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11:00 Registration
12:00 Opening Address
12:10 To Be Announced
Dr. Tino Otte,
Managing Director, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland
12:50 Extractable and leachables challenges and issues with Biologicals
Andrew Feilden,
Director Analytical Sciences, Bicycle Therapeutics, Shawbury, United Kingdom
13:30 Extractables and leachables assessments in biologics manufacturing processes
Lukas Mogler,
Principal Scientist / Sr Group Leader, Lonza, CH
14:10 Coffee break
14:30 To Be Announced
Dr. Roberto Menzel,
Laboratory Supervisor and Manager Extractables, Sartorius Stedim Biotech, Göttingen, Germany
15:10 Taking a step further in your Extractables & Leachables testing
Dr. Margherita Monico,
E&L Senior Project Manager, Mérieux NutriSciences Italy, IT
15:50 To Be Announced
Diego Zurbriggen,
Technical Account Manager, West Pharmaceutical Services, Inc., USA
16:30 Coffee break
16:50 To Be Announced
Samuel N Kikandi, PhD,
Deputy Director-Principal Engineer/ Material Science & E&L SME, Sanofi, USA
17:30 Using expert knowledge and machine learning to assess the mutagenicity and sensitisation potential of extractables and leachables
Jack Yung,
Application Scientist, Lhasa Limited, USA
18:10 Applications of computational methods in the assessment of extractables and leachables
Dr. Candice Johnson,
Senior Research Scientist, Instem, Ohio, United States
18:50 Closing remarks and end of day one
11:20 Opening Address
11:30 Challenge for Industry with new USP665/1665
Isabelle Sbille,
Associate director- Material Safety Expert (E&L), UCB Biopharma SRL, Belgium
Pierre Van Durm,
Material of Contact global quality SME, UCB Biopharma SRL, Belgium
12:10 How to Improve the Accuracy of your E&L Testing
Markus Obkircher,
Director R&D, Head of Reference Materials and Proficiency Testing, Merck, Sankt Gallen, Switzerland
12:50 To Be Announced
Jason Creasey,
Managing Director, Maven E&L Ltd, Stevenage, United Kingdom
13:30 Coffee break
13:50 To Be Announced
Erika Udovic,
Principal Scientist II, PCS Impurity Safety, Novartis, CH
14:30 To Be Announced
Atish Sen,
Director, Analytical Sciences Inhalation Product Development, AstraZeneca, North Carolina, United States
15:10 Toxicological Risk Assessment on Extractables and Leachables
Dr. Clemens Günther,
Director Nonclinical Safety Consumer Care, Bayer AG, Berlin, Germany
15:50 Coffee break
16:10 How to Write a Toxicological Risk Assessment to Support Extractables and/or Leachables: A Step-by- Step Process
Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT
AbbVie Retiree, Greg Erexson Toxicology Consulting, LLC, USA
16:50 Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable
Melisa Masuda-Herrera,
Senior Associate Scientist, Gilead Sciences, USA
17:30 PANEL DISCUSSION
Bram Jongen,
Vice President Materials & Surface Technologie, Datwyler Pharma Packaging International NV, Limburg, Belgium
Steve Zdravkovic,
Research Scientist II, Baxter International Inc., USA
Samuel N Kikandi, PhD,
Deputy Director-Principal Engineer/ Material Science & E&L SME, Sanofi, USA
Weifeng Lin,
Staff Scientist, Thermo Fisher Scientific, USA
18:10 Closing remarks and end of day two
11:20 Opening Address
11:30 How to implement USP 665 requirements before 2026
The goal will be to present a lifecycle approach of our existing park of single-use, based on leachable risk, to ensure a compliance for the effectivity date of the USP in 2026.
Marine Lepoutre,
Global Subject Matter Expert, GSK Vaccines, Belgium
Etienne Michel,
Global Quality Expert, GSK Vaccines, Belgium
12:10 Health risk assessment of Extractables and Leachables – things are not always what they seem
Chris Waine,
Senior Toxicologist, bibra toxicology advice and consulting, UK
12:50 Case sharing of chemical characterization applications during the whole life cycle of Medical Devices
Wenjing Zhao ,
Sr Scientist, Medtronic Technology Center – Greater China, Shanghai, China
13:30 Coffee break
13:50 Leveraging Analytical Chemistry Data of Medical Devices to Derisk Drug Combination Product Submission
Delphine Brissaud,
R&D Staff Scientist, BD, FR
14:30 E&L studies from a Notified Body Perspective
Dr. Christina Reufsteck,
Biocompatibility Expert, TÜV SÜD Product Service GmbH, Germany
15:10 To Be Announced
Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing, SGS Institut Fresenius GmbH, Frankfurt Am Main Area, Germany
15:50 Coffee break
16:10 Composition and shelf life considerations for the extractables profile of rubber
Dr. Tine Hardeman,
Manager Material Development Healthcare, Datwyler, Belgium
16:50 To Be Announced
Dennis Jenke,
Chief Executive Scientist, Triad Scientific Solutions, LLC, USA
17:30 ISO 10993-17 update.
Ron Brown
Owner and Principal Toxicologist, Risk Science Consortium, LLC, USA
18:10 To Be Announced
Jianfeng Hong,
Sr. Research Scientist, Fresenius Kabi, USA
18:50 Closing remarks and end of summit
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Post-event presentations with video recording, slide decks, a list of participants, and other promotional materials.
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AbbVie - AiCuris Anti-infective Cures GmbH - Angelini ACRAF s.p.a. - B. Braun - Bayer - Bayer AG - Borealis Polymere GmbH - Brooks Life Sciences - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Pharma Packaging International NV - Datwyler Sealing Solutions - EirGen Pharma - Engelhard Arzneimittel GmbH & Co KG - F. Hoffmann-La Roche Ltd - GSK - GSK Vaccines - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Intertek (Schweiz) AG - Iterum Therapeutics - Lyomark Pharma GmbH - Maven E&L Ltd - Medichem - Merck - Merck KGaA - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk - Pall Biotech - Patheon, by Thermo Fisher Scientific - PHARMIDEA SIA - Purus Plastics - RMS Foundation - Safetree Consulting e.U. - Sandoz - Sanofi - Sanquin Plasma Products - Sartorius Stedim Biotech - SAS Laboratoire Aguettant - SCHOTT AG - SE Tylose GmbH & Co. KG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - Synthon Biopharmaceuticals BV - Vifor (International) AG - West Pharmaceutical Services GmbH & Co. KG - ZETA GmbH - Others