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ADMET

SAE Media Group are proud to present their 9th annual ADMET Conference to be held from the 30th June and 1st July 2014 in Central London.

All companies involved in drug discovery and development need to use ADMET studies so as to understand and analyse whether the drug when ingested, will stay long enough in the body to fulfil its purpose and also to ensure safety and minimize toxicity. Therefore, 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.


The topics covered in this conference will focus on the role of ADMET in drug development. We will also be looking at the perdiction value of toxicity while addressing in silico and in vivo methods. there will also be a focus on biologics v/s small molecules in ADMET and an update on drug transporters. 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.
 

2014 Testimonials include:

"Excellent" - Pharmidex
"Nice mix of attendees" - Grunenthal
"Good conference at general level to update your current knowledge" - Orion Corporation 
"Great conference! (well organised)" - Sanofi 

FEATURED SPEAKERS

Adina Tocoian

Adina Tocoian

Senior Clinical Pharmacologist, UCB
Alan Wilson

Alan Wilson

Vice President, Lexicon Pharmaceuticals Inc
Chris Powell

Chris Powell

VP Safety Assessment, GSK
Dietmar Weitz

Dietmar Weitz

Lab Head DMPK, Sanofi-Aventis Deutschland GmbH
Franck Atienzar

Franck Atienzar

Associate Director, In Vitro and In Silico Toxicology, UCB
Georg Schmitt

Georg Schmitt

Head of Toxicology, Roche Pharmaceuticals
Gerry Kenna

Gerry Kenna

Safety Science Adviser and Network Partner, The Research Network Ltd
Nathalie Gobeau

Nathalie Gobeau

Research Investigator , Novartis Pharma
Richard Thompson

Richard Thompson

Principal Scientist, AstraZeneca
Sandra Baldwin

Sandra Baldwin

In Vitro DMPK Manager, GSK

Adina Tocoian

Senior Clinical Pharmacologist, UCB
Adina Tocoian

Alan Boobis

Professor of Biochemical Pharmacology , Imperial College London
Alan Boobis

Alan Wilson

Vice President, Lexicon Pharmaceuticals Inc
Alan Wilson

Andrew McElroy

CEO, EligoChem Ltd
Andrew  McElroy

Chris Powell

VP Safety Assessment, GSK
Chris Powell

David Fairman

At time of presentation preparation: Senior Clinical Pharmacokinetisist, Medimmune, Cambridge (now Director, CPMS, GSK, Stevenage), GSK
David Fairman

David Stresser

Program Manager, Drug Metabolism Services, Corning Life Sciences
David Stresser

Dietmar Weitz

Lab Head DMPK, Sanofi-Aventis Deutschland GmbH
Dietmar Weitz

Franck Atienzar

Associate Director, In Vitro and In Silico Toxicology, UCB
Franck Atienzar

Georg Schmitt

Head of Toxicology, Roche Pharmaceuticals
Georg Schmitt

Gerry Kenna

Safety Science Adviser and Network Partner, The Research Network Ltd
Gerry Kenna

Hinnerk Boriss

CEO, Sovicell
Hinnerk Boriss

Jørgen Olsen

Principle Scientist, Novo Nordisk A/S
Jørgen Olsen

Laurent Salphati

Senior Scientist, Genentech
Laurent Salphati

Nathalie Gobeau

Research Investigator , Novartis Pharma
Nathalie Gobeau

Peter Clements

Director of Pathology, GSK
Peter  Clements

Peter Littlewood

Director DMPK, Vertex Pharmaceuticals
Peter Littlewood

Richard Thompson

Principal Scientist, AstraZeneca
Richard Thompson

Sandra Baldwin

In Vitro DMPK Manager, GSK
Sandra Baldwin

If you would like to speak at the event, please get in touch with Roochita Imrit on rimrit@smi-online.co.uk

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Alan Wilson

Alan Wilson, Vice President, Lexicon Pharmaceuticals Inc

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9:10

Role of ADMET in drug development

Alan Wilson

Alan Wilson, Vice President, Lexicon Pharmaceuticals Inc

  • The role of ADMET in optimising drug discovery and development
  • The role of good laboratory practice in non-clinical ADMET studies
  • Optimising the value of predictive ADMET/PK
  • Future opportunities and challenges
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    9:50

    The challenges of making an accurate human dose prediction

    Peter Littlewood

    Peter Littlewood, Director DMPK, Vertex Pharmaceuticals

  • How to predict accurate PK parameters
  • What in vitro and in vivo tools can we use and how should we use them
  • Understanding the drifer of efficacy
  • Dealing with active processes
  • Understanding and appreciation of errors and their implications
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    10:30

    Novel tools and applications for the evaluation of drug-drug interaction in vitro: TransportoCells™ and calibrated cryopreserved human hepatocytes

    Continuing advances in our understanding of the mechanistic basis of drug-drug interactions (DDI) have led to recent changes in regulatory agency recommendations of DDI testing and evaluation. For example, the 2012 FDA and EMA guidance documents now advocate evaluation of transporters other than P-gp and the methods for data interpretation for cytochrome P450 induction studies is significantly different compared to prior versions.  Appropriate in vitro characterization of drug interactions mediated by transporters or induced enzymes facilitates decision-making and development of appropriate clinical plans in drug development. Corning Life Sciences have recently developed a novel SLC transporter model to help the pharmaceutical industry address regulatory guidance in a fast and easy manner. We have also characterized induction potential of cryopreserved hepatocytes from three single lot donors using a panel of inducing and non-inducing drugs that enables construction of a calibration curve which permits estimates of DDI potential. 

    In this talk, we will provide an overview of the product validation and applications for the recently launched TransportoCells™ cryopreserved SLC transporter model as well as an overview of our induction calibrated cryopreserved hepatocytes available for contract services.

    David Stresser

    David Stresser, Program Manager, Drug Metabolism Services, Corning Life Sciences

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    11:10

    Morning Coffee

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    11:40

    Immunogenicity assessment of monoclonal antibodies and bio-technology derived therapeutic proteins

    Adina Tocoian

    Adina Tocoian, Senior Clinical Pharmacologist, UCB

  • Scientific and regulatory considerations on the immunogenicity of biologics
  • Comparative review of the EMA vs. FDA guidelines for immunogenicity of biologics
  • A risk based approache to immunogenicity concerns in drug development
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    12:20

    Modulation of drug absorption via internal hydrogen bonding

    Andrew  McElroy

    Andrew McElroy, CEO, EligoChem Ltd

  • Impact of internal H-bonding on absorption
  • Prediction of internal H-bonding
  • Application to drug design
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    13:00

    Networking Lunch

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    14:00

    Exploring the ADME properties of peptides in drug discovery

    Jørgen Olsen

    Jørgen Olsen, Principle Scientist, Novo Nordisk A/S

  • Metabolism of peptides
  • What in vitro metabolism studies can we employ?
  • LC-MS analysis of peptides in drug discovery
  • Absorption of peptides
  • clock

    14:40

    ADME for biologics, progress and challenges

    David Fairman

    David Fairman, At time of presentation preparation: Senior Clinical Pharmacokinetisist, Medimmune, Cambridge (now Director, CPMS, GSK, Stevenage), GSK

  • Contrasting small and large molecule ADME challenges
  • Introduction to monoclonal antibody (mAB) PK and PKPD
  • mAB half life modifiction strategies
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    15:20

    Afternoon Tea

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    15:50

    The role of non-clinical safety testing in drug research & development and clinical safety

    Georg Schmitt

    Georg Schmitt, Head of Toxicology, Roche Pharmaceuticals

  • Non-regulated and regulated areas
  • Predictive value with a focus on toxicology
  • Strategic approaches within the value chain
  • Personal view and outlook
  • clock

    16:30

    The use of label free technologies in drug discovery

    Franck Atienzar

    Franck Atienzar, Associate Director, In Vitro and In Silico Toxicology, UCB

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    17:10

    Contemporary nonclinical approaches to cardiac safety assessment in drug development

    Peter  Clements

    Peter Clements, Director of Pathology, GSK

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    17:50

    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

    Gerry Kenna

    Gerry Kenna, Safety Science Adviser and Network Partner, The Research Network Ltd

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    9:10

    Risk assessment and mitigation strategies for reactive metabolites in drug discovery

    Richard Thompson

    Richard Thompson, Principal Scientist, AstraZeneca

  • Risk factors: drug related and patient related
  • Risk assessment and mitigation strategies in the pharmaceutical industry
  • Idiosyncratic adverse drug reactions: Multiple contributory mechanisms
  • Case study
  •  

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    9:50

    Experimental strategies to predict [and therefore avoid] adverse hepatic effects in clinical trials

    Chris Powell

    Chris Powell, VP Safety Assessment, GSK

  • Current challenges in predicting clinical hepatotoxicity
  • Sensitivity, specificity & clinical relevance of experimental models
  • Differences in the underlying mechanism(s) of hepatic dysfunction
  • Use of emerging technologies like 3D cell culture to predict hepatotoxicity
  • clock

    10:30

    Morning Coffee

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    11:00

    Assessing the effectiveness of non-animal models to predict toxicity

    Alan Boobis

    Alan Boobis, Professor of Biochemical Pharmacology , Imperial College London

  • Prediction goals in using computational and in vitro approaches to assess toxicity
  • Understanding and evaluating the latest models
  • Predicting end points and future challenges and opportunities
     
  • clock

    11:40

    What added value can PBPK bring to drug discovery?

    Nathalie Gobeau

    Nathalie Gobeau, Research Investigator , Novartis Pharma

  • Overview of PBPK
  • Possible applications in drug discovery
  • Case studies
  • Challenges and opportunities

     

  • clock

    12:20

    Integrating ADME and toxicity data to enhance the prediction and understanding of drug safety in humans

    Gerry Kenna

    Gerry Kenna, Safety Science Adviser and Network Partner, The Research Network Ltd

  • ADME endpoints considered most relevant to drug safety
  • Value and limitations of in vivo toxicity assessment
  • In silico and in vitro toxicity evaluation
  • Approaches for data integration – the need for physiologically based systems models

     

  • clock

    13:00

    Networking Lunch

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    14:10

    Significance of plasma protein binding for pharmacokinetics and the utility of TRANSIL assays

    Hinnerk Boriss

    Hinnerk Boriss, CEO, Sovicell

  • Free fraction and equilibrium distribution
  • Binding site affinity, receptor affinity and displacement
  • Plasma dilution, apparent recovery are absolute recovery
  • Assay systems for peptide drugs
  • clock

    14:50

    Evolving transporter strategies in drug development

    Sandra Baldwin

    Sandra Baldwin, In Vitro DMPK Manager, GSK

  • Understanding clinically relevant drug transporters and their importance in the pharmaceutical industry
  • Case study at GSK
  • Drug transporter regulatory interactions
  • Key learnings & application to future projects
  • clock

    15:20

    Afternoon Tea

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    15:50

    In vivo models for the study of drug transporters

    Laurent Salphati

    Laurent Salphati, Senior Scientist, Genentech

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    16:30

    The different roles of drug transporters in research and development

    Dietmar Weitz

    Dietmar Weitz, Lab Head DMPK, Sanofi-Aventis Deutschland GmbH

  • Drug and drug metabolites are actively transported into and out of cells by a variety of transporters
  • Transporters – a view from different angles: determinant of PK, PD, efficacy and safety
  • Regulatory guidance, clinical importance and implications
  • How far is ‘IVIVC’ for transporters?
  • clock

    17:10

    Chairman’s Closing Remarks and Close of Day Two


    Senior Clinical Pharmacologist
    UCB
    Professor of Biochemical Pharmacology
    Imperial College London
    Vice President
    Lexicon Pharmaceuticals Inc
    CEO
    EligoChem Ltd
    VP Safety Assessment
    GSK
    At time of presentation preparation: Senior Clinical Pharmacokinetisist, Medimmune, Cambridge (now Director, CPMS, GSK, Stevenage)
    GSK
    Program Manager, Drug Metabolism Services
    Corning Life Sciences
    Lab Head DMPK
    Sanofi-Aventis Deutschland GmbH
    Associate Director, In Vitro and In Silico Toxicology
    UCB
    Head of Toxicology
    Roche Pharmaceuticals
    Safety Science Adviser and Network Partner
    The Research Network Ltd
    CEO
    Sovicell
    Principle Scientist
    Novo Nordisk A/S
    Senior Scientist
    Genentech
    Research Investigator
    Novartis Pharma
    Director of Pathology
    GSK
    Director DMPK
    Vertex Pharmaceuticals
    Principal Scientist
    AstraZeneca
    In Vitro DMPK Manager
    GSK

    Interview with Alan Boobis

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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.

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    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, 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

    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@saemediagroup.com

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