John Iannone has a background in Biomedical Engineering from Boston University, where he later became a research faculty member. Since joining the Biotech/Medtech Industry 14 years ago, John has assisted multiple pharmaceutical & medical device companies with the development of their product safety evaluation strategies. Previously a Technical Specialist and Program Manager at Toxikon, he now is the Global Director of Extractables/Leachables and Impurities at Albany Molecular Research, Inc (AMRI). His areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Characterization, and attainment of Biological or Toxicological risk assessments for medical devices, pharmaceutical container systems, bioprocessing systems, and combination products. John has given numerous technical presentations and has led many workshops on Extractable & Leachable Considerations, Biocompatibility, Microbiology, and Regulatory Testing Requirements. He also participates in the development of both industry groups’ recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees, and industry collaborations. He has lead regulatory focused webinars, seminars, discussions and committees aimed at providing expert insights on the utility, limitations, and considerations of chemical characterization to support material safety evaluations. In addition to leading the AMRI E&L lab operations, his responsibilities also include providing technical consultation to clients regarding unique testing requirements in an effort for them to meet global regulatory expectations.