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2nd Impurities: Genotoxic and Beyond Summit

  • 7th – 8th June 2018
  • Germany flag Germany Berlin
  • Mövenpick Hotel Berlin Schöneberger Str. 3, 10963

We are pleased to invite you to the 2nd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 7th–8th, 2018, in Berlin, Germany. 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 practice of the implementation of recent updates in ICH M7 and Q3D, and novel strategies for efficient mutagenic and elemental impurity identification and control.

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

Who Should Attend

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

  • Research and Development
  • Drug Design
  • Safety Assessment
  • Chromatography
  • Spectroscopy
  • Purification
  • Formulation
  • Microscopy
  • Process Chemistry
  • GMP
  • Technology Transfer
  • Quality Assurance
  • Quality by Design (QbD)
  • Toxicology
  • Genotoxin
  • Genotoxic Impurities
  • Mutagenic impurities
  • Drug Discovery & Development
  • Pre-Clinical Drug Safety
  • Analytical Science
  • Mass Spectrometry
  • LC-MS
  • API Development
  • Assay Development
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Organic Synthesis
  • Good Laboratory Practice
  • Validation
  • Quality Control
  • Regulatory
  • Impurities
  • Genetic Toxicology
  • Elemental impurities
  • Extractables and Leachables

Key Practical Learning Points

  • Recent advances in Impurity profiling
  • Novel practice of the implementation of recent updates in ICH M7 and Q3D
  • Regulatory, scientific, analytical experience for efficient Mutagenic and Elemental Impurity identification, and control
  • Confident justification of Impurity limits
  • Choosing a right strategy associated with a future and regulatory predictions

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. Lutz Müller, CH

Project Leader / Pharmaceutical Sciences

Hoffmann-La Roche Innovation Center Basel

Dr. Lutz Müller is a project leader in toxicology with F. Hoffmann-La Roche in Basel, Switzerland. The focus of his work is on projects in R&D in therapeutic areas such as nervous system, cardiovascular, inflammation, immunology, oncology, and rare diseases. These span small molecules, peptides, antisense molecules, and biologicals. In terms of scientific expertise, genotoxicity, impurities, carcinogenicity, immunotoxicity, in vitro systems, risk assessment, regulatory toxicology are his primary reference areas.

Dr. Müller has been involved in the ICH guideline process since its inception in the early nineties of the last century. As disease therapeutic area liaison for NORD (Neuroscience, Rare Diseases, Ophthalmology) in pharma research and early development (Roche pRED), Dr. Lutz Müller supports the overall strategy of the company in developing new medicines in these areas. Scientific publication record: More than 100 original publications in peer reviewed journals and various book chapters. Organiser/lecturer of/on multiple international meetings and workshops.

Dr. Russ Naven, US

Associate Director / Global Discovery Toxicology Group

Takeda

Russ Naven is associate director in the Global Discovery Toxicology group at Takeda in Cambridge, Massachusetts, USA. He manages the Chemical Toxicology group at Takeda which is tasked with monitoring the portfolio for attrition risks and driving the development of robust risk assessment paradigms. Russ started life as a PhD synthetic chemist with AstraZeneca, then transitioned to computational toxicology at Lhasa Limited where he helped develop the genotoxicity endpoints in the toxicity prediction software, Derek. Russ then moved to Pfizer for 7 years where he developed structure-toxicity relationships for the prediction of repeat-dose toxicity. Russ has over 15 years’ experience in the development and validation in silico and in vitro platforms for the prediction of in vivo toxicity.

Dr. Joerg Wichard, DE

Pharmaceuticals Division / Genetic Toxicology BLN

Bayer AG

Jörg Wichard received his diploma degree in 1997 and his PhD degree in physics in 2000, both from the University of Göttingen, Germany. In 2000, he joined a small biotech company and worked in the field of computer aided drug design. From 2002-2004 he was PostDoc at the AGH University of Science and Technology in Krakow, where he developed a software toolbox for ensemble based machine learning. He joined the Computational Chemistry Department at Schering AG from 2004-2006 as a postdoctoral researcher. From 2006-2010 he was a research scientist in the Computational Chemistry and Drug Design Group at FMP (Institute of Molecular Pharmacology) in Berlin.

In 2010 he joined the Genetic Toxicology Department at Bayer AG in Berlin where he is mainly responsible for the application of in silico tools in toxicology and for the implementation of toxicological databases.

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 co-chair of the Impurities Oversight Panel, where he is a GSK mutagenic impurity risk assessment subject matter expert and Scientific Director as well as the GSK Drug Substance nitrosamine risk assessment lead for small molecules.  Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.

Dr. Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe (Formerly Toxikon Europe) in 2013 as study director at the Extractables & Leachables Department, focusing on injectables and parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. In 2016, she became responsible for the Pharma Services at Nelson Labs. The main focus of this group is identifying organic impurities in drug products as well as in use stability of drug-device combinations. In 2017, the scope expanded and now also includes all microbiological testing offered at the Nelson Labs Europe site.

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. 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. 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. 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. 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.

Dr. Catrin Hasselgren, US

Senior Scientist

Genentech

Catrin spent 12 years at AstraZeneca (AZ) in Sweden, the majority of this time as part of the Drug Safety organization. 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, 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 Genetox Expert Working Group.

Lance Smallshaw, BE

Worldwide Analytical & Strategies Expert

UCB Biopharma sprl.

Lance Smallsha has 37 years’ experience in pharma and biopharm, worldwide analytical, and strategies at UCB Biopharma, based in Belgium, working in the Corporate Analytical Sciences Team. Lance works in regulatory intelligence and develops the company’s worldwide policy for new regulatory requirements. He also developed the company’s strategy and oversaw the worldwide implementation of ICH Q3D.

He has been the co-chair of the Executive Foundation Board of the European Compliance Academy (ECA) and trainer in Good QC Laboratory Practice for European Qualified Persons (QP) Education Course for the past 10 years. He is also the associate director and European CMC Strategy Committee member for CaSSS Biopharm.

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. Lutz Müller, CH

Project Leader / Pharmaceutical Sciences

Hoffmann-La Roche Innovation Center Basel

Dr. Russ Naven, US

Associate Director / Global Discovery Toxicology Group

Takeda

Dr. Joerg Wichard, DE

Pharmaceuticals Division / Genetic Toxicology BLN

Bayer AG

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Dr. Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

Dr. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Dr. Tom van Wijk, NL

Senior Scientist / Analytical Science and Technology

Abbott Healthcare Products BV

Dr. George Johnson, UK

Associate Professor & Vice-President

Institute of Life Science at Swansea University / EEMGS

Dr. Catrin Hasselgren, US

Senior Scientist

Genentech

Lance Smallshaw, BE

Worldwide Analytical & Strategies Expert

UCB Biopharma sprl.

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

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