2017 Advisory Board

  • Dr. Andrew Feilden

    Chemistry Operations Director Smithers Rapra

    Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.

  • John Iannone

    Director of Extractables/Leachables & Impurities AMRI

    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.

  • Nick Morley

    Principal Scientist Hall Analytical

    Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing customers in the field of E&L, helping to define the most appropriate testing protocols to meet their needs. Hall Analytical is a contract analysis laboratory which focusses on problem solving.  We have an extensive range of chromatographic and mass spectrometric instrumentation, combined with highly experienced and skilled scientists, and have been developing methods for the analysis of extractables and leachables across a broad range of devices/systems for over 15 years.

    Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time he worked on a range of therapeutic areas including inhalation, topical and parenteral. Nick had a particular focus on biopharmaceutical and cell and gene therapy products, with responsibility for defining E&L strategies, authoring E&L regulatory sections and  interacting with regulatory agencies. Nick developed a leachable risk assessment process, aligned to ICH Q9 and Quality by Design (QbD) principles, and a sample enrichment technique which are widely used across GSK.

  • Dr Reinhard Stidl

    Lead Toxicological Risk Assessments Shire

    Reinhard Stidl is a chemist and toxicologist by training and started his career as a toxicologist at Baxter in 2007. Today he is Lead Toxicological Risk Assessments at Shire leading a group of Toxicological Risk Assessment experts.  Dr. Stidl is responsible for the safety assessment of impurities (incl. E&L), excipients, chemical modifications of APIs, as well as specification limits based on safety data for parenteral drug products for all global manufacturing sites of Shire.

  • Carsten Worsøe

    Carsten Worsøe

    Principal Scientist Extractables and Leachables Novo Nordisk

    Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.