Course Information

Industry Live Course

18th Annual Land O’Lakes Annual Conference on Drug Metabolism/Applied Pharmacokinetics

Factors Influencing the Future of Drug Metabolism and Pharmacokinetics

September Land O'Lakes Conference
September 21-24, 2015
Fluno Center, University of Wisconsin
Madison, WI

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin- Madison (formerly known as Extension Services in Pharmacy)


Register Now button

$1550
($1800 after 9/1/2015)
Registration special:
second person from same company 40% off
-see details below!

Other ways to register:

1. Register by phone at 608.262.3132 or toll free: 877.947.4255.

2. Download the registration form, complete and fax (608.262.2461) or mail to:

UW-Madison School of Pharmacy
DMPK Land O'Lakes Conference
Division of Pharmacy Professional Development
777 Highland Ave.
Madison, WI 53705

Goals and Objectives

Opening reception

The purpose of this three-day conference is to provide an educational forum to discuss the current issues in selecting potential new therapeutic entities for drug development and current issues in drug metabolism, drug transport, pharmacokinetics, and pharmacodynamics. General goals associated with this conference include:

  1. To provide a better understanding of the role of absorption, distribution, metabolism, and elimination (ADME) in the pharmacokinetics and pharmacodynamics of new product candidates, including small molecular entities, biologicals, and biotechnology-derived molecules.
  2. To gain insight into problems and issues encountered during the drug discovery and lead optimization processes and with the interface between drug discovery and development..
  3. To discuss current regulatory issues affecting preclinical and clinical development, within the United States and globally.
  4. To identify processes for improving the identification of successful drug candidates using ADME technologies, in-vitro/in-vivo relationships, and modeling and simulation.
  5. To discuss current ADME experimental systems and their applicability in R&D activity.
  6. To gain insight on the drug-development process from various perspectives, including industry, academia, and regulatory agencies.
  7. To discuss new technologies and processes that help describe the ADME characteristics of potential therapeutic entities and mechanisms of biotransformation.

View 2014 conference evaluation results.

^ Back to menu

General Information

Location and Travel

Fluno Center

The conference is held at the University of Wisconsin and will be presented at Fluno Center in Madison, Wisconsin (http://fluno.com). The Fluno Center is located on the UW campus and within a short walk of the State Capital, shops on the State Street pedestrian mall and lakes Monona and Mendota. The conference atmosphere offers an informal setting for interaction and networking with industrial peers.

This venue offers many advantages:

  • Choice of hotel accommodations
  • Conference facilities on the University of Wisconsin-Madison campus
  • Easy and quick access to the Madison airport; shorter drives from Chicago and Milwaukee
  • New condensed format resulting in one day less away from work!! Same number of educational contact hours.
  • Evenings free to explore Madison's restaurants and attractions
  • All the above while retaining the quality of learning, hours for learning, and a continued relaxed environment to maximize learning

For those registrants flying into Madison (MSN), the Fluno Center is 10-15 minutes from the airport. For those driving, the location is only 15-20 minutes from the intersection of Interstates 90 and 94.

Lodging & Meals

Hotel accommodations are the responsibility of the registrant. The Division of Pharmacy Professional Development has reserved a block of guest rooms at the Fluno Center, at the DoubleTree (1 ½ blocks away) and the Hampton Inn (2 1/2 blocks away). These are available on a first come basis. View information about guest rooms at these facilities and a list of additional hotels within walking distance.

The registration fee will include continental breakfasts, buffet lunches and break service will offer options including coffee, tea and soda, as well as rolls and sweets. Sponsored social events in the late afternoons will offer appetizers and drinks.
Madison Area Information:

Things to do, attractions, restaurants: http://www.visitmadison.com
Interactive Visitor Guide: http://www.nxtbook.com/nxtbooks/greatermadison/guide_2012fallwinter/

Registration & Fees

Early Registration $1550
Registration after 9/1/2015 $1800
Reduced Rate for second registrant from same company (prior to 9/1/2015) $930
Special rate for Academic and government employes
(prior to 9/1/2015)
$1050

Fee includes: 1) education: instruction; handout materials (electronically as pdf files); and documentation of completion; and 2) daily continental breakfast, mid-am/pm breaks, lunches and all social events listed in the program. Because the handout material will be provide electronically, registrants are encouraged to bring a laptop for the conference.

Enrollment Deadline / 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 prior to September 1; after September 1, no refunds will be made.

Laptops Required

Conference materials will no longer be presented in the traditional large blue binders. Instead all presentations will be provided as PDF files on memory sticks distributed at the beginning of the conference.

^ Back to menu

Optional Short Course for Monday afternoon, September 21, 2015

Scientists arriving early may wish to take advantage of this optional short course opportunity to evaluate the relationship of bioanalysis to other departments working together for the development of new pharmaceuticals. Monday, September 21, 2015; 1:30-5:00 PM in the Fluno Center, Madison, WI.

An Introduction and Practical Aspects of Modeling


Goals and Objectives:

The purpose of this course is to provide the learner with an overview and provide insight on selecting the most appropriate biomarkers during drug development.  It will focus on practical aspects of both exploratory models for drug development and models that can be used for regulatory submissions. Case studies will be used to illustrate to fundamental presented in the course.  Upon completion of the program the learner will be able to:

1) Describe how modeling fits into the overall drug development process;
2) Identify various ways that data can be modeled;
3) Discuss how non-clinical data can be used to predict human response;
4) Describe the role of modeling in predicting drug-drug interactions; and
5) Discuss how population PK modeling can be used for regulatory submissions.

Who should attend:

Scientists and project leaders/managers working in the areas of drug metabolism and pharmacokinetics who have no or little experience with modeling and wish to obtain a better understanding of how modeling can be used and currently available tools to assist in this process.   

More information and to register

Go to: http://ce.pharmacy.wisc.edu/2015SeptLOLShortCourseInfo

^ Back to menu

Poster Session

poster session

Poster Submission Deadline: July 10, 2015

Previous Posters Accepted

Call for Posters

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. There will be ample networking opportunities during the opening reception, round table discussions and the poster session. Evenings are free to explore Madison and the University of Wisconsin Campus.

^ Back to menu

2015 Conference Sponsors

Special thanks for unrestricted educational grants and other support for this conference from:



Simulations Plus,
Lancaster, CA

Simulations Plus

Future Science Group
London, United Kingdom

^ Back to menu

Contents for 2015


Monday, September 21, 2015

12:00 pm

Registration (12:00 – 6:00 PM)

1:30 pm

Optional Short Course – separate registration required

5:00 pm

Registration for Conference

6:00 pm

Opening Reception

Sponsors:

In Vitro ADMET Labs
Columbia, MD/Malden, MA

Seventh Wave Laboratories
Chesterfield, MO

In Vitro ADMET Labs

SeventhWave

7:00 pm

Dinner and welcomes

David A. Hartman Memorial Lecture

Neglected Tropical Diseases

Dale J. Kempf, Ph.D.
Distinguished Research Fellow
Abbvie, North Chicago, IL

Tuesday, September 22, 2015

First Plenary Session: Translating Preclinical Data to Project Clunical Outcomes
Moderator:

Donald L. McKenzie, Ph.D., Conference Chair
Executive Director, Drug Metabolism
Covance Laboratorioes, Madison, WI

8:30 am

Welcome and Conference Introduction

Donald L. McKenzie, Ph.D.

8:45 am

Predicting Human Clinical Parameters

Marilyn E. Morris, Ph.D.
UB Distinguished Professor and Vice Chair
Department of Pharmaceutical Sciences
University at Buffalo, Buffalo, NY

9:05 am

Discussion

9:15 am

The Search for an Appropriate Methodology in Predicting Clearance for Substrates of Aldehyde Oxidase

J. Matthew Hutzler, Ph.D.
Director, In Vitro Metabolism, Bioanalytical and ADME Labs
Q2 Solutions (A Quintiles Quest Joint Venture), Indianapolis, IN

9:50 am

Discussion

10:00 pm

Break

10:20 am

Projecting Clinical Exposure/Dose

Shinji Yamazaki, Ph.D.
Associate Research Fellow, Pharmacokinetics, Dynamics & Metabolism
Pfizer World Wide Research Development, Inc., San Diego, CA

11:10 am

Discussion

11:20 am

Clinical DDI program for a combination containing Three NCEs

Rajeev Menon, Ph.D.
Senior Director, Clinical Pharmacokinetics and Pharmacodynamics
AbbVie, Abbott Park, IL

11:50 am

Prediction of Clinical Efficacious Doses for Antibody-Based Therapeutics: Case Studies

Amrita Kamath, Ph.D.
Senior Scientist Preclinical and Translational PK and PD
Genentech, South San Francisco, CA

12:20 PM

Discussion for two case studies

12:30 pm

Lunch

1:30 pm

Afternoon Session: Translating Preclinical Data to Project Clinical Outcomes (cont.)

Moderator:

Paul Savina, R.Ph.
Consultant
Research Triangle Park, NC

1:30 pm

Translating Toxicology & Safety Pharmacology Data

Mark Holbrook, Ph.D.
Vice President
Global Leader Safety Pharmacology & Site Lead Safety Assessment
Covance, Keeds,  United Kingdom

2:25 pm

Case study - Use of a surrogate molecule in the development of Polatuzumab Vedotin

Dongwei Li, MD
Senior Scientific Researcher
Preclinical and Translational PK and PD
Developoment Sciences
Genentech, Inc.

2:50 pm

Case study on QT prolongation - TBA

Mark Holbrook, Ph.D.
Vice President
Global Leader Safety Pharmacology & Site Lead Safety Assessment
Covance, Leeds, UK

3:15 pm

Discussion for two case studies

3:25 pm

Break

3:45 pm

Round Table Discussions

 

5:00 pm

Continuation of Round Tables, Reception and Tour of the Wisconsin Brewery (transportation provided)

Sponsors:

Triangle Research Labs
Research Triangle Park, NC

To be determined

Triangle Research Labs

7:00 pm

Evening free to explore Madison

Wednesday, September 23, 2015

Second Plenary Session: DMPK and Pediatric Indications

Moderator:
Gordon Loewen, Ph.D.
Senior Director, Drug Development
FORUM Pharmaceuticals, Watertown, MA

8:30 am

The Effects of Age on Enzymatic Systems

Jane Alcorn, DVM, Ph.D.
Professor of Pharmacy and University Veterinarian
College of Pharmacy and Nutrition
University of Saskatchewan, Saskatoon, Canada

9:20 am

Discussion

9:30 am

Prediction Pharmacokinetics in Pediatrics

Eva Huehn, PharmD, Ph.D.
Scientist II, Simulation Studies Team
Simulations Plus, Inc., Lancaster, CA

10:20am

Discussion

10:30 am

Break

11:00 am

Genomic and Ontogeny-Based Dose Individualization for Children: The GOLDILOKs Initiative

J. Steven Leeder, Pharm.D., Ph.D.
Marion Merrell Dow/Missouri Endowed Chair, Pediatric Clinical Pharmacology
Director, Division of Clinical Pharmacology
Toxicology and Therapeutic Innovation, Department of Pediatrics
Children’s Mercy Hospital and Clinics, Kansas City, MO

11:45 am

Discussion

11:55 am

Case Study - Development of a Physiologically-based Pharmacokinetic Model (PBPK) of Montelukast in Adults and its Translation to Pediatric Populations

Christopher Gibson, Ph.D.
Senior Principal Scientist
Pharmacokinetics, Pharmacodynamics and Drug Metabolism
Merck Research Laboratories, West Point, PA

12:20 pm

Discussion for two case studies

12:30 pm Lunch

1:30 pm

Afternoon Session: Challenges in Developing Non-Antibody Based Biologics

Moderator:
Michael W. Sinz, Ph.D., Conference Chair
Research Fellow, Pharmacokinetics and Drug Metabolism
Bristol-Myers Squibb, Wallington, CT

1:30 pm

Antisense Oligonucleotides

Anand Balakrishnan, Ph.D.
Senior Research Investigator
Bristol-Myers Squibb, Wallingford, CT

2:20 pm

Bispecific Tumor and Immune Targeting Products

Theresa Yuraszeck, Ph.D.
Senior Scientist, Clinical Pharmacology, Modeling and Simulation
Amgen, Thousand Oaks, CA

3:10 pm

Break

3:40 pm

Imaging of Biologics

C. Andrew Boswell, Ph.D.
Scientist, Preclinical and Translational Pharmacokinetics
Genentech Research and Early Development
South San Francisco, CA

4:30 pm

Poster Session and Reception

Sponsors:

Optivia Biotechnology, Inc.
Menlo Park, CA

BioReliance
St. Louis, MO

Optivia Biotechnology

BioReliance

6:30 PM

Evening free to explore Madison

Thursday, September 11, 2014

Third Plenary Session: Advances in Drug Transporters

Moderator:
Larry J. Jolivette, Ph.D.
Director of DMPK, Heart Failure Discovery Performance Unit
GlaxoSmithKline, Upper Merion, PA

8:30 am

Regulatory Guidances on Drug-drug Interactions

Heidi J. Einolf, Ph.D.
Director, Enzyme Drug-Drug Interactions and Modeling
Drug Metabolism and Pharmacokinetics
Novartis, East Hanover, NJ

9:20 am

Discussion

9:30 am

Case Study - An Unexpected DDI with Rosuvastatin Explained

Harma Ellens, Ph.D.
Director, Drug Metabolism and Pharmacokinetics
GlaxoSmithKline, King of Prussia, PA

10:10 am

Discussion

10:20 am

Break

10:50 am

Regulatory Issues Related to Biosimilars

Rodeina Challand
Executive Director, Biosimilars Development, Scientific Affairs
PRA HealthSciences, Reading, Berkshire, United Kingdom

11:30 am

Discussion

11:40 am

Companion Diagnostics Guidance

Steve Anderson, Ph.D.
Global Head of LabCorp Clinical Trails
Chief Scientific Officer of Oncology and Genetics
LabCorp, Hopkins, MN

12:30 pm

Conference Adjournment

Distribution of Traditional Wisconsin Cheese Boxes

Sponsor:

BioreclamationIVT
Baltimore, MD

BioreclamationIVT


^ Back to menu

2015 Conference Planning Committee

Donald L McKenzie, Ph.D., Covance Laboratories, Madison, WI, Chair for 2015
Daniel Bow, Ph.D., AbbVie Inc., North Chicago, IL
Eric Buxton, Ph.D., University of Wisconsin, Madison, WI
Matthew Cerny, Ph.D., Boehringer Ingelheim, Richfield, CT
James E. De Muth, Ph.D., University of Wisconsin, Madison, WI
James L. Ferrero, Ph.D., Biogen Idec, San Deigo, CA
Robert J. Guttendorf, Ph.D., Aclairo Pharmaceutical Development Group, Vienna, VA
Suhasini Iyer, Ph.D., Genentech, Inc., South San Francisco, CA
Larry J. Jolivette, Ph.D., GlaxoSmithKline, Upper Merion, PA
Gordon R. Loewen, Ph.D., FORUM Pharmaceuticals, Watertown, MA
Jasminder Sahi, Ph.D., GlaxoSmithKline, Shanghai, China
Paul Savina, Consultant, Research Triangle Park, NC
Arzu Selen, Ph.D., Center for Drug Evaluation and Research, FDA, Silver Springs, MD
Michael Sinz, Ph.D., Bristol Myers Squibb, Wallingford, CT
Helen Shen, Ph.D., QPS, LLC, Newark, DE
Steven Swanson, Ph.D., Eli Lilly and Company, Indianapolis, IN
Richard L. Voorman, Ph.D., Covance Laboratories, Madison, WI
Ping Zhao, Ph.D., Center for Drug Evaluation and Research, FDA, Silver Springs, MD

^ Back to menu

Contact Us

If you should have questions or require more information, please contact:

James E. De Muth, Ph.D.
Course Coordinator
Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 262-3130

^ Back to menu

Last modified: Friday, September 11, 2015, 2:18 PM