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The poor success rate in developing a new drug from discovery to market is a major problem faced by the pharmaceutical industry today.
The goal of early ADME is to determine whether a candidate drug forms reactive metabolites as early as possible and mitigate attrition rates.
Reactive drug metabolites are known to be one of the factors behind unexpected drug-induced toxicity and therefore their identification early in the drug discovery process is of big importance.


Furthermore, cardiovascular toxicity is often to blame, accounting for approximately 27% of drug failures due to toxicity in the preclinical phase:
The overall attrition rate due to cardiovascular events in clinical development is 21%, indicating that several cardiovascular effects occur in Phase II and III clinical trials which are not detected in the preclinical studies or earlier clinical trials. Thus, the conference will feature a dedicated session on toxicity and highlight emerging technology to aid better prediction.

 

ADME parameters obtained from in vitro and in vivo models, which aid in the prediction of drug behaviors in patients, are important for the decision to advance, hold or terminate a drug candidate. However, incomplete ADME studies or misinterpretation of ADME data may cause failures in drug development. ADME studies are conducted with in vitro, in vivo or in silico models.


In vitro models generate many ADME parameters, including apparent permeability, metabolic stability, protein binding, blood-to-plasma partitioning, drug–drug interaction potentials (e.g., inhibition and induction of cytochrome P450 (CYP) and transporters), cell proliferation and cytotoxicity, and hERG inhibition. In vivo models of animals and healthy human subjects provide information such as drug oral bioavailability, exposures, distribution, clearance, and duration of exposure for a drug and its metabolites.


Finally, in silico models predict drug behaviors based on physicochemical properties of drug candidates in combination with crystal structures of a protein (an enzyme or a transporter) and database of ADME properties generated in laboratories. With the numerous models available, proper experimental model selection is essential for ADME property optimization.

 

 

The conference will draw focus on:
• Progresses in AMDET-enabling technologies
• Human ADME studies and challenges with standardisation.
• Emerging assays to monitor cardiotoxicity
• Lead optimisation of PK/PD modelling
• In Silico modelling techniques
• Drug-Drug interaction 
 • Learn new stratgeies of optimising in vitro/ in vivo extrapolation
• Translation issues of animal-derived metabolic results to predict human drug metabolism
• Emerging assays to monitor cardio toxicity and hepatotoxicity
• Regulatory guidelines on safety and toxicity risk assessments
 

   

Admescope Ltd; Astra Zeneca; AstraZeneca; Biolab Sanus Farmaceutica Ltda; Cancer Research Technology; Cancer Research Technology Ltd; Corning Life Sciences; CXR Biosciences; Debiopharm; Eisai Pharmaceuticals; EligoChem Ltd; Galapagos NV; Genentech, Inc.; GlaxoSmithKline; GSK; Imperial College London; Ipsen Pharma; Janssen Strategic Marketing; Johnson & Johnson; King's College London; Lexicon Pharmaceuticals Inc; Medicyte GmbH; Northeastern University; Novartis AG; Novartis Pharma; Novo Nordisk A/S; Peakdale Molecular Ltd; Proximagen; Roche Pharmaceuticals; Sanofi-Aventis Deutschland GmbH; Shire plc; Sovicell; Takeda Pharmaceuticals Europe; The Edge; The Institute of Cancer Research; The Research Network Ltd; TranScrip Partners; UCB; University Of Sussex; Vertex Pharmaceuticals; Xenotech;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Araz Raoof

Araz Raoof, Head Scientific Affairs & Analysis, Janssen Pharmaceutica

9:10 OPENING ADDRESS: How is ADMET Tackling Key Challenges of Drug Development?

Araz Raoof

Araz Raoof, Head Scientific Affairs & Analysis, Janssen Pharmaceutica

 

·          The role of ADME in drug discovery and its impact on clinical attrition rate
·          Bridging the translational gap from bench to bed
·          Future outlook of ADME in drug development

9:50 In Silico DMPK: A Bridging Position

Fabio Broccatelli

Fabio Broccatelli, Scientist, Genentech, Inc.

 

 

·          Maximizing the value of experimental data through modelling and data mining
·          Real life examples of how models can influence project teams
·          In Silico DMPK, an environment for pre-competitive collaboration

10:30 Morning Coffee

11:00 SPONSORED SESSION: How we set about revolutionizing in-vitro membrane drug transporter assays

Paul Brooks

Paul Brooks, Head of Discovery Research Services, Sigma Aldrich

 


ABSTRACT:

The drug discovery process is both a high cost and high risk endeavour. It has been estimated that bringing a drug candidate to market can cost in the range of $1–2 billion dollars and typically takes 12 years to complete. It is therefore no surprise that withdrawal in the later stages of this process is devastatingly expensive to the pharmaceutical industry. An obvious improvement to these high costs and long timelines is to find ways to eliminate non-viable drug candidates from therapeutic programs much earlier in the process. This has made the ADME and toxicology stages of drug discovery a focal point for improvements by the pharmaceutical industry. Advances in ADME and toxicology studies have the potential to increase the probability of success, decrease overall costs and reduce the time to market.

In this seminar we highlight one such advance in the use of genetically modified cell lines that improve upon, and simplify, in-vitro membrane drug transporter research. These cell lines hold the potential to help clarify complex drug-transporter interactions without some of the limitations of current chemical or genetic knockdown approaches.


BENEFITS:
· Learn about the latest assays for drug transporter investigations.
· Discover how these assays relate to the FDA and EMA Guidances for Drug Interaction Studies.

11:40 Complementary use of high-throughput ADMET screening and In Silico modelling systems to strengthen non-animal alternatives

Mark Wenlock

Mark Wenlock, Research Scientist, AstraZeneca

 

  •  Supervised integration of experimental data to maximise the predictive quality of In Silico modeling
  •  Optimising predictive parameters to make the best informed decisions
  •  Mitigating errors in early human dose predictions and setting the criteria for ADME end points
  • 12:20 Networking Lunch

    13:30 KEYNOTE ADDRESS: Opportunities for modelling of kidney disease and general toxicology studies.

    Jamie Davies

    Jamie Davies, Professor of Experimental Anatomy, University Of Edinburgh

     

  • The human relevance, sensitivity and specificity of current experimental models
  • Use of emerging technologies in 3D cell culture to predict hepatotoxicity
  • Current challenges in determining underlying mechanisms of toxicity
  • Enabling complete metabolism studies, confirmation of structure and quantitative measures of toxicity.
  • CYP activities and sensitivities to multiple model hepatotoxins
  • 14:10 Transational PK/PD modeling for efficacy and safety

    Thierry Lave

    Thierry Lave, Head DMPK and TOX Project Leaders and Modeling & Simulation, F. Hoffmann-La Roche

     

    • Value of integrating translational PKPD in early development
    • Understand the requirements for translational PKPD
    • Illustrate use of exposure-response modelling to:
      • optimize FIH study designs
      • aid dose selection for proof of concept studies
      • translate from preclinical to clinical 

    14:50 Dealing with the challenges of making an accurate human dose prediction

    Peter Littlewood

    Peter Littlewood, Director DMPK, Vertex Pharmaceuticals

     

    ·          Accurately profiling metabolic pathways and unexpected metabolites
    ·          PK/PD models that support in vitro to in vivo extrapolation
    ·          Challenges with biological barriers
    ·          Impact of genetic variations on predictive PK/PD modelling for dose regimes

     

    15:30 Afternoon Tea

    16:10 Exploratory ADME in preclinical and clinical studies to guide and accelerate clinical development

    Mario Monshouwer

    Mario Monshouwer, Senior Director Drug Metabolism Pharmacokinetics & Bioanalysis, Johnson & Johnson

     

    ·          The value of mechanism based drug disposition to drive decision making
    ·          Role of humanized mouse models to obtain mechanistic insights on pharmacokinetics
    ·          Including microtracers and endogenous markers for CYP3A4/5 during phase 1 studies.

    16:50 Application of PK/PD Modelling in ADMET

    Laurent Salphati

    Laurent Salphati, Senior Scientist, Genentech

     

    ·          Optimising the translational use of preclinical PK/PD modelling in drug development
    ·          Predictive quality of PK/PD models in oncology
    ·          Case study: tumour growth inhibition and setting targets for clinical efficacy

    17:30 Panel Discussion

     

    ·          How useful are the cut-off values set out by FDA/EMA guidelines in determining CYP inhibition?
    ·          The challenge to the drug developer is deciding how to invest resources appropriately to address the MIST requirements at a stage of development when the risk-benefit ratio of a drug is still largely unknown.
    ·          What ADMET studies should be performed for pre-clinical studies?
    Araz Raoof

    Araz Raoof, Head Scientific Affairs & Analysis, Janssen Pharmaceutica

    Laurent Salphati

    Laurent Salphati, Senior Scientist, Genentech

    Jamie Davies

    Jamie Davies, Professor of Experimental Anatomy, University Of Edinburgh

    18:10 Chair’s Closing Remarks and Close of Day One

    Araz Raoof

    Araz Raoof, Head Scientific Affairs & Analysis, Janssen Pharmaceutica

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Ian D. Wilson

    Ian D. Wilson, Professor of Drug Metabolism and Molecular Toxicology, Imperial College London

    9:10 OPENING ADDRESS: Future perspectives of ADMET evaluations and the current paradigm shifts in toxicology

    Ian D. Wilson

    Ian D. Wilson, Professor of Drug Metabolism and Molecular Toxicology, Imperial College London

  • State-of-the-art analytical methods for screening drug metabolism
  • Evaluating biotransformation and reactive metabolite production
  • Advances in in vivo models to accurately predict human metabolism and toxicity


  • 9:50 Assessing transporter-mediated drug-drug interactions

    Guy Webber

    Guy Webber, Scientific Manager for In Vitro and Discovery Services ,

  • Review of current in vitro models available and practical considerations of transporter testing
  • Regulatory DDI Guidance(s) for drug transporters - an overview review of current FDA, EMA and JMHLW (Japan) guidance for industry
  •  

    10:30 Morning Coffee

    11:00 Metabolic Drug-Drug Interactions due to CYP Enzyme Inactivation (Time-Dependent Inhibition)

    Stephen Fowler

    Stephen Fowler, ADME Group Leader, In Vitro ADME, F. Hoffmann-La Roche

     

  • Effects of enzyme inactivation and how to screen for this
  • Chemistries often associated with time-dependent CYP inhibition
  • Assessment of TDI risk
  • 11:40 Toxicology pathways – Evidence-based mechanistic modelling

    Nick Plant

    Nick Plant, Reader in Molecular Toxicology, University Of Surrey

     

  • What are we lacking in evidence-based toxicology?
  • Identifying interactions and predicting emergent phenotypes
  • Using mechanistic modelling to drive early drug discovery
     
  • 12:20 Networking Lunch

    13:30 Predicting human drug-Induced hepatotoxicity

    Gerry Kenna

    Gerry Kenna, Director, FRAME

     

      • Idiosyncratic vs. dose dependent drug hepatotoxicity
      • Drug-related initiating mechanisms and patient-related susceptibility factors
      • Value and limitations of conventional toxicity studies in animals
      • Opportunities provided by transgenic and chimeric humanized animal models
      • Use of in vitro models to de-risk drug related liabilities
      • Challenge of tackling inter-species and inter-individual variability

    14:10 New strategies to reduce drug induced cardiovascular toxicity

    Peter K Hoffmann

    Peter K Hoffmann, Global Preclinical Expert for Cardiovascular Safety, Novartis Institutes for BioMedical Reseach

     

  • Concordance of preclinical and clinical QT data
  • Comprehensive in vitro pro-arrhythmia assay (CiPA)
  • Translatability of preclinical contractility data
  • Expanding in vitro models for earlier drug safety assessment
  • Human stem cell derived cardiomyocytes
  • 14:50 Afternoon Tea

    15:20 In vitro models and technologies for detecting Cardiotoxicity

    Peter  Clements

    Peter Clements, Director of Pathology, GSK

     

    ·          Integrated use of in vitro models to detect cardiotoxicity in a safety screening strategy
    ·          Progress of hERG/ion channel inhibition as a pre-clinical tool
    ·          Use of surrogate biomarkers for cardiac safety predictions
    ·          Can in vitro data predict pathology in toxicology or clinical studies?
    ·          State-of-the art Human cellular models to reduce reliance of animal-based prediction

    16:00 Which in vitro models, technologies and strategies to detect Hepatotoxicity and Cardiotoxicity at early stages of drug development?

    Frank Atienzar

    Frank Atienzar, Associate Director In Silico in Vitro Toxicology, UCB BioPharma SPRL

     

  • Performance of different in vitro models to detect human hepatotoxic drugs
  • Comparison of metabolic patterns in different in vitro models  
  • CIPA initiative (proarrhythmia): non-clinical safety testing paradigm shift and impact on strategy
  • Label free technologies applied to drug discovery  
  • 17:20 Chair’s Closing Remarks and Close of Day Two

    Ian D. Wilson

    Ian D. Wilson, Professor of Drug Metabolism and Molecular Toxicology, Imperial College London

    +

    FEATURED SPEAKERS

    Paul Brooks

    Paul Brooks

    Head of Discovery Research Services, Sigma Aldrich

    Araz Raoof

    Head Scientific Affairs & Analysis, Janssen Pharmaceutica
    Araz Raoof

    Fabio Broccatelli

    Scientist, Genentech, Inc.
    Fabio Broccatelli

    Frank Atienzar

    Associate Director In Silico in Vitro Toxicology, UCB BioPharma SPRL
    Frank Atienzar

    Gerry Kenna

    Director, FRAME
    Gerry Kenna

    Guy Webber

    Scientific Manager for In Vitro and Discovery Services ,
    Guy Webber

    Ian D. Wilson

    Professor of Drug Metabolism and Molecular Toxicology, Imperial College London
    Ian D. Wilson

    Jamie Davies

    Professor of Experimental Anatomy, University Of Edinburgh
    Jamie Davies

    Laurent Salphati

    Senior Scientist, Genentech
    Laurent Salphati

    Mario Monshouwer

    Senior Director Drug Metabolism Pharmacokinetics & Bioanalysis, Johnson & Johnson
    Mario Monshouwer

    Mark Wenlock

    Research Scientist, AstraZeneca
    Mark Wenlock

    Nick Plant

    Reader in Molecular Toxicology, University Of Surrey
    Nick Plant

    Paul Brooks

    Head of Discovery Research Services, Sigma Aldrich
    Paul Brooks

    Peter Clements

    Director of Pathology, GSK
    Peter  Clements

    Peter K Hoffmann

    Global Preclinical Expert for Cardiovascular Safety, Novartis Institutes for BioMedical Reseach
    Peter K Hoffmann

    Peter Littlewood

    Director DMPK, Vertex Pharmaceuticals
    Peter Littlewood

    Stephen Fowler

    ADME Group Leader, In Vitro ADME, F. Hoffmann-La Roche
    Stephen Fowler

    Thierry Lave

    Head DMPK and TOX Project Leaders and Modeling & Simulation, F. Hoffmann-La Roche
    Thierry Lave

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    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

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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.

    CPD AND PROFESSIONAL INSTITUTES

    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)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘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.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    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.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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