Tobias Weimer

Product Specialist LC-MS

Agilent Technologies Deutschland GmbH

Tobias Weimer hat in Marburg an der Philipps Universität Chemie studiert. Seine Leidenschaft für die analytische Chemie und Chromatographie wurde bereits in der Oberschule geweckt und im Studium vertieft mit einer gezielten Ausrichtung auf analytische Trenntechniken. Über die Flüssigkeitschromatographie im Bereich LC Säulen führte Ihn sein Weg zu LC-Systemen.

J. Susanne Becker

Head of Extractables and Leachables Labs

Intertek (Schweiz) AG

J. Susanne Becker did her Ph.D. at the University of Konstanz in Analytical Chemistry in the field of Proteomics and Organic Mass Spectrometry. After several years’ experience in the pharmaceutical industry at Aeropharm and Baxter as Analytical Expert and Project Manager, she joined Intertek (Schweiz) AG in April 2016, where she is working as Project leader in E&L and since 2021 as Head of Extractables and Leachables Labs.

Will Parker

E&L Technology Manager

West Pharmaceutical Services

Will Parker earned a B.S. in chemistry in 2004 from Penn State Erie where he will soon be serving on a School of Science alumni advisory board and will be earning a master’s degree in data analytics from Penn State in May 2024. Will has over 18 years of analytical chemistry professional experience with 13 of them in extractables and leachables labs as both a lab scientist and manager. He has spent the past nearly 8 years in lab management roles, mostly in E&L, with his current role as the E&L technology manager at West where he assists Services and Solutions in meeting industry expectations and our clients’ needs. Will has designed and executed hundreds of various E&L studies comprising the breadth of the field including studies of drug product packaging, manufacturing in-process contact materials, single-use systems, and medical devices.

Ana Kuschel

Principal Scientific Affairs

West Pharmaceutical Services

Ana Kuschel as Principal Scientific Affairs Europe is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This is complementing her previous role as Manager Material Development, where she worked on both existing and new rubber formulations.
Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.

Armin Hauk

Principal Scientist

Sartorius Stedim Biotech GmbH

Armin Hauk has a position as Principal Scientist at Sartorius Stedim Biotech GmbH since 2016. Before that he was over 20 years active as head of laboratories for organic trace-analysis, GLP & GMP analytics in Ciba-Geigy, Novartis, and Ciba Specialty Chemicals. For Intertek, Switzerland he worked as consultant and Qualified Person (QP). Armin is a lecturer and trainer in E&L at conferences and seminars and is a member of various industry consortia (BPSA, BPOG, DECHEMA, and MIT BioMan). He is chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).

Katherine Lovejoy

Application Chemist

Thermo Fisher Scientific

Katherine Lovejoy is an Application Chemist at the Thermo Fisher Scientific production site for HPLC and for the charged aerosol detector. She has 7 years of experience in that role and enjoys helping others get the best possible CAD results. She earned a PhD in Inorganic Chemistry from the Massachusetts Institute of Technology and has a h-index of 15. Her experience also includes time as a chemist reviewer at the FDA and a scientist at Los Alamos National Laboratory.

Jason Creasey

Managing Director

Maven E&L Ltd

Jason Creasey is a graduate analytical chemist. In 2019, he established Maven E&L Ltd, as its Manging Director and Principal Consultant. Maven E&L was setup to provide advice to clients working in the pharmaceutical industry on all aspects relating to the topic of extractables and leachables (E&L) and the risks that leachables pose to the quality and safety of drug products. Prior to this, he worked for GSK where he was the director of their R&D E&L Team.

He has worked in the topic area of E&L since the mid 1990’s on a wide range of modalities and dose forms seeing this area expand and grow in significance for the pharmaceutical and medical device industries. In addition to running his consultancy, he is a scientific advisor to the ELSIE consortium. Since setting up Maven E&L; he continues to present, discuss, and write about E&L. He now publishes a regular E&L blog through LinkedIn and his Website (www.MavenEandL.com), for the exchange of ideas and discussion.

As well as supporting client projects, among recent E&L activity, he is presenting and commenting on risk- based approaches to E&L requirements within the pharmaceutical industry that he hopes will form part of an ICH guidance in the not-too-distant future and has helped ELSIE publish and discuss their whitepapers linked to Concepts in Leachable Risk Management and develop their database further.

Divya Regulagedda

Manager (Global SME)

Chemo Group

Divya Regulagedda is analytical person from technical perspective and have experience in the field of E & L for 11+ years. She has hands on experience with LC-MS/MS, LC-QTOF, GC-MS/MS, ICP-MS and IC.
Previously, she worked with a CRO and was responsible for the work of E &L.

Currently, she is responsible for the E & L work in Insud Pharma for Pharmaceutical products and medical devices.
Also, she has experience with risk assessments and toxicological evaluations.

Dr. Jianwei Li

Principal E&L and Chemical Characterization Consultant and Technical Writer

Chemical Characterization Solutions LLC

Dr. Jianwei Li is currently the principal E&L and chemical characterization consultant, and chemistry writer at Chemical Characterization Solutions LLC. He worked at Medtronic for nearly 17 years as a technical fellow and subject matter expert in the chemical characterization of medical devices. Over the course of his nearly 30-year academic and industry career, he has published extensively in the area of analytical chemistry with nearly 50 publications, eight of which were devoted to the chemical characterization of medical devices over the last three years. He also served as frequent scientific reviewers for over ten international journals.
He received his PhD in analytical chemistry from Purdue University, and did his postdoctoral research @ University of Minnesota.

Candice Johnson, PhD

Senior Research Scientist

Instem

Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. Dr. Johnson has co-authored several peer-reviewed publications 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 supports 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.