i am a highly motivated, proactive and creative PhD Candidate deeply interested in combining science and business. what i thrive on is doing science-driven Drug Development by problem-solving, Troubleshooting and working as a team. as for Research, topics of interest include but are not limited to: - science-based Drug Development: utilisation of Biomarkers in early development to improve dose-setting and cpoc; - poppk, pbpk and pk/pd modelling; - Innovation in Clinical trials: new designs, dose-setting and poc-oriented by Biomarkers and systems pharmacology; - innovative solutions to replace animal model use in Drug Development; - the interface between regulatory science and Translational Medicine.
External Consultant - Global Evidence and Value Development
Since June 2016
Project Management, scientific support on strategic decisions and general tasks related to a high-priority program. Project management, scientific support on strategic decisions and general tasks related to a high-priority program.
Enabling Clinical Sciences (Clinical Pharmacology and Biomarkers Operations) InternJuly 2015 --- November 2015
retrospective analyses of dose selection (dose escalation mode, driver of selection - pk/pd or tolerability etc) of high priority programmes from merck serono. targeted literature review of Biomarkers to support companion Diagnostics development and Phase I trial designs. self-Training on phoenix winnolin® Software. supervision of jürgen scheuenpflug.
Global Evidence and Value Development InternJanuary 2015 --- August 2015
activities included vendor and Project Management, targeted Literature Reviews (Epidemiology, outcomes, diagnosis, trial designs, standard of care), regulatory intelligence and Analysis of economic models (cost-effectiveness/utility and budget impact Analysis) proposals from vendors. draft and review of requests for proposals (rfps). support in imi’s getreal project. supervision of boris pfeiffer.
Regulatory Affairs TraineeJanuary 2014 --- December 2014
elaboration of regulatory intelligence weekly journal; assessment of new projects and their regulatory Strategy in different agencies such as FDA and EMA; support in coordination of the data Verification task for global products in the regulatory information management system - rims (liquent insight®); coordination of data Verification task of local products; assessment and filling of all types of variations for Biological, new, generic and branded generics products; response to Health authority objections; daily reading and divulgation of relevant information published in the official gazette; revision and approval of final arts (pil and Packaging). supervision of renata braga and vanessa gomes.
Clinical research internJanuary 2013 --- August 2013
research over drivers for dose selection of oncology drugs approved by FDA (tolerability or pharmacodynamic considerations) during the exploratory phase of Clinical research. participation in intervision meetings discussing general matters in order to provide quality consultancy. supervision of edwin spaans.
Products Development TraineeMay 2012 --- August 2012
development and Validation (Technology transfer) of new Analytical methods for drug Analysis, including stability, dissolution, assay and impurities Testing via HPLC (both gradient and isocratic) and Spectrophotometry. supervision of fabiane lisboa.
LinkedIn Assessment :
Pharmacist in Pharmacy from Universidade Federal Fluminense in 2015
Master of Drug Innovation (MSc) in Pharmaceutics and Drug Design from Universiteit Utrecht in 2013
High School in Health from Escola Politécnica de Saúde Joaquim Venâncio/FIOCRUZ in 2008
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