Achievements

ROLES, RESPONSIBILITIES AND ACHIEVEMENTS

Description of major achievements

Abbott

Head of Medical Affairs, Brazil
2003-2007

 

Major Activities:

Humira Launch Preparation: building and development of a Medical Affairs team: 08 medical managers; 03 MM for each Humira indication and 02 MSLs for RA (before 2003, there were only 04 MM).

Interaction with Peers:
  • Development of Medical Affairs Plans in alignment with Marketing/Commercial Plans;
  • Discussions with Humira’s Global Development Team to place clinical trials in Brazil (Crohn’s disease).

Achievements:
  • National TB Guidelines: development of a TB screening protocol in collaboration with Brazilian Rheumatology Society. The aim was to prevent reactivation of latent tuberculosis in patients who are candidates to receive anti-TNF drugs: Click Here;
  • Successful Humira launch for 02 indications: Rheumatoid Arthritis, Psorisis and Crohn’s disease;
  • TB guidelines were used by other affiliates in countries with high TB prevalence.

 

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Genzyme

Head of Clinical Operations, Latin America
2009-2012

 

Major Activities:

 Leadership of re-structuring of Genzyme’s Clinical Operations Area, building and developing a multicultural, multifunctional, multidisciplinary regional team: from 12 to 40 HCs, based in BR, ARG, CHI, COL and MEX.

Interaction with Peers:
  • Management of 03 Global/Regional CROs: Quintiles, PPD and Intrials;
  • Discussions with Global Clinical Teams (Rare Diseases, Multiple Sclerosis and Onclo-Hematology) to place clinical trial in the region).

Achievements:
  • Management of 15 Phase 2 -4 clinical trials at regional level, with a budget over USD 15 M/year;
  • Latin America countries had top enrolling clinical research sites;
  • Implementation of an innovative inspection-readiness program;
  • 03 FDA inspections with no major findings for the Eliglustat program in BR and ARG sites;
  • BR and ARG had top enrolling sites in all Rare Disease clinical trials.

 

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Vertex

Head of Medical Affairs, Latin America
2015-2019

 

Major Activities:

 First employee to join Vertex in Latin America, building the Medical Affairs organization: 04 MSLs, 01 project coordinator and 01 assistant.

Interaction with Peers:
  • Interaction with country manager to hire other colleagues;
  • Support to implement Vertex as a company to comply with local regulations and laws: SP office, Warehouse and Quality Control Lab;
  • Development of Medical Affairs Plans in alignment with Marketing/Commercial Plans;
  • Collaboration with CF Medical Society in CMEs and other projects.

Achievements:
  • Mapping all 48 Cystic Fibrosis Reference Centers in Brazil and CF Centers in ARG, CHI, COL and MEX;
  • Mapping 150 thought leaders who are CF Experts with Tier Ranking and Engagement Plans;
  • Collaborative project with local CF medical society (GBEFC) aiming to provide genetic tests to 3,000 CF patients enrolled into the National CF Registry, 02 posters presented at NACFC 2019, Denver, CO. This project was used to calculate the size of the market/eligibility and was the basis for the 5-year budget impact model to be submitted to CONITEC;
  • 02 products approved (Kalydeco and Orkambi in BR and COL); 01 product, SYM, submitted to ANVISA.

Collaboration with Marketing & Market Access departments
in the product pipeline pre-launch, launch and post launch commitments

Abbott

Project:

Support to regulatory and reimbursement submission

Product:

 Simdax (levosimendan)

Description:

 The Brazilian Evaluation of Levosimendan Infusion Efficacy (BELIEF) study was prospective, multicenter, and observational and included 182 high-risk DHF patients and 10 HF Centers levosimendan. This HEOR data were collected as well.

Interaction with Peers:
  • Market Access and HEOR team;
  • Coordination with a local HEOR vendor to analyze economic data collected from this study.

Achievements:

 

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Abbott

Project:

Collaboration study with Marketing team in order to create awareness of primary hypothyroidism.

Product:

 Synthroid (levothyroxine)

Description:

 Epidemiology study conducted in Rio de Janeiro city: 1,500 households visited.

Interaction with Peers:
  • Collaboration with Dep. of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro and IBGE.

Achievements:

 

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Genzyme

Project:

Support to Pricing and Reimbursement dossiers, developed by a local.

Product:

 Cerdelga (eliglusat)

Description:

 Support to a local vendor in the adaptation and validation of Core Value Dossier.

Interaction with Peers:
  • Market Access;
  • Local HEOR vendor.

Achievements:
  • CMED dossier.

 

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Vertex

Project:

Brazil CFTR Sequencing Project:
A Collaborative Research Project between Vertex and the Brazilian CF Registry, the largest genotyping project ever done in CF.

Product:

 Kalydeco
Orkambi
Symdeco
Trikafta

Description:

 Mapping of 3,000 CF patients enrolled in the Brazilian CF Registry. As all CFTR modulators are mutation-specific, it is important to genotype all patients using Next Generation Sequencing (NGS).

Interaction with Peers:
  • Collaboration with Brazilian Cystic Fibrosis Registry and Brazilian CF Medical Society (GBEFC): http://portalgbefc.org.br/;
  • Collaboration with a local vendor , Mendelics Lab in SP, specialized in NGS.

Achievements:
  • Identification of 131 novel variants, mainly prevalent in the Brazilian CF patient population. The next step is to check pathogenicity and responsiveness of these novel variants before we have a discussion with ANVISA;
  • Identification of 2,231 patients eligible for 04 drugs, used in Vertex’s LRP;
  • Results of this project was used to elaborate the 5-year budget impact model, which will be submitted in November 2019 to CONITEC;
  • Publication: manuscript under preparation;
  • 02 Posters presented at NACFC 2018 in Denver, CO: https://www.nacfconference.org/Submissions/Abstracts/

 

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Interaction with health technology assessment agencies

Vertex

Product:

 Kalydeco (ivacaftor) Orkambi (Luma/ivacaftor)

Symdeco (teza/Ivacaftor)

Description:

 Development of CMED and CONITEC dossier Development of CMED and CONITEC dossier Development of CMED dossier

Interaction with Peers:
  • Global market Access team.
  • Local vendor (Sense and IQVIA);

Achievements:
  • Meeting with CMED to present clinical development program in Feb 2019;
  • Category I was granted;
  • 04 meetings with head of SCTIE and CONITEC to propose a portfolio deal agreement (Mar-Aug 2019).
  • Meeting with CMED to present clinical development program in Feb 2019;
  • Category I was granted;
  • 04 meetings with head of SCTIE and CONITEC to propose a portfolio deal agreement (Mar-Aug 2019).
  • As there are some overlap indications with previous approved products (KLD and OKB), I worked with global MA team to develop some scientific arguments (inter trials comparison, coverage of a new CF patient population in order to get Category I for SYM;
  • Product is under regulatory assessment by ANVISA, market authorization is expected to be granted by end of Q4 2019.