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SMi 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.
 

  • Examine how new strategies in ADME impact drug discovery, development, safety; and most importantly the subsequent clinical implications.
  • Discuss the predictive methods of ADME, pre-clinical translational approaches, the various up-to-date transporter and screening assays.
  • Hear the latest on predictive toxicology, genotoxicity, and metabolic toxicity.
  • Explore emerging issues within the field including Drug-Drug interactions, regulatory guideline changes and the impact on ADME studies.

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
 

Companies attending previously:


Absorption Systems; Blizard Institute of Cell & Molecular Science; Boehringer Ingelheim; BTG; Cancer Research UK; Cancer Research Technology; Cellectis Bioresearch; CEREP; CXR Biosciences; Cyprotex Discovery Ltd; Debiopharma Group; Dr Margareta Fischer-Bosch Institute Of Clinical Phamacology; Eisai; Eli Lilly; European Collection Of Cell Cultures; FIS; FMC Corporation; Gentronix; GlaxoSmithKline; GmbH; Heptares Therapeutics; Hypha Discovery Ltd.; Instem Scientific; Institute of Cancer Research; Janssen; LEO; London Technology Network; Lundbeck; Merck; Molecular Devices Ltd.; Muscagen Ltd.; Novartis; Orion Corporation; Pfizer; Pharmidex; Polyphor Ltd; Proximagen; Selvita; Simultaneous Plus Inc; Sirius Analytical Instruments; Solvo Biotechnology; Syntaxin Ltd; Takeda; UCB; Vertex; Xenogesis; Xenotech;
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Stephen Clarke

Stephen Clarke, Head Drug Metabolism & Pharmacokinetics , GlaxoSmithKline

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

 

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
  • 10:30 Morning Refreshments

    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
  • 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.
  • 12:10 Networking Lunch

    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.

     

  • 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
  • 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
  • 15:20 Afternoon Tea

    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
  • 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
  • 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
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alan Boobis

    Alan Boobis, Professor of Biochemical Pharmacology , Imperial College London

    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)
  • 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
  • 10:30 Morning Refreshments

    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
  • 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
  • 12:10 Networking Lunch

    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
  • 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
  • 14:50 Afternoon Tea

    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)
  • 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 

    16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    Workshops

    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.

     

    HOTEL BOOKING FORM

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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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