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Dr Jonathan Janes

MB BCh BSc FFPM FRCP

 

About

Experienced Senior Medical Director with a demonstrated history of success working in the pharmaceutical industry over 28 years. Skilled in global Pharmaceutical Development, providing pharmaceutical consulting, specialising in clinical development, regulatory interactions, and asset due diligence, focusing on immunology, dermatology, endocrinology, cardiovascular and critical care.

 

Key Activities and Experience

  • Asset due diligence for acquisition and internal commercial decision

  • Phase 2 and phase 3 global study design, implementation, data interpretation and study report completion

  • Regulatory strategy including

    • Regulatory interactions with FDA, EMA and PMDA

    • Regulatory submissions

    • Regulatory responses

  • Experience with both recombinant protein and small molecule development

  • Relevant experience with product launch and commercialisation

  • Broad range of therapeutic experience including immunology, dermatology, endocrinology, cardiovascular and critical care