Dr. Laurence J. Harris joined Pfizer in Sandwich, UK, in 1999 as a process de­velopment chemist in chemical research and development (CRD), where he led project teams, API technology transfer, new API technology and green chemistry implementation programs. In 2008 he joined the analytical research and develop­ment (ARD) department in a team leader role before moving into the GMP ana­lytics function of ARD. He is currently a director within the global GMP analytics function with responsibilities for stability testing, drug product release, excipients and packaging component release. Since 2014 he has been leading efforts within Pfizer worldwide research and development to fully understand and implement ICH Q3D into the development workflow. This role has resulted in him becoming a key contributor to the cross-industry consortium working towards the delivery and use of the Lhasa elemental impurities excipient database in ICH Q3D risk as­sessments. In 2019 he is the industry co-chair for the Lhasa/industry consortium.

Dr. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland, as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety and is responsible for the QSAR predictions and impurity/excipient assessments at Novartis. Currently, Susanne is head of the in silico and impurity safety group in preclinical safety at Novartis.

Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University Wuerzburg and obtained his PhD in biochemical toxicol­ogy in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis glob­ally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in com­bination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the White Paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally he is member of the task force to support the in-house implementation of ICH M7.

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to chemistry manufacturing and control (CMC) project manager. During his GSK career, Mike has led the primary development / delivery of 10 products, spanning early through to late phase development. Mike’s current roles are GSK CMC due diligence lead for small molecules and co-chair of the Genotoxic Risk Assessment (GRA) review team, where he is GSK subject matter expert. Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium.