs training. Omnicare Clinical Research. Buenos Aires. Argentina. 2004. CRAs training. Omnicare Clinical Research. King of Prussia. Philadelphia. U.S.A. 2004. Training for trainers. Improve of Communications skills. Aventis Pharma. Sao Paulo. Brazil. 2003. Clinical Research and Medicine based on Evidence. Duration: April- December. Sociedad Argentina de Gastroenterología/ Sociedad Argentina de Hematología. 2002. Clinical Development SOPs Training. July 17, 18 and 19. Aventis Pharma. Argentina. 2001. Workshop on new SOPs for Aventis Pharma. Argentina. 2000. Workshop on Intensive treatment for Type 1 and 2 Diabetes. Aventis Pharma. Argentina. 2000. Workshop on Medicine based on Evidence. Duration 2 days. Aventis Pharma. Argentina. 1999. Good Clinical Practices Training Course. HMR. Argentina. 1998. First Latin American Clinical Development Training Seminar. HMR Argentina

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PROFESSIONAL EXPERIENCE

SLACOM (Sociedad Latinoamericana y del Caribe de Oncología Médica). August 2016 and continues today

Lead Clinical Research Associate Responsibilities include:

o Coordination of activities related to clinical trials, conduct meetings with CRA relating progress of the study, and attend study related teleconferences as needed.

o Ensure that the contracted services are fulfilled according to Protocol, compliance with SLACOM requirements

o Relationship with Regulatory Agency and Ethics Committee o Senior Clinical Research Trainer o Mentor less experienced personnel of SLACOM and research sites

Blanchard & Asociados (CRO, member of AICROS). July 2006 and continues today • Project Manager/ Lead Clinical Research Associate Responsibilities include:

o Coordination of activities related to clinical trials, conduct meetings with CRA relating progress of the study, and attend study related teleconferences as needed.

o Ensure that the contracted services are fulfilled according to Protocol, compliance with Monitoring Plan, Safety Plan and Communication Plan.

o Link between client and B&A o GCP Audits and other Clinical Research related services (Training,

Project management, monitoring, etc) o Relationship with Regulatory Agencies o Senior Clinical Research Trainer o Mentor less experienced CRAs

Fundación Dra. Cecilia Grierson. July 2006 and continues today

Senior Clinical Research Trainer

Universidad de Buenos Aires, Facultad de Medicina. 2014-2016

Teacher at Graduate Update Program, Postgraduate Course in Clinical Research

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Buenos Aires City Parliament. September 2008-December 2009

Coauthor of Law for Conduction of Clinical Trials in the city hospitals. Patient rights protection (voted by the parliament as Best project in 2010)

Omnicare Clinical Research, Buenos Aires, Argentina 2004-2006

Senior Clinical Research Associate Responsibilities include:

o Identification of potential investigational sites o Coordinates and performs comprehensive site management o Conduct of pre-study, initiation, interim and close out monitoring

visits o Produces comprehensive visit reports and status reports o Resolves data issues and audit issues o Adherence to the study timelines and budget o Mentors less experienced CRAs o Within International - when applicable, the collection of high quality

critical documents and completion of ethics committee and regulatory submissions in association with Investigator Services.

Aventis Pharma, San Isidro, Buenos Aires, Argentina 2000- 2004

Senior Clinical Research Associate Responsibilities included:

o Collection and submission of regulatory documents to MoH/IEC as applicable

o Conduct pre-study, initiation, interim and close-out visits o Conduct Study Investigator’s Meetings o Produce comprehensive visit reports and status reports o Perform site management o Ensure adherence to study timelines and budget o Resolve data issues o Resolve audit issues o Maintenance of Study Wide File up to final archive o Training of Junior CRAs/New hired employees

Hoescht Marion Roussel, Buenos Aires, Argentina 1997- 2000

Junior Clinical Research Associate Responsibilities included:

o Conduct initiation, interim and close-out visits o Produce comprehensive visit reports and status reports o Resolve data issues o Accomplish study timelines o Perform site management o Maintenance of Study Wide File up to final archive

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Laboratorios König, Buenos Aires, Argentina 1995- 1997

Regulatory Affairs Assistant Responsibilities included:

o New Drug Application for Veterinary Products (include field assays) o Collection and submission of documents to Regulatory Authorities

THERAPEUTIC EXPERIENCE Therapeutic Categories Specialized Area(s) Phase(s) Role(s)/Year(s) of Experience

Treatment for metastasic Breast Cancer (Capecitabine in 2 different administration schemes). Lead CRA. SLACOM. 2016 ongoing.

Treatment for Acute and Long Term Recovery from Childhood Diarrheal Disease with Nutritional Product. Lead CRA. 2015-2016.

Treatment for Preeclampsia Prevention. Phase III. Project Management/Lead CRA. 2012-2016

Treatment for Primary Biliary Cirrhosis. Phase III. Project Management/ Regional Lead CRA. 2014-2016

Breast Cancer. CTN Translational Project involving Bio banks. GCP Audits. 2011 - 2014.

Acute Lung Injure. ARDS. In-patients requiring mechanical ventilation treated with surfactant protein C (recombinant protein).Phase IIB IIIA. Lead Clinical Research Associate. 2004-2006

Cardiovascular DVT Phase IIIB Clinical Research Associate: 2003

Endocrinology and Metabolism Diabetes Mellitus - Insulin Dependent Phase III - Clinical Research Associate: 2001-2003 - Data Entry: 2000-2002

Musculoskeletal. Rheumatoid Arthritis Phase IIIB. Clinical Research Associate: 2000 - 2002

Respiratory Disorders Asthma Phase IV Clinical Research Associate: 1997-1998

Respiratory Disorders Bronchitis - Chronic Phase III Clinical Research Associate: 1998-1999

Musculoskeletal. Rheumatoid Arthritis Phase II. Local Project Manager. 1999-2000.