With over 30 years’ experience, Sandi Schaible is responsible for oversight and direction of WuXi AppTec’s analytical chemistry and regulatory toxicology departments in St Paul, Minnesota, USA. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterisation and target analysis testing, method development, and method validation, as well as completing risk assessments and biological evaluations.

Sandi received her bachelor's in chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental, and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA, and ISO regulated laboratories. She provides technical guidance and testing program design, and is an international and US delegate for TC 194, the technical committee for ISO 10993.

Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the pharmaceutical industry, 10 of them as manager to the toxicology group. She's the main or co-author of several papers and posters, has published in peer-reviewed journals, and she's an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy company specialised in toxicological risk assessment and regulatory toxicology.

Dr. BM Rao possess a PhD in chemistry and has about 31 years of work experience in pharmaceutical analytical R&D, quality control, and assurance functions in reputed organisations including Janssen (pharmaceutical companies of Johnson & Johnson), Novartis, Zydus Cadila, Nicholas Piramal, and Dr. Reddy’s. He has extensive hands-on experience on analytical instruments related to chromatography, spectroscopy, and thermal analysis. He has exposure to various regulatory audits includes USFDA, EMEA, TGA, Health Canada, etc., and worked with reputed international consultants in QC remediation. He has about 80 scientific publications in reputed peer reviewed national/international journals and successfully guided eight part-time PhD candidates. During his professional career he has been recognised for his contributions at work and won awards including Chairman’s Excellence Award from Dr. Reddy’s Laboratories (Feb. 2018 and Jan. 2003), Standards of Leadership from J&J at Janssen, Mumbai site (2010), and Best New Leader Award at SAI Life Sciences Limited (2013). He has extensively travelled to USA, Mexico, Germany, Belgium, Singapore, Brazil, and Malaysia, and interacted with several big and emerging biotech pharmaceutical analytical and quality experts. Since September 2015, he has been working as head of quality for emerging markets, analytical science and technology (ASAT), and corporate quality control at Dr. Reddy’s Laboratories and providing technical leadership to the analytical method validations/transfers and quality control labs of APIs and formulations.

Dr. Jianwei Li is currently the principal E&L consultant and chemistry writer at Chemical Characterization Solutions LLC. He worked at Medtronic, a leading global medical device company, for nearly 16 years as a technical fellow and subject matter expert in chemical characterisation. He also worked in the pharmaceutical industry for eight years. Over the course of his nearly 23-year industry career, he has published extensively in the areas of analytical chemistry with nearly 50 publications and four patents and has frequently served as a scientific reviewer for over 10 international journals.

He received his PhD in analytical chemistry from Purdue University, USA, and did his postdoctoral research at the University of Minnesota, USA.

After studying molecular biology at Bielefeld University and graduating with a PhD in genetics and molecular biology in 2005, Dr. Steven Watt was granted a position as an assistant professor. There, he was in charge of a mass spectrometry service unit, dealing with proteome and metabolome projects. In 2009, he joined a vendor of scientific instruments as an instructor for pharmaceutical mass spectrometry applications. In his current position as head of business development at A&M STABTEST, he is in charge of customer relations, marketing, and sales. He also acts as scientific advisor for the development of new analytical services in the field of biopharmaceutical analysis.

Nick Morley is a principal scientist at Element Materials Technology responsible for providing technical support to new and existing pharma, med device, and consumer products for customers in the field of extractables and leachables. He has over 15 years of experience in the field of E&L, both in large pharma and at a CRO. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments, and authoring E&L regulatory sections. Nick is the E&L expert on the British Standards Institute (BSI) and European Standards Committee (CEN) for electronic cigarettes and e-liquids. Nick has presented on a number of different E&L related topics internationally and has developed and run pre-conference workshops on E&L assessment at a number of international conferences.

Prior to joining Element Material Technology, Nick spent over 10 years at GSK in the field of E&L. 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. Whilst at GSK, Nick was a member on one of the ELSIE (Extractable and Leachables Safety Information Exchange) working groups.

Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master's and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). Paulo's experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the global discovery chemistry department. After that Paulo worked mainly in regulatory affairs, quality audits, and drug product and drug substance development with focus on impurities control, including E&L, mutagenic impurities, such as nitrosamines, in his own consulting company, Integra Consultancy. Paulo also is a founder of another company, BIND, which is a startup for synthesis and characterisation of analytical standard for development processes, and teaches postgraduate courses that cover various pharmaceutical topics.

Simone Biel is a Senior Regulatory Consultant and provides regulatory expertise to our customers and internal stakeholders with a focus on Single-Use Technology and filtration. Over the years, Simone has supported biopharmaceutical drug manufacturer’s implementation of Single-Use Technology in their manufacturing process and gained a deep understanding of market needs and industry trends in this field. Her objective is to ensure that product performance meets quality and regulatory requirements.

Simone holds a Ph.D. from the University of Frankfurt in Microbiology.

Mike Ludlow is science lead for the analytical and materials science division within Drug Development Solutions (formerly LGC). He is an analytical chemist with over 25 years’ experience in chromatographic and spectroscopic techniques, specialising in the area of extractable and leachable testing and impurity characterisation.

In his current position, Mike provides technical support to operational and commercial colleagues and to an extensive client base, primarily focussed on the pharmaceutical and consumer healthcare sectors. He has presented at numerous international events on topics including extractables and leachables, genotoxic impurity analysis, and experimental design.

Mike is currently on the Register of Specialists for the UK Government Office of Product Safety and Standards (OPSS). He previously worked for ICI Chemicals and Polymers division where he was responsible for the NMR area providing support to the research function at Runcorn in the UK.

Mike holds a BSc Hons in applied chemistry, an MSc in analytical chemistry, and an MBA from Warwick Business School.