www.admet-event.comRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Molecular properties and intermolecular interactions in virtual ADMET assessment Led by Mire Zloh, Head of Medicinal and Analytical Chemistry Research Group, University of Hertfordshire

and Teresa Barata, Research Associate, UCL School of Pharmacy8:30 - 12:30

PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP | WEDNESDAY 15TH JUNE 2016, HOLIDAY INN KENSINGTON FORUM, LONDON, UK

@SMIPHARM#smiADMET

CHAIRMAN FOR 2016:• Thierry Lave, Head DMPK Discovery and

Development Project Leaders (CNS/CVM), Roche

KEYNOTE SPEAKERS INCLUDE:• Karelle Menochet, Principal Scientist DMPK,

UCB Pharma• Laurent Salphati, Senior Scientist, Genentech• Carl Petersson, DMPK NCE Senior Designer, Merck

Serono• Kunal Taskar, Senior Investigator, DMPK, GSK• Lena Gustavsson, Head of Sections Drug-Drug

Interactions, Lundbeck• Friedemann Schmidt, R&D DSAR Preclinical Safety,

Sanofi-Aventis• Pau Aceves, Senior Clinical Pharmacologist, Takeda

HIGHLIGHTS FOR 2016:

• Discover application of PBPK to drug development in rare diseases

• Review the role of drug transporters in drug delivery to CNS diseases

• Learn about better models for understanding, predicting and avoiding drug induced liver injury

• Discuss in silico approaches to evidence-based mechanistic modelling

• Analyse early dose predictions – a valuable tool in risk assessment and optimisation of small molecules

13TH - 14TH

JUNE 2016HOLIDAY INN KENSINGTON FORUM, LONDON, UK

SMi Presents the 11th Annual Conference and Exhibition on

ADMETLinking ADME and PK with safety to an overall

assessment of risk/benefit

BOOK BY 29TH FEBRUARY TO SAVE £400 • BOOK BY 31ST MARCH TO SAVE £300 • BOOK BY 29TH APRIL TO SAVE £200

Sponsored by

ADMET Day One 13th June 2016 www.admet-event.com

8.30 Registration & Coffee

9.00 Chairman’s Opening RemarksThierry Lave, Head DMPK Discovery and Development Project Leaders (CNS/CVM), Roche

ADME/PK: OPTIMISATION FOR DRUG DESIGN AND DISCOVERY

OPENING ADDRESS9.10 Application of PBPK to drug development in rare diseases

• Clinical drug development programmes in rare diseases are starting to be more common in the pharmaceutical industry

•Thesepatientpopulationstendtobedifficulttorecruitandare usually complex to deal with in early clinical development studies due to co-morbidities and concomitantly administered medications

• An example of how PBPK modeling can facilitate the conduct of clinical trials in these populations by the ability to simulate and anticipate PK variability will be presented

Pau Aceves, Senior Clinical Pharmacologist, Takeda 9.50 Cell-based models for drug transport, metabolism studies and services

•Learnabouttheperformance,featuresandbenefitsofCorning® TransportoCells™, a new cell-based model to study SLC transporters for predicting drug clearance, drug-drug interactions, and the impact of genetic polymorphism on drug disposition

• Introduce a novel human hepatocyte-like model, Corning® HepatoCells, and its applications of predicting drug-drug interaction and hepatic toxicity in 3D culture Na Li, Senior Staff Scientist, Corning

10.30 Morning Coffee

11.00 Transporter interaction in the ADME pathway • Uses and limitations of in vitro transporter assays in the

predictions of drug disposition and DDIs• Humanised models available and characterisations• Case studies: Translation to human and limitations of humanised

models for drug disposition and DDI predictionsLaurent Salphati, Senior Scientist, Genentech

11.40 In silico approaches to evidence-based mechanistic modelling• Why do we need to know mechanisms?• Can QSAR help to elucidate mechanisms?• Use of mechanistically-based QSARs in toxicology• Use of adverse outcome pathwaysJohn C. Dearden, Emeritus Professor of Medicinal Chemistry, Liverpool John Moores University

12.20 Networking Lunch

TRANSLATING NON-CLINICAL ADME DATA TO THE CLINIC

1.30 Better models for understanding, predicting and avoiding drug

induced liver injury

•Unexpectedhepatotoxicityremainsasignificantcauseofdrug

failure and withdrawal

• The prevention of DILI requires better in vitro, in vivo and in silico

methods of prediction

• Improved understanding of the mechanisms of DILI is leading

the development of new model systems

Ian Wilson, Professor of Toxicology, Imperial College London

2.10 Early dose predictions - a valuable tool in risk assessment and

optimisation of small molecules

• Value of integrating translational PKPD in early development

• Understand the requirements for translational PKPD

• Illustrate the use of exposure-response

Carl Petersson, DMPK NCE Senior Designer, Merck Serono

2.50 Afternoon Tea

3.20 Integrated modelling of metabolism and PBPK

•BasicintroductiontoPBPK–thebenefitsofareductionist

approach

• Integration of mechanistic models – increased information at

key biological hubs

• Integration of regulation – making models adapt to drug

exposure

• Integration of whole-cell metabolism – understanding the wider

implications of drug exposure

Nick Plant, Reader in Systems Biology, University of Surrey

4.00 Cross-platform/cross-species application of physiologically based

pharmacokinetics for biologics

• Biologics are taking up an increasing share of therapeutic

portfolio

• Early assessment of target druggability is expected to improve

resource allocation and reduce attrition

• The PBPK model developed allows to estimate soluble protein

tissue penetration and elimination kinetics as a function of size

andFcRn-bindingaffinity

Armin Sepp, SeniorScientificInvestigator,GSK

4.40 Chair’s Closing Remarks and Close of Day One

Register online at www.admet-event.com

Want to know how you can get involved? Interested in promoting your services to this market? Contact Zoe Gale SMi Marketing on

+44 (0)20 7827 6132 or email: zgale@smi-online.co.uk

Corning Incorporated offers integrated solutions to support life sciences and accelerate drug discovery and development with reagents and contract research services for in vitro analysis of xenobiotic metabolism and drug transport. Products include Corning® Gentest™ Hepatocytes, tissue fractions, various transporter models, Corning Supersomes™ Enzymes, and Corning Gentest Contract Research Services. www.corning.com

Sekisui XenoTech is a global contract research organization with unparalleled experience and proven expertise from discovery through clinical support, providing cell and tissue-based products, screening, radiolabeling, API manufacturing, in vitro ADMET and pharmacology, in vivo ADMET and QWBA, metabolite ID and production, bioanalytical services and consulting. www.xenotech.com

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ADMETwww.admet-event.com Day Two 14th June 2016

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks

Thierry Lave, Head DMPK Discovery and Development Project

Leaders (CNS/CVM), Roche

LINKING PK WITH SAFETY

OPENING ADDRESS

9.10 Computational drug hazard assessment: From ADMET prediction

towards organ toxicity

• Current preclinical in silico toxicology

• ADMET modelling, leading to quantitative structure-toxicity

relationships

• Analysing and predicting pre-/clinical toxicity based on target

interactionprofiles

Friedemann Schmidt, R&D DSAR Preclinical Safety, Sanofi-Aventis

9.50 Mapping dynamic pathways towards multiscale drug therapy

• Human metabolic map

• Metabolic diseases

• Individualized medicine

• Differential network-based drug design

Hans V. Westerhoff, Synthetic Systems Biology, University of

Amsterdam

10.30 Morning Coffee

11.00 Providing an ADMET safety to logical transition

• Identifying which transporters to screen and monitor their

interactions with drugs and new molecular entities

•Screeningsitespecificinteractionsandproteinfoldinteractions

•Highthroughputmethodsformembraneinandeffluxtransport

systems

Karelle Menochet, Principal Scientist DMPK, UCB Pharma

11.40 Translational modelling in support to efficacy and safety

assessments

• Critical consideration of the value of model-based approaches

for supporting safety assessments during drug discovery and

development

• Value of integrating translational PKPD in early development

• Understand the requirements for translational PKPD

Thierry Lave, Head DMPK Discovery and Development Project

Leaders (CNS/CVM), Roche

12.20 Networking Lunch

1.30 In silico predictions of drug-drug interactions: Limitations and

perspectives

• Introduction to different types of prediction models

• Competitive binding, protein-drug interactions versus small

molecule interactions

• Current progress of the in silico prediction of drug safety

Mire Zloh, Head of Medicinal and Analytical Chemistry Research

Group, University of Hertfordshire

IMPROVING DRUG-DRUG INTERACTION

2.10 Contribution of metabolites to DDI

• Regulatory guidelines and risk based approach to evaluate

metabolite related DDI

• Inhibition/induction of drug metabolising enzymes and

transporters by metabolites including time dependent effects on

pharmacokinetics

• Impact of transporters on metabolite disposition and local

concentration

Lena Gustavsson, Head of Sections Drug-Drug Interactions,

Lundbeck

2.50 Afternoon Tea

3.20 Estimating human plasma concentrations using in silico

ADMET models

• Building in silico models for human PK parameters

•Profilingtheestimatedhumanplasmaconcentrationsof

marketed oral drugs

• Influencingdrugdesign:Anewdefinitionfororaldrug-likeness

Mark Wenlok, Principal Scientist, InSilicoLynx Limited

4.00 Role of drug transporters in drug delivery to CNS diseases

•Roleofnoveleffluxtransportersinanticancerdrugdelivery

across the blood-brain barrier (BBB)

• Role of uptake transporters at the BBB

• DDI risk with drug transporters modulation at the BBB

Kunal Taskar, Senior Investigator, DMPK, GSK

4.40 Chairman’s Closing Remarks and Close of Day Two

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

SUPPORTED BY

WHO SHOULD ATTEND THIS CONFERENCE: You should attend this event if you are a Chief Executive, Vice President, Head, Director, Chief Scientist, Principal Scientist, Project Leader, Manager from within the Pharmaceutical or Healthcare industry within responsibilities in the following areas:• ADME • Toxicology • DMPK • PBPK

• PD/PK • Computational Modelling and

Simulation • Pathology

• Computational Chemistry • Computational Toxicology • Pre-clinical Safety • Clinical Pharmacology

• Genotoxicity • Drug Metabolism • Regulatory Pharmaco-Toxicology

HALF DAY POST-CONFERENCE WORKSHOP Wednesday 15th June 2016

Holiday Inn Kensington Forum, London, UK8.30am – 12.30pm

Molecular properties and intermolecular interactions in

virtual ADMET assessment Leaders:

Mire Zloh, Head of Medicinal and Analytical Chemistry Research Group, University of Hertfordshire

Teresa Barata, Research Associate, UCL School of Pharmacy

Workshop overview:

The workshop will provide an overview of principles behind in silico methods used currently in prediction of ADMET properties. The alternative approaches to prediction of toxicity of drug candidates will be demonstrated and discussed. The practical issues related to the use of predictive methods will be demonstrated by the use of opensource software and relevant examples. Delegates are advised to bring their own laptops.

Key Benefits of Attending:

• Introduction into a range of in silico methods to predict ADMET properties

• Insight into alternative approaches to toxicity predictions

• Exploring the application of open source software in industrial setting

• Hands on experience

Agenda

8.30 Registration & Coffee

9.00 Opening Remarks

9.15 Chemoinformatics and ADMET

10.15 Prediction of off-target interactions

10.45 Coffee Break

11.15 Interactive session

12.15 Closing Remarks

12.30 End of Workshop

About the Workshop Leaders:

Professor Mire Zloh has joined Department of Pharmacy at the University of Hertfordshire in 2013. He was awarded a BSc and an MSc in Physical Chemistry by University of Belgrade and was awarded a PhD in Chemistry by University of London in 1998. Previously he was a Senior Lecturer and Director of the Centre for Structural Chemistry at the UCL School of Pharmacy. His research interests include computer aided drug design, structural chemistry and chemometrics. Currently, he is working on rational design of pharmaceutical formulations, in silico prediction of off-target activities, modeling of PEGylated proteins and dendrimers, and developing strategies to utilize small molecule-small molecule interactions for enhancing activities of therapeutics.

Dr Teresa Barata is a Research Associate at the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, UCL, where she focus on computational and experimental formulation of therapeutic proteins. Teresa has extensive experience in iterative modelling where computational and experiment work are applied in shared experimental design. Her main expertise is in molecular modeling techniques and tool development for the design and study of novel polymers including hyperbranched molecules and their interaction with protein structures. She has also worked in formulation of poor soluble drugs at Polytherics Ltd.

About the Organisations:

The University of Hertfordshire (UH) is the UK’s leading business-facing university and an exemplar in the sector. UH was named Entrepreneurial University of the Year in 2010 in the Times Higher Educational. The Department of Pharmacy, Pharmacology and Postgraduate Medicine has a thriving research community focused around drug discovery and development, topical drug delivery and toxicology, pharmacology and patient safety. 72% of our research was recently classed as internationally or nationally excellent.

The UCL School of Pharmacy is the pharmacy school of University College London (UCL). The School was founded by the Royal Pharmaceutical Society of Great Britain in 1842 as the College of the Pharmaceutical Society. It was renamed The School of Pharmacy in 1949 when it became independent of the Pharmaceutical Society and was incorporated into the University of London as a constituent college. The School was granted a royal charter in 1952 and merged with UCL in January 2012.

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

SMi PHARMACEUTICALEVENT PLANNER 2016

FEBRUARY

Parallel Trade8th - 9th FebruaryHoliday Inn Kensington Forum, London, UKAdvances and Progress in Drug Design15th - 16th FebruaryHoliday Inn Kensington Forum, London, UKRNAi Therapeutics15th - 16th FebruaryHoliday Inn Kensington Forum, London, UK

MARCH

Superbugs & Superdrugs - A Focus on Antibacterials16th - 17th MarchHoliday Inn Kensington Forum, London, UKPaediatric Clinical Trials16th - 17th MarchHoliday Inn Kensington Forum, London, UK

APRIL

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JUNE

Pre-Filled Syringes West Coast6th - 7th JuneHyatt Regency Mission Bay, San Diego, USAADMET13th - 14th JuneHoliday Inn Kensington Forum, London, UKImmunogenicity13th - 14th JuneHoliday Inn Kensington Forum, London, UKBioBanking20th - 21st JuneHoliday Inn Kensington Forum, London, UK

JULY

Lyophilisation Europe4th - 5th JulyHoliday Inn Kensington Forum, London, UKAllergies6th - 7th JulyHoliday Inn Kensington Forum, London, UKPeptides6th - 7th JulyHoliday Inn Kensington Forum, London, UK

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ADMETConference: 13th – 14th June 2016, Holiday Inn Kensington Forum, London, UK Workshop: 15th June 2016, London

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