1. Featured Topics:
• In vitro models and technologies for detecting Cardiotoxicity
• Analyse performance of different in vitro models to detect
human hepatotoxic drugs
• Human stem cell derived cardiomyocytes
• Regulatory DDI Guidance(s) for drug transporters - an overview
review of current FDA, EMA and JMHLW (Japan) guidance for
industry
• Mitigating errors in early human dose predictions and setting the
criteria for ADME end points
PLUS A HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 1st July 2015, Marriott Regents Park Hotel, London, UK
ADME(T) Strategies for Pharmacological Space Beyond Ro5 and Eukaryotic Enzyme Inhibitors
Workshop Leader: Constance Höfer, Chief Development Officer, Priaxon AG
8.30am – 12.30pm
Araz Raoof, Head Scientific Affairs & Analysis,
Janssen Pharmaceutica
Professor Ian D. Wilson, Professor of Drug
Metabolism, Imperial College London
Key Speakers Include:
• Laurent Salphati, Senior Scientist, Genentech
• Thierry Lave, Global Head DMPK & Tox Project Leaders
and Modelling & Simulation, F. Hoffmann-La Roche
• Peter Clements, Director of Pathology, GSK
• Stephen Fowler, Group Leader, In Vitro ADME,
F. Hoffmann-La Roche
• Franck Atienzar, Associate Director In Silico In Vitro
Toxicology, UCB BioPharma SPRL
• Peter Hoffmann, Executive Director, Pre-Clinical Safety,
Novartis Institutes for BioMedical Research
• Mario Monshouwer, Senior Director Drug Metabolism
Pharmacokinetics & Bioanalysis, Johnson & Johnson
BOOK BY 27TH FEBRUARY 2015 AND SAVE £400
BOOK BY 31ST MARCH 2015 AND SAVE £200
BOOK BY 30TH APRIL 2015 AND SAVE £100
SMi presents the 10th annual conference on
29th - 30th
JUNE
2015Marriott Regents Park Hotel, London, UK
Mitigating Drug Toxicities and Developing New Tools to Model
Drug Metabolism to Strengthen Human Relevant Results
ADMET
www.admet-event.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
@SMIPHARM
CHAIRS FOR 2015:

2. Register online at: www.admet-event.com • Alternatively fax yo
ADMET
Day One I Monday 29th June 2015 www.admet
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Araz Raoof, Head Scientific Affairs & Analysis,
Janssen Pharmaceutica
STREAMLINING DRUG DEVELOPMENT WITH ADME-TOX INVESTIGATIONS
OPENING ADDRESS
9.10 How is ADMET Tackling Key Challenges of Drug Development?
• The role of ADME in drug discovery and its impact on clinical
attrition rate
• Bridging the translational gap from bench to bed
• Future outlook of ADME in drug development
Araz Raoof, Head Scientific Affairs & Analysis,
Janssen Pharmaceutica
KEYNOTE ADDRESS
9.50 Opportunities for modelling of kidney disease and general
toxicology studies
• The human relevance, sensitivity and specificity of current
experimental models
• Use of emerging technologies in 3D cell culture to predict
hepatotoxicity
• Current challenges in determining underlying mechanisms of
toxicity
• Enabling complete metabolism studies, confirmation of
structure and quantitative measures of toxicity.
• CYP activities and sensitivities to multiple model hepatotoxins
Professor Jamie Davies, Professor of Experimental Anatomy,
University of Edinburgh
10.30 Morning Coffee
OPTIMISING PRE-CLINICAL APPROACHES AND HUMAN RELEVANCE
11.00 Complementary use of high-throughput ADMET screening and In
Silico modelling systems to strengthen non-animal alternatives
• Supervised integration of experimental data to maximise the
predictive quality of In Silico modeling
• Optimising predictive parameters to make the best informed
decisions
• Mitigating errors in early human dose predictions and setting
the criteria for ADME end points
Mark Wenlock, Research Scientist, AstraZeneca
11.40 ADME evaluation and PK prediction for peptidomimetic NCEs
• Utility of current ADME assay formats/sequences selecting for
drug-like properties and predicting target engagement/
favourable PK
• Sources of uncertainty affecting activity/ safety predictions and
possible alternative testing strategies
• Case studies
Dr. Constance Höfer, CDO, Priaxon AG
12.20 Networking Lunch
1.30 In Vitro simulation tools for better predictions
• Value of integrating translational PKPD in early development
• Understand the requirements for translational PKPD
• Illustrate use of exposure-response modelling to:
- optimize FIH study designs
- aid dose selection for proof of concept studies
- translate from preclinical to clinical
Thierry Lave, Global Head DMPK & Tox Project Leaders and
Modelling & Simulation, F. Hoffmann-La Roche
POPULATION PHARMACOKINETICS, PREDICTION AND PK/PD MODELLING
2.10 PK/PD modelling to validate drug targets and toxicity
• Accurately profiling metabolic pathways and unexpected
metabolites
• PK/PD models that support in vitro to in vivo extrapolation
• Challenges with biological barriers
• Impact of genetic variations on predictive PK/PD modelling for
dose regimes
Peter Littlewood, Director DMPK, Vertex Pharmaceutical
2.50 Application of PK/PD Modelling in ADMET
• Optimising the translational use of preclinical PK/PD modelling
in drug development
• Predictive quality of PK/PD models in oncology
• Case study: tumour growth inhibition and setting targets for
clinical efficacy
Laurent Salphati, Senior Scientist, Genentech
3.30 Afternoon Tea
4.00 Exploratory ADME in preclinical and clinical studies to guide and
accelerate clinical development
• The value of mechanism based drug disposition to drive
decision making
• Role of humanized mouse models to obtain mechanistic
insights on pharmacokinetics
• Including microtracers or endogenous markers for CYP3A4/5
during phase 1 studies
Mario Monshouwer, Senior Director Drug Metabolism
Pharmacokinetics & Bioanalysis, Johnson & Johnson
4.40 Panel Discussion:
• How useful are the cut-off values set out by FDA/EMA
guidelines in determining CYP inhibition?
• The challenge to the drug developer is deciding how to invest
resources appropriately to address the MIST requirements at a
stage of development when the risk-benefit ratio of a drug is still
largely unknown.
• What ADMET studies should be performed for pre-clinical
studies?
Panel Leader:
Araz Raoof, Head Scientific Affairs & Analysis,
Janssen Pharmaceutica
Panellists:
Laurent Salphati, Senior Scientist, Genentech
Dr. Constance Höfer, CDO, Priaxon AG
Professor Jamie Davies, Professor of Experimental
Anatomy, University of Edinburgh
5.20 Chair’s Closing Remarks and Close of Day One
Supported by
Official Media Partner

3. our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
ADMET
Day Two I Tuesday 30th June 2015t-event.com
8.30 Registration & Coffee
9.00 Chair's Opening Remarks
Professor Ian D. Wilson, Professor of Drug Metabolism,
Imperial College London
INVESTIGATING DRUG METABOLISM AND TRANSPORTER-MEDIATED DDI
OPENING ADDRESS
9.10 Future perspectives of ADMET evaluations and the current
paradigm shifts in toxicology
• State-of-the-art analytical methods for screening drug
metabolism
• Evaluating biotransformation and reactive metabolites
• What is needed for advanced in vivo techniques to
accurately translate human response to toxicity
Professor Ian D. Wilson, Professor of Drug Metabolism,
Imperial College London
9.50 Assessing transporter-mediated drug-drug interactions
• Assessing transporter-mediated drug-drug interactions
• Review of current in vitro models available and practical
considerations of transporter testing
• Regulatory DDI Guidance(s) for drug transporters - an overview
review of current FDA, EMA and JMHLW (Japan) guidance for
industry
Guy Webber, Scientific Manager of In Vitro and Discovery Services
10.30 Morning Coffee
11.00 Metabolic Drug-Drug Interactions Due to CYP Enzyme
Inactivation (Time-Dependent Inhibition)
• Effects of enzyme inactivation and how to screen for this
• Chemistries often associated with time-dependent CYP
inhibition
• Assessment of TDI risk
Stephen Fowler, Group Leader, In Vitro ADME, F. Hoffmann-La Roche
11.40 Toxicology pathways – Evidence-based mechanistic modelling
• What are we lacking in evidence-based toxicology?
• Identifying interactions and predicting emergent phenotypes
• Using mechanistic modelling to drive early drug discovery
Nick Plant, Reader in Toxicology, University of Surrey
12.20 Networking Lunch
CASE STUDIES: PREDICTING CARDIOTOXICITY AND HEPATOTOXICITY
1.30 Predicting human drug-Induced hepatotoxicity
• Idiosyncratic vs. dose dependent drug hepatotoxicity
• Drug-related initiating mechanisms and patient-related
susceptibility factors
• Value and limitations of conventional toxicity studies in animals
• Opportunities provided by transgenic and chimeric humanized
animal models
• Use of in vitro models to de-risk drug related
liabilities
• Challenge of tackling inter-species and
inter-individual variability
Dr. Gerry Kenna, Director, FRAME
2.10 CASE STUDY: Drug-Induced Liver assessment
• Concordance of preclinical and clinical QT data
• Comprehensive in vitro pro-arrhythmia assay (CiPA)
• Translatability of preclinical contractility data
• Expanding in vitro models for earlier drug safety assessment
• Human stem cell derived cardiomyocytes
Peter K Hoffmann, Global Preclinical Expert for Cardiovascular
Safety, Novartis
2.50 Afternoon Tea
3.20 In vitro models and technologies for detecting Cardiotoxicity
• Integrated use of in vitro models to detect cardiotoxicity in a
safety screening strategy
• Progress of hERG/ion channel inhibition as a pre-clinical tool
• Use of surrogate biomarkers for cardiac safety predictions
• Can in vitro data predict pathology in toxicology or clinical
studies?
• State-of-the art Human cellular models to
reduce reliance of animal-based prediction
Peter Clements, Director of Pathology, GSK
4.00 Which in vitro models, technologies and
strategies to detect Hepatotoxicity an
Cardiotoxicity at early stages of drug development?
• Performance of different in vitro models to detect human
hepatotoxic drugs
• Comparison of metabolic patterns in different in vitro models
• CIPA initiative (proarrhythmia): non-clinical safety testing
paradigm shift and impact on strategy
• Label free technologies applied to drug discovery
Franck Atienzar, Associate Director, In Silico In Vitro Toxicology,
UCB BioPharma SPRL
4.40 Chair’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 Margaret Mugema,
SMi Marketing on
+44 20 7827 6072, or email:
mmugema@smi-online.co.uk
Drug Induced-
Liver Injury
accounts for
13%-50% of
clinical failure
Innovation for
In Vitro
Technology

4. Overview of workshop:
Addressing novel therapeutic targets, such as
eukaryotic and prokaryotic protein-protein interactions
with NCEs, requires expansion of discovery chemistry
into highly innovative chemical space. Embracing new
pharmacological and chemical space entails low
predictive power of hitherto highly useful approaches
for compound selection and advancement, and
requires urgent attention to the development of
adapted prediction parameters as well as suitably
predictive in silico and in vitro methods. The workshop
will provide an overview of recent insights and some
case studies as a basis for discussions on current gaps
and potential solutions.
Benefits of attending:
Drugs for eukaryotic and prokaryotic intracellular PPIs
are clearly an area of high opportunity for the
renaissance of small molecule therapeutics.
Developing ADMET selection and optimization
strategies adapted to the new challenges inherent in
this approach is a prerequisite for successful
development of novel drugs for these highly innovative
targets.
Programme:
8.30 Registration and Coffee
9.00 Opening remarks
9.10 Session1: Review of current ADME strategies
9.50 Session 2: Challenges posed by non-
traditional targets and innovative non-Ro5
chemistry
10.30 Coffee Break
11.00 Session 3: Experience so far
(Publication review)
11.40 Session 4: Case Studies and joint analysis
− Gaps & Solutions
12.20 Closing remarks
12.30 Close of Workshop
About the workshop leader:
Constance Höfer has more than 20 years of
international non-clinical development and
management experience in academic and
regulatory as well as industry roles in pharmaceutical
and biotech companies. Following her PhD in 1995
(Pharmacogenetics Research Unit, Uni Newcastle,
Prof JR Idle) and post-doc work in cancer research
(University of Trondheim, Norway) she joined the
Norwegian Medicines Control Authority in 1997
where she was co-responsible for NDA safety and
efficacy assessment with a focus on Oncology and
Immunology . She started her industry career at
Celltech in Cambridge in 2001, followed by
increasingly responsible roles in drug R&D with Solvay
Pharmaceuticals and Merck KGaA, before
establishing an independent consultancy in 2006.
Since 2014, she is responsible for the development of
Priaxons novel peptidomimetic SMOLs targeted at
protein-protein interactions.
About the organisation:
Priaxon AG, based in Munich, Germany, discovers
and develops small molecule therapeutics for novel
target-ligand interactions. Proprietary, highly
versatile chemo-informatics tools rapidly identify
essential molecular determinants of novel target-
ligand interactions, and apply this information to
select suitable ligand motifs in previously unexplored
chemical space for further optimization and
development.
ADME(T) Strategies for
Pharmacological Space Beyond Ro5
and Eukaryotic Enzyme Inhibitors
Workshop Leader:
Constance Höfer, Chief Development Officer, Priaxon AG
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 1st July 2015 I 8.30am – 12.30pm
Marriott Regents Park Hotel, London, UK

5. SMi's PHARMACEUTICAL PORTFOLIO 2015
MARCH
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ADMET
Conference: 29th - 30th June 2015, Marriott Regents Park Hotel, London I Workshop: 1st July 2015, London
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