www.admet-event.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 SMi Pharma @SMiPharm #SMiADMET HIGHLIGHTS IN 2018: • Discuss cutting-edge toxicology research strategies and how they enable early prediction of drug-induced liver injury (DILI) • Understand the correlation between drug exposure, efficacy and toxicity in transporter-mediated drug interactions • Hear about Genentech’s novel hepatocyte transporter assay used to predict the pharmacokinetic profiles of target compounds • Explore unique applications of PKPD modelling in oncology • Gain insight into the advances in models for the prediction of human drug metabolism CHAIR FOR 2018: • Eric Blomme, Vice President, Global Pre-Clinical Safety, Senior Research Fellow, AbbVie FEATURED SPEAKERS: • Justin Pittaway-Hay, Pharmacokinetic Assessor, MHRA • Filipe Lopes, Laboratory Head, DMPK, Roche • Nenad Manevski, Senior Scientist, DMPK Design Lead, UCB Pharmaceuticals • Sheila Annie Peters, Head, Translational Quantitative Biology, Merck Serono • Andreas Reichel, VP, Head of Research Pharmacokinetics, Bayer AG • Laurent Salphati, Principal Scientist, Genentech • Timothy Schulz-Utermoehl, Director of DMPK and Physical Sciences, Sygnature Discovery • Kunal Taskar, Senior DMPK Investigator, GSK • Robert Van Waterschoot, Head of Pharmacokinetics, Dynamics & Metabolism PDM Leaders, Roche Pharmaceuticals • Ian Wilson, Professor, Drug Metabolism and Molecular Toxicology, Imperial College London • Peter Littlewood, Director of DMPK, Vertex Pharmaceuticals BOOK BY 29TH MARCH TO SAVE £400 • BOOK BY 30TH APRIL TO SAVE £200 • BOOK BY 31ST MAY TO SAVE £100 HOLIDAY INN KENSINGTON FORUM, LONDON, UK SMi Presents the 13th Annual Conference on… CONFERENCE: 9TH - 10TH JULY 2018 ADMET Exploring the optimisation of ADMET modelling techniques, preclinical DMPK applications and development of biopharmaceuticals
Transcript
www.admet-event.com Register online or fax your registration to
+44 (0) 870 9090 712 or call +44 (0) 870 9090 711
SMi Pharma
@SMiPharm #SMiADMET
HIGHLIGHTS IN 2018: • Discuss cutting-edge toxicology research
strategies and how they enable early prediction of drug-induced liver injury (DILI)
• Understand the correlation between drug exposure, effi cacy and toxicity in transporter-mediated drug interactions
• Hear about Genentech’s novel hepatocyte transporter assay used to predict the pharmacokinetic profi les of target compounds
• Explore unique applications of PKPD modelling in oncology
• Gain insight into the advances in models for the prediction of human drug metabolism
CHAIR FOR 2018: • Eric Blomme, Vice President, Global Pre-Clinical Safety,
• Ian Wilson, Professor, Drug Metabolism and Molecular Toxicology, Imperial College London
• Peter Littlewood, Director of DMPK, Vertex Pharmaceuticals
BOOK BY 29TH MARCH TO SAVE £400 • BOOK BY 30TH APRIL TO SAVE £200 • BOOK BY 31ST MAY TO SAVE £100
HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi Presents the 13th Annual Conference on…
CONFERENCE: 9TH - 10TH
JULY 2018
ADMET Exploring the optimisation of ADMET modelling techniques, preclinical DMPK applications and development of biopharmaceuticals
Register online at www.admet-event.com
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks Eric Blomme, Vice President, Global Pre-Clinical Safety,
Senior Research Fellow, AbbVie
DEVELOPMENTS IN TOXICOLOGY
OPENING ADDRESS 09.10 Novel technologies and computational tools in discovery
toxicology: opportunities and challenges • Driving nonclinical safety-related attrition to sustainable
levels • Technologies to defi ne target-related safety • Computational prediction of off-target interactions • Opportunistic use of in vitro models to tackle complex
toxicity issues Eric Blomme, Vice President, Global Pre-Clinical Safety,
Senior Research Fellow, AbbVie
09.50 How advanced are our in vitro discovery toxicology assays for predicting DILI risks?
• Generating an understanding as to when predictive in vitro screening should be performed in discovery
• Use of case studies to qualify the predictability of the available in vitro assays
• Defi ning if potential metabolites should be screened alongside the active drug
Timothy Schulz-Utermoehl, Director of DMPK and Physical Sciences, Sygnature Discovery
10.30 Morning Coffee
11.00 Understanding the correlation between drug exposure, effi cacy and toxicity in a transporter mediated drug-drug interaction
• Pushing towards more accurate and effi cient drug testing in vitro, and most importantly leading the way towards a reduction in animal testing
• Examples of novel toxicity test platforms: embryonic stem cells • Organ-on-a-Chip: CN Bio Innovations Limited’s
collaboration with AstraZeneca to validate a new in vitro research tool that enables the high throughput evaluation of multi-drug dosing regimens
• Ex Vivo – The best design to establish causality and to detect effects?
Kunal Taskar, Senior DMPK Investigator, GSK
11.40 The importance of ADMET in medicines regulation: First in human studies and dose-exposure-response analyses
• Regulations concerning FIH studies and PBPK modelling and simulation: ADMET considerations
• Importance of demonstrating dose-exposure response relationships
• Extrapolation of PK and role in paediatric populations Justin Pittaway-Hay, Pharmacokinetic Assessor, MHRA
12.20 Networking Lunch
AN UPDATE IN ADMET MODELLING TECHNIQUES
13.20 Use of early dose prediction and ADMET properties to guide chemical design
• Early dose predictions can be used to guide chemical design and prioritise efforts.
• Multi-parameter design improves quality of drug-like properties.
• Metabolic stability, permeability, and solubility are linked with toxicological outcomes.
14.00 PKPB – Strengths and limitations of compartmental modelling • The making of a successful drug candidate • Defi ning parameters in acute and chronic toxicity
evaluations • Drug safety testing – should we be aiming at more fl uid
constructs? • Cost-benefi t assessments Sheila-Annie Peters, Head, Translational Quantitative
Pharmacology, Merck Serono
14.40 Afternoon Tea
15.10 The use of precision-cut lung slicing model to study pulmonary disposition of a drug
• Assessment of the pulmonary CYP1A1 metabolism of mavoglurant in rat
• Functional assessment of rat pulmonary Flavin-containing Monooxygenase activity
• Optimization of the precision cut lung slices (PCLS) as a useful tool for assessment of the pulmonary drug disposition in rat and human
Yildiz Yilmaz, Pharmacokinetics, ADME and Biotransformation, Novartis
15.50 Applications of PKPD modelling in oncology – an overview • Binary safety/effi cacy endpoints are simplifi cations and
often based on relatively arbitrary thresholds of underlying biological longitudinal process
• Patients’ individual characteristics may have as big impact on e.g. safety response as solely a dose
• Processes underlying dose-limiting toxicities in oncology are often reversible therefore how do we best manage toxicity?
• PK and PKPD time-course described via a mechanistic model, thus may be used for predictions, where fi xed AND random effects are estimated
APRIL 2018Antibodies and Antibody Drug Conjugates9th - 10th April 2018, London, UK
Adaptive Designs in Clinical Trials9th - 10th April 2018, London, UK
Asthma & COPD11th - 12th April 2018, London, UK
Pre-Filled Syringes East Coast11th - 12th April 2018, Boston, MA
MAY 2018Injectable Drug Delivery16th - 17th May 2018, London, UK
Pain Therapeutics21st - 22nd May 2018, London, UK
Highly Potent Active Pharmaceutical Ingredients21st - 22nd May 2018, London, UK
JUNE 2018Pre-Filled Syringes West Coast4th - 5th June 2018, San Diego, CA
Pharmaceutical Microbiology West Coast7th - 8th June 2018, San Diego, CA
Drug Safety11th - 12th June 2018, London, UK
Pharmaceutical Freeze Drying Technology13th - 14th June 2018, London, UK
BioBanking13th - 14th June 2018, London, UK
JULY 2018ADMET9th - 10th July 2018, London, UK
Molecular Diagnostics9th - 10th July 2018, London, UK
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
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08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks Eric Blomme, Vice President, Global Pre-Clinical Safety,
Senior Research Fellow, AbbVie
OPENING ADDRESS 09.10 Human PK and dose predictions for compounds with
challenging physiochemical profi les • Understanding the physicochemical properties of a
compound: solubility, stability, form defi nition, solid-state properties, partition coeffi cient and ionization constants
• The optimization of these properties is fundamental to the drug discovery process, mainly due to their infl uence on absorption and distribution in vivo.
• Alterations of physicochemical properties such as molecular weight, log d, polar surface area or pKa may infl uence the absorption, distribution, metabolism or excretion (ADME) of a chemical series in a chemotype-dependent manner
• Application of mechanistic approaches to solving ADME issues provides insight as to why a change in properties causes a desired outcome in some cases, while leading to poorer outcomes in others.
Peter Littlewood, Director of DMPK, Vertex Pharmaceuticals
09.50 Biotransformation of biotherapeutics – Impact on candidate selection
• Metabolism of small-molecule drugs vs. biotherapeutics
• Impact of protein biotherapeutics biotransformation on bIoanalysis
• Workfl ows for studying protein biotherapeutics • The future of the fi eld Filipe Lopes, Laboratory Head, DMPK, Roche
10.30 Morning Coffee
EVOLVING TECHNIQUES IN PREDICTIVE PHARMACOLOGY
11.00 Impact of target interactions on small-molecule drug disposition: an overlooked area?
• Relevance of target-mediated drug disposition (TMDD) for small molecules
• Impact of TMDD on pharmacokinetic parameters • Consequences of TMDD in human micro-dosing studies • When and how to evaluate TMDD for small molecules? Robert Van Waterschoot, Head of Pharmacokinetics, Dynamics
& Metabolism PDM Leaders, Roche Pharmaceuticals
11.40 Distribution, Metabolism and Excretion – Hepatocyte transporters, a case study at Genentech
• In vitro and in vivo techniques used to predict pharmacokinetic profi le of a compound at a pre-clinical stage
• Explore the use of an assay developed to measure the disposition of a compound from hepatocytes into the blood
• Transport systems include transporters for amino acids, monocarboxylic acids, organic cations, hexoses, nucleosides, and peptides and most of these function in the direction of (mainly) effl ux from liver to blood
Laurent Salphati, Senior Scientist, Genentech
12.20 Networking Lunch
13.20 Advances in models for the prediction of human drug metabolism
• Avoiding problems in drug development requires good methods for the prediction of drug metabolism/toxicology
• Accurate models that to predict liver-based metabolism in humans are needed
• Liver humanised models in rodents based on genetic modifi cation or “chimeric” livers show some promise in this area
• The pros and cons of the use of each type of systems will be described and illustrated with examples
Ian Wilson, Professor, Drug Metabolism and Molecular Toxicology, Imperial College London
14.00 Intracellular pharmacokinetics: Emerging opportunities for tailoring project support
• Free drug levels in plasma are generally used as measure for drug concentrations at the pharmacologically active site, serving as appropriate exposure surrogate for setting-up PK/PD models of extracellular drug targets
• About 50% of therapeutic drug targets, however, are thought to reside in the inside of cells where unbound drug concentrations may be very different from those on the outside, i.e. in the interstitial space and in the plasma compartment
• The presentation will discuss i) mechanisms that control intracellular drug concentrations, ii) experimental approaches that are suitable to estimate unbound intracellular concentrations in selected cell types, and iii) their applicability to advance our understanding of intracellular drug-target interactions
• Initial case studies will be shown to illustrate how the fi eld of ICPK can offer novel opportunities that can be used to address key questions in drug discovery projects, thereby enhancing our understanding of the intracellular fate of drugs - a topic of growing impact and interest
Andreas Reichel, VP, Head of Research Pharmacokinetics, Bayer AG
14.40 Afternoon Tea
FUTURE OF PRE-CLINICAL DMPK STUDIES
15.10 Towards a fully PBPK compliant ADME-MOC • Introduction to Multi-Organ-on-chip (MOC) solutions • The 4-Organ-Chip: A fi rst proof of concept for ADME-studies • A PBPK modelling approach for Multi-Organ-Chips • Current and future applications Reyk Horland, Head of Business Development, TissUse
15.50 Chairman’s Closing Remarks and Close of Day Two
ADMET www.admet-event.com Day Two | Tuesday 10th July 2018
ADMET Day One | Monday 9th July 2018 www.admet-event.com
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ADMET Conference: Monday 9th & Tuesday 10th July 2018, Holiday Inn Kensington Forum, London, UK
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