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 Conference Registration Fee
$1375 Conference Registration Fee after July 29, 2019
$850 Academic-Government Conference Registration Fee

Conference Registration Fee includes the opening dinner and all receptions.

$175 Optional Short Course Fee

Refund Policy: All requests for refunds, less a $75 administrative fee, will be honored if received prior to July 29, 2019. No refunds will be provided after that date.

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 - 5:15 pm

Optional Pre-Conference Short Courses: 
Elemental Impurities Testing 101: Understanding the ICH Q3D and USP<232>/233> Requirements

Speaker: Nancy Lewen, Retired Research Fellow, Bristol-Myers Squibb

or

Nanotechnologies in Drug Delivery

Speaker: Sandro Mecozzi PhD, Professor, School of Pharmacy, Division of Pharmaceutical Sciences, University of Wisconsin School of Pharmacy

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
and
Sotax, Westborough, MA

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 Analytical 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 Solutions 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: Jason Rodriguez, PhD, Laboratory Chief, Branch I, FDA Division of Pharmaceutical Analysis
1:30 pm Sequence Confirmation of Oligonucleotides using LCMS and LCMS/MS: a Comparison
Speaker: Gordon Nicol, PhD, Principal 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 Analytical Life Sciences, 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: Ivelisse Colón-Rivera, PhD, Senior Director, Technical Operations, Vertex Pharmaceuticals
8:00 am New Technology for Testing Pharmaceutical Impurities at Trace Levels: Process, Procedures, and Tactics
Speaker: Ray Xie, PhD, Senior Scientist, 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 Automating the Data Workflow for Assay, Content Uniformity and Dissolution Testing
Speaker: Kevin Whitkanack, Director of Sales & Marketing, North America, SOTAX Corporation
11:30 am Technology Showdown #2
Speaker: Bérangère Tissot, PhD, General Manager, SGS Life Sciences
12:00 pm Applying the Regulatory Framework for Extractables and Leachables in Laboratory
Speaker: Cheryl Johnson, MBA, Commercial Development Mananger, Biologics, Alcami
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: Holly Bridges, R&D Operations Supervisor, Perrigo Company
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 Commercial Readiness: Risk Assessment and Inspections
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 Kevin Roberson, Senior Director, Quality Assurance, Eurofins BioPharma Product Testing
5:00 pm

Adjourn Afternoon Session
Exhibits, Poster Session and Reception
Sponsor: Eurofins BioPharma Product Testing

Exhibitors:
Alcami
Almac Group
Boston Analytical
Cambrex
Eurofins BioPharma Testing
Pace Analytical Life Sciences
PPD
SGS Life Sciences
SOTAX Corporation
USP

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, Senior 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 - In Vitro Biorelevant Dissolution 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

Holly Bridges, R&D Operations Supervisor, Perrigo Company, Allegan, MI

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 

Cheryl Johnson, MBA, Commercial Development Mananger, Biologics, Alcami, Wilmington, NC

Nancy Lewen, Retired Research Fellow, Bristol-Myers Squibb

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 

Sandro Mecozzi PhD, Professor, School of Pharmacy, Division of Pharmaceutical Sciences, University of Wisconsin School of Pharmacy, Madison, WI

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

Gordon Nicol, PhD, Principal Scientist, PPD, Middleton, WI

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

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

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

Bérangère Tissot, PhD, General Manager, SGS Life Sciences, West Chester, PA

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

Kevin Whitkanack, Director of Sales & Marketing, North America, SOTAX Corporation, Westborough, MA

Ray Xie, PhD, Senior Scientist, analytical Development, Celgene, Summit, NJ

Planning Committee

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

Ivelisse Colón, PhD, Senior Director, Technical Operations, 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,Laboratory Chief, Branch I Food & Drug Administration, Division of Pharmaceutical Analysis, St. Louis, MO

Madhavi Srikoti, MS, Senior Research Scientist, Drug Product Science and Technology, 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
(2.5 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

(2 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 Langdon Street
Madison, WI  53703
Rate: $115.00
Group code: LANDPA
Rooms held until July 14, 2019
608.256.2621
Booking link

Sponsors

Alcami Logo Almac Logo
Eurofins BioPharma Logo Pace Analytical Life Sciences Logo
USP Logo

EDUCATIONAL GRANTS PROVIDED BY

PPD 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