Senior Director Impurity Expert

Teva Pharmaceutical Industries Ltd

In-person

Raphael has over 20 years of pharmaceutical industry experience. He has a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, a post-doctorate at the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and another post-doctorate at Duke University Medical Center, North Carolina.

In 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals. In 2010 he established the Chemical & Computational Toxicology group in Teva, and now he is Senior Director Impurity Expert in R&D Operations. Raphael’s main topics of expertise are impurity and excipient qualification in drug substances and drug products. Over the past few years he has specialized in risk assessment of nitrosamine impurities in pharmaceuticals.

Head Analytical Research

Sandoz

In-person

Rok Grahek received his B. Sc in Chemistry and his Ph.D. in Science from the University of Ljubljana, Slovenia.
In 1986 Rok was employed in Research and development in Lek Pharmaceuticals d.d.. Slovenia.
As a researcher he started with GC and after few years HPLC and MS became his main area of interest in connection with impurities in drugs. Trace analysis of impurities (Genotoxic Impurities, Synthetic Tracers, Nitrosamines) with LC-MS and GC-MS is an important area of Rok’s research.
For the past 25 years Rok is leading a group or researchers dealing mainly with impurity profiles, impurities isolation, identification, and trace analytics.
Rok is author or co-author of nearly 40 patents and scientific papers and more than 50 scientific conference contributions.

Principal Scientist

Abbott Healthcare Products B.V

In-person

TBA

Technical Specialist EMEAI

SCIEX

In-person

Jack joined SCIEX in 2019 as a technical specialist, his main responsibilities include the creation and proliferation of technical marketing content such as application notes and presentations as well as having a strong focus on the pharma market and small molecule analysis. Prior to joining SCIEX, Jack was employed by a CRO working mainly in small molecule method development and validation, with an emphasis on LC and LC-MS analysis.

President

Florian Consulting in Toxicology and Safety Assessment, LLC

In-person

Vincent L. Reynolds, PhD, DABT is a toxicologist with over 3 decades of experience in the chemicaland pharmaceutical industries. He completed his undergraduate degree (Chemistry/Biology) at theUniversity of Delaware and his PhD (Toxicology) at the University of Kentucky where his studieselucidated the molecular structure and DNA sequence specificity of several DNA-reactive antitumorantibiotics. He pursued postdoctoral studies on metabolic effects of oncogenes at Fox Chase CancerCenter in Philadelphia and then worked for 12 years in the chemical industry with DuPont and DowCorning where his activities included study director roles in genetic and general toxicology, riskassessment to support workplace exposure guidelines and environmental remediation, and thedesign and oversight of developmental/reproductive toxicity studies of commodity chemicals andconsumer product components. Dr. Reynolds recently retired as a Senior Director after 23 yearswith Eli Lilly & Company where he was responsible for the design, conduct, and oversight of thefull range of nonclinical safety assessment studies required to support regulatory filings andclinical trials for numerous small molecules, biologics, monoclonal antibodies, epigeneticmodulators, and siRNAs indicated for the treatment of cancer, metabolic disorders, and neurodegenerative diseases. He has provided numerous lectures on toxicology topics for graduate-levelcourses at the University of Delaware, University of Illinois-Urbana, and University of Cincinnati.Dr. Reynolds has chaired, co-chaired, or contributed to numerous symposia and ContinuingEducation sessions at national and international meetings, and has authored/co-authored over 80publications, abstracts, and book chapters on a broad range of toxicology topics. As an independentconsultant, Dr. Reynolds now brings his deep expertise in developing and applying innovativeexperimental strategies to assist clients seeking to resolve a range of toxicology issues and concerns.

Associate Professor

Swansea University

In-person

George is an Associate Professor at Swansea University, Wales UK. He continues to work with the invitro Toxicology group in the Institute of Life Science.

He is a steering member of the Health and Environmental Sciences Institute (HESI) GeneticToxicology Technical Committee (GTTC) and co-chair of the quantitative workgroup, working onprojects including nitrosamine impurities.

George has worked on projects with US-FDA-NCTR, BfArM, European Medicines Agency (EMA), Health Canada, RIVM-Netherlands, Food Standards Agency along with the pharmaceutical industry and many other companies.

George has won both the UKEMS and EEMGS young scientist awards, and was voted in as President of the EEMGS society in 2019.

George has recently become a consultant, with clients including the pharmaceutical, food additive, fragrances, agrochemical and chemical industries. A major aspect of many of these projects has been the derivation of point of departure metrics for use in human health risk assessments.

Former Head of Division A EDQM

Council of Europe

In-person

Dr. Rose is pharmacist by training and obtained his PhD in pharmaceutical chemistry in 1985.Before joining the EDQM in 1991 he was assistant professor and lecturer for pharmaceutical analysisand physico-chemistry at the University of Mainz in Germany.

Until 2011 he was responsible for the establishment and monitoring of Ph. Eur. reference standards in the European Pharmacopoeia laboratory. Moreover, he was involved in the elaboration and revision of Ph. Eur. monographs. After that he became co-ordinator and auditor for EDQM’s Mutual Joint Audit program. Within this function he audited the Official Medicines Control Laboratories in and sometimes outside Europe. Since 2014 he has been head of division A and deputy head of the European Pharmacopoeia department where he was overlooking the monograph work on chemically defined substances, herbals, medicinal products and general chapters and was involved in the international harmonisation of pharmacopoeias.

He is retired since March 2022 but still active as trainer for different topics like reference standards, impurity control, quality control of herbals or Pharmacopoeias.

Scientific Manager Toxicology

B. BRAUN MELSUNGEN AG

In-person

Dr. Alina Martirosyan is a European Registered Toxicologist with a doctoral degree in biochemistry.She is experienced in non-clinical evaluation of pharmaceuticals and medical devices. In her currentrole she is planning, coordinating and managing non-clinical studies for pharmaceuticals,performing biological risk assessment of medical devices and toxicological risk assessment ofchemical constituents. She is acting as an expert in ISO/TC 194 for the ‘Biological and clinicalevaluation of medical devices’.

Scientist Computational and Systems Toxicology

Sanofi

In-person

Jan Wenzel studied chemistry at the Goethe University Frankfurt, focusing research projects in computational quantum chemistry. His PhD was received from the University of Heidelberg, where he conducted fundamental research for simulation of X-ray absorption spectroscopy. Afterwards, Jan started as PostDoc at Sanofi in Frankfurt. The project’s focus was on artificial intelligence methods and deep learning in the field of safety big data analytics, to advance the capabilities to analyze, predict and optimize safety parameters of novel drug candidates. Currently, Jan is Scientistfor computational and systems toxicology at Sanofi. Besides QSAR and artificial intelligence topics in the field of preclinical safety, Jan also supports the analysis of the genotoxic potential of N-Nitrosamine impurities with computational quantum chemical methods.

Director Safety & Toxicology

Frontage Laboratories

In-person

Dr. Bhalli received his Ph.D. in Biotechnology in 2009 from the National Institute for Biotechnologyand Genetic Engineering (NIBGE), Pakistan in a collaborative program between NIBGE, Pakistanand University Autonoma de Barcelona (UAB), Spain. His research topic was “GenotoxicEnvironmental Risk Assessment of Pesticides Using Molecular Biomarkers”. Dr. Bhalli joinedNational Center for Toxicological Research (NCTR), US Food and Drug Administration (FDA) in 2008as postdoctoral fellow and played a pivotal role in the development of in vivo gene mutation assay,the Pig-a assay. He contributed making this assay high throughout and studied novel compoundsto evaluate the potential of the assay to detect the compounds which are gene mutagens only and todifferentiate between week and strong mutagens. Dr. Bhalli is one of the authors of the Pig-a OECDTest Guideline. Dr. Bhalli worked as Study Director and Associate Director of Genetic and GeneralToxicology at Covance and Millipore Sigma between 2012 and 2021. He is currently working asDirector of DMPK, Safety and Toxicology at Frontage Laboratories. His area of interest for the past10 years has been pre-clinical drug development with focus on toxicology and safety assessment ofthe potential drug candidates. Dr. Bhalli is an active member of the US Environmental Mutagenesisand Genomics Society (EMGS), Society of Toxicology (SOT), and American College of Toxicology.Dr. Bhalli is a European Registered Toxicologist (ERT) with Royal Society of Biology. He has publishedover 50 research papers and book chapters in peer reviewed journals.

Principal Expert Quality Control Systems

Merck Healthcare KGaA

In-person

Joerg Schlingemann is a Director and Principal Expert for Quality Control Systems within Merck KGaA’s / EMD Serono’s Healthcare Quality Unit. He studied Molecular Biology in Uppsala and Heidelberg, where he completed a Doctorate degree at German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry from various roles within Quality Control and Quality Assurance. Since late 2019 Joerg is leading EMD Serono’s analytical activities for N-nitrosamines. Joerg is married and has three children.

Head of in Silico &I mpurity Safety

PA Consultingaceuticals

In-person

Dr. Susanne Glowienke graduated at 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. She joined Novartis, Basel, Switzerland, in 2000 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 a Director in Preclinical Safety at Novartis, Basel, Switzerland. She held several positions at Novartis including positions in Genetic Toxicology and QSAR modelling. She is currently head of the Impurity Safety group and as such responsible for contaminant issues including nitrosamines. Susanne is part and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE) and several data sharing initiatives.