For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.
The Genotoxic Impurities in Pharmaceuticals Summit 2023 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.
10:00 Registration
10:40 Opening Address
11:10 To Be Announced
Dr. Andrew Teasdale,
Senior Principal Scientist / Head of Impurity Management & CMC Strategy, AstraZeneca, UK
11:50 Analytical approaches to cover potentially harmful Impurities in drug formulations
Despite the guidance about assessment of genotoxic impurities in ICH M7 there are still difficulties when it comes to analytical screening and characterization of such compounds.
Frequently, the interference of drug matrix components makes impurity analysis quite difficult. Moreover, in case of presence of substances of the cohort of concern the analytical limits are often extremely low and could hardly be reached with current methods or instruments.
In this presentation the following topics will be covered:
Dr. Tino Otte,
Senior Scientific Consultant, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland
12:30 Exploring the scale of potential nitrosamine risk associated with existing approved APIs
Dr. Michael Burns,
Principal Research Scientist, Lhasa Limited, United Kingdom
13:10 Coffee break
13:30 Development of a Drug Product workflow for Nitrosamine Risk Assessments
Mike Urquhart,
Scientific Director, GlaxoSmithKline, Stevenage, United Kingdom
14:10 Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines
Dr. George Johnson,
Associate Professor in the Institute of Life Science, Swansea University, United Kingdom
14:50 Technologies for Optimising Performance, Minimising Risk and preparing for the Future in Trace Impurity Quantification
Quantification of GTIs can be challenging particularly when considering the complex and diverse matrices, combined with ever changing and extremely low limits of quantification. Continuing with the theme of evaluating risk, I am going to expand this to considering the risk to analytical integrity, presenting the methodologies developed to quantify genotoxic impurities including nitrosamines and boronic acids. I’ll discuss a systematic approach to quantitative method development, some of the analytical issues that can arise, and share some of the latest waters technologies that are used for low level quantification of GTIs and explain how their inclusion in the analytical workflow can help mitigate predicted and unforeseen analytical errors and issues.
Antonia Wierzbicki,
Principal Pharma Market Development Manager EMEA, Waters Corporation, UK
15:50 Coffee break
16:10 Setting Limits for Complex Nitrosamines (NDSRIs)
Raphael Nudelman, Ph.D., ERT,
Senior Director Impurity Expert, Teva Pharmaceutical Industries Ltd., Israel
16:50 To Be Announced
Mark Harrison,
Principal Analyst, AstraZeneca, Sheffield, United Kingdom
17:30 Panel Discussion:
Lance Smallshaw,
Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia), UCB Biopharma sprl., BE
Olivier Dirat,
Senior Director, Pfizer, UK
Dr. Alexander Amberg,
Head of In Silico Toxicology, Sanofi Aventis Deutschland GmbH, DE
Dr. M. Vijay Reddy,
Senior Principal Scientist in the department of Genetic Toxicology, Merck & Co., Inc., USA
Dr. George Johnson,
Associate Professor in the Institute of Life Science, Swansea University, United Kingdom
Marina Couva,
QPPV, Medochemie Ltd, CY
Raphael Nudelman, Ph.D., ERT,
Senior Director Impurity Expert, Teva Pharmaceutical Industries Ltd., Israel
Dr. Joel Bercu PhD, MPH, DABT,
Sr. Director in the Nonclinical Safety and Pathobiology, Gilead Sciences, USA
18:10 Incorporating Nitrosamine Risk Mitigation Activities Across a Diverse Development Portfolio
Jared Fennell,
Senior Scientist, Eli Lilly and Company, Indiana, United States
18:50 Inhibition of Nitrosamine Formation in Drug Products
Steven Tignor,
Senior Scientist, Merck & Co., Inc., New York, USA
19:30 Closing remarks and end of day one
09:20 Opening Address
09:30 Impact of different rat or hamster S9 fractions on the metabolic activation of low-molecular-weight N-nitrosamines – a comparative analysis
Dr. Stephanie Simon, PhD,
Head, Genetic Toxicology, Merck Healthcare KGaA, DE
10:10 Analytical testing and control approaches for GTIs in drug substance
Tom van Wijk,
Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis, Abbott Healthcare Products B.V., Weesp, The Netherlands
10:50 To Be Announced
Jason Creasey,
Managing Director, Maven E&L Ltd, Stevenage, United Kingdom
11:30 Coffee break
11:50 Case Studies of Nitrosamines in Pharmaceuticals
Dr. Joerg Schlingemann,
Director, Principal Expert Quality Control Systems, Merck Healthcare KGaA, DE
12:30 Recent updates on Nitrosamine Impurities by EMA & FDA
BM Rao, Ph.D,
VP & Head – Emerging Markets, Analytical Science & Technology & Corporate Quality control, Dr. Reddy’s Laboratories, India
13:10 Coffee break
13:30 Enhancing nitrosamines analysis: a focus on complex nitrosamines (NDSRIs or NO-APIs) - Part 1: General considerations and challenges
With more than 15 years’ experience on nitrosamine analysis, Mérieux NutriSciences enjoys sound experience in the implementation and validation of nitrosamine impurities target research methods with a special focus on NDSRIs / NO-APIs:
Sergio Fasan,
Business Director – Pharma, Healthcare & Cosmetics, Mérieux NutriSciences Italy, IT
13:50 Enhancing nitrosamines analysis: a focus on complex nitrosamines (NDSRIs or NO-APIs)
With more than 12 years’ experience on nitrosamine analysis, Mérieux NutriSciences’ Pharmaceutical and R&D Divisions enjoy sound experience in the implementation and validation of nitrosamine impurities target research methods with a special focus on NDSRIs / NO-APIs:
Emiliano De Dominicis,
Chemistry Research Director, Mérieux NutriSciences Italy, IT
14:30 How Sanofi scientists streamlined their in silico hazard assessment of potential genotoxic impurities by collaborating with Discngine
Sébastien Conilleau, PhD,
Customer Success and Delivery Manager, Discngine, FR
15:10 Development of in silico systems for expert review under ICH M7 guideline: increasing efficiency through automated arguments
Robert Foster,
Senior Scientist, Lhasa Limited, United Kingdom
15:50 Coffee break
16:10 Expert Review of In Silico Mutagenicity Predictions
Alyssa Musso,
Senior Scientist, Drug Safety Research and Development, Global Risk Assessment Services Toxicologist, Pfizer, USA
16:50 Analytical Strategies for Enhancing Selectivity and Sensitivity of Genotoxic Impurities
C. J. Venkatramani,
Senior Principle Scientist, Genentech, USA
17:30 A review of ongoing efforts to optimize the Ames assay by the HESI-GTTC Nitrosamine Mechanism-based Genotoxicity Risk Assessment (NA-MGRA) Subgroup
Leon F. Stankowski,
Senior Scientific Director, Genetic and In Vitro Toxicology, Charles River Laboratories, Chicago, USA
18:10 Applications of computational methods in the assessment of extractables and leachables
Dr. Candice Johnson,
Senior Research Scientist, Instem, Ohio, United States
18:50 Closing remarks and end of summit
To register to the summit as a Delegate, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
To register to the summit as a Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
Please fill in the details below to get the latest news, discounts, early-bird rates, and upcoming annual details.
Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
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Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - Others