IVAL Boston Hepatocyte Technology Center BHTC is committed to providing hands-on training on the use...

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



Hands-on Hepatcyte Workshop:

April 13th (full day) – April 14th (am only)

About the workshop

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. 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.

Workshop Agenda:

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

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

At right: Workshop participants review and

discuss cell morphology and confluency

from their plating exercise.



3

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.



4

Hepatocyte Technology Conference Program:

Joseph A. DiMasi Tufts Center for the Study of Drug Development The Cost to Develop and Win Marketing Approval for a New Drug 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

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.

R. Scott Obach Pfizer Understanding of Hepatic Drug Metabolism Using Human Hepatocytes

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.

A. David Rodrigues Pfizer In Vitro Phenotyping of Liver Uptake Transporters; A Report from the Front Line 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.



5

Hepatocyte Technology Conference Program, continued:

Yuichi Sugiyama RIKEN Research Cluster for Innovation

The Use of “Extended Clearance Concept” and PBPK Modeling to Interpret Clinical Outcomes from In Vitro Metabolism and Transport Data

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.

Sandy Pang University of Toronto

Chimeric Mouse Liver Models 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.

Program At-A-Glance

9:30 – 10:00 Arrive and check in

10:00 Opening Remarks Albert Li, IVAL

10:15 The Cost to Develop and Win Marketing Approval for a New Drug

Joseph DiMasi, Tufts University

11:15 Accurate assessment of human ADMET drug properties with human hepatocytes: Challenges and accomplishments

Albert Li, IVAL

12:15 Lunch (provided)

1:00 In Vitro Phenotyping of Liver Uptake Transporters; A Report from the Front Line

A. David Rodrigues, Pfizer

2:00 Understanding of Hepatic Drug Metabolism Using Human Hepatocytes

R. Scott Obach, Pfizer

3:00 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



6

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 state-

of-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.

This two-day course will provide attendees

with an overview of the key concepts of

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.

Lecture Syllabus and Timetable

Lecture Titles Lecturer

Wednesday

April 15th

9 am

to

4:30 pm

Principles and scientific concepts of toxicology Hayes

Absorption, metabolism, disposition, and excretion of administered

drugs Hayes

Lunch Break

Mechanism of action of toxic drugs Hayes

Experimental protocols for toxicological evaluation in drug

development Hayes

Thursday

April 16th

9 am

to

4:30 pm

Dose-response relationship and risk assessment Hayes

Translational biology and toxicology Hayes

Lunch Break

In vitro approaches to evaluate adverse drug effects: Drug-drug

interactions Li

In vitro approaches to evaluate adverse drug effects: Drug toxicity Li

Class discussion Hayes and

Li



7

Toxicology and Drug Development Faculty

A. Wallace Hayes,

Ph.D., D.A.B.T., FATS,

FIBiol, FACFE, FACN,

ERT, CNS

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.

Albert P. Li, Ph.D.

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.



8

Registration Selection and Fee Schedule (fees listed are before / after March 31st)

Please complete and email to: [email protected] or fax: (410) 869-9034)

A. Credit Card Information: *Required fields to be

completed *American Express VISA MC *Cardholder Name:

*Cardholder Billing Address:

*Cardholder Billing City:

*Cardholder Billing State / Zip (Postal) Code:

*Cardholder Phone #:

*Cardholder Email:

*Card Number:

*Exp Date: *3 or 4 Digit Security Code:

*Amount: U.S. $

B. Registrant Information:

Please print your name as you wish it to appear on your badge Dr.________ Mr.________ Ms._________

Last Name First Name Mid. Initial Job Title Company/Agency/Institution Address 1 Address 2 City State Postal Code Country Telephone FAX Email Address Any special dietary concerns to be considered for catered lunch (vegetarian, allergies, etc)

Check to

select Event Options Single program rate

With Hepatocyte Workshop

Tox Course and Conference

(no Workshop)

All Three Programs

Toxicology Course (April 15th – 16th)

$435 / $485 $700 / $800 $600 / $750

$915 / $1135 Boston- Hepatocyte Technology

Conference 2015 (April 14th) $350 / $450 $600 / $750

Hepatocyte Workshop:

(April 13th – 14th) $ 435 / $485 N/A

mailto:[email protected]



9

About In Vitro ADMET Laboratories, LLC.

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. 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) 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

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: 410-869-9034; E-mail: [email protected] ; Cancel Deadline: April 10th, 2014 Academic/Government participants will receive a 50% discount.

Click here for a map of IVAL’s Malden, MA facility.

http://www.invitroadmet.com/

http://www.mbta.com/

http://bostonmedford.place.hyatt.com/en/hotel/home.html



http://invitroadmet.com/IVAL-MaldenMap.pdf

IVAL Boston Hepatocyte Technology Center BHTC is committed to providing hands-on training on the use...

Documents

Transcript of IVAL Boston Hepatocyte Technology Center BHTC is committed to providing hands-on training on the use...