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SMi 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 

  • Understand how to integrate ADME and toxicity data to enhance the prediction and understanding of drug safety in humans
  • Hear the latest updates on drug transporters including the evolving transporter strategies in drug development and the different roles of drug transporters in R&D
  • Explore the ADME properties of peptides in drug discovery
  • Evaluate and overcome the challenges of making an accurate human dose prediction

Chief Executives, Vice Presidents, Heads, Directors, Chief Scientists, Principle Scientists, and Project Leaders, Managers, in:

• ADME
• Toxicology
• DMPK
• PD-PK
• PBPK
• Computational modelling and simulation
• Computational chemistry
• Computational toxicology
• Pre-clinical safety
• Clinical pharmacology
• Gentoxicity
• Drug metabolism
• Regulatory Pharmaco-Toxicology

 

A snapshot of our previous delegates at the 2013 event included:

Astrazeneca; Biolab Sanus Farmaceutica Ltda; Biopharm Insight; Boehringer Ingelheim Austria; BTG; Cancer Research Technology; Chiesi Farmaceutici S. P. A. ; Corning BV; Cyprotex Plc; F. Hoffmann-La Roche; Fidelta; Genentech; GlaxoSmithKline; Grunenthal Gmbh; GSK; Heptares Therapeutics; Hypha Discovery Ltd; Imperial College London; Institute of Cancer Research; Johnson & Johnson; Leo Pharma; Lhasa Ltd; MedImmune Ltd; MG Toxicology Consulting Ltd.; National Institute Of Advanced Industrial Science And Technology; Nemaura Pharma; Novo Nordisk A/S; Orion Corporation Orion Pharma; Paterson Institute For Cancer Research; Peakdale Molecular Ltd; Pharmacelsus Gmbh; Pharmidex; Pharmidex Pharmaceutical Services Ltd; Polyphor Ltd; Sanofi; Sanofi Aventis; Sanofi-Aventis; Solvo Biotechnology; Sovicell; Sussex University; Takeda Pharmaceuticals Europe Ltd; The University of Manchester; UCB; Unilever Plc; University of Manchester; University Of East London; University of Sussex; Vernalis; Vertex; Vertex Pharmaceuticals; Vitilis; Xenologiq Ltd.;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Alan Wilson

Alan Wilson, Vice President, Lexicon Pharmaceuticals Inc

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
  • 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
  • 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

    11:10 Morning Coffee

    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
  • 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
  • 13:00 Networking Lunch

    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
  • 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
  • 15:20 Afternoon Tea

    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
  • 16:30 The use of label free technologies in drug discovery

    Franck Atienzar

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

    17:10 Contemporary nonclinical approaches to cardiac safety assessment in drug development

    Peter  Clements

    Peter Clements, Director of Pathology, GSK

    17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Gerry Kenna

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

    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
  •  

    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
  • 10:30 Morning Coffee

    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
     
  • 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

     

  • 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

     

  • 13:00 Networking Lunch

    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
  • 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
  • 15:20 Afternoon Tea

    15:50 In vivo models for the study of drug transporters

    Laurent Salphati

    Laurent Salphati, Senior Scientist, Genentech

    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?
  • 17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    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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    ‘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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