Services

/Services
Services 2018-04-27T20:32:18+00:00

Translational Medicine

  • Develop translational medicine strategy that includes relevant preclinical disease and safety models, biomarker identification and selection, and precision medicine strategies that can form the basis for a pre-IND meeting with the FDA
  • Design and execute clinical first-in-human, proof-of-principle and proof-of-concept studies, including writing protocols, CRO selection and management, and medical safety monitoring
  • Identify, recruit and manage KOLs and scientific advisory board meetings
  • Therapeutic areas: regenerative medicine, neurology/neurodegeneration, cardiovascular disease, immunology, hematology and oncology
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Clinical Pharmacology

  • Design project clinical pharmacology plan based on latest FDA and ICH guidances
  • Design and execute CP studies, including protocol generation for:
    • PK/PD and dose identification
    • Thorough QTc/ECG
    • Food-effect
    • Drug-drug interactions
    • Pharmacogenetics (e.g., CYP P450 genotypes: EM, PM, UM)
    • Special patient populations (e.g., renal impairment, hepatic impairment)
  • Identification, selection and management of Phase I CRO’s
  • Serve as medical safety monitor for CP studies
Our approach

Clinical And Regulatory Affairs Strategy

  • Preparation of clinical and regulatory affairs strategy documents including study protocols, Investigators’ Brochure,  FDA meeting packages (e.g., pre-IND, EOP2), INDs and IND updates, and European CTAs
  • Prepare for and participate in meetings with regulatory agencies (US & EU)
  • Target product profile (TPP) preparation and updating
  • Generate product development plans (PDP)
  • KOL identification, selection and management, and organize KOL advisory board meetings
  • Prepare an overall project regulatory strategy based on region-specific regulatory guidances and guidelines
  • Review and analyze biotechnology company portfolio/assets and intellectual property in order to prioritize and allocate resources for development based on PTS
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