University of Wisconsin–Madison

Annual Drug Metabolism and Applied Pharmacokinetics Conference (September Land O’ Lakes)

New Opportunities for DMPK: The 21st Century Cures Act

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.

Attendees at the Drug Metabolism and Applied Pharmacokinetics Conference

The Land O’Lakes Conferences are recognized worldwide as one of the premier teaching conferences for pharmaceutical scientists. The September Land O’Lakes Conference on Drug Metabolism and Applied Pharmacokinetics is a three-day conference that brings leaders from multiple disciplines in the DMPK arena together to share new advances in drug delivery, action and metabolism. Relevant regulatory updates are provided every year to ensure that the attendees are aware of the latest changes in drug development regulations.

Registration Information

Register

Refund Policy

Register by: Sep 20, 2018
Course date:Sep 17, 2018 - Sep 20, 2018
Location:

Fluno Center
601 University Avenue
University of Wisconsin-Madison Campus
Madison, WI

Course fee:

$1075
$1375 after Sept 3
$850 Academic-Government rate

$175 Optional Short Course

Registration fee includes the opening dinner and all receptions.

Course Objectives

Overall Goal:

The 21st Annual DMPK Conference will discuss the current issues in selecting potential new therapeutic entities for drug development and current issues in drug metabolism, drug transport, pharmacokinetics, and pharmacodynamics.

Conference objectives:

The objectives for 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.

ABBREVIATED-RESULTS-from-2017DMPK

Poster Session:

The Planning Committee for the 21st Annual Land O’Lakes Conference on Drug Metabolism and Pharmacokinetics and Applied Drug Development, invites interested parties to submit research poster abstracts for the 2018 Conference Poster Session on Wednesday, September 19, at the Fluno Center, Madison, Wisconsin. 

All abstracts must be submitted via email to the University of Wisconsin by Monday, July 23, 2018.  Proposals will be reviewed and evaluated by a review panel of Planning Committee members.  Acknowledgement of receipt will be sent by e-mail, as well as notification of the acceptance or rejection of abstracts to primary presenters by August 13.  Please do not call the University of Wisconsin to find out the status of your abstract(s).  

To submit a poster for consideration, at least one author must be registered for the conference.  If the poster is not accepted, authors have the right to cancel their registration by the registration deadline of September 3 and will receive a full refund.  Any author present at the Conference must be registered for the entire Conference.

Accepted abstracts will be placed on the University of Wisconsin Web site by August 20, 2018.

Call for Posters 2018DMPK 

Who Should Attend

Drug metabolism and delivery scientists and managers from virtual to big pharma, CROs and researchers in academia will all benefit from attending this conference. The planning committee sought to include perspectives from the regulatory, industrial and academic disciplines to ensure a broad diversity of thought.

Course Outline

Monday, September 17, 2018
1:00 pm - 4:30 pm

Optional Pre-Conference Short Course:
Drug Transporters

Speaker: Daniel Bow, PhD, Senior Principal Scientist, AbbVie, Inc.

5:00 pm Registration for Conference
5:00 pm

Opening Reception

Sponsorship: Charles River Laboratories

6:00 PM

Opening Dinner

Sponsorship:
Nuventra Pharma Sciences, Inc.
and
TBA

6:45 - 8:00 pm

Opening Remarks and David Hartman Memorial Dinner

Translating Biosynthetic Gene Clusters into Fungal Armor and Weaponry:  A Source for Pharmaceutical Development

Speaker: Nancy Keller, PhD, Director of Microbial Doctoral Training Program (MDTP)-UW Robert L. Metzenberg and Kenneth B. Raper Professor of Mycology, Department of Medical Microbiology and Immunology, Department of Bacteriology

Tuesday, September 18, 2018
8:30 am Welcome and Conference Overview
Speaker: Robert Guttendorf, Conference Co-chair, CSO and Sr. Consultant, DMPK at Aclairo Pharmaceutical Development Group, Inc.
 

Plenary Session 1: Mechanistic PK/PD

8:35 am

An Introduction to Model Informed Drug Discovery and Development (MID3)

Speaker: Tjerk Bueters, PhD, Director, Preclinical ADME, Merck

9:25 am Discussion
9:35 am

Day-to-Day Applications of PK/PD: Optimizing Utility and Avoiding Pitfalls

Speaker: Harvey Wong, PhD, Associate Professor of Pharmacokinetics, Faculty of Pharmaceutical Sciences, University of British Columbia

10:15 am

Discussion

10:25 am Networking Break
10:45 am

Application of the Model-based Translation Analysis in the Development of an Irreversible KAT II Inhibitor

Speaker: Cheng Chang, PhD, Associate Director, Pfizer Clinical Pharmacology

11:25 am

Discussion

11:35 am

Mechanistic PK at the Discovery-Development Interface: Modeling with Confidence and Uncertainty

Speaker: Dan Mudra, PhD, Director of Discovery ADME, Elli Lilly and Company

12:20 pm

Discussion

12:30 pm Lunch
 

Plenary Session 2: New Regulatory Considerations (New FDA/EMA Guidances)
Moderator: Gordon Loewen, PhD, Neurocrine Biosciences, Inc., Co-Chair

1:15 pm

In vitro DDI Guidance: The in vitro DDI guidance covering inhibition and induction and reaction phenotyping 
Speaker: Mike Sinz, PhD, Director, DMPK, Bristol-Myers Squibb

1:55 pm Discussion
2:05 pm

Clinical DDI Guidance

Speaker: Elimika Pfuma Fletcher, PhD, CDER, Clinical Pharmacology Policy Lead, US Food and Drug Administration

2:45 pm

Discussion

2:55 pm

Networking Break

3:10 pm

EMA guideline on first-in-human and early clinical trails

Speaker: John Lambert MB, BS, PhD, FRACP, FFPM, Chief Medical Officer Early Phase, Corporate Vice President, Head Global Early Phase Medical Sciences, PAREXEL International

3:45 pm

Discussion

3:55 pm

Panel Discussion
Moderators: Mike Sinz, John Lambert, Elimika Pfuma Fletcher

5:00 pm Round table discussion - Reception at the Pyle Center
7:00 pm Evening free to explore Madison
Wednesday, September 19, 2018
 

Plenary Session 3: Special Topics in Metabolism
Moderator: Larry Jolivette, PhD, Director of DMPK, GlaxoSmithKline

8:30 am Reaction Phenotyping
Speaker: Angela Doran, PhD, Scientist, Pfizer
9:20 am

Discussion

9:30 am

Assessing Metabolite Profile and DDI Profile for Low Clearance compounds
Speaker: Cheul Cho, PhD, Chief Scientific Officer, Hµrel Corporation

10:15 am

Discussion

10:25 am Networking Break
10:50 am Using NMR for Metabolite Identification
Speaker: Raman Sharma, PhD, Senior Scientist, Pfizer
11:35 am Discussion
11:45 am

Taking Advantage of Hepatic Enzymes for Liver Targeted Drug Delivery
Speaker: Eisuke Murakami, PhD, Senior Scientist I, Drug Metabolism, Gilead

12:20 pm

Discussion

12:30 pm Lunch
 

Plenary Session 4: Microbiome Influences on Drug Disposition
Moderator:  Celeste MacElrevey, PhD, Senior Pharmacokineticist and QA Specialist,  Nuventra, Inc.

1:30 pm

What is the Microbiome and its effects on Physiology/Disease State
Speaker: Emily Balskus, PhD, Associate Professor, Harvard University

2:10 pm Discussion
2:20 pm Microbiome and Drug Metabolism/Absorption
Speaker: Kishore Pasikanti, PhD, DMPK Translation Program Leader, Neurosciences, GlaxoSmithKline
2:55 pm Discussion
3:00 pm Networking Break
3:20 pm Microbiome's Impact on Human Health
Speaker: Federico Rey, PhD, Assistant Professor, Bacteriology, University of WI-Madison
4:00 pm

Discussion

5:00 pm

Poster Reception/Graduate Research Presentations

Sponsorship available
7:00 pm Evening free to explore Madison
Thursday, September 20, 2018
 

Plenary Session 5: Optimizing Translational Drug Development (Early Drug Development Preclinical-Clinical)
Moderator: Kirk Henne, PhD,  Director, DMPK, Denali Therapeutics

8:30 am

Translational Drug Development: What Preclinical Data are Required and How is it Best Integrated into Early Clinical Drug Development
Speaker: Griff Humphreys, PhD, Executive Director, Bristol-Myers Squibb,

9:20 am Discussion
9:30 am

Dosimetry for Human ADME Studies
Speaker: Eric Solon, PhD, Senior Director, Pharmacology and ADME, Madrigal Pharmaceuticals

10:10 am

Discussion

10:20 am Networking Break
10:50 am

Adaptive Trial Models
Speaker: Sandeep Menon, PhD, Vice President and Head of Early Clinical Development, Biostatistics, Pfizer

11:40 am

Panel Discussion and Conference Wrap Up

12:30 pm Conference Adjournment

 

Instructors

Emily Balskus, PhD, Associate Professor, Harvard University, Cambridge, MA

Tjerk Bueters, PhD, Director, Preclinical ADME, Merck, West Point, PA

Daniel Bow, PhD, Senior Principal Scientist, AbbVie, Inc., Chicago, IL

Cheng Chang, PhD, Associate Director, Pfizer Clinical Pharmacology, Groton, CT

Cheul Cho, PhD, Chief Scientific Officer, Hµrel Corporation, New Brunswick, NJ

Angela Doran, PhD, ADME Scientist, Pfizer, Groton CT

Kirk Henne, PhD, Director, DMPK, Denali Therapeutics, South San Francisco, CA

Griff Humphreys, PhD, Executive Director, Bristol-Myers Squibb, Princeton, NJ

John Lambert, MB BS, PhD, FRACP, FFPM, Chief Medical Officer Early Phase, Corporate Vice President, Head Global Early Phase Medical Sciences , PAREXEL International, Middlesex, UK

Sandeep Menon, PhD, Vice President and Head of Early Clinical Development, Biostatistics, Pfizer, Boston, MA

Dan Mudra, PhD, Director of Discovery ADME, Elli Lilly and Company, Indianapolis, Indiana

Eisuke Murakami, PhD, Senior Scientist, Gilead Sciences, Foster City, CA

Kishore Pasikanti, PhD, DMPK Translation Program Leader, Neurosciences, GlaxoSmithKline, Collegeville, PA

Elimika Pfuma Fletcher, PhD, CDER, Clinical Pharmacology Policy Lead, US Food and Drug Administration, Silver Spring, MD

Federico Rey, PhD, Assistant Professor, Bacteriology, University of WI-Madison, Madison, WI

Mike Sinz, PhD, Director DMPK, at Bristol-Myers Squibb, Wallingford, CT

Raman Sharma, PhD, Senior Scientist, Pfizer, Groton, CT

Eric Solon, PhD, Senior Director, Pharmacology and ADME, Madrigal Pharmaceuticals, West Conshohocken, PA

Harvey Wong, PhD, Associate Professor of Pharmacokinetics, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada

Planning Committee

Daniel A Bow, PhD, Abbott, Abbott Park, IL
Matthew Cerny, PhD, Pfizer, Groton, CT
Cheng Chang, PhD, Pfizer
Stephanie Pasas-Farmer, PhD, Bio Data Solutions, Inc, Eagleview, PA
Randall H. Guthrie, Co-Chair, Pyxant Labs, Lodi, WI
Robert J. Guttendorf, RPh, PhD, CSO and Senior Consultant, Clinical Pharmacology and DMPK, Aclairo Pharmaceutical Development Group, Vienna, VA, Co-Chair
Kirk Henne, PhD, Denali Therapeutics, South San Francisco, CA
Larry J. Jolivette, PhD, GlaxoSmithKline, Upper Merion, PA
Stefan Linehan, Imabiotech Corp, Cambridge, MA
Gordon Loewen, PhD, Neurocrine Biosciences, Inc., Co-Chair
Celeste R. MacElrevey, PhD, Nuventra Pharma Sciences, Inc., Exton, PA
Donald L McKenzie, PhD, Covance Laboratories, Madison, WI
Dan Norris, PhD, Ionis Pharmaceuticals, Carlsbad, CA
Michael Sinz, PhD, Bristol Myers Squibb, Wallingford, CT
Jennifer Thomas, PhD, Associate Director, ADME/DMPK, Charles River, Ashland, OH

Accommodations

Hotel accommodations are the responsibility of the registrant.

The Graduate Madison 
(1.5 blocks away)
601 Langdon St
Madison, WI  53703
608.257.4391  800.589.6285
Rate: $139.00
Release Date:
Event Title: UW School of Pharmacy - Land O Lakes Conference September
Booking link

Fluno Center
(conference location)
601 University Ave
Madison, WI  53715
608.441.7148   877.773.5866
Price $143.00
Release Date: August 16, 2018
Booking link

Hampton Inn
(5 blocks away)
440 West Johnson St
Madison, WI  53703
608.255.0360
$169.00
Release Date: August 17, 2018
Group Code: Land O' Lakes Conference September
Booking link

DoubleTree by Hilton Madison
(4 blocks away)
 525 West Johnson St
Madison, WI  53703
608.251.5511
$159.00
Release Date: August 17, 2018
Group ID: 314901  Group Code:DRU
Booking link

 

Sponsors

Nuventra logo

SimulationsPlus logo

charles_river_logo

Program Coordinator

Eric Buxton, PhD

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-2259
eric.buxton@wisc.edu