Services

LEOconsulting supports biotech and major pharmaceutical companies in early-stage drug development from discovery to phases I through III. The firm’s focus is clinical development, translational research support, biomarker development, portfolio analysis and investor relations. LEOconsulting has in-depth and hands-on therapeutics development expertise in hematology, medical oncology, autoimmune diseases, rheumatology, ophthalmology and related clinical fields.

Select services at a glance:

Clinical Development

  • De-novo clinical development plan conceptualization and generation
  • Optimization of existing clinical development plans
  • Clinical trial design and study protocol generation
  • Clinical trial support (medical monitoring, safety physician tasks, investigator meetings)
  • Key opinion leader (KOL) selection and relations
  • Advisory board set-up and management
  • All medical director and chief medical officer functions (interim/midterm/longterm)

Compound Portfolio Review and Build-up

  • Compound analyses
  • Portfolio reviews and assessments
  • Inlicencing activity support (candidate selection, due diligences, data reviews, pipeline analyses)

Biomarkers

  • Full translational research support
  • Advise on (potential) need for biomarkers
  • Building biomarker evaluation programs
  • “Companion diagnostic” program conceptualization and support

Preclinical/Discovery Phase

  • Advise on optimal preclinical models
  • Preclinical data review and analysis
  • Adjusting preclinical programs to optimally serve clinical needs
  • Evaluating discovery stage opportunities regarding clinical value and viability

Regulatory Authorities

  • Company medical and strategic representation for all agency meetings (FDA/EMA)
  • IND/IMPD support
  • Scientific advice support

Medical Affairs

  • Compound positioning assessment and strategy
  • Market access strategies (publication streaming, messaging, positioning)

Investor Relations

  • Compound pipeline/platform review
  • Compound valuation
  • Development plan review
  • Investment opportunity advice
  • Inlicencing support
  • Development capability reviews
  • Biotech staff hiring/selection support

Networking

  • Set-up of “virtual development” teams
  • Set-up of full development departments
  • Selection of regulatory, clinical operations, manufacturing/CMC, biomarker and other specialists related to clinical development