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ADMET screening is crucial to the drug development process and assists the elimination rate of weak drug candidates early in the drug-discovery process, and decreases the proportion of compounds failing in clinical trials for ADMET reasons. SMi's 5th Annual ADMET Conference will bring you up to date with the latest developments, technologies and techniques that are in use across the industry and look towards the future.

By attending this conference, you will learn:

  • How to effectively integrate ADMET optimisation into drug discovery to reduce attrition rates from AstraZeneca
  • Strategies for predicting drug-drug interactions arising from CYP450 inhibition from Pfizer
  • How to develop a mechanism-based PK/PD model from Eli Lilly
  • The application of  High Content Analysis for predictive cytotoxicity testing & preclinical toxicity biomarkers from University College Dublin
  • Tools and strategies to consider in characterising and investigating hepatotoxicity from Genetech
  • What the emerging in vitro toxicity assays are and the role of stem cells in assessing human toxicology from Roche
  • Case studies demonstrating the benefits of evaluating PK in early stage drug development from Merck
     

The conference will provide a look at how the big names in the pharma industry are approaching ADMET. With a case study focus and presentations from companies including Novartis, AstraZeneca, Pfizer, Eli Lilly, Genentech, MSD, Merck & Co., Roche, Gedeon Richter and more along with distinguished representatives from top academic organisations this conference promises to provide an intimate environment for benchmarking against industry leaders and networking.

Featured Presentations:

  • Building hypotheses in lead selection and optimisation
    Bernard Faller, Director of Metabolism & Pharmacokinetics / in-vitro ADME, Novartis, Switzerland
     
  • ADME Optimisation in Early- and Late-Phase Drug Discovery
    Gerhard Gross, Global Discipline Leader ADME, AstraZeneca, UK
     
  • In Vitro and In Vivo Approaches for Assessing the Potential for Drug Induced Liver Injury
    Donna Dambach, Director, Investigative Safety Assessment, Genentech, USA
     
  • Emerging In Vitro Toxicity Assays and the Role of Stem Cells in Assessing Human Toxicology
    Claudia McGinnis, Group Head, In Vitro Toxicology, Roche, Switzerland

For speaker opportunities, contact smiproduction@smi-online.co.uk

For sponsorship and exhibitioning opportunities, contact  sponsorshipdept@smi-online.co.uk


 

Bernard Faller
Director of Metabolism & Pharmacokinetics / in-vitro ADME
Novartis

Donna Dambach
Director, Investigative Safety Assessment
Genentech

Gerhard Gross
Global Discipline Leader ADME
AstraZeneca

Claudia McGinnis
Group Head, In Vitro Toxicology
Roche

Willem Schoonen
Senior Research Scientist, Toxicology & Drug Disposition
MSD

Punam Sandhu
Senior Investigator
Merck

Kuresh Youdim
Senior Principal Scientist
Pfizer

Richard Weaver
Associate Principal Scientist
AstraZeneca

See the full lineup...
 

 


 

CEOs, CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Drug Discovery
  • Preclinical Development
  • ADME
  • DMPK
  • Pharmacokinetics
  • Toxicology / metabolism
  • Computational Chemistry
  • Molecular Modelling
  • Cheminformatics
  • Drug Design
  • Structural Biologists
  • Biomolecular Screening
  • Medicinal Chemistry
  • Screening and Lead Characterisation
  • Lead Optimisation
  • Physical Chemistry

  

Crowne Plaza St James Hotel

45-51 Buckingham Gate
London
SW1E 6AF
 
 Tel: +44 (0) 207 834 6655
Fax: +44 (0) 207 6307
www.london.crowneplaza.com
 Crowne Plaza St James Hotel

Crowne Plaza St James London is a traditional deluxe hotel right in the heart of the city, perfectly situated for all your business and leisure needs. In the heart of Westminster, it is just a stone's throw away from Buckingham Palace, The Houses of Parliament, the London Eye and Victoria Station.  

The hotel boasts three excellent restaurants. Bistro 51 with British and European cuisine, the Michelin Starred Indian restaurant Quilon serving south coastal Indian food and Bank Westminster with a modern British menu.

A beautiful, award-winning, courtyard garden surrounds the Victorian buildings of the Crowne Plaza London St James - a peaceful oasis in the centre of London.

Crowne Plaza St James

Booking:

Book your accommodation at SMi discounted rates by:

 
SMi discounted rates include Continental Breakfast & VAT
  • £ 205.63 / Standard room / night for single occupancy
  • £ 229.13 Executive  room / night for single occupancy

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Bernard Faller

Bernard Faller, Director of Metabolism & Pharmacokinetics / in-vitro ADME, Novartis Pharmaceuticals

9:05 ADME Optimisation in Early- and Late-Phase Drug Discovery

Gerhard Gross

Gerhard Gross, Global Discipline Leader ADME, AstraZeneca

  • Applicability domain and validity
  • Decision points
  • Preclinical strategies
  • False positive rates
  • 9:35 Targeting Drugs for the Brain

    Hinnerk Boriss

    Hinnerk Boriss, CEO, Sovicell

  • Fast and reliable prediction of brain disposition and free drug available in brain
  • Classification of CNS versus non-CNS drugs based on rate and extent
  • Prediction of CNS side-effects
  • 10:15 Morning Coffee

    10:45 Probabilistic Model of Regioselectivity of Metabolism in Human Liver Microsomes

    Pranas Japertas

    Pranas Japertas, Director of ADMET and PhysChem, Advanced Chemistry Development Labs

  • A ligand-based model of regioselectivity, based on >850 structures
  • Predicting probability to be a metabolism site for every atom in the molecule using separate models for different reactions
  • Estimation of the reliability of prediction defining the model applicability domain
  • Possibility to expand this applicability domain using in-house data
  • 11:25 Vinblastine Treated CaCo-2 Culture as a Drug Penetration Model

    Monika Vastag

    Monika Vastag, Head of In vitro Metabolism Laboratory, Gedeon Richter

  • Characterisation of efflux transporters: function and importance
  • Experimental approaches to identify P-gp substrates/inhibitors
  • Comparison of cell culture models of drug penetration
  • Establishment and characterisation of vinblastine treated Caco-2 culture
  • Validation of the vinblastine treated Caco-2 penetration assay
  • Practice of penetrability screening of new chemical entities in our preclinical research
  • 11:55 Integrating Predictive ADMET into Hit to Lead and Optimisation

    Robert Clark

    Robert Clark, Director of Life Sciences, Simulations Plus

  • Hedging your bets by including ADMET diversity dimensions
  • Balancing potential ADMET liability against potential potency, selectivity etc.
  • Accommodating the inherent fuzziness of ADMET exclusion thresholds
  • Managing interdependence among biological and physical properties
  • 12:35 Networking Lunch

    13:35 Structure-based ADMET Studies

    Frank Blaney

    Frank Blaney, Director, MemProt Consulting

  • Metabolite prediction of CypP450 reactions
  • Toxicity from Nuclear Receptors
  • Understanding P-glycoprotein interactions
  • Efforts towards predicting hERG liability
  • 14:05 RAPIDD plus

    Helen McKeever

    Helen McKeever, Programme Manager, Almac Group

  • Addressing challenges of increasing time-to-market, cost and attrition
  • Integrated drug and biomarker development in a pre-clinical setting
  • 14:45 Building Hypotheses in Lead Selection and Optimisation

    Bernard Faller

    Bernard Faller, Director of Metabolism & Pharmacokinetics / in-vitro ADME, Novartis Pharmaceuticals

  • Translating PK parameters into MedChem actions
  • When can one use rules derived from the analysis of generic drugs?
  • Extracting information from the absence of correlation
  • 15:15 Afternoon Tea

    15:45 Supersaturation Effects in Solubility-Enhancing Excipients and Biorelevant Media

    John Comer

    John Comer, Co-founder & Technical Director, Sirius Analytical Instruments

    16:20 Prediction of DDI's Arising from Cytochrome P450 Inhibition

    Kuresh Youdim

    Kuresh Youdim, Senior Principal Scientist, Pfizer

  • Importance of understanding CYP inhibition
  • Extrapolation of in vitro data to predict clinical interactions following CYP inhibition
  • Factors influencing the extent of a DDI due to CYP inhibition
  • Future Directions
  • 16:50 Developing a Mechanism-based PK/PD Model

    Damien Cronier

    Damien Cronier, Research Scientist, Global PK/PD, Eli Lilly

  • Influencing early phase development using preclinical models
  • Connecting the PK with the pharmacology and pre-clinical efficacy of the compound
  • Providing an improved rationale for selecting the dose rage for Phase I trials
  • 17:20 Drug Transporter Assays in Discovery

    Laurent Salphati

    Laurent Salphati, Scientist, Genentech

  • Available assays
  • How assays are used in the screening cascades
  • Utilization of the data (case study)
  • 17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Donna Dambach

    Donna Dambach, Director, Investigative Safety Assessment, Genentech

    9:10 The Utility and Application of TDI Screens in Early Discovery DMPK

    Richard Weaver

    Richard Weaver, Associate Principal Scientist, AstraZeneca

  • Importance of front-loading TDI assays in Discovery
  • In vitro - in vivo DDI extrapolation
  • MBI data as a Reactive Metabolite early-warning flag
  • 9:45 System-dependent inhibition of cytochrome P450 (CYP) enzymes

    Andrew Parkinson

    Andrew Parkinson, Chief Scientific Officer, XenoTech

  • When should cytochrome P450 (CYP) inhibition by drug candidates be evaluated in human hepatocytes and not just human liver microsomes or recombinant CYP enzymes?
  • Rules to guide the selection of the appropriate test system to evaluate CYP inhibition
  • Common errors associated with the processing of data from metabolism-dependent inhibition (MDI) studies that incorporate a dilution step.
  • Why a dilution step - even with correct data processing - should be avoided in evaluating drug candidates MDI of CYP enzymes
  • 10:25 Morning Coffee

    10:55 Integrating Predictive Toxicology Model Development

  • Data Management, Schema and Integrating Multiple Resources
  • Predictive Toxicology Application-oriented Ontology Development
  • Developing combined in silico in vitro Consensus Models
  • Model Validation and Applicability Domain
  • Incorporating Pharmacokinetics to Predict Exposure
  • OpenTox Case Study Example
  • Barry Hardy

    Barry Hardy, Director, Community of Practice & Research Activities and OpenTox Project Coordinator, Douglas Connect

    Nina Jeliazkova

    Nina Jeliazkova, Technology Director and OpenTox Lead Developer, Ideaconsult

    11:40 Application of High Content Analysis for Predictive Cytotoxicity Testing & Preclinical Toxicity Biomarkers

    Peter O'Brien

    Peter O'Brien, Veterinary Clinical Pathologist / Toxicologist, University College Dublin
    View Bio

  • Criteria for effective cytotoxicity models
  • Demonstration of predictive cytotoxicity screens and investigations of toxicity mechanisms
  • Demonstration of toxicity in vivo using high content analysis of peripheral blood lymphocytes
  • Application strategies for screening for toxicity, identification of mechanisms, and development of translational in vivo biomarkers of toxicity
  • 12:15 Segregation of Genotoxic Compounds

    Willem Schoonen

    Willem Schoonen, Senior Research Scientist, Toxicology & Drug Disposition, MSD

  • Genotoxicity testing in the early phase of the drug development process
  • Segregation of Genotoxicity scores from Salmonella, Yeast and HepG2 cells
  • HepG2 cells
    -  analysis with toxicogenomics for global gene expression profiling of genotoxicants
    -  validation of promoter based luciferase reporter assays with the promoters of RAD51C, and Cystatin A, and the responsive elements of p53 and Nrf2
    -  in vitro micronuclei analysis with high content screening, the more traditional way
    -  advantage of endogenous metabolism by phase I and II enzymes

  • 12:50 Networking Lunch

    13:50 In Vitro and In Vivo Approaches for Assessing the Potential for Drug Induced Liver Injury

    Donna Dambach

    Donna Dambach, Director, Investigative Safety Assessment, Genentech

  • The line between overt toxicity, "outliers" and idiosyncratic toxicity
  • In vitro-in vivo correlations-consideration of physiochemical and PK drivers of toxicity
  • Assessing metabolism as the basis for toxicity
  • Preclinical genomic assessments and their potential clinical application
  • Clinical trial sampling-leveraging new, 'standard' endpoints
  • 14:25 Emerging In Vitro Toxicity Assays and the Role of Stem Cells in Assessing Human Toxicology

    Stephan Kirchner

    Stephan Kirchner, Lab Head, In vitro Screening, F. Hoffmann-La Roche

  • Microscale cell culture systems: novel approaches that mimic regulatory tests and allow for higher-throughput testing
  • Current status of the development of human embryonic stem cell-derived tissue-specific cells and their applications
  • 15:00 Mechanisms of Human (Hepato)Toxicity

    Katya Tsaioun

    Katya Tsaioun, President, Apredica

  • Business and science arguments for and against early investigation of mechanisms of toxicity
  • Known mechanisms of human hepatotoxicity
  • Assays available for prediction of specific mechanisms of toxicity:
  • HCA, mitochondrial toxicity, phospholipidosis: validation
  • Case studies: when and which assays are relevant?
  • Path forward: new cell and tissue models
  • 15:40 Afternoon Tea

    16:10 Metabolism-Based Drug Toxicity in Drug Development

    Timothy Schulz-Utermoehl

    Timothy Schulz-Utermoehl, Group Manager, In Vitro ADME, Clinical Pharmacology & DMPK, AstraZeneca

  • Case Study 1 - Assessing the value of reactive metabolite assays
  • Looking to past failures - could we have predicted toxicity using modern in vitro tools?
  • Determining the cause(s) of species differentiation in toxicity
  • Case Study 2 - Exploring the value of "humanised" mice
  • Looking to past failures - could we have predicted toxicity using modern in vivo tools?
  • Translation to human toxicity prediction
     
  • 16:45 Evaluation of Microdosing Strategies Utilizing AMS and LC/MS-MS for ADME Studies in Drug Development

    Punam Sandhu

    Punam Sandhu, Senior Investigator, Drug Metabolism & Pharmacokinetics, Merck

  • Linear kinetics of test compounds across microdose/sub-pharmacological and pharmacological dose ranges
  • Analytical tools to measure plasma concentrations over time to define kinetics at micro /sub pharmacological doses
  • Review of the available information on microdosing approaches and usefulness of such studies
  • 17:20 Is There Too Much (Hot) Air in Genetic Toxicity Assessment?

    Richard Walmsley

    Richard Walmsley, Professor of Genetics, The University Of Manchester

  • Does in vitro testing in atmospheric oxygen create misleading positive results?
  • ICH S2 (R1) test guidelines update: what is the appropriate top testing dose?
  • What is on the horizon for genotoxicity assessment? Maturing new technologies
  • 17:55 Chairman’s Closing Remarks and Close of Day Two

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    London SW1E 6AF
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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

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    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

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    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

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    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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