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admet
1. www.admet-event.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
@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
JUNE
2017HOLIDAY INN KENSINGTON FORUM, 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 31ST MARCH TO SAVE £200 • BOOK BY 28TH APRIL TO SAVE £100
Sponsored by
Drug Transporters Tool Kit
08.30am - 12.30pm
Workshop Leader:
Kunal Taskar, Associate GSK Fellow, GSK
PLUS AN INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOP | WEDNESDAY 14TH JUNE 2017, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
2. ADMET
Day One 12th June 2017 www.admet-event.com
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Eric 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 promiscuity
Eric 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 questions
Andreas 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 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 studies
Laurent Salphati, Principal 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 solubility
Kiyoyuki 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/
SOLVO Biotechnology is the leading provider of transporter assays Worldwide, since 1999. With over 100
solutions, we support your in-house or outsourced projects with high quality products or services, including FDA-,
EMA, PMDA-ready reports. Please visit www.solvobiotech.com
Sponsored by
3. ADMET
www.admet-event.com Day Two 13th June 2017
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Eric 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 outcomes
Rob 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 injury
Timothy 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 predictions
Peter 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 methods
Carl Petersson, Associate Director Drug Disposition, Merck KGaA
12.00 Networking Lunch
DRUG-DRUG INTERACTIONS AND TRANSPORTERS
13.10 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 interactions
Ajit Narang, Senior Scientist, Genentech
13.45 Drug-Drug Interactions Involving Transporters – Theory and
Practice
• Short background on the subject
• Interesting examples from literature
• Bayer case-examples
Matthias Wittwer, Laboratory Head DMPK-BANP-NCPK, Bayer
14.20 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 DDIs
Kunal Taskar, Associate GSK Fellow, GSK
14.55 Afternoon Tea & Networking Break
LARGE MOLECULE PKPD, METABOLISM AND DISTRIBUTION
15.25 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-making
Karelle Menochet, Principal Scientist, UCB
16.00 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 uptake
Ben-Fillippo Krippendorff, Principal Scientist, Franchise Leader PK/
PD Immunology & Inflammation, Roche
16.35 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
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
4. HALF DAY POST-CONFERENCE WORKSHOP
Wednesday 14th June 2017
Holiday Inn Kensington Forum, London, UK
8.30am – 12.30pm
Drug Transporters Tool Kit
Workshop 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.
5. SMi PHARMACEUTICAL
EVENT PLANNER 2017
FEBRUARY
Parallel Trade
6th - 7th February 2017, London, UK
3D Cell Culture
22nd - 23rd February 2017, London, UK
RNAi Therapeutics
22nd - 23rd February 2017, London, UK
MARCH
Superbugs & Superdrugs -
A Focus on Antibacterials
20th - 21st March 2017, London, UK
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20th - 21st March 2017, London, UK
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27th - 28th March 2017, London, UK
Asthma & COPD
29th - 30th March 2017, London, UK
APRIL
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3rd - 4th April 2017, London, UK
Adaptive Designs
3rd - 4th April 2017, London, UK
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8th - 9th May 2017, London, UK
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JUNE
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8th - 9th June 2017, San Diego, USA
ADMET
12th - 13th June 2017, London, UK
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12th - 13th June 2017, London, UK
BioBanking
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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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ADMET
Conference: 12th – 13th June 2017, Holiday Inn Kensington Forum, London, UK Workshop: 14th June 2017, London
4 WAYS TO REGISTER
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