Launches

Humira (Adalimumab)

Company: Abbott

Year: 2003 – 2007

Indications: Rheumatoid arthritis, Crohn’s disease and psoriasis

Medical Affairs launch plans:

  • 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: http://www.scielo.br/pdf/rbr/v47n6/05.pdf
  • Ad Boards = 02 per indication each year
  • Medical Conferences:
      1. Med Ed booth
      2. Satellite Symposium
  • Early Access Program:
      1. Patient population: Chron’s disease
  • MSL Training Activities:
      1. Key though leaders mapping
      2. Territory Planning
      3. Round Tables at major reference centers

Simdax (Levosimendan)

Company: Abbott

Year: 2005

Indication: Heart Failure NYHA stage IV

Medical Affairs launch plans:

  • Ad Boards = 02/year
  • Medical Conferences:
      1. Med Ed booth
      2. Satellite Symposium
  • Early Access Program:
      1. Indication: HF NYHA Class IV
      2. Publication: http://www.scielo.br/pdf/abc/v90n3/en_08.pdf
  • MSL Training Activities:
      1. Key though leaders mapping
      2. Territory Planning
      3. Round Tables at major reference centers
  • Support to Regulatory and Reimbursement submissions

Replagal (alfaglusidase)

Company: Shire HGT

Year: 2008

Indication: Fabry Disease

Medical Affairs launch plans:

  • Ad Boards = 01 per year
  • Medical Conferences:
      1. Med Ed booth
      2. Satellite Symposium
  • Fabry Registry (Shire-sponsored Registry):
      1. Enrollment of Fabry patients diagnosed in Latin America
  • Other Activities:
      1. Key though leaders mapping
      2. Territory Planning
      3. Round Tables at major reference centers

Cerdelga (eliglustat)

Company: Genzyme

Year: 2014

Indication: Gaucher Disease

Medical Affairs launch plans:

  • Ad Boards = 02/year
  • Medical Conferences:
      1. Med Ed booth
      2. Satellite Symposium
  • Pricing and Reimbursement dossiers, developed with a local consultant
  • MSL Training Activities:
      1. Key though leaders mapping
      2. Territory Planning
      3. Round Tables at major reference centers
  • Support to Regulatory and Reimbursement submissions

Kalydeco and Orkambi (Ivacaftor and Ivacfator/Lumacaftor)

Company: Vertex

Year: 2018

Indication: Cystic Fibrosis, mutation-specific

Medical Affairs launch plans:

  • Ad Boards = 02/year
  • Medical Conferences:
      1. Med Ed booth
      2. Satellite Symposium
  • Nation-wide Genotyping Project:
    1. Collaborative project with local CF medical society (GBEFC) aiming to provide genetic tests to 3,000 CF patients enrolled into the National CF Registry: http://portalgbefc.org.br/wp-content/uploads/2018/10/Registro2016.pdf
    2. 02 posters presented at NACFC 2019, Denver, CO
  • MSL Training Activities:
      1. Key though leaders mapping
      2. Territory Planning
      3. Round Tables at major reference centers
  • Support to Regulatory and Reimbursement submissions