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5th Impurities: Genotoxic and Beyond Summit

  • 21st – 22nd April 2021
  • Italy flag Italy
Throughout these two inspiring days in Italy, the presenters will bring to life many exciting topics surrounding the ICH M7. This event will also cover efficient strategies to assess, test, and control impurities in pharmaceutical products, drug substances/APIs, excipients, and much more! Get a new and more in-depth understanding of recent developments in the risk assessment and recommendations on impurities' safety qualifications.

Don't miss the opportunity to exchange experience with your peers and to discuss expectations in the field. The 5th Annual Impurities: Genotoxic and Beyond Summit scheduled for April 21-22, 2021. See the key practical points below or request a brochure to get more information.
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About the Impurities: Genotoxic and Beyond Event

We are pleased to invite you to the 5th Annual Impurities: Genotoxic and Beyond Summit scheduled for April 21-22, 2021. This premier B2B event provides the appropriate platform to exchange experience with your peers and to discuss expectations in the field.

The Summit will shed light on the critical considerations and best implementation practice of ICH M7 and Q3D, as well as recent strategies for efficient mutagenic and elemental impurities identification, monitoring, and control. It is an honor and privilege to invite you to participate in this Summit. We look forward to welcoming you in April!

Who Should Attend 

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

  • 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 
  • The threshold of Toxicological Concern (TTC) 
  • Toxicology 
  • Validation 

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Critical considerations on ICH M7 and Q3D
  • Nitrosamines as part of ICH M7
  • Recent developments in the risk assessment, and recommendations on the safety qualification of impurities
  • Associated with GTI CMC regulatory pitfalls to avoid, and expectations in the field
  • Efficient strategies to assess, test and control impurities in pharmaceutical products, drug substances/APIs and excipients
  • Evaluation of extractables or leachables for genotoxic potential
  • Analytical, regulatory, toxicology approaches for compliant mutagenic, and elemental impurity identification, monitoring and control

Dr. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

About Speaker

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

About Speaker

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

About Speaker

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

About Speaker

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

About Speaker

Dr. Alessandro Brigo, CH

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

Roche Innovation Center Basel

About Speaker

Dr. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

About Speaker

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

About Speaker

Dr. Frank Liu, US

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

Takeda

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. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

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 Pfizer worldwide research and development efforts to understand and fully implement ICH Q3D into the development workflow. This role has resulted in him becoming a key contributor to the cross-industry consortium working towards delivering and using the Lhasa elemental impurities excipient database in ICH Q3D risk assessments. Since 2019 he has been the industry co-chair for the Lhasa/industry consortium.

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. 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.

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. 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. 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. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

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.

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.

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).

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. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Dr. Alessandro Brigo, CH

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

Roche Innovation Center Basel

Dr. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Dr. Frank Liu, US

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

Takeda

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

BROCHURE

Request the 5th Impurities: Genotoxic and Beyond Summit brochure, and find out the latest topics and ideas that will be shared. 

Request

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What our
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are saying

Thank you, I've really found very interesting and useful this event and enjoyed it a lot! Hope to have a chance to ask questions and to speak to the speakers face to face next time.

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Attendee

All of this year's 4th Impurities: Genotoxic and Beyond Online Summit speakers are well prepared and the topics discussed are aligned with current needs. The purge factors topic is very new and interesting for me. 

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Attendee

I appreciated the webinar was well organized and stayed on topic and time.

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