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Watch all the presentations from The Ever-Changing World of Extractables & Leachables Part 3: Lessons Learned & Future Challenges.

This event originally ran on October 4th 2021 but you can find all the videos below.  We gathered global industry and regulatory experts to discuss E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices.

Extractables and leachables is an important area in the production of medical devices and medicinal products. In this COVID-19 world, there are urgent testing requirements for new ventilators and for delivery devices for vaccines.  This conference will give you an insight into this ever-changing world of E&L.

Presentations include:

  • ISO 10993-18: Establishing an AET for Chemical Characterization of Medical Devices – Ted Heise, PhD, RAC; MED Institute
  • E&L in biological combination products – Alicja Sobańtka, PhD; Material Qualification, Octapharma
  • Managing change in this ever-changing world – Nick Morley,
    Principal Scientist, Hall Analytical.
  • Strategies to overcome challenges in extractable screening studies – Rachel Sanig, Senior Scientist, Waters
  • What is the Future of Leachables and Extractables Assessment? – Dan Norwood, Principal Consultant, Feinberg Norwood & Associates Pharma Consulting
  • What next for E&L?- Data, Information, Knowledge to Wisdom – Jason Creasey, Managing Director, Maven E&L

At the bottom, you will also find an in-depth panel discussion where all speakers address questions that were asked during the live event. If you have any questions or want to find out more about E&L testing, then get in touch.

Ted Heise, PhD, RAC – MED Institute
“ISO 10993-18: Establishing an AET for Chemical Characterization of Medical Devices”

Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute.  In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.

Alicja Sobańtka, PhD – Material Qualification, Octapharma
“E&L in Biological Combination Products”

Alicja is currently employed at the Octapharma where she is responsible for material qualification at the corporate level including chemical safety assessment of polymeric processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.

Nick Morley, Principal Scientist – Hall Analytical
“Managing Change in this Ever-Changing World”

Nick has over 12 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. He is responsible for providing technical/consultative support to new and existing customers in the field of E&L. Experience working on a range of products including pharmaceutical/biopharmaceutical (inhalation, topical and parenteral), medical device and nicotine delivery systems. Experienced in authoring successful regulatory files (BLA, NDA, MAA), performing leachable risk assessments and defining E&L testing strategies. Nick has lead workshops and given a number of presentations on the subject of E&L.

Rachel Sanig, Senior Scientist – Waters
“Strategies to Overcome Challenges in Extractable Screening Studies”

Rachel Sanig received a 1st Class Masters and BSc (Hons) in Chemistry from the University of Leeds. She joined waters as an applications scientist in 2016 and is experienced across Clinical, Pharmaceutical, and Biopharmaceutical markets areas using a range of chromatography and mass spectrometry analysis techniques. She joined the Chemicals and Materials team in 2018 and now works as a senior scientist in the areas of fine speciality chemicals, polymers and materials research, and with a focus on applications in extractables and leachables.

Dan Norwood, Principal Consultant – Feinberg Norwood & Associates Pharma Consulting
“What is Future of Leachables and Extractables Assessment”

Dr. Daniel Norwood is Principal Consultant with FNA Pharma Consulting (previously SCĪO Analytical) which he joined in June 2015. Prior to that, Dr. Norwood worked for sixteen years at Boehringer Ingelheim Pharmaceuticals, Inc. in various pharmaceutical development roles, including Director Physical and Chemical Analysis.  He retired from Boehringer Ingelheim in June 2015 with the title of Distinguished Research Fellow in Analytical Development.  Prior to joining Boehringer Ingelheim, Dr. Norwood held pharmaceutical development positions at Magellan Laboratories and the Glaxo Research Institute.  At Magellan Laboratories, Dr. Norwood established the Structural Analysis Group which became widely recognized for its work in pharmaceutical impurity structure elucidation, and leachables and extractables characterization.

Jason Creasey, Managing Director – Maven E&L
“What Next for E&L? – Data, Information, Knowledge to Wisdom”

Jason Creasey is a graduate analytical chemist. He set up in 2019 as an independent consultant forming his company, Maven E&L to provide advice on the topic of extractables and leachables (E&L). Prior to this, he worked for GSK where he was the director of their R&D E&L Team. He has worked in this topic area since the mid-1990s on a wide range of modalities and dose forms.