Expertise

Medical & clinical projects

CBD (cannabidiol)

Info sheet for consumers in three languages (English, French and German)

Oncology

Services provided to a major international pharmaceutical company as a Medical Manager, and to a contract/clinical research organization (CRO) as Clinical Project Manager:

  • Therapeutic areas:
    • Lung cancer (NSCLC & SCLC):
      • targeted therapies (angiogenesis inhibitor, EGFR+, ALK+)
      • immunotherapy (PD-L1)
    • Glioblastoma:
      • angiogenesis inhibitor
      • alternating electric field therapy
  • Management of clinical investigations in Europe and USA (including writing and review of protocols/CIP, contracts, ICF, EC application forms, IBs, MVRs, CSRs, safety narratives, investigational sites feasibility and identification, data analysis)
  • Scope of clinical studies:
    • Pharmaceuticals drugs:
      • phase II to IV trials
      • non- interventional studies/programs (NIS/NIP)
      • registries
    • Medical devices:
      • pilot to pivotal studies
  • Answer to medical queries
  • Congress reports
  • Training support, slick decks and patient educational material
  • Organisation and coordination/ of advisory boards, investigator meetings and workshops
  • Reviewing of marketing documentation (brochures, medical articles, promotional material…)
  • Newsletters

Aesthetic Dermatology

Duties as a senior clinical project manager for an international pharmaceutical company based in Austria:

  • Therapeutic area: reconstructive and aesthetic (anti-ageing) medical applications
  • Clinical development projects in Europe, USA and China (including writing and review of protocols/CIP, ICF, EC application forms, IBs, CRFs, CIRs, peer-review manuscripts, CER and data analysis)
  • Scope of medical devices studies:
    • pilot to pivotal studies
    • PMCF studies
    • investigator-initiated trials (IIT)
  • Preparation of clinical documentation for market access agencies in Europe and USA

Fundamental research

Haematology

  • Therapeutic area: anaemia (erythropoiesis)
  • 4 peer-review publications

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Translation control

  • 2 peer-review publications

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Virology

  • Therapeutic area: AIDS (inhibition of HIV replication)
  • Ph.D: ˝In vitro effect of phosphodiester and chemically modified antisense oligonucleotides on the initiation step of the HIV-1 and HIV-2 reverse transcription˝
  • 9 peer-review publications

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