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13th Annual Land O’Lakes Conference on Drug Metabolism/Applied Pharmacokinetics
September 13-27, 2010
Devil's Head Resort
Merrimac, WI

Developed & Conducted by Extension Services in Pharmacy, School of Pharmacy, University of Wisconsin- Madison.

POSTER SESSION

Guidelines for Poster Submissions

Poster Session

 

Previous Accepted Abstracts


Registration

Your registration options are as follows:

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Register Online. Login in using your user account. If you don't have a user account creating one is free & easy.

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Download the registration form, complete & mail to:

LOL Drug Metabolism Conference
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705

phone

By phone at 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment.

fax

Download the registration form, complete & fax to 608.262.2431 using a credit card for payment.

Conference Goals & Objectives

The purpose of this four-day professional development conference is to provide an educational outreach forum to discuss the current issues in selecting potential new therapeutic entities for preclinical trials and current issues in drug metabolism and preclinical pharmacology. General goals associated with this conference include:

  1. To provide a better understanding of the role of drug metabolism in the pharmacokinetics and pharmacodynamics of new product candidates, including biotechnology-derived drugs.
  2. To evaluate new techniques and shared experiences in the area of “high through-put screening” and drug discovery screenings.
  3. To gain insight into problems and issues encountered during the pharmaceutical industry research and drug development process and the interface between drug discovery and development.
  4. To discuss current regulatory issues affecting preclinical and early clinical development, both within the United States and globally.
  5. To identify processes for improving the identification of successful drug candidates through metabolite identification and in-vitro/in-vivo implications.
  6. To discuss current drug metabolism systems and their applicability in R&D activity.
  7. To gain insight from various perspectives on the drug-discovery process, including industry, academia, and regulatory agencies, including the Food and Drug Administration (FDA).

Last years course evaluation results.

Special Offer for Academic Institutions

Extension Services in Pharmacy at the University of Wisconsin School of Pharmacy has instituted a new policy for industrial professional development programs to encourage greater participation by faculty, graduate students and post doctoral students at academic institutions. Programs will be offered at a significantly reduced price, based on space availability. For information about any specific course please contact Dr. James E. De Muth by email.

2010 Conference Planning Committee

Robert J. Guttendorf, Ph.D., Conference Chair, Sequoia Pharmaceuticals, Inc., Gaithersburg, MD

James E. De Muth, Ph.D., Conference Director, University of Wisconsin, Madison, WI

James L. Ferrero, Ph.D., DMPK Consultant, La Jolla, CA

Randall H. Guthrie, Xcelience, LLC, Lodi, WI

David A. Hartman, Ph.D., Fulcrum Pharma Developments, Inc., Morrisville, NC

Suhasini Iyer, Ph.D., Genentech, Inc., South San Francisco, CA

Patrick Koch, Ph.D., Sepracor, Inc., Marlborough, MA

Gordon R. Loewen, Ph.D., BiogenIdec, Cambridge, MA

Mark N. Milton, Ph.D., Novartis Biologics, Cambridge, MA

Ivan Nestorov, Ph.D., BiogenIdec, Cambridge, MA

Jasminder Sahi, Ph.D., CellzDirect/Invitrogen, Ann Arbor, MI

Paul Savina, GlaxoSmithKline, Research Triangle Park, NC

James M. Schmidt, Lexicon Phamraceuticals, The Woodlands, TX

Arzu Selen, Ph.D., Center for Drug Evaluation and Research, FDA, Rockville, MD

Michael Sinz, Ph.D., Bristol Myers Squibb, Wallingford, CT

Vangala Subrahmanyam, Ph.D., Sai Advantium Pharma Limited, Hinjewadi, India

Steven Swanson, Ph.D., Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN

Larry M. Tremaine, Ph.D., Pfizer, Inc., Groton, CT

Richard L. Voorman, Ph.D., Abbott Laboratories, Abbott Park, IL

Ping Zhao, Ph.D., Office of Clinical Pharmacology. CDER, Food and Drug Administration, Silver Spring, MD

Conference Support for 2009

Speical thanks for unrestricted educational grant to help support this conference from

Charles River Laboratories
Wilmington, MA

NoAb BioDiscoveries Inc.
Mississauga
Ontario, Canada

NoAb BioDiscoveries, Inc.

BD Biosciences
Franklin Lakes, NJ

Conference Travel Information

Location & Travel

The conference will be presented at Devil's Head Resort in Merrimac, Wisconsin. Merrimac is approximately 40 minutes from Madison. For those registrants flying into Madison, bus transportation will be available to and from Devil's Head Resort.

Shuttle Bus Service to and from the Dane County Regional Airport

Monday 1:30 and 4:30 PM

Friday 10:45 AM

Sponsored by:
Fulcrum Pharma Developments, Inc.
Morrisville, NC

2010 Conference Fees

Registration Fee

$1250

Lodging & Meals: Single Accommodations

$625

Total Amount

$1875

If Payment received prior to June 21, 2010

-$150

EARLY REGISTRATION

$1725

NOTE: All accommodations at Devil's Head for conference registrants will be processed through Extension Services in Pharmacy. Fees are based on a single accommodation. Additional fees will be assessed for both lodging in the event more than one person occupies a room.

Enrollment Deadlines/Limits

A check in the total amount payable to UNIVERSITY OF WISCONSIN should accompany your application to ensure that space will be held for you. Credit card payment is also acceptable. Total payment will be returned /refunded if space is not available.

In the event your registration is confirmed and at a later date you are unable to personally attend, a refund (less a $50 administrative fee) will be provided June 21; after June 21, no refunds will be made. You may fax your registration (608) 262-2431 with payment to follow no later than June 21. After June 21, space will not be held without receipt of payment.

 

Social Activities

In addition to the educational benefits of this program, the conference is designed to provide registrants with a relaxing environment to meet and share ideas with colleagues with similar interests and network for future collaborative effort. To this end, Devil's Head Resort offers a variety of activities including tennis, indoor and outdoor swimming pools, mountain bikes, nature trails and one of the finest golf courses in Wisconsin. Golf, at a significantly reduced rate, is available to all registrants during Tuesday and Wednesday afternoons of the conference.

For More Information

James E. De Muth, Ph.D., Conference Director
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email

2009 Program Outline (2010 Program is currently being developed)

Monday, September 14

 

6:00pm

Opening Reception

Sponsored by:

Celsis | In Vitro Technologies
Baltimore, MD

7:00pm

Dinner

Tuesday, September 15

First Plenary Session - Application and Development of Monoclonal Antibodies as Drugs

8:00am

Welcome and Conference Overview

Moderator:

Paul Savina
Section Manager
World Wide Drug Metabolism and Pharmacokinetics
GlaxoSmithKline, Research Triangle Park, NC

8:15am

Overview Presentation

Suhasini Iyer, Ph.D.
Senior Scientist and Group Leader, Early Development PKPD
Genentech, Inc., South San Francisco, CA

9:15am

Assay Methodologies

Huifen Faye Wang, Ph.D.
Director, Regulated Bioanalytical Research, Biotherapeutics
Pharmacokinetics, Dynamics and Metabolism
Pfizer, Groton, CT

10:00am

Break

10:30am

PK/PD Modeling

Joseph P. Balthasar, Ph.D.
Professor & Director of the Center for Protein Therapeutics
Department of Pharmaceutical Sciences
University at Buffalo, Buffalo, NY

11:15am

First in Human studies: The Impact of the TeGenero Incident

Mark N. Milton, Ph.D.
Senior Pharmacokinetics and Pharmacodynamics Expert
Novartis Biologics, Cambridge, MA

12:00pm

Lunch

Moderator:

Steven Swanson, Ph.D.
Senior Research Advisor, Drug Disposition
Lilly Research Laboratories
Eli Lilly and Company, Indianapolis, IN

1:00pm

Afternoon Session – Case Studies of a Monoclonal Antibody Development

Ryan J. Hansen, Ph.D.
Principal Research Scientist, Drug Disposition
Eli Lilly and Company, Riverton, UT

Susan Paulson, Ph.D.,
Director, Clinical Pharmacology & Pharmacometrics
Abbott Laboratories, Abbott Park, IL

Mark C. Peterson, Ph.D.
Associate Director, Drug Metabolism and Pharmacokinetics
Biogen Idec, San Diego, CA

2:45pm

Boat Tour of Upper Dells

Sponsored by:

Promega Corporation
Madison, WI

6:30pm

Dinner

Evening Session

Moderator:

Randall H. Guthrie
Vice President
Xcelience, LLC, Tampa, FL

8:00pm

Disease States and Effects on the Drug Metabolizing Systems

Edward T. Morgan , Ph.D.
Professor, Department of Pharmacology
Emory University, Atlanta, GA

9:00pm

Dessert Reception

Sponsored by:

Covance Laboratories
Madison, WI

Wednesday, September 16

Second Plenary Session: Dealing with Disproportionate Metabolite Exposure

Moderator:

David A. Hartman, Ph.D.
Senior Director, Preclinical Development
Fulcrum Pharma Developments Inc., Morrisville, NC

8:00am

Overview of the MIST Guidance and Implications for DM/PK

Greg Slatter, Ph.D.
Scientific Director, Pharmacokinetics and Drug Metabolism
Amgen Inc., Seattle WA

9:00am

Application of Metabolites in Drug Development

Douglas K. Spracklin, Ph.D.
Director, Biotransformation & Enzymology
Pfizer Global Research and Development, Groton, CT

9:50am

Break

10:20am

Analytical Identification of Metabolites

Steve X. Castellino, Ph.D.
Director of US Structural ID, Preclinical DMPK
GlaxoSmithKline, Research Triangle Park, NC

11:10am

Pharmacogenomics and Implications of the PhRMA White Paper Report

Steven Wrighton, Ph.D.
Senior Research Fellow, Drug Disposition
Eli Lilly & Company, Indianapolis, IN

12:00pm

Lunch

1:00pm

Afternoon Session: Relevant White Paper Reports

Moderator:

Gordon R. Loewen, Ph.D.
Senior Director of Clinical Pharmacology and ADME
Infinity Pharmaceuticals, Cambridge, MA

Transporters

Lei Zhang, Ph.D.
Senior Clinical Pharmacology Reviewer
Office of Clinical Pharmacology, Center for Drug Evaluation and Research
Food and Drug Administration, Silver Spring, MD

1:30

Time-Dependent Enzyme Inhibition

Heidi J. Einolf, Ph.D.
Group Head, Drug-Drug Interactions, Drug Metabolism and Pharmacokinetics
Novartis, East Hanover, NJ

2:00

Enzyme Induction

Michael Sinz, Ph.D.
Research Fellow, Pharmaceutical Candidate Optimization
Metabolism and Pharmacokinetics
Bristol-Myers Squibb, Wallingford, CT

2:30

Panel Discussion

Lei Zhang, Ph.D.
Heidi J. Einolf
Michael Sinz, Ph.D.

5:00pm

Poster Session with Authors

5:00pm

Wine and Cheese Reception

Sponsored by:

Xeno Tech LLC
Lenexa, KS

6:30pm

Dinner

8:00pm

Evening – Round Table Discussions

1. Interspecies Scaling for Large Protein Molecules

Mark N. Milton, Ph.D.
Senior Pharmacokinetics and Pharmacodynamics Export
Novartis Biologics, Cambridge, MA

Ivan Nestorov, Ph.D.
Director, Drug Metabolism and Pharmacokinetics
Biogen Idec, Cambridge, MA

2. Metabolite Scale-up, Isolation, and Identification

James M. Schmidt
Senior Research Scientist, Drug Metabolism and Pharmacokinetics
Lexicon Pharmaceuticals, The Woodlands, TX

3. Successes and failures in accelerating compounds to FIH trials

Randall H. Guthrie
Vice President
Xcelience, LLC, Tampa, FL

4. How are we dealing with Reactive Metabolites?

Michael Sinz, Ph.D.
Research Fellow, Pharmaceutical Candidate Optimization
Metabolism and Pharmacokinetics
Bristol-Myers Squibb, Wallingford, CT

James L. Ferrero, Ph.D.
DMPK Consulting
Carlsbad, CA

5. Role of DMPK Data on Candidate Progression from Nomination to Regulatory Approval

Larry M. Tremaine, Ph.D.
Senior Director, Pharmacokinetics, Dynamics & Metabolism
Pfizer, Inc., Groton, CT

Thursday, September 17

Third Plenary Session: Integrated Models

Moderator:

James L. Ferrero, Ph.D.
Formerly, Director of DMPK
Metabasis Therapeutics, Inc., La Jolla, CA

8:00am

Overview of Integrated Models for Drug Development

Xiang-Qing Yu, Ph.D., M.D.
Scientific Fellow, Drug Metabolism and Pharmacokinetics
Lexicon Pharmaceuticals, Inc., The Woodlands, TX

8:50am

Increasing Accuracy of Drug Interaction Predictions through Modeling and Simulations: Applications in Discovery and Development

Volker Fischer, Ph.D.
Senior Director, GPRD, DMPK and Bioanalysis
Abbott Laboratories, Abbott Park, IL

9:30am

GastroPlus

John Crison, Ph.D.
Director, Life Sciences
Simulations Plus, Inc., Lancaster, CA

10:10am

Break

10:30am

An Integrated Model to Predict in vivo Metabolic Interactions that Involve CYP Inactivation,Induction and Inhibition

Jashvant (Jash) Unadkat, Ph.D.
Professor, School of Pharmacy
Department of Pharmaceutics and Research Affiliate
University of Washington, Seattle, WA

11:10pm

FDA Perspective

Ping Zhao, Ph.D.
Senior Staff Fellow
Office of Clinical Pharmacology, Center for Drug Evaluation and Research
Food and Drug Administration, Silver Spring, MD

12:00pm

Lunch

1:00pm

Afternoon Session: Emerging Novel Drug Delivery Systems

Moderator:

Patrick Koch, Ph.D.
Executive Director, DMPK
Sepracor, Inc., Marlborough, MA

1:00pm

Nanotechnology Applications for Drug Delivery

Kinam Park, Ph.D.
Showalter Distinguished Professor of Biomedical Engineering
Professor, Pharmaceutics/Biomedical Engineering/Cancer Center
College of Pharmacy, Purdue University, West Lafayette, IN

2:45pm

Tour to Wollershiem Winery

Sponsored by:

Invitrogen
Durham, NC

6:30pm

Dinner

Evening Presentations

Moderator:

Mark N. Milton, Ph.D.
Senior Pharmacokinetics and Pharmacodynamics Expert
Novartis Biologics, Cambridge, MA

8:00pm

Big Battles and Big Pharma: The Drug Industry Comes of Age During the American Civil War

James M. Schmidt
Senior Research Scientist, Drug Metabolism and Pharmacokinetics
Lexicon Pharmaceuticals, The Woodlands, TX

9:00pm

Traditional Wisconsin Cheese Boxes

Sponsored by:

MPI Research
Mattawan, MI

Friday, September 18

Fourth Plenary Session: Pediatric Guidances

Moderator:

Robert J. Guttendorf, RPh, PhD
Vice President, Pharmacology and Experimental Therapeutics
Sequoia Pharmaceuticals, Inc., Gaithersburg, MD

8:30am

EMEA Perspective on Pediatrics in Drug Development

Siri Wang, Ph.D., MScPharm.
Senior Advisor
Norwegian Medicines Agency, Oslo, Norway

9:20am

FDA Perspective on Pediatrics in Drug Development

William J Rodriguez, M.D., Ph.D.
Science Director, Office of Pediatric Therapeutics
Office of the Commissioner, Food and Drug Administration, Rockville, MD

10:10am

Panel Discussion

Siri Wang, Ph.D., MScPharm.
William J Rodriguesz, M.D., Ph.D.

10:30am

Adjournment

 

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