Program Advisory Committee
Speakers
Philip Clay
Director and Principal Toxicologist, Chorley Consulting
Philip is Director and Principal Toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in medical device safety assessment with over 30 years experience in toxicology and safety assessment.
He is a BSI committee member on CH/194 (Biological evaluation of medical devices) and Principal Expert for WG6 (Mutagenicity, carcinogenicity and reproductive toxicity). He established his reputation as a genetic toxicologist working within the agrochemical, chemical and pharmaceutical industries. He has contributed to many expert panels, helping to shape the testing guidelines and strategies in place today. More recently, this experience and depth of understanding has been applied to designing safety assessment programmes for medical devices for a wide range of device manufacturers. He has published and presented widely in the field of toxicology throughout his career.
Kelly Coleman
PhD, DABT, ERT, ATS, RAC Distinguished Toxicologist Medtronic plc
Kelly Coleman is a Distinguished Toxicologist, Technical Fellow, and Bakken Fellow at Medtronic where he provides preclinical product development support. He is also a U.S. Expert on ISO Technical Committee 194’s Working Group 11, which is responsible for the medical device toxicology risk assessment standard (ISO 10993-17), and a U.S. Expert on Working Group 8, which is responsible for the medical device sensitization and irritation testing standards (ISO 10993-10 and ISO 10993-23). In this role, he co-directed a successful international round robin study which proved that 3D human skin models are suitable replacements for the rabbit skin irritation test. Kelly earned Ph.D. in Toxicology from the University of Minnesota. He is a Diplomate of the American Board of Toxicology, a European Registered Toxicologist, a Fellow of the Academy of Toxicological Sciences, and is certified in U.S. regulatory affairs. He is a past president of the Society of Toxicology’s In Vitro and Alternative Methods Specialty Section and the Medical Device and Combination Product Specialty Section. In addition, he recently served on NIH’s Scientific Advisory Committee on Alternative Toxicological Methods (SACATM).
Jianwei Li
Principal E&L and chemical characterization consultant, and chemistry writer at Chemical Characterization Solutions LLC
Dr. Jianwei Li is currently the principal E&L and chemical characterization consultant, and chemistry writer at Chemical Characterization Solutions LLC.
He worked at Medtronic, a leading global medical device company, for nearly 16 years as a technical fellow and subject matter expert in chemical characterization of medical devices. Over the course of his nearly 30-year academic and industry career, he has published extensively in the area of analytical chemistry with nearly 50 publications with over six of them devoted to chemical characterization, particularly on extraction solvent selection. He also served as frequent scientific reviewers for over ten international journals. Dr. Li was issued four patents as well.
He received his PhD in analytical chemistry from Purdue University, USA, and did his postdoctoral research @ University of Minnesota, USA.
Lars Magnus Bjursten
Senior professor Bioimplant Research. Convenor ISO 18562 series
Lars Magnus is an experienced Senior Professor at Lund University, Sweden, with clinical board certificates as specialist in Internal Medicine, Clinical Immunology and Transfusion services. His primary research interest is in local tissue reactions to implanted biomaterials.
He is head of the Swedish mirror committee of ISO 194, convenor for the work with ISO 18562 standards on indirect contact via the breathing gas pathways. He has been active working with the ISO 10993 series from early 1990s. Lars Magnus will take part in panel discussion and present a thought-provoking poster about local and systemic effects of implants.
Jeremy Tinkler
Chair of ISO/TC 194: Biological and Clinical Evaluation of Medical Devices. Regulatory Affairs Director, Strategic Regulatory Services - Medical Devices, ICON plc.
Jeremy Tinkler, ERT, is Chair of ISO/TC 194: Biological and Clinical Evaluation of Medical Devices and is working as Regulatory Affairs Director, Strategic Regulatory Services – Medical Devices, at ICON plc. Since 1987, when Jeremy joined what is now MHRA, he has taken a leading role in standards development as a member of many ISO Working Groups and as chair of UK committees covering biological safety, risk management and cardiovascular and neurological implants. He played a key role in introducing risk management principles from ISO 14971 into other standards. Prior to joining the medical devices world, Jeremy spent 10 years in general toxicology, at laboratories and the UK Health and Safety Executive. He then worked for 20 years at MHRA as Principal Specialist in Biosciences and Implants.
Ron Brown
Toxicologist at Risk Science Consortium (former FDA reviwer)
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices, Leader of the Laboratory of Biological Risk Assessment where he conducted bench-top research to reduce uncertainty in the risk assessment process, and trained FDA staff in toxicological risk assessment procedures. While at the FDA, he served in a number of leadership roles in standards development organizations; for many years as convenor of ISO TC194 WG11, responsible for the ISO 10993-17 standard, and as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Alexander Tropsha
UNC-Chapel Hill, US
Alexander Tropsha, PhD. is K.H. Lee Distinguished Professor at the UNC Eshelman School of Pharmacy (ranked #1 in the country by US News & World Report), UNC-Chapel Hill. Prof. Tropsha obtained his PhD in Chemical Enzymology in 1986 from Moscow State University, Russia and came to UNC-Chapel Hill in 1989 as a postdoctoral fellow. He joined the School of Pharmacy in 1991 as an Assistant Professor and became full professor in 2002. His research interests are in the areas of Computer-Assisted Drug Design, Cheminformatics, Computational Toxicology, Materials Informatics, Structural Bioinformatics, and Biomedical Knowledge Graph Mining. He has authored or co-authored more than 290 peer-reviewed research papers, reviews, and book chapters and co-edited two monographs. He has trained more than 30 graduate students and over 30 postdoctoral fellows. He has served as a member of the Editorial Board and Associate Editor of the ACS Journal of Chemical Information and Modeling. His research has been supported by multiple grants from the NIH, NSF, EPA, DOD, foundations, and private companies. He is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a consultant to several technology and drug discovery companies. He is a co-founder of Predictive, LLC, a UNC startup specializing in building models and tools for chemical toxicity prediction.
Arthur Brandwood
Medtech Regulatory Expert with International Perspective
Joel Cohen
Principal at Gradient Consulting
Dr. Joel M. Cohen is a board certified toxicologist and Principal at the consulting firm Gradient. With expertise in computational toxicology and human health risk assessment, Dr. Cohen’s primary responsibilities include non-clinical safety assessments of medical device and pharmaceutical components, regulatory compliance assessments, cancer risk assessment, and physiologically based pharmacokinetic modeling. Before joining Gradient, Dr. Cohen earned his doctoral degree at the Harvard School of Public Health, applying in vitro cellular models to study the fate, transport and toxicity of nanoparticles in the lung. He has authored over twenty high impact peer-reviewed articles and one patent, and presented his work to academic and general audiences.
Eric Sussman
Director for Biocompatibility at MCRA, LLC
Dr. Eric M. Sussman has 15+ years of experience in biomaterials science, biocompatibility evaluation, and regulatory affairs, Dr. Sussman provides consulting services to medical device manufacturers for US and international regulatory submissions. Dr. Sussman joined MCRA from the US Food and Drug Administration (FDA), where he spent 10 years in the CDRH Office of Science and Engineering Laboratories (OSEL), most recently as a staff Biomedical Engineer leading regulatory research efforts related to biocompatibility evaluation and performing consultant review of regulatory submissions. Review subjects included chemical characterization, toxicological risk assessment, nanomaterials evaluation, and biological testing based on international standards (e.g., ISO 10993), FDA guidance and regulations. While at FDA, Dr. Sussman led authorship of FDA’s perspective on chemical characterization of medical devices published in 2022. Dr. Sussman earned his Ph.D. in Bioengineering from the University of Washington in 2012 and his B.S.E. in Bioengineering with Materials Science and Engineering minor from the University of Pennsylvania in 2005. Dr. Sussman is active in the international biomaterials and toxicology communities, having served in several leadership roles in the Society for Biomaterials (SFB) and as a member of the Society of Toxicology (SOT).
Ted Heise
Vice President Regulatory and Clinical Services at Cook 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 Cook MED Institute. In this capacity, he leads efforts to develop scientifically robust regulatory and clinical study strategies for successful development of new medical products that improve patient well being. Ted has a BS in chemistry and a PhD in analytical chemistry. For the past 15 years he has been a U.S. delegate to ISO TC 194 and currently serves as convenor of 10993-18. As convenor, Ted 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 is also a member of the USP expert committee on packaging, and is supporting revisions of the chapters on biocompatibility.
Amy Clippinger
PETA Science Consortium International e.V.
Dr. Amy Clippinger is the President of PETA Science Consortium International e.V. She received her doctorate in Cellular and Molecular Biology and Genetics in 2009 from Drexel University College of Medicine and was a postdoctoral fellow in the Cancer Biology Department at the University of Pennsylvania from 2009 to 2012. In 2012, Dr. Clippinger joined the Science Consortium where she collaborates with industry, academia, and regulatory agencies to advance robust non-animal toxicity testing approaches. She is a past member of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). She is a member of the Society of Toxicology (SOT), recipient of the SOT 2022 Enhancement of Animal Welfare Award, and Past President of the SOT In Vitro and Alternative Methods Specialty Section. She is on the board of directors of the American Society for Cellular and Computational Toxicology and is coauthor of more than 40 publications.
Primary Contact
Mikaela Mattsson
Conference Coordinator, Limulus Bio
E-mail: mikaela.mattsson@limulusbio.com
Phone: +46 (0) 70 308 06 62