Hall Analytical Laboratories
Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections.
Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.
Charles E Ducker
Eurofins Medical Device Testing
Bio coming soon!
Dr. Matthew Jorgensen
Senior Extractables and Leachables Expertat
I am a seasoned scientist with a diverse background in chemistry and material sciences. Currently I focus my efforts on using chemistry in the evaluation of medical device biocompatibility. My academic work has focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. I have a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles.
At Nelson Labs I draw on my chemistry and materials experience as well as my research acumen to create solutions for sponsors with interesting and challenging problems facing the assessment of their devices.
Senior Director, Analytical Chemistry and Regulatory Toxicologyat
Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry and Regulatory Toxicology departments based in St Paul, Minnesota supporting manufacturers of pharmaceuticals, medical devices and combination products. With over 30 years’ analytical experience and over 10 years specializing in international support for extractable and leachable studies, including Toxicological Risk Assessments and Safety Assessments, Sandi and her team have supported thousands of products. Ms. Schaible is also an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Benton Cartledge, Ph.D.
Dr. Cartledge is an associate research scientist with the extractables and leachables group at PPD® Laboratories in Middleton, Wisconsin. In 4 years at PPD, he has performed extractables and leachables studies including routine stability testing, controlled extraction studies, method development and validation, and medical device studies. He has successfully executed many programs leading to drug product approval by the FDA.
Robert E. Malick
Principal Research Scientist II, Combination Products, Operations Science & Technologyat
Robert Malick is a Principal Research Scientist II in Operations Science & Technology Combination Products with AbbVie. He started his 30th year at AbbVie/Abbott having joined after receiving his Ph.D. in Analytical Chemistry from the University of Cincinnati. Robert has been active in extractable & leachables since 2006 for dosing devices and container closure systems ranging from metered dose inhalers to implantable devices. He has spoken at several conferences, chaired industry working sessions and has several publications in the E&L field. Robert is active with industry consortia including ELSIE (Extractables and Leachables Safety Information Exchange), currently serving as Co-Chair of the Materials Safety Working Group and representing AbbVie on the ELSIE Board of Directors.
Manager - Chemical Sciencesat
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.
Center Devices and Radiological Health, Office of Science & Eng. Lab., US Food & Drug Administration
Candice Johnson, Ph.D.
Candice Johnson, Ph.D. is a Research Scientist at Leadscope, Inc. She is working alongside an international consortium to develop in silico protocols for the assessment of skin sensitization, respiratory sensitization, and skin irritation/corrosion.
One of the aims of her work is to present a harmonized strategy for integrating in silico assessments of biological pathways which are relevant to each of the aforementioned endpoints. She is particularly interested in approaches used to derive a confidence measure in integrated assessments.
Dr. Johnson’s experience includes developing dose-response models and computational methods for environmental mixture assessments.
Scientific and Educational Affairs Managerat
Thermo Fisher Scientific
Bio coming soon!
General Manager E&Lat
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 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.
Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development. Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.
Dr. Norwood is an internationally recognized expert in the field of E&L assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on E&Ls in inhalation drug products. He is also a member of the PQRI Working Group on E&Ls in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on E&Ls.
Technical Scientific Liaisonat
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.