PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 2nd July 2014, The Marriott Regents Park Hotel, London, UK

A: Computational Approaches in ADMETWorkshop Leader: Dr Nick Plant, Reader in Molecular Toxicology,

University of Surrey

8.30am - 12.30pm

B: ADME for the Medicinal ChemistWorkshop Leader: Dr Corinne Kay, Company DIrector, Med-Simple

1.30pm - 5.30pm

BOOK BY 31ST MARCH AND SAVE £300 BOOK BY 30TH APRIL AND SAVE £100

30TH JUNE -1ST JULY

2014Enhancing drug quality by ADMET optimisation in discovery

The Marriott Regents Park Hotel, London, UK

SMi present their 9th annual conference on…

ADMET

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

BOOK BY 31ST MARCH AND SAVE £300 • BOOK BY 30TH APRIL AND SAVE £100

Conference chairs: • Gerry Kenna, Safety Science Adviser and Network Partner,

The Research Network• Alan Wilson, Vice President, Lexicon Pharmaceuticals

Key Speakers:• Natalie Gobeau, Metabolism and Pharmacokinetics, Novartis• Dietmar-Weitz, Lab Head/ADME In Vitro Systems, Sanofi-Aventis• Sarah Baldwin, In Vitro DMPK Manager, GSK• Chris Powell, VP Safety Assessment, GSK• Georg Schmitt, Head of Toxicology, Roche Pharmaceuticals• Richard Thompson, Principal Scientist, AstraZeneca• Franck Atienzar, Associate Director, In Vitro and In Silico Toxicology, UCB• Adina Tocoian, Senior Clinical Pharmacologist, UCB• David Fairman, Senior Clinical Pharmacokinetist, MedImmune

WHY ATTEND THIS EVENT:

• 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

“Great conference! Well organised” Sanofi

Sponsored by

Register online at: www.admet-event.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

ADMET 2014Day One I Monday 30th June 2014 www.admet-event.com

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks Alan Wilson, Vice President, Lexicon Pharmaceuticals

ADMET IN DRUG DEVELOPMENT

9.10 Role of ADMET in drug development• Role of ADMET in optimizing drug discovery and

development

• The role of good laboratory practice in non-clinical ADMET

studies

• Optimizing the value of predictive ADMET/PK

• Future opportunities and challenges

Alan Wilson, Vice President, Lexicon Pharmaceuticals

9.50 The challenges of making an accurate human dose prediction

• How to predict accurate PK parameters

• What in vitro and in vivo tools can we use and how should

we use them

• Understanding the driver of efficacy

• Dealing with active processes

• Understanding and appreciation of errors and their

implications

Peter Littlewood, Director DMPK, Vertex

10.30 Session reserved for Corning Life SciencesDavid 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

• Scientific and regulatory considerations on the

immunogenicity of biologics

• Comparative review of the EMA vs. FDA guidelines for

immunogenicity of biologics

• A risk based approach to immunogenicity concerns in drug

development

Adina Tocoian, Senior Clinical Pharmacologist, UCB

BIOLOGICS V/S SMALL MOLECULES IN ADMET

12.20 Modulation of drug absorption via internal hydrogen bonding• Impact of internal H-bonding on absorption

• Prediction of internal H-bonding

• Application to drug design

Andy McElroy, CEO, EligoChem Ltd

1.00 Networking Lunch

2.00 Exploring the ADME properties of peptides in drug discovery

• Metabolism of peptides

• What in vitro metabolism studies can we employ?

• LC-MS analysis of peptides in drug discovery

• Absorption of peptides

Jørgen Olsen, Principal Scientist, Novo Nordisk

2.40 ADME for biologics, progress and challenges

• Contrasting small and large molecule ADME challenges

• Introduction to monoclonal antibody (mAB) PK and PKPD

• mAB half life modification strategies

David Fairman, Senior Clinical Pharmacokinetist, MedImmune

3.20 Afternoon Tea

PREDICTIVE VALUE OF TOXICITY

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

development and clinical safety

• Non-regulated and regulated areas

• Predictive value with a focus on toxicology

• Strategic approaches within the value chain

• Personal view and outlook

Georg Schmitt, Head of Toxicology, Roche Pharmaceuticals

4.30 The use of label free technologies in drug development

• xCELLingence platform (impedance)

• Advantages and drawbacks

• Defining optimal conditions for your cells

• Toxicity and pharmacology

• Coupling RTCA with cell imaging

Franck Atienzar, Associate Director, UCB

5.10 Contemporary nonclinical approaches to cardiac safety

assessment in drug development

• Overview of CV data generated in the preclinical space

• Reducing attrition: in silico, in vitro, in vivo assessment

• Integration of data to inform on pathogenesis

• Building an integrated structure/function strategy to CV

safety

Peter Clements, Director of Pathology, GSK

5.50 Chairman’s Closing Remarks and Close of Day One

Supported byOfficial Media Partners

CASESTUDY

CASESTUDY

Register online at: www.admet-event.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

ADMET 2014Day Two I Tuesday 1st July 2014www.admet-event.com

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks

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

• 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

Richard Thompson, Principal Scientist, AstraZeneca

9.50 Experimental strategies to predict [and therefore avoid]

adverse hepatic effects in clinical trials

• 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

Chris Powell, VP Safety Assessment, GSK

10.30 Morning Coffee

11.00 Assessing the effectiveness of non-animal models to predict

toxicity

• 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

Alan Boobis, Professor of Biochemical Pharmacology,

Imperial College London

IN SILICO AND IN VITRO APPROACHES

11.40 What added value can PBPK bring to drug discovery?

• Overview of PBPK

• Possible applications in drug discovery

• Case studies

• Challenges and opportunities

Nathalie Gobeau, Metabolism and Pharmacokinetics, Novartis

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

• 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

Gerry Kenna, Safety Science Adviser and Network Partner,

The Research Network Ltd

1.00 Networking Lunch

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

• Free fraction and equilibrium distribution

• Binding site affinity, receptor affinity and displacement

• Plasma dilution, apparent recovery are absolute recovery

• Assay systems for peptide drugs

Hinnerk Boriss, CEO, Sovicell

UPDATE ON DRUG TRANSPORTERS

2.40 Evolving transporter strategies in drug development

• 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

Sandra Baldwin, In Vitro DMPK Manager, GSK

3.20 Afternoon Tea

3.50 In vivo models for the study of drug transporters

• Animal models available

- Knockout and transgenic animals

• Relevance and experimental settings

• Case studies and potential applications

Laurent Salphati, Senior Scientist, Genentech

4.30 The different roles of drug transporters in research and development

• 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?

Dietmar Weitz, Lab Head/ADME in Vitro Systems, Sanofi-Aventis

5.10 Chairman’s Closing Remarks and Close of Day Two

Supported by Want to know how you can get involved?

Interested in promoting your services to this market?

Contact Teri Arri, SMi Marketing on

+44 (0) 207 827 6162 or email tarri@smi-online.co.uk

CASESTUDY

CASESTUDY

Overview of workshop:

Within the last few years there has been a step-change in the use of computational approaches to examine biological processes. An important challenge is to use these new approaches to better predict drug action (both pharmacology and toxicology) as early in the drug pipeline as possible

This workshop will cover both the theory of these new approaches, and the application of them to a real test case. No previous experience in computational modelling will be assumed!

Why you should attend:

Computational biology is a rapidly changing field, with new approaches being developed every day. This workshop will help the non-specialist understand what they can expect from such approaches, why these approaches can be applied to ADMET and how they can apply them to their own projects.

Note: Practical Session presume that attendees will have access to a PC/tablet and Internet access. Practical Sessions will be run via the network.

Programme:

08.30 Registration and coffee09.00 Opening remarks09.10 Session 1 Theory of Relational Databases09.50 Session 2 Practical Session on Relational Databases10.30 Coffee break11.00 Session 3 Theory of Constraint-Based Models 11.40 Session 4 Practical Session on Constraint-Based Models12.20 Closing remarks

About the workshop host:

Dr Nick Plant has nearly 20 years’ experience researching the coordination of cellular responses, which balance the adaptation to altered chemical environments within the body, while maintaining core body functioning. His research has focussed on members of the super-family of nuclear receptors, which act as ligand-

activated transcription factors, sensing their cellular surroundings and coordinating network responses. Utilising both small- and large-scale computational approaches his lab aims to understand the coordination of body responses to both external perturbations (e.g. dietary and pharmacological) and during disease progression (e.g. breast cancer), as well as feasibility studies towards the reconstruction of the “silicon human”.

About The University of Surrey

The University of Surrey is a UK top-ten research intensive University based at Guildford, Surrey, UK. Its computational and Systems biology research group is based within the Faculty of Health and Medical Sciences.

Overview of workshop:The session will begin an overview of the digestive system and relate each organ to its corresponding ADME issue. An interactive workshop will focus on routes of administration.

A second session will focus on permeability, Pgp and CYP 450 and will be followed by a workshop where participants will explore the literature to distil working solutions to recurrent medicinal chemistry issues.

Why you should attend:Medicinal chemists with up to 5 years in industry. Academics who wish to acquaint themselves with key issues in the drug discovery process. The session is suitable to graduates, PhD and Post Doctoral fellows and assumes no prior knowledge. This workshop is not suitable for scientists already versed in ADME.

Programme:13.30 Registration and coffee14.00 Opening remarks14.10 Session 1 ADME – Voyage through the digestive system14.50 Session 2 Workshop – Routes of administration & literature

abstraction15.30 Coffee break16.00 Session 3 Permeability & Pgp16.30 Session 4 Liver Metabolism17.20 Closing remarks17.30 End of workshop

About the workshop hosts:Corinne read Organic Chemistry at Lyon University, France (1984). She then joined Roche (1984-1990) as a medicinal chemist where she was involved in the Trocade as well as the Saquinavir projects. In addition, she played a key role in establishing a Solid Phase Peptide and Oligonucleotide synthesis facility in house. She then Joined Glaxo in 1990,

where she has worked on a number of Protease and GPCR drug Discovery projects at various stages of lead discovery and lead optimisation. Corinne then obtained a GlaxoSmithKline sponsored PhD at the University of Cambridge (2000) having worked with Prof S V Ley, FRS on the discovery of novel solid phase amine linkers. She then joined Organon in 2001 where she became responsible for Medicinal Chemistry training of staff and more recently founded Med-Simple, a company specialising in applied Medicinal Chemistry training. She is the author of over 45 publications, book chapters and reviews in these areas. Her research interests include the design of chemical libraries, peptide synthesis, solid phase synthesis and ADME.

About the organisationMed-Simple was created in 2004 and provides tailor-made medicinal chemistry courses for the pharmaceutical industry. In the spirit of the company motto is ‘Things should be as simple as they can be’ (A. Einstein) Med-Simple prides itself in delivering complex medicinal chemistry concepts in an easy to digest format. Its trademark ‘Succeed through the li terature approach’, as well as innovative teaching methods have placed the company finalist in the 2012 Small Business Award for Innovation.

Computational Approaches in ADMET

ADME for the Medicinal Chemist

HALF-DAY POST-CONFERENCE WORKSHOP A

Wednesday 2nd July 2014 I 08.30 – 12.30 I Marriott Regents Park Hotel, London, UK

HALF-DAY POST-CONFERENCE WORKSHOP A

Wednesday 2nd July 2014 I 13.30 – 17.30 I Marriott Regents Park Hotel, London, UK

In association with

In association with

Sponsored by

Admescope provides innovative contract research services for preclinical ADME-Tox, from tailor-made assays to HTS-studies. In addition to having comprehensive service portfolio in the field, we are specialized in drug metabolism and drug interaction studies. Currently Admescope serves customers in Europe, USA and Canada, from virtual biotechs to Big Pharma companies. To learn more, please visit www.admescope.com

Corning Life Sciences is a global manufacturer of tools and equipment for cell culture, molecular biology, drug discovery and microbiology. Our leading Corning®, Falcon®, Costar®and Gosselin™ brands include vessels and differentiated surfaces for cell culture and scale-up, liquid handling products, ADME/Tox products and services, microbiology consumables and purification kits. www.corning.com/lifesciences

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on+44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

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:

Previous Attendee Profile

Chief Principle Scientist 35%CEO/Director/Manage 23%Head of Pharmacology/DMPK/Toxicology 21%Professor/Academia 14%Other 5%

• 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

35%

21%

14%

23%

5%

SMi FORWARD PLANNER

MARCH

Superbugs & Superdrugs - A Focus on Antibacterials5 – 6 March 2014, London

Imaging in Cancer Drug Development12 – 13 March 2014, London

Controlled Release12 – 13 March 2014, London

Adaptive Designs24 – 25 March 2014, London

Paediatric Clinical Trials31 March – 1 April 2014, London

Pre-Filled Syringes USA31 March – 1 April 2014, USA

APRIL

Asthma & COPD

2 – 3 April 2014, LondonBiosimilars USA7 – 8 April 2014, USA

MAY

Big Data in Pharma12 – 13 May 2014, London

Pain Therapeutics19 – 20 May 2014, London

ADC Summit 19 – 20 May 2014, London

Clinical Trial Logistics 21 – 22 May 2014, London

JUNE

BioBanking23 – 24 June 2014, London

Peptides30 June – 1 July 2014, London

ADMET30 June – 1 July 2014, London

JULY

Lyophilisation7 – 8 July 2014, London

BioNetworks7 – 8 July 2014, London

Allergies9 – 10 July 2014, London

Immunogenicity14 – 15 July 2014, London

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ADMET 2014Conference: Monday 30th June and Tuesday 1st July 2014 , The Marriott Regents Park Hotel, London, UK I Workshops: Wednesday 2nd July 2014, London

4 WAYS TO REGISTERONLINE www.admet-event.com

Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received.

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VENUE The Marriott Regents Park Hotel, 128 King Henry’s Rd, London NW3 3ST

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I would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops £2697.00 + VAT £3236.40□ Conference & 1 Workshop £2098.00 + VAT £2517.60□ Conference only £1499.00 + VAT £1798.80□ 1 Workshop only £599.00 + VAT £718.80□ 2 Workshops only £1198.00 + VAT £1437.60 Workshop A □ Workshop B □

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