The ever-changing world of E&L virtual conference. On Demand.

The Ever-Changing World of Extractables and Leachables Virtual Conference: Lessons Learned and Future Challenges.

Watch On Demand

Join global industry and regulatory experts as they discuss E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices.

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

Conference Running Order (BST)

15:00 Introduction
15:05 Ted Heise
“ISO 10993-18: Establishing an AET for Chemical Characterization of Medical Devices”
15:30 Alicja Sobantka
“E&L in biological combination products”
15:55 5-Minute Break
16:00 Nick Morley
“Managing change in this ever-changing world”
16:25 Rachel Sanig
“Strategies to overcome challenges in extractable screening studies”
16:55 5-Minute Break
17:00 Dan Norwood
“What is the Future of Leachables and Extractables Assessment?”
17:25 Jason Creasey
“What next for E&L?- Data, Information, Knowledge to Wisdom”
17:50 Panel Discussion
“Qualification of screening methods, how is this achieved?”

Speakers

Ted Heise, PhD, RAC
MED Institute

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.

Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University.  He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.

For the past 15 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices.  He currently serves as convenor of TC 194/WG 14.  As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables from medical devices.  He also is a member of the USP expert committee on packaging, and is supporting revisions of the chapters on biocompatibility.


Alicja Sobańtka, PhD
Material Qualification, Octapharma

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.

Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma employs more than 6,200 people worldwide to support the treatment of patients in 105 countries with products across three therapeutic areas: critical care, haematology (coagulation disorders), immunotherapy (immune disorders). Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.


Nick Morley.
Principal Scientist. Hall Analytical.

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.
Nick has a BSc in Chemistry, is a BSI Committee member and British representative on the CEN (European standards Committee) working group for extractables and leachables of Electronic Cigarettes & E-liquids.


Rachel Sanig
Senior Scientist, Waters

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 specialty chemicals, polymers and materials research, and with a focus on applications in extractables and leachables.


Dan Norwood,
Principal Consultant, Feinberg Norwood & Associates Pharma Consulting

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.

He served as chair of the Product Quality Research Institute (PQRI) working group on leachables and extractables in inhalation drug products, whose recommendations are generally recognized as the standard in this area. He is also a member of the PQRI working group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). From 2010-2020, he served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables.

Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his masters and doctorate degrees in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.


Jason Creasey
Managing Director, Maven E&L

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.

He is a scientific advisor to ELSIE. Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He now publishes a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), for the exchange of ideas and discussion.

As well as supporting client projects, among recent E&L activity, he is presenting and commenting on risk-based approaches to E&L requirements that he hopes will form part of an ICH guidance in the not-too-distant future.


Moderator

Andrew Feilden. Hall Analytical.

Dr Andrew Feilden is the European E&L Strategic Director at Hall Analytical.  He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide.  Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE