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’.
Pete is a Toxicology Director at bibra toxicology advice & consulting, with over 45 years’ experience in the pragmatic application of health risk assessment methodology to mammalian toxicity data sets, with the objective of deriving robust conclusions on any health risks posed by exposure to chemicals. Heading up the bibra extractables and leachables (E/Ls) team, Pete has provided assistance (in line with national and international regulation and guidance) to a broad spectrum of companies in the Pharmaceutical, Medical Device, ENDS, food, drink and food-contact sectors.
Dr. Reinhard Stidl is Senior Toxicologist @ Safetree Consulting e.U., founded in 2018 and located in Vienna, Austria. Reinhard holds a Master and PhD in Chemistry, a Master of Advanced Studies (Toxicology) and is EUROTOX registered toxicologist. He has more than 16 years of experience in the pharmaceutical industry, 11 years employed as Toxicological Risk Assessor and team leader at Baxter, Baxalta, and Shire. He specialized as toxicologist in human health safety assessment of active ingredients, excipient, impurities and contaminants in pharmaceuticals and medical devices, since 2010 with strong focus on E&L. During the assignments in the pharmaceutical industry, he was responsible for the global design and refinement of the global E&L safety assessment strategy . Today, he provides his expertise to clients around the world to assure that pharmaceuticals and medical devices are safe for patients.
Board certified toxicologist.
Expertise in occupational toxicology, including hazard assessment of potent pharmaceuticals, product quality, and genetic toxicology.
Instructor for the SafeBridge Potent Compound Safety Boot Camp
Former study director for non-animal safety studies of pharmaceuticals, consumer products and cosmetics in a GLP contract research lab.
Speaker Bio: Currently: Principal Investigator at U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (Maryland, USA). Research work: head of laboratory studying mechanisms of blood coagulation, in particular, related to treatment of Hemophilia A. Regulatory work: review of biological drug products’ quality-related information (protein-, gene therapy- and cell therapy-based products) in INDs, BLAs and supplements to approved products. This involves review of analytical assessment of extractables and leachables (E&L) due to previous experience in development of GC- and ICP-MS -based methods for analysis of small organic compounds and trace elements in biological tissue, relevant to the E&L assessment. Previous employments: J. H. Holland Laboratory of the American Red Cross (Rockville, MD), 1998-2004; University of Maryland School of Medicine (Baltimore, MD), 2004-2006; Armed Forces Institute of Pathology, Walter Reed Army Medical Center (Washington, DC), 2006-2008. Education: BS/MS in Biochemistry - 1982, Moscow State University, USSR. PhD in Molecular Biology - 1998, Engelhard Institute of Molecular Biology, Russian Academy of Sciences, Moscow.
Petra is currently working in GSKs Trace Analysis Extractables & Leachables team based in Stevenage, United Kingdom. She is a project manager of extractable and leachable studies, and her work focusses on extractable and leachable risk assessment of medical devices, container close systems and manufacturing processes within biopharma. Her areas of expertise are E&L study design, defining E&L strategies, trace level analysis of nitrosamines and authoring regulatory sections.
I have joined Novartis in 2021 and since then, I’ve immersed myself in the fascinating world of E&L. In my current role of Expert E&L, I focus on compiling E&L assessments for biologics and manage both in-house and outsourced extractables and leachables studies.
I hold a master’s degree in Analytical Chemistry and before joining Novartis, I worked as an analytical chemist across diverse sectors (parenteral nutrition, hyaluronic acid gel injection, and feed additives for animal nutrition, etc.). These experiences provided me with a deep understanding of various analytical techniques and methodologies.
Mohinish Sahai, PhD, MBA, is a Group Leader for Extractable and Leachables within PPD (Part of Thermo Fisher scienfic) at Athlone, Ireland. He has about 16 years of experience in the pharmaceucal industry from various roles within Analycal method development, validaons , Extractable and Leachables. In the following years he had developed his experse parcularly in Extractables and Leachables(E&L), Nitrosamine tesng and genotoxic impuries evaluaons. At PPD, Athlone Ireland site , he leads the E&L group and work extensively on E&L studies for Parenteral products, Manufacturing process components assessment, OINDP’s and other inhalaon and different formulaons CCS.
He holds a Doctorate in chemistry and a master’s degree in management. He is a Black belt in Lean Six Sigma.
Davide Angelini is a Project Leader of the Extractables and Leachables team at Eurofins BPT Italy. He graduated from the University of Pisa in 2015 with a master’s degree in chemistry, specializing in analytical chemistry. Since 2020 he has been directly involved in the study of packaging, medical devices and SUS for pharmaceutical companies based in Europe, US and Asia. He is also following several internal Eurofins R&D projects with a focus on data quality improvement.
Stephan is currently Operational Laboratory Manager at SGS INSTITUR FRESENIUS GmbH. He is working for the last 14 years as responsible for emerging/new relevant contaminants. As part of it, he is one of our PFAS experts at SGS gaining the full view, from environmental over consumer products to industrial products and pharmaceuticals.
Graduated in 2010 in Veterinary Medicine at the University of Padua, Margherita Monico has also obtained a Master’s degree in Biotechnology for Business at CUOA Business School.
In Mérieux NutriSciences since 2019, Margherita is one of the Science Center Project Managers dedicated to designing and supervising Extractables & Leachables studies, and also provides customized courses and webinars on the subject.
I run the E&L Knowledge and Service Team at Bayer. We serve and support globally our project teams, working with marketed products and in the development. My 15 years of analytical experience in the academic research group of nutritionists, epidemiologists, public health experts and medical doctors is of great benefit in understanding the chemical behavior of drug products during a long-term contact with plastic and rubber components. Since starting at Bayer over 7 years ago, I have created practical solutions in our laboratory to confirm the safety of plastic and rubber materials together with our toxicologists. I represent Bayer in the ELSIE consortium and am known at Bayer as a customer-focused E&L expert who can provide science-based solutions and answers.
William Bello is an analytical pharmacist within the Pharmacy Department of the Lausanne University Hospital (Switzerland). He is a quality control specialist as well as an analytical developer of validated analytical methods for stability studies of future compounded drug products in accordance with Pharmacopeial and ICH standards. During his PhD, he has become an expert in the Extractables and Leachables (E&L) field in hospital pharmacy. He has installed an analytical screening system for plastic additives in hospital pharmacy-compounded drug products. He also set up a multi-purpose database named DELTA (Database for Extractable and Leachable Trace Assessment) used for the identification, semi-quantitation and toxicology assessment of these compounds. He holds a B.Sc., M.Sc. in Pharmaceutical Sciences as well as a Ph.D. specialising in hospital pharmacy E&L.
Tine Hardeman studied Polymer Chemistry at the University of Leuven and received her MSc in 2013. She acquired a PhD for her dissertation on the controlled synthesis of conjugated polymers in 2017.
After gaining further R&D experience at Kaneka Belgium, Tine started her career at Datwyler in 2018 as Manager Material Development. In this role, she is working on the development of new rubber formulations, raw material management, and helping customers with rubber compound-related questions, among other things. Additionally, she has been focusing on the field of Extractables & Leachables.
Prabhakar has joined USP in January of 2020 and he is currently the Director of Pharmaceutical Sciences, General Chapters, and works with Microbiology, Dosage Forms and Packaging & Distribution Expert Committee related activities. He is also the scientific lead for the Complex Generics initiatives at USP, including developing standards for Extractables & Leachables, as well as other complex products such as Complex Injectables, Ophthalmics, Topical & Transdermal, Nasal & Inhalation products.
Prior to joining USP, Prabhakar worked in the pharmaceutical industry for more than 27 years at various small and large pharmaceutical companies in the field of analytical and bio-analytical chemistry. His expertise includes analytical and bioanalytical method development and validations, use of modern analytical technologies such as HPLC/UPLC and LC-MS/MS for characterization of both small and large molecules, use of automated instrumentation (TPW, and Sotax AT MD) for assay and dissolution testing, ICH stability testing, and preparation of regulatory documentation for IND/ANDA/NDA submissions.
Prabhakar has BS and MS degrees in chemistry and PhD degree in bioanalytical chemistry.
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.
Kai is a physician holding postgraduate degrees in tropical medicine, immunology, toxicology and business administration. Kai has spent >30 years in the pharmaceutical industry serving in R&D, marketing, business development and quality. Business areas spanned small molecules, biologicals, cell therapy and vaccines. Areas of expertise include transfusion medicine, hemostasiology (clotting), transplantation immunology, self tolerance and, on a more mundane level, particulate matter (colloquially known as dirt) contaminations. In his current role, Kai authors medical risk assessments for deviations in manufacturing and E&L tox assessments.
Dr. Yana Chervona is a Drug Safety Team Lead in Drug Safety Research and Development at Pfizer, where she is responsible for the development and implementation of nonclinical safety scientific and regulatory strategies across various therapeutic areas, including vaccine, anti-infectives, and inflammation/immunology. Her educational background includes a BA from Barnard College, an MPH in Molecular Toxicology from Columbia University, and a Ph.D. from New York University, where her research focused on arsenic’s impact on the epigenome.
With extensive expertise in toxicology, Dr. Chervona has had roles in at the Department of Environmental Medicine, NYU, and SafeBridge Consultants, Inc., where she focused on occupational toxicology, product safety, and risk assessment. Dr. Chervona is a Diplomate of the American Board of Toxicology, and a member of both the American College of Toxicology and Society of Toxicology.
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. Dr. Johnson has co-authored several peer-reviewed publications and book chapters describing the implementation of in silico approaches and methodologies for gaining confidence in in silico predictions. Her work expands into novel application of in silico approaches and supporting the advancement of alternative methods. She is particularly interested in the application of computational tools to support toxicological evaluations; for example, in the assessment of extractables and leachables.
Christian Novello (MSc) is a junior scientist graduated at the University of Milan (Italy) in toxicological risk assessment. During his master studies, he carried out an internship in computational modelling at the Mario Negri Institute for Pharmacological Research. He is currently employed in Innovatune Srl, where he provides a comprehensive support to the consulting services that the company offers to Industry, as well as to the projects commissioned by regulatory authorities. He is actively involved in the promotion of the use of computational methods at international conferences. Christian Novello is presenting an analysis conducted in collaboration with Arianna Bassan and Manuela Pavan (Innovatune Srl), and Kevin Cross and Candice Johnson (Instem).
Nina Macho graduated in nutritional sciences at the University of Vienna, and in toxicology at the Medical University of Vienna. After investigating dietary factors which protect against DNA damage at the Cancer Research Institute of Vienna, she worked in the field of ecotoxicology at the Austrian Institute of Technology. In 2013 she joined the Department of Pharmacology and Toxicology at Octapharma, where she is responsible for toxicological risk assessment of impurities in biopharmaceutical products. Since 2023, Nina is board member of the ELSIE Consortium and participating in several toxicological working groups.
Helen manages the Project Management team at the Smithers cGMP E&L testing laboratory in the UK.
With over 26 years of experience in Extractables and Leachables, Analytical Chemistry, and E&L Regulatory Support across the US and Europe, Helen’s expertise is founded in a variety of analytical chemistry, including: method development, method validation, and identification using a variety of instrumentation.
Currently, Helen leads the E&L experts at the Smithers E&L testing laboratory. The Smithers team offer E&L testing and effective program management to the medical device, pharmaceutical and biopharmaceutical industries to fulfil regulatory compliance. The team’s activities encompass performing and managing material characterisation, pharmacopeia testing, E&L testing, toxicity assessments, and submission preparation.
Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry. He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues. Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.
Francois Bianchi served as the Head of Extractables and Leachables Management at B. Braun Medical. Throughout his distinguished 20-year career in life sciences, he has led in his roles pioneering advancements in biocompatibility and E&L, specifically refining SOPs and work instructions for primary packaging qualification processes.
Prior to joining B. Braun, Francois made significant contributions to biocompatibility qualifications at Johnson & Johnson, which were crucial for FDA approvals and deepened his expertise in regulatory compliance. His subsequent roles at Ferring Pharmaceuticals, Merck Serono, and Debiotech further highlighted his skill in navigating complex project management challenges.
With a PhD in analytical chemistry and a comprehensive network within the industry, Francois is renowned for his strategic leadership and deep regulatory knowledge, positioning him as a leading consultant in E&L and biocompatibility testing.
Since founding Niu Consulting in 2018, Chiara has worked with a wide range of
companies world-wide as well recognized consultant specializing in biological safety
assessment of medical devices. She provides her expertise to medical device
manufacturers and supports them with the biological safety assessment of their
products, according to ISO 10993 standard series and US-FDA Guidance. She interacts
with European Notified Bodies and FDA to address topics related to biological safety
evaluation plans, biological testing, material chemical characterization and toxicological
risk assessment. She also supports companies in the in the definition of most
appropriate testing plans as well as in the management and optimization of project
timelines to facilitate the achievement of their product development objectives.
Chiara has scientific-technical background in biotechnology and holds the qualification
to the profession of Biologist. She is a specialized Project Manager and worked for many
years in the medical device industry leading several cross-functional teams focused on
the development of new and innovative products from idea generation to product
launch on the market. She was also in charge of leading a laboratory devoted to the
development and implementation of biological/biochemical assays (both in vitro and in
vivo) for drug discovery and pharmaceutical compounds’ activity testing.
