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Therapeutic Areas


Indications include

  • Various oncohematology tumors/basket trials
  • Acute Myeloid Leukemia (AML)
  • Chronic Myeloid Leukemia (CML)
  • Leukemia unspecified
  • Myelofibrosis
  • Multiple Myeloma (MM)
  • NHL
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Follicular Lymphoma (FL)
  • T cell Lymphoma

Recent assignments:

  • Nonclinical and clinical gap analysis
  • Clinical trial development plan and protocol review
  • Investigational Brochure (IB) authoring and reviewing
  • TTP
  • Global regulatory roadmap planning
  • Assist in EMA Scientific Advice (SA) for
    • EMA and HTA Parallel Consultation
    • Advisory boards
    • ODD submission/resubmission
    • PIP
  • Rehearsal and preparation prior to CHMP oral explanation for a MAA
  • PreIND meeting and IND in T-cell lymphoma
  • Preparation of FDA Type B/C meetings
  • Seek Fast Track Designation (FTD)
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Other therapeutic areas