University of Wisconsin–Madison

Annual Pharmaceutical Analysis Conference (August Land O’ Lakes)

Pharmaceutical Analysis Conference attendees at a reception.

Addressing Technical and Regulatory Challenges in Pharmaceutical Analysis

The Land O’Lakes Conferences are recognized worldwide as one of the premier teaching conferences for pharmaceutical scientists. The 59th Annual Land O’Lakes Pharmaceutical Analysis Conference is a three-day conference focused on the application of analytical techniques to pharmaceuticals. This insightful, interactive annual gathering is an excellent way to advance your knowledge base and network with colleagues from around the globe

AAPS logo

Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison in partnership with AAPS (American Association of Pharmaceutical Scientists).

Registration Information

Register

Refund Policy

Register by: Aug 12, 2019
Course date:Aug 12, 2019 - Aug 15, 2019
Location:

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

Course fee:

$1075
$1375 after July 29
$850 Academic-Government rate

$175 Optional Short Course

Registration fee includes the opening dinner and all receptions.

Course Objectives

Overall Goal:

The purpose of this three-day conference is to provide an educational forum to discuss issues and applications related to pharmaceutical analysis.  The conference connects leaders together to share new scientific and regulatory developments in the areas related to or with direct application for pharmaceutical analysis, product development, product quality and the analytical method lifecycle applications.

The Land O’ Lakes Conference on Pharmaceutical Analysis is well-recognized as one of the premier teaching conferences for colleagues in the pharmaceutical industry.  Attendees are primarily from the pharmaceutical industry (worldwide) but also include those affiliated with governmental agencies, as well as academia.

Conference objectives: 

The objectives for this conference include:

  1. Discuss and evaluate the major challenges to pharmaceutical analysis in today’s environment;
  2. List primary differences in analysis of large molecules and material characterization;
  3. Describe key new technologies and approaches for increasing laboratory efficiency;
  4. Evaluate new technological approaches to solving analytical challenges;
  5. Discuss possible answers to some of the global regulatory challenges to pharmaceutical analysis.

ABBREVIATED RESULTS from 2018 AUGUST LOL Conf

Poster Session:

The Planning Committee for the 59th Annual Land O’Lakes Conference on Pharmaceutical Analysis invites interested parties to submit research poster abstracts for the 2019 Conference Poster Session on Wednesday, August 14, at the Fluno Center, Madison, Wisconsin.

All abstracts must be submitted via email to the University of Wisconsin by Monday, June 17, 2019.  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 July 10.  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 early registration deadline of July 29 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 July 14, 2019. 

Call for Posters 2019 August Conference

Previous Poster Abstracts 2018

Course Outline

Monday, August 12, 2019
1:00 pm - 5:00 pm

Optional Pre-Conference Short Courses:

TBA

5:30 pm Registration for Conference
5:30 pm

Opening Reception

Sponsored by: United States Pharmacopeia (USP), Rockville, MD

6:30 PM

Opening Dinner

Sponsored by: Alcami, Wilmington, NC
and
Almac Group, Craigavon, United Kingdom

6:30 pm

Welcome
James E. De Muth, PhD, RPh, Conference Coordinator
Professor Emeritus, Division of Pharmacy Professional Development
School of Pharmacy, University of Wisconsin

Dinner Speaker: Shaoqin Sarah Gong, PhD, Vilas Distinguished Achievement Professor, Department of Biomedical Engineering, University of Wisconsin, Madison, WI

Genome Editing and Potential Therapeutic Implications

Tuesday, August 13, 2019
7:30 am Continental Breakfast
 

First Plenary Session: Current Challenges to Pharmaceutical Analysis

Moderator: Asha Rajapakshe, PhD, Director, Analytical Commercialization Technology, Merck & Co., Inc.

8:00 am

Welcome and Conference Overview

Presentation of the Mel Weinswig Award of Excellence in Pharmaceutical Analysis

8:15 am

Analytical Challenges with Modified Release Formulation Development

Speaker: Shelly Li, PhD, Senior Principal Scientist, Analytical Research and Development, Pharmaceutical Sciences Small Molecules, Pfizer Worldwide Research and Development

9:05 am Discussion
9:15 am

Pediatric Formulations: Technical and Regulatory Considerations

Speaker: Shrinivas (Cheenu) Murti, PhD, MBA, Director, Global Regulatory Affairs, CMC, Merck & Co., Inc.

9:50 am Discussion
10:00 am Networking Break
10:15 am

Oncology: Developing strategies for New, Unique and Difficult Formulations

Speaker: Elizabeth Pierson, PhD, Associate Principal Scientist, Analytical Sciences, Merck Research Laboratories

10:50 am Discussion
11:00 am

Regulatory Issues with Accelerated Product Development

Speaker: Derek Vrieze, MS, Associate Director Global Regulatory Affairs CMC, Vertex Pharmaceuticals, Inc.

11:35 am Discussion
11:45 am

Accelerated Stabililty Studies

Speaker: Russell L. Hertzler, PhD, Principal Research Scientist, Global Analytical R&D, AbbVie Inc.

12:20 pm Discussion
12:30 pm Lunch/Networking
 

Afternoon Session: Analytical Challenges and Approach Differences in Characterizing Biopharmaceuticals versus Small Molecules

Moderator: TBA

1:30 pm

Impurity Analysis of Oligonucleotides by LC-UV-MS: Quantitating Co-eluting Components

Speaker: Carolyn Rosewall, PhD, Associate Research Scientist, PPD

2:00 pm Discussion
2:10 pm

Foreign Particulate Matter Analysis of Biologics: Review, Challenges, and Case Studies

Speaker: Kristy Moeller, Associate Research Scientist, Physical and Chemical Characterization, PPD

3:00 pm Discussion
3:10 pm Time to explore Madison
5:30 pm

Evening Reception

Sponsors:
Boston Analytical, Salem, NH
Cambrex, East Rutherford, NJ
Pace Labs, Oakdale, MN

7:00 pm Evening free to explore Madison
Wednesday, August 14, 2019
7:30 am Continental Breakfast
 

Second Plenary Session: New Technologies and Approaches for Increasing Laboratory Efficiency

Moderator: Jason Rodriguez, PhD, Laboratory Chief, Branch I, FDA Division of Pharmaceutical Analysis

8:00 am

New Technology for Testing Pharmaceutical Impurities at Trace Levels: Process, Procedures, and Tactics

Speaker: David Q. Liu, PhD, Director, Analytical Development, Celgene

8:45 am

Discussion

8:55 am

Field Flow Fractionation Technologies for Product Development

Speaker: TBA

9:40 am

Discussion

9:50 am

Continuous Manufacturing and Analytical Considerations

Speaker: Joseph Medendorp, PhD, Director, Technical Operations, Vertex Pharmaceuticals Inc.

10:35 am

Discussion

10:45 am Networking Break
11:00 am

Technology Showdown #1

11:30 am

Technology Showdown #2

12:00 pm Technology Showdown #3
12:25 pm

Discussion

12:30 pm Lunch/Networking
 

Afternoon Session : Data Integrity

Moderator: Nathan Whitford, MBA, Site Director, Eurofins Lancaster Laboratories

1:30 pm

Improving Documentation Practices for Accuracy and Efficiency

Speaker: James M. Roberts, PhD, Scientific Director, Analytical Sciences & Development, R&D Medicinal Science & Technology, GlaxoSmithKline

2:05 pm Discussion
2:15 pm

Data Integrity and Compliance from a Regulatory Perspective

Speaker: Kevin Roberson, Senior Director, Quality Assurance, Eurofins BioPharma Product Testing

2:50 pm

Discussion

3:00 pm Networking Break
3:15 pm

Interactive Workshop on Risk Assessment for Commercial Readiness

Facilitators:

Ivelisse Colón-Rivera, PhD, Senior Director, Technical Operations, Vertex Pharmaceuticals

Timothy Graul, PhD, Associate Research Fellow, Analytical Research & Development, Pfizer

George Reid, PhD, Principal Scientist – CMC, Cardinal Health Regulatory Science

5:00 pm

Adjourn Afternoon Session
Exhibits, Poster Session and Reception

Sponsor: Eurofins BioPharma Product Testing

Exhibitors: TBA

7:00 pm Evening free to explore Madison
Thursday, August 15, 2019
7:30 am Continental Breakfast
 

Third Plenary Session: Global Regulatory Challenges to Pharmaceutical Analysis

Moderator: Madhavi Srikoti, MS, Research Scientist, Drug Product Science and Technology, Bristol-Myers Squibb

8:00 am

Global Challenges with Regulatory Agencies

Speaker: Joseph A. Albanese, PhD, Director – Analytical Strategy and Compliance, Discovery, Product Development and Supply, Janssen Research and Development, LLC

8:35 am

Discussion

8:45 am

Relevance of Biopharmaceutical Testing

Speaker: Zongming Gao, PhD, Research Chemist, CDER/OPQ/OTR/Division of Pharmaceutical Analysis, Food and Drug Administration

9:20 am

Discussion

9:30 am

Regulatory Issues with Pediatric Administration

Speaker: Divyakant Desai, PhD, Research Fellow, Drug Product Science and Technology, Bristol-Myers Squibb

10:05 am

Discussion

10:15 am Closing remarks
Asha Rajapakshe, PhD, 2019 Conference Chair
10:30 am Conference Adjournment

Instructors

Joseph A. Albanese, PhD, Director – Analytical Strategy and Compliance, Discovery, Product Development and Supply, Janssen Research and Development, LLC, Spring House, PA

Ivelisse Colón-Rivera, PhD, Senior Director, Technical Operations, Vertex Pharmaceuticals, Boston, MA

Divyakant Desai, PhD, Research Fellow, Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ

Zongming Gao, PhD, Research Chemist, CDER/OPQ/OTR/Division of Pharmaceutical Analysis, Food and Drug Administration, St Louis, MO  

Shaoqin Sarah Gong, PhD, Vilas Distinguished Achievement Professor, Department of Biomedical Engineering, University of Wisconsin, Madison, WI

Timothy Graul, PhD, Associate Research Fellow, Analytical Research & Development, Pfizer, Groton, CT

Russell L. Hertzler, PhD, Principal Research Scientist, Global Analytical R&D, AbbVie Inc., North Chicago, IL 

Shelly Li, PhD, Senior Principal Scientist, Analytical Research and Development, Pharmaceutical Sciences Small Molecules, Pfizer Worldwide Research and Development, Groton, CT  

David Q. Liu, PhD, Director, Analytical Development, Celgene, Summit, NJ 

Joseph Medendorp, PhD, Director, Technical Operations, Vertex Pharmaceuticals Inc., Boston, MA

Kristy Moeller, Associate Research Scientist, Physical and Chemical Characterization, PPD, Middleton, WI

Shrinivas (Cheenu) Murti, PhD, MBA, Director, Global Regulatory Affairs CMC, Merck & Co., Inc., Rahway, NJ

Elizabeth Pierson, PhD, Associate Principal Scientist, Analytical Sciences, Merck Research Laboratories, Rahway, NJ

Asha Rajapakshe, PhD, Director, Analytical Commercialization Technology, Merck & Co., Inc., West Point, PA

George Reid, PhD, Principal Scientist – CMC, Cardinal Health Regulatory Science, Overland Park, KS

Kevin Roberson, Senior Director, Quality Assurance, Eurofins BioPharma Product Testing, Columbia MO

James M. Roberts, PhD, Scientific Director, Analytical Sciences & Development, R&D Medicinal Science & Technology, GlaxoSmithKline, Collegeville, PA

Jason Rodriguez, PhD, Laboratory Chief, Branch I, FDA Division of Pharmaceutical Analysis, St. Louis, MO

Carolyn Rosewall, PhD, Associate Research Scientist, PPD, Middleton, WI

Madhavi Srikoti, MS, Research Scientist, Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ

Derek Vrieze, MS, Associate Director Global Regulatory Affairs CMC, Vertex Pharmaceuticals, Inc., Boston, MA

Nathan Whitford, MBA, Site Director, Eurofins Lancaster Laboratories, Inc., Portage, MI

Planning Committee

Asha Rajapakshe, PhD, Director, Analytical Commercialization TechnologyMerck & Co., Inc., West Point, PA, Conference Chair

Ivelisse Colón, PhD, Vertex Pharmaceuticals, Boston, MA, Past Conference Chair

Nathan Whitford, MBA, Eurofins Lancaster Laboratories, Inc., Portage, MI, 2020 Chair

Erik C. Burns, EdD, American Association of Pharmaceutical Scientists, Arlington, VA

James E. De Muth, PhD, University of Wisconsin, Madison, WI

Timothy Graul, PhD, Pfizer, Groton, CT

Russell L. Hertzler, PhD, AbbVie Inc., North Chicago, IL

Susan Lerke, PhD, Johnson & Johnson, Malvern, PA

Michael H. Murphy, Mallinckrodt Pharmaceuticals Company, St. Louis, MO

Horacio Pappa, PhD, United States Pharmacopeia Convention, Rockville, MD

George Reid, PhD, Cardinal Health Regulatory Sciences, Overland Park, KS

Stefanie Rentfrow, Perrigo, Allegan, MI 

Jason Rodriguez, PhD, Food & Drug Administration, St. Louis, MO

Madhavi Srikoti, MS, Bristol-Myers Squibb. Princeton, NJ

Harley Wilcox, EAG Laboratories, Columbia, MO

Derek Wood, PPD, Middleton, WI

Naijun Wu, PhD, Celgene Corporation, Summit, NJ

Accommodations

Hotel accommodations are the responsibility of the registrant.

Fluno Center
(conference location)
601 University Ave
Madison, WI  53715
608.441.7148   877.773.5866
$143.00
Release Date: July 14, 2019
Booking link

Hampton Inn
(5 blocks away)
440 West Johnson St
Madison, WI  53703
608.255.0360
$169.00
Group Name: Pharmaceutical Analysis Conference   Group Code: PHM
Release Date: July 13, 2019
Booking link

DoubleTree by Hilton

(4 blocks away)
 525 West Johnson St
Madison, WI  53703
608.251.5511
$169.00
Release Date: July 12, 2019
Booking link

Graduate Hotel
(3 blocks away)
601 Langdon Street
Madison, WI  53703
608.257.4391
Rate: $189.00
Room block held until July 1, 2019
Booking link

The Lowell Center
(3 blocks away)
610 Langon Street
Madison, WI  53703
Rate: $115.00
Group code: LANDPA
Rooms held until July 14, 2019
608.256.2621
Booking link

Sponsors

Alcami Logo

 

 

Eurofins BioPharma Logo

 

Pace Analytical Life Sciences Logo

USP Logo

Program Coordinator

James DeMuth, PhD

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 262-3132
james.demuth@wisc.edu