Lee Mia Nagao, Ph.D. advises domestic and international clients in the areas of evaluation and
regulation of pharmaceutical development and manufacturing. She also advises clients on
pharmaceutical packaging and materials issues, pre-clinical toxicology, auditing, current Good
Manufacturing Practices (cGMPs), supply chain issues, drug master files and other regulatory
submissions. Lee has experience with the development of methods and standards requirements for
drug products and the scientific development and regulation of medical countermeasures (vaccines
and therapeutics) for biosecurity applications. She has broad scientific interests and experience, and
represents industry groups before the FDA, Health Canada, EMA, MHRA, CFDA, ANVISA, USP and other regulatory, standards, industry and scientific organizations world-wide.
Pharmacist and doctor in toxicology with emphasis on degradation products. 10 years of experience in degradation chemistry, including stress testing, development of stability-indicating methods, identification and qualification of degradation products. She worked at Aché Laboratórios Farmacêuticos as senior researcher and, nowadays, is a consultant in the area impurities assessment that includes degradation products, mutagenic impurities, elemental impurities and extractable and leachable, offering both analytical and toxicological support at Spektra Consultoria, at which is founder.
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.
Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and became board certified in general toxicology (DABT) in 2003. Doug is a full member of the American College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, VP and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). Doug was employed as a toxicologist at Sandoz (now Novartis) and Boehringer Ingelheim. Doug has assumed various project and regulatory strategy roles and is currently a Research Fellow in Regulatory Strategy and Compliance at Pfizer. Doug has been the Nonclinical Drug Safety Team Lead for 5 drug product approvals, the most recent being Xeljanz (tofacitinib citrate) for the treatment of rheumatoid arthritis.
A recognized expert in the evaluation and qualification of E&L in drug products. He co-chaired a PQRI L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (OINDP, 2006). Doug serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products (PODP), the Co-Topic Lead for the International Conference on Harmonisation (ICH) Expert Working Group (EWG) and Implementation. Working Group (IWG) for Elemental Impurities (Q3D), an Expert Panel member for USP <381> Elastomeric Closures for Injection and Biocompatibility <87> and <88>, and is past Chair and current Board member of ELSIE.
Dr. Allan Ader is co-founder and Principal Toxicologist 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 25 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.
Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During his tenure, Jordi labs has experienced 14 years of consecutive growth and has become a leader in the polymer analysis industry. Jordi provides over 2,000 analyses annually and offers more than 60 analytical techniques serving a wide range of industries including the chemical, pharmaceutical, and medical device industries. Dr. Jordi completed his B.S. in chemistry at Olivet Nazarene University and his Ph. D. at the University of Connecticut in the materials science division. His primary interests include development of improved strategies for identification and quantification of Extractables and Leachables as well as chromatographic and mass spectrometric analysis. Dr. Jordi is also an inventor and has developed a number of novel chromatographic stationary phases, some of which are patented.
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.
Dr. Dujuan Lu has been leading the extractables and leachables (E&L) team at SGS Fairfield New Jersey site since 2015. She has extensive pharmaceutical industry experience with more than 200 E&L studies on a broad range of container closure systems, including pharmaceutical finished packaging, process equipment (SUS, MUS, etc) and medical devices. Before joining SGS, she was working at Fresenius Kabi, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has more than 10 years of experience on trace analysis by LC/MS and GC/MS.
Dr. Dujuan Lu obtained her PhD in analytical chemistry from the University of Pittsburgh. She has authored more than 10 peer-reviewed journal publications with more than 300 citations. She has more than 20 international conference presentations as invited speakers and technical session chairs. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories.
From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).
From 2001 onwards, Mr. Christiaens held the position of Scientific Director at Toxikon Europe where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries.
Currently Mr. Christiaens oversees all laboratory operations at Nelson Labs NV and is also giving support to the European business development.
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.
Simone Biel is a Regulatory Consultant providing regulatory and scientific expertise to customers and internal stakeholders focusing on Single-Use Technology (SUT). Over the last years, she supported biopharmacuetical drug manufacturer's implementation of SUT in their manufacturing process to ensure that product performance meets quality and regulatory requirements. Simone holds a PhD from the University of Frankfurt in Microbiology.
An analytical scientist by training, Mike graduated from the University of Nottingham with a PhD in flavour and aroma science in 2004. The sample preparation and trace analysis experience gained during his time analysing and modelling the real time release and delivery of common flavour substances facilitated the transition into Pharma, and specifically the area of Extractables & Leachables. Over the past 12 years, Mike has held roles of increasing responsibility within GSK and Pfizer, where he has been accountable for defining and executing the regulatory strategy that mitigates the risk of patient exposure to leachables for a variety of product types including inhalation (DPIs and MDIs), parenteral (LVP, PFS and lyophilised formulations), biopharmaceutical (manufacturing processes, primary container closure and administration) and most recently cell & gene therapy products. In October 2016 Mike joined the Advanced Chemical and Investigations group within Baxter as a Senior Research Manager of the Extractables and Leachables Team. Areas of technical interest include coupling micro-extraction and enrichment techniques to high end chromatographic and mass spectrometry instrumentation in a highly automated fashion to enable the creation of large databases that support a scientifically led risk based approach through effective retrieval of knowledge and collaboration with the material supply chain.
Dr. Sahotra got his BSc in Chemistry from the University of Central Lancashire, followed by MSc in Drug Chemistry from Newcastle University. In 2018 he completed his PhD in organic chemistry. Since then he has been working for Markes International, specialist in thermal desorption technology. His current job involves the sampling and analysis of air borne chemical from products and materials.
Benton Cartledge is a senior scientist with the extractable and leachables group at PPD® Laboratories. He received a bachelor’s degree in chemistry from the University of Indianapolis (Indiana, USA) and Ph.D. in analytical chemistry from the University of Denver (Denver, CO).
As general manager, Paul is responsible for the Smithers Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers Rapra’s existing analytical and physical testing laboratories.
Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services. He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck.
Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army.
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.
Yanxin Luo, PhD, scientist of Process Development at Amgen. She is responsible for extractables/leachables and non-conformance investigations related to single-use systems, primary containers, and manufacturing processes.