Petra Booij | Investigator, Structure and Function Characterization, Analytical Development, GSK
Jason Creasey I Managing Director I Maven E&L Ltd.
Thomas Egert | Research Scientist Pharmaceutical Contact Materials | Boehringer Ingelheim
Alicja Sobantka I Corporate Operational Excellence and Support I Octapharma
Asger W. Nørgaard MSc PhD | Senior Research Scientist, CMC Analytical Support, Novo Nordisk A/S
Carsten Worsøe | Principal Scientist Extractables and Leachables, Novo Nordisk A/S
Caroline Jaegger is a technically proficient Mass Spectrometry Expert with 12 years laboratory experience and excellent academic qualifications (B.Sc., M.Sc., Ph.D.). Substantial experience in MS instrumentation (LC-MS/MS, GC-MS, MALDI-MS, Orbitrap and IMS) within a range of complex matrices (peptides, lipids, protein) and small molecules. Expert knowledge in sample preparation for identification and quantification of small and large molecules such as LLE, SPE, SPME, DLLME, ultrasonic extraction and QuEChERS. Wide and deep expertise in analytical method development and method validation based on FDA and ICH guidelines, and in working understanding of quality systems such as GMP and/or GLP. Known for unique and creative solutions to analytical challenges, delivering game changing strategies. 20+ works presented at national and international conferences and 11 scientific papers published.
Dr. Weifeng Lin received his PhD at UC Davis. Currently, he is a staff scientist at R&D of Bioproduction group in Thermo Fisher Scientific. Weifeng is leading the extractable analysis lab to support the SUS R&D and manufacture. Dr. Lin is member of BioPhorum and attended meeting for the revision of BioPhorum best practices guide for extractables testing of polymeric single-use components used in biopharmaceutical manufacturing.
Gilbert Tumambac, Ph.D. is a Sr. Principal Scientist in the Technical Communications and Regulatory Strategy group at Pall Life Sciences (NY, USA). He holds a PhD in Organic Chemistry and has over 16 years of pharmaceutical and biotech experience. He currently leads the Pall Biotech Materials Science and Attributes Council and serves as an E&L SME supporting SUT and bioprocessing.
Christina studied Biology and graduated at the University of Cologne. Then she moved to the German Cancer Research Center in Heidelberg, where she worked in cancer research, and received her PhD. Afterwards, she joined BioMedimplant, an accredited biocompatibility test laboratory in Hannover. There she conducted studies of cytotoxicity, hemocompatibitity and implantation according to the ISO 10993 series. Since 2014, she is working as an expert at the notified body TÜV SÜD Product Service GmbH in Munich and assesses the manufacturers’ technical documentation with focus on biocompatibility. Christina is a member of the German working committee for ISO/TC 194 (Biological and clinical evaluation of medical devices).
Tim Petermann graduated as Food Chemist in 2012 at the University of Würzburg and in 2013 graduated as a State Certified Food Chemist at the Landesamt für Gesundheit und Lebensmittelsicherheit Bayern (State Office for Health and Food Safety Bavaria). From 2013-2017 he was Study Director and HPLC Systems’ Owner for a Contract Laboratory in the field of food supplements, dietetic food, pharmaceuticals and water. In 2017 he joined NAMSA Obernburg as Study Director with responsibility for UPLC-MS in the field of chemical characterization and E&L Studies of Medical Devices, and in 2021 became Principal Chemist with responsibility for technical and scientific questions and projects.
As an engineer from the Ecole Centrale Paris and having a PhD in Mechanics Thomas has broad technical skills related to chemistry and material science but also a good understanding of operational project management. Thomas joined FILAB in 2017 and is now in charge of FILAB's scientific and technical development, as well as managing the entire laboratory.
Chris Waine is a toxicologist with 10 years of experience in human health hazard and risk assessment of chemicals. Along with his work on extractables and leachables, he specialises in the evaluation of pharmaceutical impurities, submissions under the EU REACH Regulation and the application of (Q)SAR models for toxicology. He is a member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.
Delphine Brissaud is a Senior Scientist at BD Medical Pharmaceutical Systems with over 20 years of experience focused on extractables and leachables in prefillable syringes. Her main responsibility has been supporting new product development as well as current business on extractable studies. This included definition of extraction parameters, development and validation of analytical methods and laboratory management. She holds a degree in chemistry from Clermont-Ferrand School of Chemistry (ENSCCF – France) and a specialization in drug/packaging interactions from the Faculty of Pharmacy of Paris (France).
Michael manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009.
Michael has uses his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.). Michael’s team supports a diverse range of clients and industries requiring the support of analytical experts working within a cGMP and ISO17025:2017 environment.
Prior to joining Smithers, Michael worked in the validation department for one of the largest Single Use System suppliers and previous to that at a petrochemical organisation.
Michael has a BSc in Chemistry, and is a Member of the Royal society of Chemistry (MRSC).
Jason set up Maven E&L in 2019 to provide expert advice in the area of extractables and leachables, after working for GSK in the area of E&L since the mid 1990’s where he held roles of increasing seniority providing support to E&L across many modalities and product types. Jason is a scientific advisor to ELSIE and publishes blogs and article on E&L with a focus on risk based management of leachables.
Glenn J. Myatt is the co-founder of Leadscope and currently Vice President, Informatics of Instem with over 25 years’ experience in computational chemistry/toxicology. He holds a Bachelor of Science degree in Computing, a Master of Science degree in Artificial Intelligence and a Ph.D. in Chemoinformatics. He has published 34 papers, 10 book chapters and three books.
Dr. Allan Ader is co-founder and Managing Director for SafeBridge Consultants, Inc., the premier resource for high level risk assessment, safety, health and environmental support to the biotechnology and pharmaceutical industry, located in Mountain View, CA. Dr. Ader has extensive experience in:
• Developing Occupational Exposure Limits and assessing compounds for toxicity and potency for compound categorization / banding and recommending handling practices and controls based on the toxicity/potency characteristics;
• Assisting companies in testing of chemicals for their toxic effects and interpreting data from these tests,
• Performing health-based risk assessments including evaluating toxicological and exposure information to determine potential health effects of chemicals, and
• Responding to crises caused by occupational health illnesses from chemicals by assessing and evaluating risks and communicating them to employees and management.
Dr. Ader has over 35 years of experience in the pharmaceutical and chemical industry including working for Syntex, Inc. in Palo Alto, CA and Olin Corporation, New Haven, CT. He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University. He is a Diplomate of the American Board of Toxicology.
Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E.
Ilaria Coccoglioniti has a Master’s Degree in Safety Assessment of Xenobiotics and Biotechnological Products from the University of Milan, Italy (2021). Her role at Eurofins Biolab is to perform toxicological evaluations after Extractable & Leachable studies are performed on medical devices and pharmaceutical products primary packaging and production processes.
Carsten has 20+ 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. He is a member of the International Standardisation Organisation Technical Committee 194 working group for several biocompatibility standards of medical devices (ISO 10993 series), handling the assessment of pharmaceutical excipients, impurities and leachables from materials of construction used in delivery devices and manufacturing of drug products. Carsten is a driver of innovation in strategies and development of state-of-art practices for health risk assessment of polymer materials.
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 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, where her detailed knowledge of rubber formulations provides an interesting perspective.
Dr. Roberto Menzel graduated from FSU University Jena and holds a Ph.D. in Chemistry. He started his career as an assistant editor in the natural science book section at Wiley followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech where he is heading the internal analytical laboratory and Extractables group. The main working areas are material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. He authored several articles on the characterization of plastics and SU devices regarding extractable compounds.
I completed my PhD in Analytical Chemistry at the end of 2019 and began working for Smithers in January 2020 as a Senior Analyst, specializing in LC-MS analysis. My PhD involved developing methods for metabonomic studies using high resolution LC-MS analysis. In May 2021 I became Principal Scientist and alongside other responsibilities I now use my previous method development and LC-MS experience to develop and validate methods for leachables studies in an E&L environment.
Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.
From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.
Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
Ferran obtained his PhD in Pharmaceutical Sciences at the University of Barcelona in 2005 and has been involved with mass spectrometry ever since. He has worked for SCIEX for 15 years holding different positions in sales, marketing and business development covering the EMEAI region. During this time, Ferran has been working closely with customers in the pharmaceutical industry to deepen his understanding of the market and user needs and help deliver the right solutions at the right time.
Markus Obkircher is Director R&D heading Merck’s Reference Materials and Proficiency Testing division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation with a strong focus on quantitative NMR. Prior to this position he was R&D Manager in Buchs, Switzerland, with a strong focus on synthesis, characterization and certification of reference materials. He joined Merck / Sigma-Aldrich eight years ago after heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, and further holds an executive MBA degree from the University of Zurich.