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4th Impurities: Genotoxic and Beyond Summit

  • 15th – 16th September 2020
  • Zoom flag Zoom
  • ONLINE (CET)

This premier B2B summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic and elemental impurities identification and control.  

It is an honor and privilege to invite you to participate in our virtual Summit. Don’t miss out on this opportunity to discuss ideas with your peers. Request the brochure.   

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About

The Summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic and elemental impurities identification and control. 

It is an honor and privilege to invite you to participate in this virtual Summit.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specializing in:

  • ADC (Antibody Drug Conjugates)
  • Analytical Science
  • API Development
  • Assay Development
  • Biotherapeutics
  • Carcinogenic Impurities
  • Carcinogenicity
  • Carcinogens
  • Chemistry (Analytical, Organic,
  • Medicinal, Protein)
  • Chromatography
  • Degradation Products
  • DNA Reactive Impurities
  • DNA Reactivity
  • Drug Design
  • Drug Development
  • Drug Discovery
  • Drug Safety
  • Drug Substance
  • Elemental Impurities
  • Extractables & Leachables
  • Formulation
  • Genetic Toxicology
  • Genotoxic Impurities
  • Genotoxicity
  • Genotoxin
  • GMP
  • Good Laboratory Practice
  • GRAs
  • GTIs
  • Impurities
  • In Silico
  • Large Molecule
  • LC-MS
  • Mass Spectrometry
  • Microscopy
  • Mutagenic Impurities
  • Mutagenicity
  • Nanomaterials
  • Nanoparticles
  • New Modality
  • Oligonucleotide
  • Organic Synthesis
  • Particles
  • Peptide
  • PGTIs
  • Preclinical Drug Safety
  • Process Chemistry
  • Process-Related Impurities
  • Product-Related Impurities
  • Protein
  • Purification
  • Purge Factors
  • Quality Assurance
  • Quality By Design (QbD)
  • Quality Control
  • Regulatory
  • R&D
  • Safety Assessment
  • Small Molecule
  • Spectroscopy
  • TDI
  • Technology Transfer
  • Threshold of Toxicological Concern (TTC)
  • Toxicology
  • Validation

Key Practical Learning Points

  • Recent experience and perspectives on compliant implementation of ICH M7 and Q3D
  • Risk assessment of potentially genotoxic impurities and safety testing: critical issues and best practices for regulatory submissions
  • Extractables and leachables, elemental impurities in drugs and biologics: quality concerns, recommendations for comprehensive evaluations, upcoming changes in standards and regulations
  • Regulatory, toxicology, analytical practice for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
  • Valsartan incident and its implications for ICH M7

Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

About Speaker

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

About Speaker

Dr. Alessandro Brigo, CH

Toxicology Project Leader, Pharmaceutical Sciences / Roche Pharma Research & Early Development

Roche Innovation Center Basel

About Speaker

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

About Speaker

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

About Speaker

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

About Speaker

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

About Speaker

Dr. Tom van Wijk, NL

Senior Scientist / Analytical Science and Technology

Abbott Healthcare Products BV

About Speaker

Dr. Catrin Hasselgren, US

Principal Scientist

Genentech

About Speaker

Dr. Frank Liu, US

Associate Director, Head of Product Characterisation & Risk Assessment (PCARA) | DSRE | R&D

Takeda

About Speaker

Dr. George Johnson, UK

Associate Professor & Vice-President

Institute of Life Science at Swansea University / EEMGS

About Speaker

Carla Landolfi, IT

European Registered Toxicologist (ERT) / Founder & Toxicology Risk Assessor

ToxHub-Consulting

About Speaker

Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

About Speaker

Dr. Suman Chakravarti, US

Vice President & Chief Scientific Officer

MultiCASE

About Speaker

Dr. Karl Abele, CH

High Res. Acc. Mass LC/MS/MS of small molecules: Impurity ID, E&L, GTI Quan

Solvias AG

About Speaker

Dr. Dimitrios Spiliotopoulos, CH

Scientific Director

Xenometrix AG

About Speaker

Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

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.

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years' experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca's Impurity Advisory Group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, 'Genotoxic Impurities Strategies for Identification and Control' (Wiley and Son), and is soon to publish as editor a book focussed on the practical implementation of ICH Quality Guidelines.

Dr. Alessandro Brigo, CH

Toxicology Project Leader, Pharmaceutical Sciences / Roche Pharma Research & Early Development

Roche Innovation Center Basel

Alessandro Brigo is a senior principal scientist and toxicology project leader in the pharmaceutical sciences organisation at the Roche Innovation Center Basel, Switzerland. In this role, Alessandro leads drug discovery and development programs from a toxicology perspective to provide expert support through all development phases and for marketed products.

In addition, Alessandro has been working in the field of computational toxicology since 2006, with great emphasis on the assessment of potential genotoxic impurities in active pharmaceutical ingredients at development and marketing stages. On the topic, Alessandro authored and co-authored six peer-reviewed articles and three book chapters.

Alessandro is a pharmacist by training with a PhD in pharmaceutical sciences obtained at the University of Padua, Italy, and he's a board-certified toxicologist (DABT).

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Raphael Nudelman holds a master's of pharmaceutical sciences from the Hebrew University of Jerusalem and a PhD in organic chemistry from the Weizmann Institute of Science in Rehovot, Israel. He held research fellow positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, USA, and at the Duke University Medical Center, North Carolina, USA. He has been with Teva Pharmaceutical Industries in Israel since 2003 and held research positions in the medicinal chemistry department and the patent department. Since 2010, he has been the head of chemical and computational toxicology in Teva's non-clinical safety department. From 2011-16, Raphael also served as the president of the medicinal chemistry section of the Israel Chemical Society.

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

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.

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and, over the last 12 years, has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in the ICH M7 working group to develop Appendix 3 and co-authored the hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

Fenghe received his Ph.D. in physical chemistry from the Chinese Academy of Sciences and a B.S. degree in chemistry from Shandong University, China. He has been with Boehringer Ingelheim Pharmaceuticals Inc. for 16 years and currently is a senior research fellow in the department of material and analytical sciences. His primary responsibility involves analytical development of small molecule entities which includes providing leadership in impurity elucidation and mutagenic impurity risk assessment and control. He is the current organiser of the GTI Advisory Council within the company. Prior to BI, Fenghe had several academic assignments including, mass spectrometry lab manager, department of chemistry, Northwestern University and associate professor, National Center of Biomedical Analysis of China.

Dr. Tom van Wijk, NL

Senior Scientist / Analytical Science and Technology

Abbott Healthcare Products BV

Tom van Wijk is a senior scientist with 20 years of experience in pharmaceutical analysis. He is working at Solvay Pharmaceuticals in early and late phase chemical and pharmaceutical development and currently supporting established marketed products at Abbott Healthcare Products in the analytical science and technology department. He specializes in small molecule impurity profiling, mass spectrometry, and method development for the active materials as well as the formulated products. One of his key interests is developing applications and strategies to control trace levels of potential mutagenic impurities in pharmaceutical products. He received his Ph.D. from the faculty of pharmaceutical sciences at the Utrecht University in November 2016.

Dr. Catrin Hasselgren, US

Principal Scientist

Genentech

Catrin Hasselgren spent 12 years at AstraZeneca (AZ) in Sweden, the majority of this time as part of the drug safety organisation. After finishing her PhD in computational chemistry, she began her industrial career at AZ as a postdoc in 2002 in drug metabolism, where she developed predictive models to aid early drug discovery. In 2003, she moved to drug safety, where she worked to develop databases and computational models for safety endpoints. Catrin has also worked as an assistant professor at the University of New Mexico, she’s worked part time for Leadscope and also consulted for UCB in Belgium. In January 2018, she joined Genentech, where she is responsible for the potential genotoxic impurity assessments and is also part of the internal tenetox expert working group.

Dr. Frank Liu, US

Associate Director, Head of Product Characterisation & Risk Assessment (PCARA) | DSRE | R&D

Takeda

Dr. Frank Liu has close to 10 years' experience in chemical risk assessment and safety evaluation, many years of solid research experience, significant publication, and paper review experience, and successful NIH grant application record in DNA and telomere damage and repair and general toxicology. After his master's and PhD education in environmental toxicology and two postdoctoral trainings in pharmaceutical sciences and human toxicology, Frank moved to the product safety assessment area in the personal care and pharmaceutical product industries. Currently, he leads the pharmaceutical risk assessment and safety evaluation team responsible for the patient, environmental and occupational safety at Takeda. One of his major focusses and capabilities is to perform safety assessments of impurities such as extractables, leachables, intermediates, catalysts, particulate matters, and of genotoxic, elemental, and solvent impurities using classic and alternative approaches (e.g., read-across, in silico, QSAR, and TTC).

Dr. George Johnson, UK

Associate Professor & Vice-President

Institute of Life Science at Swansea University / EEMGS

George Johnson is an associate professor in the Institute of Life Science at Swansea University UK, and vice president of the European Environmental Mutagenesis and Genomics Society (EEMGS). George obtained his PhD degree in Swansea 2006, under supervision of Professor Jim Parry, and since then has developed a great interest in the statistical approaches and underlying mechanisms that support points of departure (PoD) for genetic toxicity. This expertise has lead George to be a Steering Member of the International Life Science Institute—Health and Environmental Science Institute (ILSI-HESI) Genetic Toxicology Technical Committee (GTTC), as well as being co-Chair of the GTTC ‘Quantitative Workgroup’. His work includes improving the quantitative use of genetic toxicity data for human-health risk-assessment, and he links this to his great interest in replacing, reducing, and refining (3Rs) the use of animals in research.

Carla Landolfi, IT

European Registered Toxicologist (ERT) / Founder & Toxicology Risk Assessor

ToxHub-Consulting

Carla has 20 years of experience in the toxicology field in the pharmaceutical industry in management positions. Experience in safety programs for pharmaceuticals, cosmetics, medical devices, biocides, and other consumer products. She has experience in REACH, toxicological risk assessment, environmental risk assessment, and occupational toxicology. She's the main author or co-author of several papers and posters, published in peer-reviewed journals or presented at international congresses.

Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

Manuela Pavan provides toxicology consulting services to the industry for the evaluation of human health endpoints, including the genotoxic and carcinogenic potential assessment of pharmaceutical impurities. Her main interest lies in the use of in silico approaches (read-across, QSAR, alerts, grouping, categories) that the industry uses in compliance with regulations such as ICH M7, REACH, CLP guidelines, biocides, and cosmetics guidelines; she is then committed to combining information and data coming from different sources in an efficient and informed way. Her experience thus includes topics such as weight of evidence, integrated testing strategy, chemical safety assessment. She was working for the former European Chemicals Bureau (ECB) at JRC of the European Commission from 2004 to 2008, where she was actively involved in developing technical guidance documents for REACH.

Dr. Suman Chakravarti, US

Vice President & Chief Scientific Officer

MultiCASE

In MultiCASE, Suman is responsible for research and oversees product design and development, including converting ideas to viable products. He is the principal author of the CASE Ultra and META Ultra software. He has a masters and PhD in medicinal and pharmaceutical.

Dr. Karl Abele, CH

High Res. Acc. Mass LC/MS/MS of small molecules: Impurity ID, E&L, GTI Quan

Solvias AG

Dr. Karl Abele has specialized in the use and development of hyphenated MS equipment since 1986 at the Ruhr University in Germany, where he obtained a Ph.D. in chemistry in 1990. He moved to Switzerland in 1990, where he worked as an MS application specialist for three GC/LC/MS manufacturers. In 2010 he joined Solvias, a Basle based contract research organization serving pharmaceutical manufacturers worldwide. He is currently leading a group of 15 scientists, performing identification and quantification of impurities in drug products at ultra-trace level, as well as E&L studies. His team is using state-of-art equipment (HRAM-LC/MSMS, e.g., ThermoFisher Q-Exactive Systems) in a GMP regulated environment. Dr. Karl Abele and his team have been involved in the analytical evaluation of nitrosamines from the start in June 2018 and have continuously improved their methodology, and software solutions applied.

Dr. Dimitrios Spiliotopoulos, CH

Scientific Director

Xenometrix AG

After his M.Sc. in Biology at the Università degli Studi di Milano-Bicocca, Dimitrios Spiliotopoulos worked on neural stem cells in the group led by Sen. Prof. Elena Cattaneo at Università degli Studi di Milano. He then directed his scientific interest to structural biology, was awarded a fellowship in the Molecular and Cellular Biology PhD program of Università Vita-Salute San Raffaele in association with the Open University, and investigated protein-peptide interactions using experimental and computational techniques in Dr. Giovanna Musco's group.  After winning an SNF fellowship, Dr. Spiliotopoulos joined the group led by Prof. Amedeo Caflisch at the University of Zürich, where he worked on the in silico identification of small molecule inhibitors of protein-protein interaction modules and enzymes and their validation by means of biophysical, biochemical, and cell biology techniques.  Since 2017 Dimitrios Spiliotopoulos has been Scientific Director at Xenometrix AG, working and optimizing miniaturized assays to identify genotoxic agents and endocrine disruptors.

Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Alessandro Brigo, CH

Toxicology Project Leader, Pharmaceutical Sciences / Roche Pharma Research & Early Development

Roche Innovation Center Basel

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

Dr. Tom van Wijk, NL

Senior Scientist / Analytical Science and Technology

Abbott Healthcare Products BV

Dr. Catrin Hasselgren, US

Principal Scientist

Genentech

Dr. Frank Liu, US

Associate Director, Head of Product Characterisation & Risk Assessment (PCARA) | DSRE | R&D

Takeda

Dr. George Johnson, UK

Associate Professor & Vice-President

Institute of Life Science at Swansea University / EEMGS

Carla Landolfi, IT

European Registered Toxicologist (ERT) / Founder & Toxicology Risk Assessor

ToxHub-Consulting

Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

Dr. Suman Chakravarti, US

Vice President & Chief Scientific Officer

MultiCASE

Dr. Karl Abele, CH

High Res. Acc. Mass LC/MS/MS of small molecules: Impurity ID, E&L, GTI Quan

Solvias AG

Dr. Dimitrios Spiliotopoulos, CH

Scientific Director

Xenometrix AG

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What our
participants
are saying

“It is a great opportunity to connect with colleagues, share our experience and process with and learn from our colleagues about their experience and process. “

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Frank Liu

Takeda

“I absolutely enjoyed the meeting with such a focused topic”

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Brinda Mahadevan

Abbott Laboratories

“Thanks a lot for all your organization which made this summit a real success.”



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Simone Carrara

Eurofins Biopharma Product Testing Italy