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@SMIPHARM#smiADMET

CHAIR FOR 2017:• Eric Blomme, Vice President Preclinical Safety, AbbVie

FEATURED SPEAKERS: • Valeriu Damian, Director System Modeling &

Translational Biology, GSK• Handan He, Director, Section Head, Nonclinical PK/

PD, Novartis • Ben-Fillippo Krippendorff, Franchise Leader PK/PD

Immunology & Inflammation, Roche• Andreas Reichel, VP, Head Research

Pharmacokinetics, Bayer • Peter Littlewood, Senior Director Head of DMPK

Europe, Vertex Pharmaceuticals• Timothy Schulz-Utermoehl, Director of DMPK,

Sygnature Discovery

HIGHLIGHTS IN 2017:

• Predictive Human Toxicity, Transporters and ADMET Studies

• ADME/PK Optimisation for Drug Design and Discovery

• Preclinical In Vivo Pharmacology Testing and Translational PK/PD• Developments in Drug Screening Technology• In Vitro to Human In Vivo Translation• Physiologically Based PK Modeling

CONFERENCE: 12TH -13TH

WORKSHOP: 14TH

JUNE2017COPTHORNE TARA HOTEL, LONDON, UK

SMi Presents the 12th Annual Conference and Exhibition on

ADMETAddressing early ADME application strategies and discussing the latest technologically advanced screening and testing models

BOOK BY 28TH FEBRUARY TO SAVE £300 • BOOK BY 31ST MARCH TO SAVE £200 • BOOK BY 28TH APRIL TO SAVE £100

Sponsored by

Drug Transporters Tool Kit08.30am - 12.30pmWorkshop Leader:

Kunal Taskar, Associate GSK Fellow, GSK

PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP | WEDNESDAY 14TH JUNE 2017, COPTHORNE TARA HOTEL, LONDON, UK

ADMET Day One 12th June 2017 www.admet-event.com

08.30 Registration & Coffee

09.00 Chairman’s Opening RemarksEric Blomme, Vice President, Preclinical Safety, AbbVie

DRUG DISCOVERY STRATEGIES

09.10 OPENING ADDRESS: Toxicology Strategies for Drug Discovery: Personal Thoughts • Issues with front-loading in vitro tox assays• What type and how many in vitro assays are necessary to

identify problematic chemical matter• Addressing secondary pharmacology and chemical promiscuityEric Blomme, Vice President, Preclinical Safety, AbbVie

09.45 Understanding CNS penetration – how far have we gotten?• Current concept and methods to assess brain pharmacokinetics• Unbound brain concentrations, Kpuu and PK/PD• Case studies to illustrate both the potential and limitations of the

current concept• Open issues and questionsAndreas Reichel, VP, Head Research Pharmacokinetics, Bayer

10.20 Morning Coffee & Networking Break

10.50 Understanding PK/PD during drug discovery• Understanding drug exposure at the target site • Free drug hypothesis revisited• Which parameters determine the efficacious dose?Robert van Waterschoot, Head of Pharmacokinetics, Dynamics & Metabolism (PDM) Leaders, Roche

11.25 Advanced In vitro Models for Studying Drug Absorption, Distribution, Metabolism and Elimination• An overview of the current in vitro models for studying drug

metabolism and transport: pros and cons• Introducing the advanced recombinant enzyme and

transporter models developed using mammalian expression system

• Overview of the product characterization and applications, including robust dynamic range, lot to lot consistency and validation with known clinically relevant substrates and inhibitors

Na Li, Senior Staff Scientist, Corning

12.05 Networking Lunch

PBPK MODELING – CHALLENGES AND DEVELOPMENTS

13.15 Mechanistic modeling and simulations of oral drug absorption/food effect/PPI/PB IVIVC: opportunities and challenges• An overview on Novartis applications of PBPK modeling of

formulation dependent exposure and BCS/BDDCS• Case examples on PBPK applications including supersaturation

challenge, formulation dependent PBPK, positive/negative food effect predictions, prediction on PPI effects, comparison of IVIVC vs PBIVIVC

• Overall recommendations: opportunities and challenges of PBPK modeling together with a collective and multi-disciplinary paradigm approach

Handan He, Director, Section Head, PK Sciences, Novartis

13.50 PBPK modelling – Pragmatic application in drug development• Physiologically based pharmacokinetic modelling is well

established as a clinical prediction tool• PBPK models can be applied to impact mechanistic

understanding, clinical development plans and regulatory communication

• Modelling approaches can be optimised depending on the available data and the clinical question

• Case histories from GSK will illustrate how bespoke application of PBPK modelling can influence decision making throughout drug development

Jackie Bloomer, Director, GSK

14.25 Physiological Based Pharmacokinetic modeling – the road ahead• PBPK modelling has evolved in the last two decades from a few

pioneering applications to regulatory acceptance. It may seem that PBPK has reached its peak potential – but has it?

• EMA and the FDA have published draft PBPK guidance for industry insuring an increase use of PBPK modelling in regulatory submissions

• Next few years will bring significant developments in PBPK science: from data integration to pure prediction from structure, from oral and IV to dermal, inhaled, intramuscular, long acting, intraocular, from drug alone to drug and metabolites, from small molecules to large molecule constructs, from dissolution to formulation design, from ODE’s to partial differential equations

• We will explore directions in which PBPK is likely to develop providing examples and case studies

Valeriu Damian, Senior Director, System Modelling and Translational Biology, GSK

15.00 Afternoon Tea & Networking Break

SPECTROMETRY, PHARMACOKINETICS AND INHIBITORS

15.30 Labelled free MS spectrometry for cellular drug concentrations and stability• Target engagement• Cell permeability and drug delivery• Small Molecules and New modalities• Labelled free MS spectrometry Elisabetta Chiarparin, Head of Oncology Analytical and Structural Chemistry, AstraZeneca

16.05 Impact of Drug-Excipient Interactions on Pharmacokinetics• Overview of Pharmacokinetic Impact of Drug-Excipient

Interactions• Case Study: Oral drug absorption impact of drug-

croscarmellose in a tablet• Case Study: Intravenous pharmacokinetics of drug-cyclodextrin

interaction in solution• Discussion: Role of drug self-association on pharmacokinetics

and influencing drug-excipient interactionsAjit Narang, Senior Scientist, Genentech

16.40 Allosteric TrkA inhibitors, from data mining to clinical candidate• Structure-based design to optimize potency• Use of in-house ADME prediction tools in design• Bioavailability and intestinal metabolism• Efforts to design molecules with higher solubilityKiyoyuki Omoto, Scientist, Associate Research Fellow, Pfizer

17.15 Chairman’s Closing Remarks and Close of Day One

Register online at www.admet-event.com

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 on +44 (0) 20 7827 6168 or email: amalick@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/lifesciences/

Sponsored by

ADMETwww.admet-event.com Day Two 13th June 2017

08.30 Registration & Coffee

09.00 Chairman’s Opening RemarksEric Blomme, Vice President, Preclinical Safety, AbbVie

ADME PROPERTIES AND PRECLINICAL IMPACT

09.10 OPENING ADDRESS: Physical Properties and their impact on ADMET parameters and profiles• How physical properties influence ADMET parameters,

compound progression and chances of success• Better insight from new standards in measurements and

predictions of physical parameters• Improving the effectiveness of predictive methods• Influence of properties on toxicological outcomesRob Young, Senior Scientific Investigator & GSK Associate Fellow, GSK

09.45 Deciphering the mechanism of drug-induced liver injury (DILI) of Cinchophen• Introduction to cinchophen toxicity in patients• In vitro ADME properties of cinchophen• In vivo preclinical excretion profile of cinchophen• Mechanistic studies using modern techniques to understand

cinchophen-induced liver injuryTimothy Schulz-Utermoehl, Director of DMPK, Sygnature Discovery

10.20 Morning Coffee & Networking Break

STRATEGIES FOR ACCURATE HUMAN DOSE PREDICTIONS

10.50 Addressing the continuing challenges of making accurate human dose predictions• Understanding the requirements• Understanding how to use in vitro data• Obtaining the right in vivo data in the right species• IVIVC• Dealing with non P450 clearance pathways• Incorporating errors and variability into predictionsPeter Littlewood, Senior Director Head of DMPK Europe, Vertex Pharmaceuticals

11.25 Estimation of human volume of distribution; methods, accuracy and impact in human dose prediction• Drivers of volume of distribution• Impact of preclinical species used for extrapolation• Method comparison of accuracy and statistical significance of

differences• Application of Monte-Carlo simulations to visualize impact of

accuracy differences between methodsCarl Petersson, Associate Director Drug Disposition, Merck KGaA

12.00 Networking Lunch

DRUG-DRUG INTERACTIONS AND TRANSPORTERS

13.10 Drug-Drug Interactions Involving Transporters – Theory and Practice• Short background on the subject• Interesting examples from literature• Bayer case-examplesMatthias Wittwer, Laboratory Head DMPK-BANP-NCPK, Bayer

13.45 Utility of endogenous probes for predicting transporter mediated drug-drug interactions• Endogenous transporter substrates• Review of assessments to identify appropriate endogenous

markers for predicting transporter activity/modulations• Relevance of transporter biomarkers in the clinic and

application in the predictions of transporter mediated DDIsKunal Taskar, Associate GSK Fellow, GSK

14.20 Assessment of therapeutic index: Moving beyond single point estimate• Inclusion of variability and uncertainty in the human PK

prediction and therapeutic indices• Effective representation of therapeutic indices at various stage

of drug discovery for decision-makingKarelle Menochet, Principal Scientist, UCB

14.55 Afternoon Tea & Networking Break

LARGE MOLECULE PKPD, METABOLISM AND DISTRIBUTION

15.25 Large molecule PK/PD and new predictions of relevant tissue concentrations • Introduction to physiological processes driving large molecule PK • New approaches to estimate the distribution and clearance of

large molecules• How to quantitatively predict target mediated and unspecific

tissue uptakeBen-Fillippo Krippendorff, Principal Scientist, Franchise Leader PK/PD Immunology & Inflammation, Roche

16.00 Quantitative prediction of gut wall metabolism• In vivo, in situ and in vitro models for the prediction of gut

metabolism• Challenges in the establishment of good preclinical models

- species differences in the isoforms; regional abundances and activities of drug metabolizing enzymes; the interplay of enzyme-transporter proteins; and lack of knowledge on enzyme abundances and availability of empirical scaling factors

• Focus on CYP3A • Current gaps in the mechanistic understanding and the

prediction of gut metabolism and how they can be overcome in the future

Sheila Annie Peters, Head, Translational Quantitative Pharmacology, Merck KGaA

16.35 Novel in vitro and in vivo models for the study of drug transporters in discovery and development• Descriptions of in vitro models applied to transporter studies• Applications in Discovery and Development• Case studiesLaurent Salphati, Principal Scientist, Genentech

17.10 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 BYOFFICIAL PUBLICATIONS

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

+44 (0)20 7827 6012 or email: kwilliams@smi-online.co.uk

HALF DAY POST-CONFERENCE WORKSHOP Wednesday 14th June 2017

Copthorne Tara Hotel, London, UK8.30am – 12.30pm

Drug Transporters Tool KitWorkshop Leader:

Kunal Taskar, Associate GSK Fellow, GSK

Workshop overview:

The workshop will focus on membrane transporters and their application in drug discovery and development. The workshop will introduce the clinically relevant uptake and efflux transporters and their role in drug pharmacokinetics and the important concept of transporter mediated clinical drug-drug interactions. The attendees will also learn about the various transporter in vitro and in vivo tools and prediction models as well as strategies.

Key Benefits of Attending:

The workshop will serve as a nice introductory course to Pharmaceutical scientists to gain knowledge of drug transporters as well as be a refresher to experienced scientists in the field of drug development and research. The workshop will be a nice platform to discuss any case-studies or strategies related to the transporter science.

Agenda

8.30 Registration & Coffee

9.00 Opening Remarks

9.10 Session 1: Introduction to Membrane Transporters

9.50 Session 2: Clinically Relevant Drug Transporters

10.30 Morning Coffee

11.00 Session 3: How to study the Drug Transporters and why to study Drug Transporters

11.40 Session 4: Regulatory Recommendations and when to study the Drug Transporters

12.20 Closing Remarks

12.30 Close of workshop

About the Workshop Leader:

Kunal Taskar, Ph.D., is currently working as an Associate GSK Fellow at GlaxoSmithKline, U.K. in Mechanistic Safety and Disposition, IVIVT R&D department. He is the transporter expert at the GSK UK site and consults on drug transporter related project questions from early drug discovery to post-marketing drug development. His past experience includes working as a drug transporter expert in the DMPK Pharmaceutical Candidate Optimization department at Biocon Bristol-Myers Squibb Research and Development. Kunal completed his doctorate and postdoctoral research at Texas Tech University Health Sciences department, USA, in Quentin Smith’s lab with research focused on drug delivery to central nervous system and role of transporters in drug delivery across the blood-brain barrier (BBB).

About the Organisation:

GlaxoSmithKline is a science-led global healthcare company on a mission: GSK wants to help people do more, feel better, live longer. Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this. GSK has three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. GSK is committed to widening access to its products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

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

SMi PHARMACEUTICALEVENT PLANNER 2017

FEBRUARY

Parallel Trade6th - 7th February 2017, London, UK

3D Cell Culture22nd - 23rd February 2017, London, UK

RNAi Therapeutics22nd - 23rd February 2017, London, UK

MARCH

Superbugs & Superdrugs -A Focus on Antibacterials20th - 21st March 2017, London, UK

Paediatric Clinical Trials20th - 21st March 2017, London, UK

Drug Discovery27th - 28th March 2017, London, UK

Asthma & COPD29th - 30th March 2017, London, UK

APRIL

Controlled Release Delivery3rd - 4th April 2017, London, UK

Adaptive Designs3rd - 4th April 2017, London, UK

Pre-Filled Syringes East Coast26th - 27th April 2017, Boston, USA

MAY

Pharma Freeze Drying Technology8th - 9th May 2017, London, UK

Orphan Drugs Europe15th - 16th May 2017, Berlin, Germany

Pharma Logistics and Supply Chain18th - 19th May 2017, London, UK

Pain Therapeutics22nd - 23rd May 2017, London, UK

Highly Potent Active PharmaceuticalIngredients22nd - 23rd May 2017, London, UK

JUNE

Pre-Filled Syringes West Coast5th - 6th June 2017, San Diego, USA

Microbiology USA8th - 9th June 2017, San Diego, USA

ADMET12th - 13th June 2017, London, UK

Immunogenicity12th - 13th June 2017, London, UK

BioBanking14th - 15th June 2017, London, UK

In Vitro Diagnostics14th - 15th June, London, UK

JULY

Allergies6th - 7th July 2017, London, UK

Peptides6th - 7th July 2017, London, UK

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 on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

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ADMETConference: 12th – 13th June 2017, Copthorne Tara Hotel, Kensington, London, UK Workshop: 14th June 2017, London

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VENUE Copthorne Tara Hotel, Kensington, London, UK

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