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ADMET

SAE Media Group are proud to present their 8th annual ADMET Conference, held in central London on the 10th and 11th July, 2013.

ADMET plays an integral role in drug discovery, development, and safety. Predictive ADMET methods are also a necessary step in minimising drug failure. As such, strategies and approaches are constantly evolving, improving, and developing. This conference will draw upon ADMET, Safety, and Translation and encapsulate them in regards to drug discovery and development.


The topics covered in this conference not simply run through in vivo, in vitro, and in silico approaches to ADMET but will integrate them with an emphasis on the clinical implications. Attendees will be at a distinct advantage and hear from the most important people in the field on themes including Predictive ADME, Screening Approaches, Pre-clinical Screening Approaches, and Predictive Toxicology, emerging issues such as, regulatory changes and Drug-Drug interactions.

This year’s conference will not simply concentrate on current strategies but will be focused on emerging trends, new and novel approaches, and issues and problem areas within the field.
 

FEATURED SPEAKERS

Alan Boobis

Alan Boobis

Professor of Biochemical Pharmacology , Imperial College London
Amin Rostami-Hodjegan

Amin Rostami-Hodjegan

Professor of Systems Pharmacology, University of Manchester
Hans Westerhoff

Hans Westerhoff

Professor of Microbial Physiology, University of Manchester
Katharina Mertsch

Katharina Mertsch

Head of In-Vitro DMPK, Sanofi-aventis
Stephan Kirchner

Stephan Kirchner

Head Discovery Genotoxicity and in vitro Phototoxicity, F. Hoffmann-La Roche
Stephen Clarke

Stephen Clarke

Head Drug Metabolism & Pharmacokinetics , GlaxoSmithKline

Alan Boobis

Professor of Biochemical Pharmacology , Imperial College London
Alan Boobis

Amin Rostami-Hodjegan

Professor of Systems Pharmacology, University of Manchester
Amin Rostami-Hodjegan

Constance Höfer

Founder and Partner, Vitilis
Constance Höfer

Cyrus Khojasteh

Associate Director, Genentech
Cyrus Khojasteh

David Fairman

Senior Clinical Pharmacokinetist, MedImmune Ltd
David Fairman

Friedemann Schmidt

Senior Scientist, Preclinical Safety, Sanofi
Friedemann Schmidt

Hans Westerhoff

Professor of Microbial Physiology, University of Manchester
Hans Westerhoff

Hinnerk Boriss

CEO, Sovicell
Hinnerk Boriss

Jørgen Olsen

Principle Scientist, Novo Nordisk
Jørgen Olsen

Karen Tilmant

Research Scientist, UCB
Karen Tilmant

Katharina Mertsch

Head of In-Vitro DMPK, Sanofi-aventis
Katharina Mertsch

Laurent Salphati

Senior Scientist, Genentech
Laurent Salphati

Mark Graham

Independent Drug Safety / Toxicology Consultant, MG Toxicology Consulting Ltd.
Mark Graham

Mohammed Yaqoob

Operations Manager, Pharmidex
Mohammed Yaqoob

Neil Benson

Director, Xenologiq Ltd.
Neil Benson

Robert Kime

Laboratory Head, Grunenthal Gmbh
Robert Kime

Stephan Kirchner

Head Discovery Genotoxicity and in vitro Phototoxicity, F. Hoffmann-La Roche
Stephan Kirchner

Stephen Clarke

Head Drug Metabolism & Pharmacokinetics , GlaxoSmithKline
Stephen Clarke

Tim Smith

Principal Scientist, Cyprotex Plc
Tim Smith

Conference agenda

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13:30

Registration & Coffee

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14:00

Welcome & Introduction

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14:10

Objectives of predicative toxicology

Mark Graham

Mark Graham, Independent Drug Safety / Toxicology Consultant, MG Toxicology Consulting Ltd.

  • Addressing safety related attrition
  • Influencing target and chemical selection
  • Translational risk assessment
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    15:00

    Advantages and limitations of in silico and in vitro methods – and their combination

    Mark Graham

    Mark Graham, Independent Drug Safety / Toxicology Consultant, MG Toxicology Consulting Ltd.

  • Review of current methods  tools
  • Application in Drug Discovery and Drug Development

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    15:50

    Coffee & Networking

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    16:20

    Case studies and the resulting impact on drug discovery and problem solving.

    Mark Graham

    Mark Graham, Independent Drug Safety / Toxicology Consultant, MG Toxicology Consulting Ltd.

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    17:00

    Further discussion session

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    17:30

    Close of workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Stephen Clarke

    Stephen Clarke, Head Drug Metabolism & Pharmacokinetics , GlaxoSmithKline

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    9:10

    The importance of understanding the contribution of metabolism for the accurate prediction of toxicity in early drug discovery

    Tim Smith

    Tim Smith, Principal Scientist, Cyprotex Plc

    Relevance of in vitro models in toxicity testing

    Importance of incorporating metabolism in in vitro models

    Comparison of in vitro models for detecting metabolism dependent toxicity

    Strategy for classifying and predicting metabolism dependent toxicity from in vitro data

     
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    9:50

    Early ADME screening – a step wise approach

    Robert Kime

    Robert Kime, Laboratory Head, Grunenthal Gmbh

  • Project based or process based?
  • The in vitro step
  • The in vivo step
  • The triangle of early screening – Chemistry, Pharmacodynamics and Pharmacokinetics
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    10:30

    Morning Refreshments

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    10:50

    The lost art of determining mechanisms of metabolism

    Cyrus Khojasteh

    Cyrus Khojasteh, Associate Director, Genentech

  • Why is it critical to propose and test mechanisms?
  • Beyond P450 enzymes
  • Tools available for performing mechanistic studies 
  • Case studies
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    11:30

    Human first metabolism

    Stephen Clarke

    Stephen Clarke, Head Drug Metabolism & Pharmacokinetics , GlaxoSmithKline

  • Typically metabolism is well characterised in preclinical species prior to equivalent studies in humans.
  • This results in significant effort being expended before the main causes of project attrition have been addressed,
  • And metabolites with no relevance to humans being characterised.
  • A combination of NMR/MS and AMS enables a human first strategy to be considered.
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    12:10

    Networking Lunch

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    13:20

    TRAC and TRANSIL: In vitro assays for drug-drug interaction screening, tissue binding, tissue distribution and membrane permeability

    Hinnerk Boriss

    Hinnerk Boriss, CEO, Sovicell

  • FDA and EMEA recommend CYP expression level screening for drug-drug interaction studies because gene expression fold change measurements have much higher sensitivity than activity screens.
  • TRAC is the fasted and most cost effected method for FDA recommended CYP expression level screening.
  • Membrane affinity is a versatile measure for brain tissue binding, microsomal binding, plasma binding as well as for measuring intestinal absorption rates and brain-to-plasma distribution.
  • TRANSIL Microsomal binding assays allow easy and highly accurate fu(mic) measurements.

     

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    14:00

    Permeability and transport assays in drug discovery

    Laurent Salphati

    Laurent Salphati, Senior Scientist, Genentech

  • Background and Purposes of Permeability and Transport Assays
  • Systems and Assays Available
  • Relevance and experimental settings
  • Case studies    
  • Transporters and DDI – Guidance and Impacts
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    14:40

    In vitro PK parameters in discovery and development: bridging high throughput, modelling, and quality for FDA/EMA requirements

    Katharina Mertsch

    Katharina Mertsch, Head of In-Vitro DMPK, Sanofi-aventis

  • Focus on CYP inhibition and transporters (DDI)
  • Modelling and optimization in discovery
  • Data generation and proof of concept in discovery and development 
  • Regulatory environment and submission packages for DDI
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    15:20

    Afternoon Tea

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    15:40

    ADME for biologics, the progress and challenges

    David Fairman

    David Fairman, Senior Clinical Pharmacokinetist, MedImmune Ltd

  • Differences between small molecules and biologics
  • Complexities in modelling biologic PK and PKPD
  • Half life modification for antibody therapeutics
  • Future progression
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    16:20

    Peptides, proteins, and ADME

    Jørgen Olsen

    Jørgen Olsen, Principle Scientist, Novo Nordisk

  • Challenges of peptides in ADME studies
  • LC-MS Analysis of peptides/proteins
  • Peptide metabolism
  • Absorption of biomacromolecules
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    17:00

    Application of modeling and simulation in drug discovery; use cases in PKPD and systems pharmacology

    Neil Benson

    Neil Benson, Director, Xenologiq Ltd.

  • Tackling attrition
  • PKPD modelling
  • Dose projection
  • Systems pharmacology
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    17:40

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Alan Boobis

    Alan Boobis, Professor of Biochemical Pharmacology , Imperial College London

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    9:10

    Toxicity prediction in drug development: Opportunities and challenges

    Alan Boobis

    Alan Boobis, Professor of Biochemical Pharmacology , Imperial College London

  • Why change is needed
  • Emerging methods for toxicity prediction
  • Importance of mode of action
  • Incorporating human variability (genetic and non-genetic)
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    9:50

    Networks for ADMET systems biology around glutathione

    Hans Westerhoff

    Hans Westerhoff, Professor of Microbial Physiology, University of Manchester

  • Modelling the glutathione networks aids understanding detoxification capacity
  • Network assessment of potential biomarkers
  • Adaptation explains paradoxes around glutathione
  • Individualized medicine may become possible
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    10:30

    Morning Refreshments

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    10:50

    Role of Zebrafish in drug discovery and development

    Mohammed Yaqoob

    Mohammed Yaqoob, Operations Manager, Pharmidex

  • Role of Zebrafish in target validation, disease modelling,  lead compound discovery and toxicology
  • Zebrafish  as an alternative to mammalian models of (ADME)/ pharmacokinetics and efficacy.
  • Minimize use of large animals (3Rs), where absolutely necessary, such as in preclinical toxicity and safety assessment
  • Zebrafish embryos and larvae size with optical transparency and rapid development ex utero, allows in vivo analysis of embryogenesis.
  • Zebrafish assays allow to use smaller quantities of precious test compounds
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    11:30

    Emerging challenges in computational approaches to drug toxicity prediction

    Friedemann Schmidt

    Friedemann Schmidt, Senior Scientist, Preclinical Safety, Sanofi

  • Implementing predictive global in-silico models from growing screening data: hERG as an example
  • Optimizing the 3Ps with the help of in-silico may require a sufficiently high level of theory: Phototoxicity, phospholipidosis and physicochemistry in lead optimization
  • Modelling relevant clinical endpoints in-silico from complex and heterogenous data: Hepatotoxicity as an example
  • In-silico off-target profiling and beyond: Cross-pharmacology relating targets to side effects
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    12:10

    Networking Lunch

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    13:30

    Early genotoxicity assessment – avoiding late stage genetox failures

    Stephan Kirchner

    Stephan Kirchner, Head Discovery Genotoxicity and in vitro Phototoxicity, F. Hoffmann-La Roche

  • Bacterial mutagenicity screening
  • Screening for chromosomal damage
  • Non-DNA reactive mechanisms
  • addressing aromatic amines/amide issues in the discovery phase
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    14:10

    Mechanistic modelling of the kidney: Implications for assessing nephrotoxicity

    Amin Rostami-Hodjegan

    Amin Rostami-Hodjegan, Professor of Systems Pharmacology, University of Manchester

  • The impact of transporters in modulating the renal excretion of drugs
  • The ability to predict renal clearance under genetic variability
  • The impact of interactions related to renal transporters
  • The accumulation of xenobiotics within the kidney leading to nephrotoxicity
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    14:50

    Afternoon Tea

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    15:10

    The in vitro assessment of mitochondrial dysfunction in early drug development

    Karen Tilmant

    Karen Tilmant, Research Scientist, UCB

  • Mitochondrial toxicity is at the basis of different drug induced organ toxicities such as hepatotoxicity and cardiotoxicity
  • Literature update on the relevance of in vitro mitochondrial toxicity testing
  • Different methodologies were applied to predict mitochondrial toxicity in vitro
  • Comparison of different cellular models and methods (Ratio of LC50s of cells grown in glucose and galactose, Oxygen consumption rate)
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    15:50

    Disposition mechanisms, predictive toxicology and regulatory aspects

    Constance Höfer

    Constance Höfer, Founder and Partner, Vitilis

    Possible consequences of disregarding early warning signals 

    Trouble shooting approches in vitro and in vivo
    Implications for clinical trial design
    Discussion of potential regulatory consequences 
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    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Professor of Biochemical Pharmacology
    Imperial College London
    Principal Scientist
    Cyprotex Plc
    Senior Scientist, Preclinical Safety
    Sanofi
    Head Discovery Genotoxicity and in vitro Phototoxicity
    F. Hoffmann-La Roche
    Research Scientist
    UCB
    Professor of Systems Pharmacology
    University of Manchester
    Professor of Microbial Physiology
    University of Manchester
    Senior Scientist
    Genentech
    Head of In-Vitro DMPK
    Sanofi-aventis
    CEO
    Sovicell
    Founder and Partner
    Vitilis
    Director
    Xenologiq Ltd.
    Laboratory Head
    Grunenthal Gmbh
    Operations Manager
    Pharmidex
    Associate Director
    Genentech
    Head Drug Metabolism & Pharmacokinetics
    GlaxoSmithKline
    Senior Clinical Pharmacokinetist
    MedImmune Ltd
    Principle Scientist
    Novo Nordisk
    Independent Drug Safety / Toxicology Consultant
    MG Toxicology Consulting Ltd.

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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.

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    CPD AND PROFESSIONAL INSTITUTES

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    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.

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    As a formal provider of CPD certified activities, SAE Media 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

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