Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Dr. Reinhard Stidl is Managing Director of the independent consultancy office Safetree Consulting e.U., founded in 2018. Reinhard holds a Master in Chemistry (University of Vienna, 2002), a PhD in Chemistry (University of Vienna, 2007), a Master of Advanced Studies Toxicology (Medical University of Vienna, 2007) and is EUROTOX registered toxicologist (ERT) since 2011. Before working as a consultant, he gained more than 10 years of experience as a Toxicological Risk Assessor and team leader at Baxter, Baxalta, and Shire, where his last assignment was Associate Director Toxicological Risk Assessments.

 Dr. Stidl is an internationally known expert in chemical safety assessment in the context of pharmaceuticals since 2010, with a strong focus on extractables and leachables (E&L). During the assignments in the pharmaceutical industry, he was responsible for the global design and refinement of the global safety assessment strategy within Baxter, Baxalta, and Shire. Today, he provides his expertise to clients around the world, assisting in making pharmaceutical and medical products safe for patients.

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010, he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry.

With over 25 years’ experience in the Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Devices, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory-controlled industries are challenged by ongoing regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from the Life Industry or organizations to work together to realize or achieve a better and effective cross-departmental collaboration to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Mike has over 25 years of experience as an analytical chemist specializing in the characterization of pharmaceutical drug products, storage devices, and delivery systems. He joined LGC in 1998 as part of a multi-disciplinary chromatography and spectroscopy function and has played a key role in establishing the current E&L testing services within LGC’s Drug Development Solutions Group. Mike is a regular contributor to events concerning E&L and traces impurity analysis.

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and provides support for companies developing New Approach Methods (NAMs) that can serve as alternatives to animals models for toxicity testing. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is a founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis. 

Dr. Elizabeth Martin is currently based in Cambridge, UK and is a Senior Director at AstraZeneca with the joint role of Project Toxicologist and Strategic Impurities Toxicology Lead. She is a European Registered Toxicologist. Dr. Martin gained her PhD at the University of Wales, before joining the Medical Research Council Toxicology Unit where she led a research group focused on assessing the consequences of DNA damage and their use in predicting carcinogenic risk. Dr. Martin joined AstraZeneca in 2001 and in her current role supports the portfolio with the safety assessment of impurities, including the risk assessment of Extractables & Leachables.

Dr. Tino Otte is the Head of Sales and Consulting at Intertek in Switzerland. He joined the company in 2016. Tino is specialized in Extractables & Leachables Studies, Impurity Characterization, and Method Development. Tino has more than 13 years of experience in Analytical Chemistry, Pharmaceuticals, and Polymer Characterization. He holds a degree in Polymer-Chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. Prior to joining Intertek, he worked at different CROs and Laboratory Instrument Manufacturers in Switzerland and Germany.