Michael Imperiale is a biopharmaceutical executive with 15 years of Industry experience, holding a number of leadership positions in the Biotechnology and Pharmaceutical businesses. Leading teams in clinical development (Phases I-IV), drug safety, and medical affairs. Successful completion of 4 INDS and 2 NDAS. Proven experience with Global regulatory submissions and negotiations with the FDA, EMEA and CONEP. Medical Affairs lead on Brand Teams and Strategic Marketing Teams. Development of Target Product Profiles and life cycle management, Tactical negotiator for reimbursement and development of key opinion leaders for steering committees and advisory boards. Line management and international responsibility for branded products. In licensing opportunity review, Venture Capital negotiator for orphan product development.