Berk Oktem is a Chemist and Toxicologist at US FDA’s Center for Devices and Radiological Health, Office of Orthopedic Devices. He serves as a lead or technical expert for pre-market reviews and conducted research focused on extractables, leachables analysis, small molecule identification and analysis, polymer degradation and proteomics for more than 20 years. He received his Ph.D. in Analytical Chemistry from the University of Delaware, performed post-doctoral research at Johns Hopkins School of Medicine and also spent 10 years in private sector as research and applications scientist in product development of chemical analysis systems prior to joining FDA.
Bio is coming soon....
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Candice is part of Smithers’ Extractables and Leachables (E&L) team at Shawbury in the UK. She has been working for Smithers for 6 months so far and has been learning as much as possible about E&L.
Candice has completed a PhD in oral nanoscience at the University of Bristol. She began her work career as a technical specialist in the healthcare industry, particularly supporting laboratories in the NHS and private sector before moving into the chemical sector as a technical sales manager.
Qualifications
Candice has a BSC (Hons) in Biomedical Materials Science and a PhD in Oral Nanoscience.
Dr. Leshuai Zhang obtained his PhD from North Carolina State University in 2010, where he studied skin toxicology. After graduation, Dr. Zhang joined the Center for Drug Evaluation and Research, US FDA as a Research Fellow where he received drug reviewer training for drug evaluation and investigated the mechanisms of drug induced toxicity. In 2012, Dr. Zhang joined Nanotechnology Innovation Center in Kansas State University as a research assistant professor, focusing on hepatotoxicity of food additives and nanomaterials. Since 2014, he joined Soochow University as a professor, currently working on nano-immunotherapy and hepatotoxicity evaluation of nanomaterials using 3D liver models. He has published over 40 SCI papers in toxicology, pharmacology and nanomedicine area with more than 1500 citations. He holds internationally certified/registered toxicologist including DABT, ERT, UKRT and DCST.
Jingwen Shi is currently a chemical scientist at the Medtronic China R&D Center. She is responsible for researching materials of concern (MOC), chemical characterization, and general chemical analysis for medical devices. She has successfully completed MOC assessments for several globally submitted medical device products throughout their entire lifecycle, including material screening, supplier information evaluation, testing research, and regulatory compliance documentation. Prior to joining Medtronic, she focused on antibody and peptide research, successfully completing multiple IND and NDA projects. She got a master’s degree in organic chemistry from Shanghai Jiao Tong University.
Zhai Zhichen, Director of the IBMD-TC (Guangdong Institute of Advanced Biomaterials and Medical Devices, Testing Center); Standing member of the Regenerative Medicine Translational Group of the Restorative Surgery Professional Committee, Chinese Society Association of Rehabilitation Medicine; Member of the Biomaterials Biological Evaluation Branch of the Chinese Society for Biomaterials. He is mainly engaged in basic and applied research in the fields of biomaterials/medical devices, stem cells, and regenerative medicine; evaluation and development of safety and effectiveness testing methods for medical devices and stem cells; medical device regulatory science research, etc. He has published 15 scientific papers in international peer-reviewed journals, such as Matter, Cell Death & Disease, Theranostics, Scientific Reports, etc., and applied & authorized 4 patents.
Xiaoxia Ye is the manager of trace impurity investigation lab at Huadong Medicine. She is responsible for E/L and trace-impurity-related studies for pharmaceutical products. Xiaoxia Ye obtained Ph.D. degree from University of Alberta and has more than 15 years’ experience in chemical characterization using mass spectrometry.
Pu Xiaocong, PhD, senior engineer, graduated from the National Biomedical Materials Engineering Technology Research Center of Sichuan University with a major in materials science. She is a high-level overseas student in Sichuan Province and a visiting scholar at the University of Maryland. He is the deputy director of the Packaging Materials and Pharmaceutical Excipients Inspection Institute of Sichuan Provincial Institute of Drug Inspection (Sichuan Medical Device Testing Center). He is an industry mentor for professional degree graduate students at Sichuan University, an off-campus master's mentor for the School of Pharmacy of Chengdu University, an off-campus practice mentor for master's students of pharmacy at Chengdu Medical College, and an expert of the Sichuan Provincial Intermediate Professional Title Evaluation Committee for Pharmaceutical Engineering. He is a provincial medical device inspector in Sichuan Province, an authorized signatory in the field of pharmaceutical packaging materials and medical devices, and has entered the talent echelon of the special working group of the Pharmaceutical Packaging Materials Professional Committee of the 12th Pharmacopoeia Committee.
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
Dr. Yang Weichun is currently the Global Laboratory Head and Senior Director of Fresenius. Prior to joining Fresenius, Dr. Yang was the Senior Director of Heshen Pharmaceuticals, responsible for all analytical activities in the Wuxi plant. He has worked in the fields of medicine and environment for more than 20 years. He has published more than 30 academic papers at home and abroad and participated in the writing of several professional books and industry standards.
Paavo Sillanpää is Global Senior Manager Business Development, Pharma in UPM Raflatac and has more than 20 years’ experience in the label industry. He is focusing on developing solutions to different pharmaceutical and healthcare labeling applications and helping brand owners in label material selection and qualification process. Paavo holds a master’s degree in marketing from University of Vaasa. He currently based in Europe, but has gained understanding of the global market requirements by living and working both in Asia and in United States.
Fu Peilin, R&D center director, Shenyang Sinqi Pharmaceutical Co.,Ltd., Ph.D of pharmaceutical analysis, Shenyang Pharmaceutical University; Master’s supervisor, China Medical University; Pharmaceutical analysis expert, China Medicine Education Association; China youth May 4th Medal; Person in charge of public platform for science and technology services of "compatibility of pharmaceutical products and packaging research", Shenyang Bureau of Science and Technology; Specializing in the compatibility of pharmaceutical products and packaging materials; Co-edited the first book in China — “Theory and Practice of Compatibility of Pharmaceutical Products and Packaging”.
Yi Zhang has over 20 years experiences in developing analytical methods for drug products and was responsible for Guangzhou E/L laboratory building and operation from 2010. As the principal scientist, she currently leads E/L study programs in packaging systems for pharmaceutical products and in disposable components for manufacturing process, and has engaged in hundreds of compatibility testing on drug packaging. In additional, she is also senior researcher of Guangdong Academy of Sciences Drug Preclinical Evaluation Center and supports the new products development for industries.
With years of dedication to the establishment of extractables data for filters and single-use system components, I am well-versed in the potential leachables of various types of filters and plastic components. I have extensive experience in developing methods for extractables and leachables studies, including qualitative and quantitative analysis, as well as safety assessments. Additionally, I possess substantial project management experience and am familiar with the application scenarios of filters and plastic components in customer settings. I understand the common challenges customers face in extractables and leachables research and regulatory submissions, and I provide scientifically validated services that meet regulatory requirements.
Armin has held the role of Principal Scientist at Sartorius Stedim Biotech GmbH in R&D and PD since 2016. After his PhD, he started his career in the R&D department of Ciba-Geigy in 1995. During his time at Ciba, Novartis, and Ciba Specialty Chemicals, he was head of laboratories for organic trace-analysis, GLP & GMP analytics, where he was responsible for impurity profiling, migration studies, E&L investigations, development of GMP quality control methods, and stability testing. After 2010 he worked as a consultant and Qualified Person (QP) for Intertek in Switzerland.
Armin is a lecturer and trainer in E&L at conferences and seminars and is a member of various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan). Since this year, he has been the nominated Chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).
