Barbara Valenta-Singer

Chief Medical Officer Fresenius-Kabi SwissBioSim

Previous work experience as

  • Independent Clinical Consultant Dr Barbara Valenta-Singer Consulting e.U.
  • Vice President Clinical Development Operations Shire ( Baxalta Acquisition)
  • Vice President Clinical Development and Operations Baxalta Innovations
  • Acting Head Global Clinical Development Baxter Bioscience
  • Senior Director Global Clinical Operations Baxter Bioscience
  • Medical Director Technical Assessment Due Diligence Baxter Bioscience
  • Regional Medical/Regulatory/Quality Director for Austria and CEE,Wyeth Whitehall Export
  • Trade Law Director for Wyeth Whitehall Export and Wyeth Lederle Pharma
  • Medical&/Regulatory and Pharmacovigilance Director ,Pfizer Austria
  • Medical & Regulatory and Pharmacovigilance Director,Pharmacia Austria
  • Head Medical and  Regulatory and Department SERONO, Austria
  • Fellowship – Internal and Psychiatric Ward University Hospital of Vienna
  • Research Assistant Pharmacological Institute University of Vienna, Research in CNS regulation of antihypertensive drugs
  • Assessor Austrian Regulatory Authorities (preclinical and clinical)

Member of the Austrian Drug Evaluation Committee (sick  funds/reimbursement)

  • Board of Austrian Pharmacological Society (APHAR)
  • Task force Rare Disease Europa Bio and EBE
  • Working Party Advanced Therapies
  • July 2010 -2013: permanent industry representative EUCERD (EU Commission
  • Working party for Rare Diseases

Title: Biosimilar global development: after >10years are we closer ?

  • FDA - EMA: how to explain and address different expectations for Equivalence margin, Confidence Interval, clinical endpoints, Reference products
  • Why has interchangeability still not taken up?
  • How does the practice of settlement interfere with the proposed benefits in case of interchangeability?