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3rd Annual Impurities: Genotoxic and Beyond Summit

  • 12th – 13th June 2019
  • Germany flag Germany Munich
  • Holiday Inn Munich - City Centre Hochstraße 3, 81669

This premier B2B event provides the appropriate platform to engage and discuss ideas with your peers, while facilitating a professional atmosphere and environment for good company representation and development.

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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 honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in June!

Who Should Attend

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

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

Key Practical Learning Points

  • Compliant practical implementation of recent updates in ICH M7 and Q3D
  • Proved strategies on impurity characterisation, qualification and risk assessment
  • Regulatory, toxicology, analytical experience for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
  • Novel approaches for in silico genotoxity testing
  • Choosing the right strategy associated with the future industry developments and changing regulatory environment
  • Comprehensive extractables and leachables evaluation and its significance to pharmaceutical quality
  • Considerations for genotoxicity assessment of peptide/protein-related and novel oligonucleotide-based biotherapeutics
  • Latest recommendations on genotoxicity assessment of nanomaterials

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. Henry Stemplewski, UK

Expert Assessor

MHRA

Henry Stemplewski is an expert non-clinical assessor in the Medicines and Healthcare products Regulatory Agency (MHRA), the competent regulatory au­thority for human medicines in the UK, located in London. He is also an assessor for the environmental risk assessment.

He has worked in the licensing division of the MHRA for over 20 years. He has extensive experience in the assessment of human medicinal products including new chemical entities, biological medicines and clinical trials.

He is a member of the CHMP Safety Working Party (SWP) expert working group, which produced a reflection paper on the qualification of non-genotoxic impuri­ties (December 2018).

He is a member of the CHMP SWP expert working group on environmental risk assessment, which in December 2018 produced a revision of the technical guideline published by the European Medicines Agency in June 2006. He was also a member of the working group that produced the original guideline during the period 2001-06.

He is the MHRA assessor to the United Kingdom (UK) Committee on Mutagenic­ity of Chemicals in Food, Consumer Products and the Environment, and also its sister committee the Committee on Carcinogenicity.

He has been a member of the British Toxicology Society since 1984 and is currently the chair of the regulatory toxicology speciality section. He has been appointed as a fellow of the BTS, and he is also a member of the British Society for Nanomedicines.

Dr. Christian-Friedrich Trendelenburg,

Senior Toxicologist, Preclinical Safety (PCS)

Novartis Institutes for BioMedical Research (NIBR)

Christian-Friedrich Trendelenburg is a senior toxicologist in preclinical safety (PCS) at the Novartis Institutes for BioMedical Research (NIBR) in Basel, Switzerland. He is a scientific expert for the safety evaluation of impurities, extractables/leachables and excipients, with major focus on the safety evaluation of pharmaceutical prod­ucts for children. As preclinical safety project leader in the neuroscience and global health therapeutic areas, he represents PCS in global project teams to support drug development by summarising, evaluating and interpreting nonclinical safety aspects. He graduated in biochemistry from the University of Kaiserslautern (Ger­many) and has a PhD (Dr. rer. nat.) in toxicology. Christian has a strong background in all areas of safety sciences, including agrochemical, food, chemical (home and personal care) and pharmaceutical products. He is a EUROTOX-certified toxicolo­gist and member of the German and Swiss toxicological societies (DGPT and SST).

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. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

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. Wolfgang Muster, CH

Senior Principal Scientist / Toxicology Project Leader, Pharmaceutical Sciences

Roche Pharma Research & Early Dev. Roche Innovation Center Basel

Wolfgang Muster graduated and obtained his PhD at the University of Würz­burg in Germany. He joined Roche in 1992 and started as a study director for genotoxicology tests. Since 2003, he has focussed his scientific interest on early safety screening, heading an in silico and in vitro screening group. He is currently the toxicology project leader and is responsible for early safety profiling of drug candidates, specialised on the topics of computational toxicology, data analysis and safety assessments of (genotoxic) impurities, extractables/leachables and contact materials. On these topics, he represents Roche in a number of global expert panels/consortia (EFPIA, IQ DruSafe, IMI2) and has published several ar­ticles. Wolfgang is a chemist by training and is a European-registered (ERT) and a board-certified toxicologist (DABT).

Dr. Ank Reumer, BE

Senior Study Director

Nelson Labs Europe

Ank Reumer received her PhD from the faculty of sciences at the University of Leuven (Belgium). As a postdoc at the mass spectrometry facility of Leuven, she developed methods for peptide biomarker discovery. In 2014, she started working at Nelson Labs. Currently she is senior study director in the pharma services team. The main focus of this group is identifying organic impurities in drug products as well as in-use stability testing of drug-device combinations and stability testing of drug products. In addition, she is in charge of a project for developing methods to analyse protein-leachables interactions.

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. Brinda Mahadevan, IN

Sr. Associate Research Fellow / Director, Global Preclinical Development (GPD), Established Pharmaceuticals

Abbott Healthcare Pvt. Ltd.

Dr. Brinda Mahadevan received her BSc in agriculture from the University of Ag­ricultural Sciences, Bangalore (India) and a master’s in bacteriology and a PhD in microbiology, molecular biology and biochemistry from the University of Idaho (USA). Brinda started her postdoctoral research in molecular biology and toxicology at Oregon State University. Later, as research assistant professor in the department of environmental and molecular toxicology at Oregon State University, she initiated her independent research career investigating the mechanisms of chemical carcino­genesis and chemoprevention. She has trained and mentored many students and has authored or co-authored more than 40 publications.

Brinda started her career in the pharmaceutical industry by joining Schering-Plough and then Merck as a senior scientist and study director in genetic toxicology. Later, in 2010, she joined as a toxicologist in corporate in global occupational toxicology in Chicago, USA, to support global pharmaceutical operations. This was followed by a move within Abbott to medical safety and surveillance at Abbott Nutrition (Columbus, Ohio) and again in 2014 to Abbott Nutrition regulatory affairs, where she supported novel ingredient petitions and development of food additive monographs.

She is currently a senior associate research fellow and functions as director of global preclinical development, product development I&D established products division, in Mumbai, India. She directs her team on global preclinical activities that supports for­mulation of new products, maintenance of established products and toxicology testing.

Dr. Marc Audebert, FR

Research Director

INRA

Dr. Marc Audebert is a research director at INRA (France). He studies the relation­ship between the biotransformation of xenobiotics and their genotoxicity. He has developed a novel genotoxic assay based on the quantification of histones H2AX/ H3 phosphorylation, with simultaneous examination of the cytotoxicity and geno­toxicity of xenobiotics on human cells. Using this assay, he successfully evaluated the genotoxic potential of several groups of food contaminants (including pesti­cides, polycyclic aromatic hydrocarbons, heterocyclic aromatic amines, mycotoxins, bisphenol, heavy metals, etc.), including at low concentrations, using single com­pounds as well as mixtures. Marc also investigates the genotoxic mode of action of food contaminants (DNA adducts, aneugens, oxidative stress). He has coordinated or participated to several projects contributing to establishing the scientific basis for predicting and assessing the genotoxic effects of multi-component mixtures.

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.

Simone Carrara, IT

Extractables & Leachables and Impurity Characterisation / Laboratory

Eurofins BioPharma Product Testing Italy

Simone Carrara holds a biotechnology degree from the University of Milan and has vast experience as a bioanalytical researcher through LC/MS method development for pharmacokinetics analysis and ADMET profiling. In his previous role as project leader, he successfully managed different projects in a wide range of areas, including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterisation. For the last five years, he has been focussing on ex­tractables and leachables studies to support drug manufacturing companies to fulfil regulatory requirements. He is currently extractables and leachables and impurity characterisation laboratory manager in Eurofins BioPharma Product Testing Italy.

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

Tino Otte joined Intertek (Switzerland) AG in 2016 as a senior scientific consultant specialising in extractables/leachables analysis and GMP testing. Before working at Intertek, he studied analytical and polymer chemistry in Leipzig and Halle (Germany). After earning his PhD at Darmstadt Technical University (Germany), he worked for different companies in the instrumental analysis and pharmaceutical services industry. Within Intertek Group, Tino is responsible mainly for projects related to trace analysis, drug and impurity characterisation, and polymer testing.

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Henry Stemplewski, UK

Expert Assessor

MHRA

Dr. Christian-Friedrich Trendelenburg,

Senior Toxicologist, Preclinical Safety (PCS)

Novartis Institutes for BioMedical Research (NIBR)

Dr. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

Dr. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Dr. Wolfgang Muster, CH

Senior Principal Scientist / Toxicology Project Leader, Pharmaceutical Sciences

Roche Pharma Research & Early Dev. Roche Innovation Center Basel

Dr. Ank Reumer, BE

Senior Study Director

Nelson Labs Europe

Dr. Frank Liu, US

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

Takeda

Dr. Brinda Mahadevan, IN

Sr. Associate Research Fellow / Director, Global Preclinical Development (GPD), Established Pharmaceuticals

Abbott Healthcare Pvt. Ltd.

Dr. Marc Audebert, FR

Research Director

INRA

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Simone Carrara, IT

Extractables & Leachables and Impurity Characterisation / Laboratory

Eurofins BioPharma Product Testing Italy

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek