Genotoxic Impurities in Pharmaceuticals Summit 2019 - Kongress / Konferenz von Qepler s.r.o.

New methodologies in GTI predictions, analysis and control during the drug development process, practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), exposure limits calculation and predictions' empowerment through in silico.

Inhalte

CONFERENCE OVERVIEW:

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 2019 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.

SPONSOR: - Intertek (Schweiz) AG

SPEAKERS BOARD:

  • Rodney Parsons | Executive Director, Chemical and Synthesis Development | Bristol-Myers Squibb, USA
  • Andrew Feilden | Technical director | Smithers Rapra Ltd., UK
  • Raphael Nudelman, Ph.D., ERT | Director, Chemical & Computational Toxicology | Teva Pharmaceutical Industries Ltd., IL
  • Carla Landolfi, ERT | European Registered Toxicologist (ERT) R&D, Head of WEP Toxicology - Preclinical Development | Angelini, IT
  • Lance Smallshaw, BSc(Hons) PhD EurChem CSci CChem FRSC | Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia) | UCB Biopharma sprl., BE
  • Mike Urquhart | Scientific Director | GlaxoSmithKline, UK
  • Tom van Wijk | Principal Scientist | Abbott Healthcare Products B.V., NL
  • Dr. Joerg Wichard | Pharmaceuticals Division / Genetic Toxicology BLN | Bayer AG, DE
  • Anja Slikkerveer,MD, PhD, ERT | Scientific Director Translational Science | Astellas Pharma Europe BV, NL
  • Prof. Dr. Johannes Harleman | Vice-President Global Preclinical Development & Management | Fresenius Kabi Deutschland GmbH, DE
  • M. Vijay Reddy, Ph.D. | Sr. Principle Scientist | Merck & Co., Inc., USA
  • Patricia Parris | Project Toxicologist (RIA Safety) | AstraZeneca, UK
  • Mark Harrison | Principal Analyst | AstraZenecat, UK
  • Leon F. Stankowski, Jr., PhD | Senior Scientific Director, Genetic and In Vitro Toxicology | Charles River Laboratories, USA
  • Koen Nuyts, Ph.D. | Study Director | Nelson Labs Europe, BE
  • Ank Reumer, Ph.D. | Study Director Pharma Services | Nelson Labs Europe, BE
  • Dr. Lutz Mueller | Toxicology Project Leader – Distinguished Scientist | F. Hoffmann-La Roche Ltd., CH
  • Dr. Stefan Heck | Business Development Manager Pharma DACH | Intertek (Schweiz) AG, CH

 

CONFERENCE PROGRAMME:

Day 1st | Thursday, 11 April 2019

08:00 - Registration and Welcome Coffee

08:30 - Opening Address from the Chairman

08:40 - ICH M7 and extractables & leachables: understanding control, analysis and regulations of E&L.

  • What are extractables and leachables
  • What are the similarities and differences between E and L and genotoxic impurities
  • What are the regulations that are applicable, specifically M7

Andrew FeildenTechnical director - Smithers Rapra Ltd., UK

09:15 - Speed ​​Networking

09:45 - Examples of use of ICH M7 in early and late drug development including pediatrics.

  • ICH M7 in use for drugs along the development phase - specific examples
  • ICH M7 use on the context of pediatric/rare disease development
  • Group limits versus individual limits
  • Differentiation between impurities and metabolites, any differences in the strategy of risk assessment?

Dr. Lutz MüllerToxicology Project Leader – Distinguished Scientist - F. Hoffmann-La Roche Ltd., CH

10:20 - ICH M7 and potential mutagenic impurities; control strategy, analysis and regulatory response.

  • Considerations in a risk assessment and technical position statement
  • Desired qualities for PMI analytical methodology
  • When is it applicable to use ICH M7 option 4?
  • Current regulatory challenges
  • Examples of regulatory communications/discussions

Mark HarrisonPrincipal Analyst - AstraZeneca, UK

10:55 - Morning coffee and networking break

11:25 - ICH Q3D: safety assessment of elemental impurities in topical drugs. The challange in defining the appropriate scenario of exposure.

  • What are elemental impurities
  • Establishing Permitted Daily Exposures for topical products
    • Focus on the mucosal route
  • Defining the appropriate scenario of exposures to set Analytical Limits
  • Case studies will be presented

Carla Landolfi, ERTEuropean Registered Toxicologist (ERT) R&D, Head of WEP Toxicology - Preclinical Development - Angelini, IT

12:00 - Screening and control of genotoxic impurities – An analytical approach.

A variety of process materials and reactive compounds are involved in the synthesis of pharmaceutical products. As a consequence, residues of such compounds and related degradation products can later be found as drug impurities in API and final formulation Some of those impurities are known to be mutagenic with the potential to cause adverse effects on the human body even when only present at trace level concentrations.

The detection, quantification and evaluation of such impurities is important but can be very challenging since matrix effects often discriminate these compounds. In many cases the route of synthesis allows to predict potential impurities. However, in other cases unexpected genotoxic compounds may be an issue since predictability is limited due to complexity of processes and formulations. In our presentation we highlight the analytical challenges and propose possible solutions:

  • Sources for known and unknown genotoxic impurities
  • Reasonable analytical control strategy
  • General Screening - choosing the right techniques
  • Structure elucidation and quantifications of GI in complex matrices
  • Validation and routine monitoring

Case studies and examples

Dr. Stefan HeckBusiness Development Manager Pharma DACH - Intertek (Schweiz) AG, CH

12:25 - Business lunch

13:25 - SPONSOR - AVAILABLE.

13:50 - ICH Q3D: elemental impurities- an insider’s perspective.

  • How did the ICH process work for this quality guideline with a large safety component?
  • How were the elements covered in the guideline selected?
  • How was relevant literature selected?
  • Do the PDE cover pediatric products?
  • Can the PDE be exceeded?

Anja Slikkerveer, MD, PhD, ERTScientific Director Translational Science - Astellas Pharma Europe BV, NL

14:25 - What to do if you need to do to propose a regulatory change to a ICH Q3D Elemental Impurity Control Threshold or PDE Limit.

  • Examples of reports including toxicology assessment
  • Typical data with revised limit calculations
  • Example letter to the authorities to request the change

Lance Smallshaw, BSc(Hons) PhD EurChem CSci CChem FRSCRegulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia) - UCB Biopharma sprl., BE

15:00 - Afternoon coffee and networking break

15:30 - Strategies for assessment of impurities and E&Ls.

  • Definitions of E&L and impurities
  • Qualification thresholds
  • Use of QSAR
  • Role of API in assessment
  • Experience with regulators on PQRI proposals

Prof. Dr. Johannes HarlemanVice-President Global Preclinical Development & Management - Fresenius Kabi Deutschland GmbH, DE

16:05 - Use of the Bacterial Reverse Mutation (Ames) Test to Evaluate Impurities.

  • Background and application
  • Case study
  • Use of miniaturized Ames assays to assess potential genotoxic impurities
  • Update on the OECD review of miniaturized bacterial mutagenicity assays

Leon F. Stankowski, Jr., PhDSenior Scientific Director, Genetic and In Vitro Toxicology - Charles River Laboratories, USA

16:40 - Challenges calculating compound-specific exposure limits..

  • Background and application
  • Case study
  • Use of miniaturized Ames assays to assess potential genotoxic impurities
  • Update on the OECD review of miniaturized bacterial mutagenicity assays

Patricia ParrisProject Toxicologist (RIA Safety) - AstraZeneca, UK

17:15 - Panel Discussion

17:40 - Chairman's closing remarks and end of day one

19:00 - Business dinner

 

Day 2nd | Friday, 12 April 2019

08:00 - Registration and Welcome Coffee

08:30 - Opening Address from the Chairman

08:40 - Assessment of mutagenic impurities to comply with ICH M7.

  • Various in silico (Q)SAR tools for evaluation
  • Lessons learnt when using more than one system
  • Use of structural analogs – Case study
  • Correlation between QSAR and Ames mutagenicity results – Case studies

M. Vijay Reddy, Ph.D.Sr. Principle Scientist - Merck & Co., Inc., USA

09:15 - Genotoxic Impurity Controls post ICH M7: BMS Work Practices for Assessing and Controlling GTIs.

The development and execution of Genotoxic Impurity control strategies has become a regulatory requirement for all phases of development. With the issuance of ICH M7 sponsors now have clear guidance on the strategies which will be required to meet these expectations. BMS has an aligned process which uses the principles in ICH M7 to define these control strategies. This presentation will review GTI examples from the BMS portfolio which highlight these different control strategies.

Rodney ParsonsExecutive Director, Chemical and Synthesis Development - Bristol-Myers Squibb, USA

09:50 - Morning coffee and networking break

10:20 - Process Development and impurity control for the PPAR-alpha agonist GW641597X.

  • Development of a synthetic process to the PPAR-alpha receptor antagonist GW641597X
  • Discussion of associated impurities, their control / removal from the process and drug substance
  • Retrospective assessment of the process for mutagenic impurities is also discussed using the Lhasa Mirabilis in silico software

Mike UrquhartScientific Director - GlaxoSmithKline, UK

10:50 - Control of toxic impurities in pharmaceutical products.

  • Analytical methods and techniques
  • Analytical strategies, challenges and perspectives
  • Potential for harmonization of approaches to control toxic impurities

Tom van WijkPrincipal Scientist - Abbott Healthcare Products B.V., NL

11:30 - SPONSOR - AVAILABLE.

11:55 - Business lunch

12:55 - Best practice for dealing with conflicting computational predictions for mutagenicity.

  • Must we always take the conservative approach when dealing with conflicting predictions?
  • When can we overrule a predictions
  • Case studies showing methods to come to a consensus predictions

Raphael Nudelman, Ph.D., ERTDirector, Chemical & Computational Toxicology - Teva Pharmaceutical Industries Ltd., IL

13:30 - In silico assessment of genotoxic impurities under the ICH M7 guideline (best practice in industry).

  • Best practice of in silico hazard assessment
  • Existing data and sharing initiatives
  • Application of expert knowledge
  • Managing conflicting results

Dr. Joerg WichardPharmaceuticals Division / Genetic Toxicology BLN - Bayer AG, DE

13:55 - Interactions of Leachables with Biopharmaceuticals:Combined In-Silico and Experimental Model to Monitor the Potential Impact on Quality and Safety of Therapeutic Proteins.

  • The potential effect of Leachables on the quality and the efficacy of Biopharmaceuticals by chemically modifying the therapeutic protein/peptide product.
  • Impact on the patient’s safety including immunogenicity (as a secondary safety effect of those interactions).
  • How to assess the reactivity of potential leachables
    • Nelson REACT: an in-silico reactivity approach to predict if any of the observed extractables could lead to a chemical interaction.
    • Chemical reactivity tests to actually screen for residual chemical reactivity as predicted by Nelson REACT.
  • Case studies

Koen Nuyts, Ph.D.Study Director - Nelson Labs Europe, BE

Ank Reumer, Ph.D.

Study Director Pharma Services - Nelson Labs Europe, BE

14:30 - Afternoon coffee and networking break

15:00 - Chairman's closing remarks and end of summit

Zielgruppen

  • Pharmaceuticals
  • Biotechnology
  • CRO
  • CMO
  • Technologies & software providers
  • Equipment providers
  • Regulatory agencies
  • NOP
  • Other

SG-Seminar-Nr.: 5266219

Anbieter-Seminar-Nr.: qgenotoxic

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