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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Drug Development Conference and Workshops at
IVAL BHTC
Joins us for one, two, or all three programs at our facility in the
greater Boston area during the week of April 13th.
These programs feature internationally-renowned leaders in
the industry, and information about the latest drug
development techniques to improve accuracy and efficiencies.
Programs:
April 13th – 14th :
Hands-on Hepatocyte Workshop
April 14th: IVAL Hepatocyte Technology Conference 2015: Accurate Prediction of
Human ADMET Drug Properties
April 15th – 16th: Toxicology and Drug Development
Other
Registration
General information
IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Hands-on Hepatcyte Workshop:
April 13th (full day) – April 14th (am only)
About the workshop
Workshop Agenda:
IVAL BHTC is committed to providing hands-on training
on the use of cryopreserved human and animal
hepatocytes to help scientists achieve optimal and
consistent results from industrial and academic
research.
Monday, April 13th, 9:00 am – 4:30 pm
Working with cryopreserved hepatocytes
 Thawing, counting, plating and Matrigel
overlaying of cryopreserved human and animal
hepatocytes
Workshop participants will learn expert hepatocyte
handling techniques that will increase their success in
hepatocyte-based research. The knowledge shared at
our workshops has been rated top-notch by previous
attendees, from novice to experienced hepatocyte
users.
In addition to improving hepatocyte handling
techniques, the workshop includes a presentation by
Dr. Albert P. Li, an internationally renowned expert in
hepatocyte technologies. Dr. Li will provide a review of
state-of-the art science and technology surrounding
the use of cryopreserved hepatocytes in drug
development and biomedical research.
At right: Workshop participants review and
discuss cell morphology and confluency
from their plating exercise.

Handling OnDemand™ pre-plated
cryopreserved human hepatocytes

Lecture: New developments in hepatocytes
cryopreservation and applications in drug
development (Dr. Albert P. Li)

Group discussion
Tuesday, April 14th, 8:00 am – 9:30 am
Morphology evaluation and discussion
 Morphology evaluation of cultured hepatocytes
 Troubleshooting results
 Group discussion
IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
IVAL Hepatocyte Technology Conference 2015:
Accurate Prediction of Human ADMET Drug Properties
April 14th: 10:00 am – 5:30 pm
Reception to follow: 5:30 pm – 7:00 pm
A major challenge in drug development is clinical trial failure due to inaccurate preclinical assessment
of human drug properties. In this conference, our internationally-renowned faculty will dissect the key
factors contributing to the high cost of drug development, and discuss promising approaches to
enhance the efficiency of drug development via accurate assessment of human ADMET drug
properties.
Faculty:
Joseph A. DiMasi, Ph. D.: Director, Tufts Center for the Study of Drug Development. Dr. DiMasi is
a world-renowned economist who has devoted the past two decades of his expertise toward
analyzing the costs of drug development. His well-recognized cost analysis is used as a blue print
by the pharmaceutical industry to develop approaches to enhance the efficiency of drug development.
Albert P. Li, Ph. D.: President and CEO, IVAL. Dr. Li is a pioneer in human hepatocyte
cryopreservation and is instrumental in the current routine application of cryopreserved hepatocytes
in drug development. He has developed novel and practical experimental approaches with human
hepatocyte for accurate assessment of human drug metabolism, drug-drug interactions, and drug
toxicity.
R. Scott Obach, Ph. D.: Senior Research Fellow, Pfizer. Dr. Obach is a pioneer in the application of
in vitro metabolic systems for early assessment of human ADME drug properties. Dr. Obach’s
research findings are instrumental for the routine application of in vitro ADME experimental systems
for drug candidate optimization and selection in pharmaceutical drug development.
K. Sandy Pang, Ph. D.: Professor, University of Toronto. Dr. Pang is a top academic scientist who
applies pharmacokinetic theory to understand the roles that transporters and enzymes play in the
disposition of drugs and metabolites in drug-eliminating organs. Her recent research topics extend to
unique PBPK models in drug absorption and the roles of the vitamin D receptor on the regulation of
transporters and enzymes.
A. David Rodrigues, Ph. D.: Research Fellow, Pfizer. Dr Rodrigues is an expert on P450 and
transporters with 25 years of drug development experience with top organizations including G. D.
Searle, Abbott Laboratories, Merck, BMS, and Pfizer. His extensive experience allows him to have a
critical perspective on the advantages and limitations of drug development approaches.
Yuichi Sugiyama, Ph. D.: Head, Sugiyama Laboratory, RIKEN Research Cluster for Innovation,
Japan. Dr. Sugiyama is a celebrated scientist with multiple Japanese and international awards for his
research accomplishment in physiologically-based pharmacokinetics, especially in drug transporters
and drug metabolism. His research contribution has led to the recognition of the roles of drug
transporter in drug-drug interactions and drug toxicity in the pharmaceutical industry and regulatory
agencies.
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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Hepatocyte Technology Conference Program:
Joseph A. DiMasi
Tufts Center for the Study of
Drug Development
R. Scott Obach
Pfizer
Understanding of Hepatic Drug
Metabolism Using Human
Hepatocytes
The Cost to Develop and Win
Marketing Approval for a New
Drug
Hepatocytes have become a
routinely applied tool in drug
metabolism research in support of drug discovery and
development efforts. They can offer the most
comprehensive picture of metabolite profile of any in
vitro system and thereby be used to predict comparative
metabolite profiles across species. They also possess a
complete complement of hepatic drug metabolizing
enzymes and can this be used to scale metabolic
clearance to in vivo clearance. Finally, as the number of
slowly, but extensively metabolized drug candidates has
been increasing, hepatocytes offer a means to measure
rates and routes of metabolism for these challenging
compounds. The use of hepatocytes in drug metabolism
studies that support drug research will be described.
Developing a new prescription
medicine that gains marketing approval, a process often
lasting longer than a decade, is estimated to cost $2,558
million. The R&D process is marked by substantial
technical risks, with expenditures incurred for many
development projects that fail to result in a marketed
product, the estimate links the costs of unsuccessful
projects to those that are successful in obtaining
marketing approval from regulatory authorities.
Albert P. Li
IVAL
Accurate assessment of human
ADMET drug properties with
human hepatocytes: Challenges
and accomplishments
A. David Rodrigues
Pfizer
In Vitro Phenotyping of Liver
Uptake Transporters; A Report
from the Front Line
Human hepatocytes represent the gold standard for the
evaluation of human drug metabolism, drug-drug
interactions, and hepatotoxicity. The current status of
this experimental tool will be reviewed, with emphasis
placed on recent technical advances which include
approaches to predict human hepatotoxicity and
evaluation of low hepatic clearance compounds.
It is now known that hepatic uptake
transporters play critical roles on in
vivo pharmacokinetic properties of administered drugs.
Phenotyping of hepatic uptake transporter and
correlation with drug pharmacokinetics allows the
identification of the role of specific transporters which will
aid structural design and may aid the understanding of
population differences in drug disposition.
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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Hepatocyte Technology Conference Program, continued:
Yuichi Sugiyama
RIKEN Research Cluster
for Innovation
Sandy Pang
University of Toronto
Chimeric Mouse Liver Models
The Use of “Extended
Clearance Concept” and PBPK
Modeling to Interpret Clinical
Outcomes from In Vitro
Metabolism and Transport Data
Chimeric mice with livers
repopulated with human
hepatocytes are now available for
use as a preclinical tool for drug
metabolism and pharmacokinetic
studies for toxicity/safety and regulatory issues, as well
as a liver-specific disease module for HBV and HCV, and
identification of unique human metabolites in doping.
We characterized the chimeric model with respect to the
integrity of the liver architecture by studying enzyme
zonation and liver microcirculation, the expression of
mouse vs. human genes on enzymes and transporters,
and inter-tissue communication between the intestine
(mouse) and liver (humanized) with respect to bile acid
homeostasis.
Many studies on genetic polymorphisms (PGx) in drug
transporters and transporter-mediated drug-drug
interactions (DDI) have been published, and these are
part of mechanisms of inter-individual difference in drug
response. This presentation will provide an overview of
“extended clearance concept” and a PBPK model. With
such concept and model, the effect of changes in
transporter function on the pharmacokinetics and,
ultimately, the pharmacological and/or toxicological
effects will be predicted.
Program At-A-Glance
9:30 – 10:00
10:00
10:15
11:15
Arrive and check in
Opening Remarks
The Cost to Develop and Win Marketing Approval
for a New Drug
Accurate assessment of human ADMET drug
properties with human hepatocytes: Challenges
and accomplishments
12:15
1:00
2:00
Albert Li, IVAL
Joseph DiMasi, Tufts University
Albert Li, IVAL
Lunch (provided)
In Vitro Phenotyping of Liver Uptake Transporters; A
Report from the Front Line
Understanding of Hepatic Drug Metabolism Using
Human Hepatocytes
3:00
A. David Rodrigues, Pfizer
R. Scott Obach, Pfizer
Break
3:15
The Use of “Extended Clearance Concept” and
PBPK Modeling to Interpret Clinical Outcomes from
In Vitro Metabolism and Transport Data
Yuichi Sugiyama, RIKEN
4:15
Chimeric Mouse Liver Models
Sandy Pang, University of Toronto
5:15
Panel discussion
5:30
Reception
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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Toxicology and Drug Development
\
April 15th & 16th 2015
About ADMET Tutorial Series
The focus of IVAL-BHTC ADMET tutorial
series is to provide expert tutorials on stateof-the art drug discovery and development
science and technology, with emphasis on
drug metabolism, drug-drug interactions, and
toxicology.
Toxicology and Drug Development is the
inaugural ADMET tutorial to be presented by
Professor A. Wallace Hayes, co-editor of
“Hayes' Principles and Methods of
Toxicology, 6th edition.” Professor Hayes is
a prestigious internationally-renowned
toxicologist with extensive industrial
experience.
toxicology in drug development,
experimental protocols for preclinical and
clinical safety studies, data interpretation, and
safety assessment.
Dr. Albert P. Li, an internationally
renowned expert on in vitro drug
evaluation, will join Dr. Hayes to lecture on
in vitro approaches to evaluate adverse drug
properties.
Toxicology and Drug Development is
intended for scientists and professionals from
pharmaceutical companies, academic
institutions, regulatory agencies, and contract
research organizations who are interested in
an updated overview of the science and
practice of toxicology in drug development.
This two-day course will provide attendees
with an overview of the key concepts of
Lecture Syllabus and Timetable
Lecture Titles
Wednesday
April 15th
9 am
to
4:30 pm
Thursday
April 16th
9 am
to
4:30 pm
Principles and scientific concepts of toxicology
Absorption, metabolism, disposition, and excretion of administered
drugs
 Lunch Break
Mechanism of action of toxic drugs
Experimental protocols for toxicological evaluation in drug
development
Dose-response relationship and risk assessment
Translational biology and toxicology
 Lunch Break
In vitro approaches to evaluate adverse drug effects: Drug-drug
interactions
In vitro approaches to evaluate adverse drug effects: Drug toxicity
Class discussion
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Lecturer
Hayes
Hayes
Hayes
Hayes
Hayes
Hayes
Li
Li
Hayes and
Li
IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Toxicology and Drug Development Faculty
Albert P. Li, Ph.D.
A. Wallace Hayes,
Ph.D., D.A.B.T., FATS,
FIBiol, FACFE, FACN,
ERT, CNS
Dr.
Li
is
the
President, CEO and
co-founder of In
Vitro
ADMET
Laboratories
LLC.
His
research
is
focused
on
the
development
and
application
of
human-based in vitro experimental models,
especially
primary
cultured
human
hepatocytes, in the accurate assessment of
human drug properties including metabolic
fate, drug-drug interactions and drug toxicity.
Dr. Li was one of the first scientists to
successfully cryopreserve human hepatocytes
to retain properties of freshly isolated cells,
and the inventor of the patented Integrated
Discrete Multiple Organ Co-culture (IdMOC)
system, which allows cells from multiple
organs to be interconnected to emulate an
entire organism. Dr. Li has published
approximately 160 research papers/book
chapters/reviews and edited/co-edited 6
books in toxicology, drug metabolism, and
cell biology.
Dr.
Hayes
is
a
toxicologist with over
35 years of experience
in
industry
and
academics. He is a Senior Science Advisor at
Spherix Consulting, providing strategic,
scientific and regulatory guidance. Dr. Hayes
lectures at Harvard University and also holds
an appointment with the School of Public
Health, University of Massachusetts,
Amherst as a Research Professor. Dr. Hayes
is the Editor-in-Chief, Food and Chemical
Toxicology, and has authored more than 200
peer reviewed publications, is the co-editor of
Hayes' Principles and Methods of
Toxicology, 6th Edition, Human and
Experimental Toxicology, Cutaneous and
Ocular Toxicology, and co-editor of the
Target Organ Toxicity Series.
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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
Registration Selection and Fee Schedule (fees listed are before / after March 31st)
Check
to
select
Event Options
Single program rate
With Hepatocyte
Workshop
Tox Course and
Conference
(no Workshop)
Toxicology Course
(April 15th – 16th)
$435 / $485
$700 / $800
$600 / $750
Boston- Hepatocyte Technology
Conference 2015 (April 14th)
$350 / $450
$600 / $750
Hepatocyte Workshop:
(April 13th – 14th)
$ 435 / $485
N/A
Please complete and email to:
[email protected] or fax: (410) 869-9034)
All Three
Programs
$915 / $1135
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IVAL Hepatocyte Technology Conference and Workshops 2015: April 14, 2015
IVAL Boston Hepatocyte Technology Center
389 Main Street, Suite 301 – 304, Malden, MA, USA. Tel:(781) 397-9300
About In Vitro ADMET Laboratories, LLC.
Cancellation Policy: All cancellations are subjected to a
$100.00 cancellation fee. Longer than 30 days, 100% refund
(less cancellation fee). Less than 30 days, no refund but
registration may be transferred to another person. All refund
requests must be in writing. All refunds will be issued after the
meeting has occurred. No refund requests will be accepted
after April 10th, 2015. Please submit cancellation and refund
requests including transferring of registration to: Fax: 410-8699034; E-mail: [email protected] ; Cancel Deadline: April
10th, 2014
In Vitro ADMET Laboratories, Inc. (IVAL) offers products and
contract services that represent our past three decades of
expertise in the application of in vitro experimental systems to
evaluate drug absorption, metabolism, drug-drug interactions
and drug toxicity.
Based in Columbia, Maryland, IVAL seeks to enhance drug
development efficiency through state-of-the-art contract
research services. Our dedicated group of professionals have
worked and collaborated with various government agencies
and for small to big pharma both domestic and international.
We aim to expedite the drug development process by providing
innovative research techniques to get data to decision-makers
fast. By partnering with our clients, we serve as an extension of
their research arm to get tomorrow’s solutions here today.
Please visit our web site at www.invitroadmet.com.
Academic/Government participants will receive a 50%
discount.
General Information: The IVAL Boston Hepatocyte Training
Center is conveniently located in downtown Malden
Massachusetts, USA. The facility is within walking distance
from the Massachusetts Bay Transportation Authority.
www.mbta.com
Please reference the subway map to your right and take the
Orange line to Malden Center.
When exiting the Malden Center station cross at the light at
Commercial Street. This will put you directly in front of the
Malden Government Center. As you face the building turn left,
once past the building take your immediate right onto Pleasant
Street (like you are walking behind the building). Please follow
this to Main Street. Turn right onto Main Street. We are across
the street at the “City Center” Building – 389 Main Street, 3rd
Floor, Malden, MA.
Parking: Paid parking is available across and to the left (as
you face away from our building) at 180 Exchange Street,
Malden MA 02148.
Parking Rates:
Per Hour: $2.00
Daily Rate: $18.00
Early Bird: $6.00 (entry before 9:00 AM, exit before7:00 PM)
Click here for a map of IVAL’s Malden, MA facility.
Hotel Accommodations:
We recommend Hyatt Place Boston/Medford:
116 Riverside Avenue
Medford, Massachusetts, USA, 02155
Tel: +1 781 395 8500
Fax: +1-781395-0077
http://bostonmedford.place.hyatt.com/en/hotel/home.html
They have shuttle service to the T stops on an as-needed
basis from 7:30 am-9:00 pm each day.
Payment: Payment may be made by check or credit card.
Email to [email protected] with remittance or FAX to:
(410) 869-9034. Checks should be made in US $, payable to
In Vitro ADMET Laboratories, LLC. Mail to: IVAL, LLC.; 9221
Rumsey Road, Suite # 8, Columbia, MD 21045, USA
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