Jason Creasey is a graduate analytical chemist. In 2019, he established Maven E&L Ltd, as its Manging Director and Principal Consultant. Maven E&L was setup to provide advice to clients working in the pharmaceutical industry on all aspects relating to the topic of extractables and leachables (E&L) and the risks that leachables pose to the quality and safety of drug products. Prior to this, he worked for GSK where he was the director of their R&D E&L Team.

He has worked in the topic area of E&L since the mid 1990’s on a wide range of modalities and dose forms seeing this area expand and grow in significance for the pharmaceutical and medical device industries. In addition to running his consultancy, he is a scientific advisor to the ELSIE consortium. 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 within the pharmaceutical industry that he hopes will form part of an ICH guidance in the not-too-distant future linked to concepts in leachable risk management as well as looking at analytical uncertainty and how that might be reduced either through better analytical approaches or more collaboration to increase reproducibility and alignment.

Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the pharmaceutical industry, 10 of them as manager to the toxicology group. She's the main or co-author of several papers and posters, has published in peer-reviewed journals, and she's an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy company specialised in toxicological risk assessment and regulatory toxicology.

Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology, and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory), and Switzerland (Paul-Scherrer-Institut). Within device and packaging development at F. Hoffmann - La Roche, he has been working in verification engineering since 2018 on improvements in CCI testing and development of new device test methods.

Crystal D’Silva is a Preclinical subject matter expert at Baxter International and based in Brussels, Belgium. She is actively involved in standard development as an expert in the ISO/TC 194 Biological and Clinical Evaluation of Medical Devices technical committee. She is also a European Registered Toxicologist (ERT) and a member of the European Society of Toxicology In Vitro (ESTIV) and the Belgian Society of Toxicology and Ecotoxicology (BELTOX). She has a PhD in Medical Biophysics from the University of Toronto in collaboration with the Princess Margaret Cancer Centre and the Hospital for Sick Children (Ontario, Canada).

Lukasz Szymański, PhD, DSc, Prof. is Deputy Head of the Department of Molecular Biology at the Institute of Genetics and Animal Biotechnology, Polish Academy of Sciences, and an expert in biocompatibility testing of medical devices and bioengineering. He serves as Chief Scientific Officer at the ISO 17025-accredited and GLP-certified European Biomedical Institute (EBI) and North American Biomedical Institute (NABI). His research interests include molecular oncology and hematology, regenerative medicine, immunology, and the development of innovative medical devices. Author of over 50 publications, he has led numerous research projects and developed Class III medical devices introduced to the European market, including 4Seal Hemostat and NE’X Glue Surgical Adhesive. He is a member of international expert bodies, including the AAMI Biological Evaluation Committee (USA), the OECD immunotoxicity group, and the Polish Committee for Standardization, actively shaping biomedical safety standards and bridging research, regulation, and technology transfer.

25+ years of expertise as toxicologist specialised in risk assessment of pharmaceutical excipients, impurities and leachables from materials of construction used in medical devices and drug/device combination products.

Member of the International Standardisation Organisation Technical Committee 194 working group for several biocompatibility standards of medical devices (ISO 10993 series). assessment of pharmaceutical excipients, impurities and leachables from materials of construction used in delivery devices and manufacturing of drug products.

Driver of innovation in strategies and development of state-of-art practices for health risk assessment of polymer materials.

Marina Daineko is an experienced Biocompatibility Consultant based in Poland, specializing in ISO 10993-1 biological evaluation of medical devices. She partners with manufacturers to develop Biological Evaluation Plans and Reports, perform strategic gap analyses, optimize test strategies, and ensure compliance with EU MDR and FDA requirements.

Marina holds an MSc in Analytical Chemistry. At Intrinsic Medical Group (IMG), she contributes to a broad portfolio of Biological Safety services, from hands-on training to Biological Evaluation process creation.

Her professional achievements include being nominated for the Women in Tech Award in 2023 for her contributions to medical device safety, recognition as one of the Top 25 MedTech Voices on LinkedIn for advancing discussions on biocompatibility and regulatory strategy, and authorship of more than fifteen publications and two patents in materials science.

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010, he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry.

With over 25 years’ experience in the Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Devices, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory-controlled industries are challenged by ongoing regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from the Life Industry or organizations to work together to realize or achieve a better and effective cross-departmental collaboration to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Dr. Alina Martirosyan is experienced in non-clinical evaluation of medical devices and pharmaceuticals, and is a Biocompatibility subject matter expert at B. Braun Melsungen AG (Germany). As part of the biological risk assessment of medical devices she is planning, coordinating and managing the biocompatibility studies, performs toxicological evaluation and risk assessment of chemical constituents, dealing with notified bodies and national agencies. She holds a PhD degree in Biochemistry, is a European Registered Toxicologist (ERT), Delegate of American Board of Toxicology (DABT), and is acting as an expert in ISO/TC 194 for the ‘Biological and clinical evaluation of medical devices’.