University of Wisconsin–Madison

Annual Pharmaceutical Analysis Conference (August Land O’ Lakes)

Analytical Considerations for a Comprehensive Control Strategy

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

Pharmaceutical Analysis Conference attendees at a reception.

The Land O’Lakes Conferences are recognized worldwide as one of the premier teaching conferences for pharmaceutical scientists. The 58th 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.

Second Annual August Devil’s Head Memorial Golf Outing

For those who enjoyed the golf when the Land O’Lakes Conference was offered at the rustic Devil’s Head Resort; there is now a chance to bring back fond memories and join other former partners for the second annual golf outing being offered immediately prior to the start of the conference on Monday afternoon at Pleasant View Golf Course  http://www.golfpleasantview.com/

 For more information on the Golf Outing contact Jim De Muth at james.demuth@wisc.edu.

Registration Information

Register

Refund Policy

Register by: Aug 8, 2018
Course date:Aug 6, 2018 - Aug 9, 2018
Location:

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

Course fee:

$1075
$1375 after 7/23/2018
$850 Government and Academic Rate

$175 Optional Short Course

Registration fee includes the opening dinner and all receptions.

Course Objectives

Overall Goal:

The 58th Annual Pharmaceutical Analysis Conference will bring together leading experts to share new scientific and regulatory developments in the areas related to or with direct application for pharmaceutical analysis, product quality and the analytical method lifecycle.

Conference objectives: 

The objectives for this conference include:

  1. Explore and evaluate the components of a comprehensive control strategy;
  2. Discuss the evolution of control strategies during different phases of a product’s life cycle;
  3. Identify criteria to use is setting appropriate specifications for evaluating drug products;
  4. Describe the role of technology and automation in increasing the effectiveness of a control strategy.
  5. Discuss the role of data integrity and analytical method performance as part of a control strategy; and
  6. Discuss how regulatory issues may impact an overall control strategy.

ABBREVIATED RESULTS from 2017

Poster Session:

The Planning Committee for the 58th Annual Land O’Lakes Conference on Pharmaceutical Analysis invites interested parties to submit research poster abstracts for the 2018 Conference Poster Session on Wednesday, August 8, at the Fluno Center, Madison, Wisconsin.

All abstracts must be submitted via email to the University of Wisconsin by Monday, June 11, 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 July 2.  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 23 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 7, 2018. 

Call for Posters 2018

Previous Poster Abstracts 2017

 

Course Outline

Monday, August 6, 2018
1:00 pm - 5:00 pm

Optional Pre-Conference Short Courses:

Statistics for Analytical Chemists

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

or

Method Validation 101: One Critical Part of an Analytical Method Lifecycle

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

or

Elemental Impurities Testing 101: Understanding the ICH Q3D and USP <232>/<233> Requirements

Speaker: Wayland Rushing, PhD, Director, Scientific Affairs, EAG Laboratories

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

Almac Group, Craigavon, United Kingdom

EAG Laboratories, Sunnyvale, CA

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

Opening Presentation: Biosimilars - Regulatory Requirements and Control Strategies

Speaker: Peter Wunderli, PhD
Associate Director, Biopharmaceuticals, PPD

Tuesday, August 7, 2018
7:30 am Continental Breakfast
 

First Plenary Session: Focusing on Control Strategies

Moderator: Elizabeth Hewitt, MS, Conference Chair, Director, Takeda Pharmaceuticals International

8:00 am

Welcome and Conference Overview

Elizabeth Hewitt, MS

8:15 am

How Does a Control Strategy Evolve?

Speaker: Weixian Shi, PhD, Principal Scientist, Drug Product and Technology, Bristol-Myers Squibb

9:05  am Discussion
9:15 am

Control Strategy Development for a Small Volume Continuous Process

Speaker: Todd Dylan Maloney, PhD, Research Advisor, Product and Analytical Development, Eli Lilly and Company

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

Opportunities, Approaches and Challenges of Developing Clinically Relevant Dissolution Specifications

Speaker: Andre Hermans, PhD, Director, Principal Scientist, Analytical Science, Merck and Company

10:50 am Discussion
11:00 am

Development of  Clinically Relevant Impurity Specifications - A Regulatory Perspective

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

11:35 am Discussion
11:45 am

In vivo Relevance of Dissolution

Speaker: Wenlei Jiang, PhD, Senior Science Advisor, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration

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

Afternoon Session: Technology Applications to Deliver Control Strategies

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

1:30 pm

PAT for Real Time Quality Assurance in Drug Product Continuous Processes

Speaker: Angela Liu, PhD, Senior Principal Scientist, Pfizer

2:05 pm Discussion
2:10 pm

Strategies for Employing High Resolution LC-MS in Impurity Identification

Speaker: James M. Schmidt, Senior Scientific Advisor, EAG Laboratories

2:50 pm Discussion
3:00 pm Networking Break
3:15 pm

Drug Product Performance by Dissolution

Speaker: Ashok Patel, Manager I, Analytical R&D, Perrigo, Consumer Healthcare

3:50 pm

Discussion

4:00 pm

Automation of Analysis for Drug Products Release and Stability Testing in the Commercial Manufacturing Space

Speaker: Joanna Everitt, Associate Principle Scientist, Analytical Development & Commercialization, Merck and Company

4:35 pm

Discussion

5:00 pm Adjourn Afternoon Session
5:30 pm

Tour and Dinner at the Wisconsin Brewing Company

Sponsors:

Avista Pharma Solutions, Durham, NC

Metrics Contract Services, Greenville, NC

and

Pace Laboratories, Oakdale, MN

7:30 pm Evening free to explore Madison
Wednesday, August 8, 2018
8:00 am Continental Breakfast
 

Second Plenary Session: Control Strategies for Complex Drug Products

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

8:30 am

Analytical Challenges of Fixed-Dose Combination Products

Speaker: Dan Tang, BS, Senior Research Scientist, Drug Product Science and Technology, Bristol-Myers Squibb

9:05 am

Discussion

9:15 am

Drug/device Combo Product Analytical Control Strategy - Infusion Products

Speaker: Jayne Zimmerman, Scientific Director, NCE analytical R&D, Drug Product Development, AbbVie, Inc.

9:50 am

Discussion

10:00 am Networking Break
10:15 am

Drug/device Combo Product Analytical Control Strategy - Transdermals

Speaker: Lakshmi Raghavan, MS, PhD, Founder & President, Solaris

11:50 am

Discussion

11:00 am

Pediatric Drug Analytical Development Strategy and Challenges

Speaker: Hanlin Li, PhD, Associate Director, Analytical Development, Vertex Pharmaceuticals, Inc.

11:35 am Discussion
11:45 am

Scientific Considerations in the Approval of Complex Generics

Speaker: Andre Raw, PhD, Acting Senior Scientific and Policy Advisor, Office of Pharmaceutical Quality/Office of Lifecycle Drug Products, US Food and Drug Administration

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

Afternoon Session : Control Strategies Involving Method Transfer

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

1:30 pm

Reference Standards: Design and Implementation of Holistic Strategies

Speaker: Louise M. Garone, PhD, Associate Director, Oncology and Biologics Quality Control, Takeda Pharmaceuticals International Co

2:10 pm Discussion
2:20 pm

Analytical Challenges with Novel Applications of Non-Chromatographic Testing

Speakers:
Lauren Levac, MS, Senior Scientist, Microbiology Dept, PPD
John Bak, PhD, Principal Scientist, Physical and Chemical Charactarization, PPD
Pamela Sheaff, MS, PMP, Senior Research Scientist, Physical and Chemical Characterization, PPD

3:00 pm Discussion
3:10 pm Networking Break
3:30 pm

CMO/CRO Interactions Workshop

Facilitators:     
Susan Lerke, PhD, Associate Director, Analytical Development, Johnson & Johnson

Alan Potts, PhD, Director of Analytical Development, Patheon, Thermo Fisher Scientific, Greenville, NC

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

Harley Wilcox, Senior Scientific Advisor, EAG Laboratories

5:00 pm

Adjourn Afternoon Session
Exhibits, Poster Session and Reception
8th Floor Fluno Center

Sponsor: Eurofins/Lancaster Laboratories, Lancaster, PA

Exhibitors:
Alcami, Wilmington, NC
Almac Group, Craigavon, United Kingdom
Avista Pharma Solutions, Durham, NC
EAG, Sunnyvale, CA
Eurofins/Lancaster Laboratories, Lancaster, PA
Metrics Contract Services, Grenville, NC
Pace Laboratories, Oakdale, MN
PPD, Middleton, WI
USP, Rockville, MD
Others - TBA

7:00 pm Evening free to explore Madison
Thursday, August 8, 2018
7:30 am Continental Breakfast
 

Third Plenary Session: Regulatory Considerations for Global Strategies

Moderator: Asha Rajapakshe, PhD., Associate Principal Scientist, Analytical Development and Commercialization-Pharmaceutical, Merck & Co.

8:00 am

Local Challenges to a Global Control Strategy Justified in a CTD Dossier

Speaker: Laura O'Brien, PhD, Distinguished Research Fellow, Global CMC Experts Group, Quality & Records Managment, Boehringer Ingelheim Pharmaceuticals, Inc.

8:40 am Discussion
8:50 am

Implementation of an Elemental Impurities Control Strategy

Speaker: Mark Schweitzer, PhD, Global Head, Analytical Science and Technology, Novartis

9:25 am

Discussion

9:35 pm Networking Break
9:55 am

Post Approval Specification Changes/Challenges from an Industrial Perspective

Speaker: Ivelisse Colón-Rivera, PhD, Senior Director, Technical Operations, Vertex Pharmaceuticals Inc.

10:30 am Discussion
10:40 am

Lifecycle Management of Product Quality from a Regulatory Perspective

Speaker: Hasmukh Patel, PhD, Director, Division of Post-Marketing Activities 1, Office of Lifestyle Drug Products, Office of Pharmaceutical Quality, CDER, US Food and Drug Administration

11:10 am Discussion
11:20 am

Post Approval Changes from a Regulatory Perspective (ANDAs)

Speaker: Paul Schwartz, PhD, Director, Division of  Post-Marketing Activities II, Office of Lifestyle Drug Products, Office of Pharmaceutical Quality, CDER US Food and Drug Administration

11:50 am Discussion
12:00 pm Conference Adjournment

Instructors

John Bak, PhD, Principal Scientist, Physical and Chemical Charactarization, PPD, Middleton, WI

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

Todd Dylan Maloney, PhD, Research Advisor, Product and Analytical Development, Eli Lilly and Company, Indianapolis, IN

Joanna Everitt, Associate Principle Scientist, Analytical Development & Commercialization, Merck & Co., Inc., West Point, PA

Louise M. Garone, PhD, Associate Director, Oncology and Biologics Quality Control, Takeda Pharmaceuticals International Co., Cambridge, MA

Andre Hermans, PhD, Principal Scientist, Analytical Science, Merck & Co., Inc., West Point, PA

Elizabeth Hewitt, MS, Conference Chair, Director, Takeda Pharmaceuticals International Co., Cambridge, MA 

Wenlei Jiang, PhD,  Senior Science Advisor, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Susan Lerke, PhD, Associate Director, Analytical Development, Johnson & Johnson, Malvern, PA

Lauren Levac, MS, Senior Scientist, Microbiology Department, PPD, Middleton, WI

Hanlin Li, PhD, Associate Director, Analytical Development, Vertex Pharmaceuticals Inc., Boston, MA

Angela Liu, PhD, Senior Principal Scientist, Pfizer, Groton, CT

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

Laura O'Brien, PhD, Distinguished Research Fellow, Global CMC Experts Group, Quality & Records Managment, Boehringer Ingelheim Pharmaceuticals, Inc.

Ashok Patel, Manager I, Analytical R&D, Perrigo, Consumer Healthcare, Allegan, MI

Hasmukh Patel, PhD, Director, Division of Post-Marketing Activities I, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, MD  

Lakshmi Raghavan, MS, PhD, Founder & President, Solaris, Bridgewater, NJ        

Asha Rajapakshe, PhD, Associate Principal Scientist, Analytical Development and Commercialization-Pharmaceutical, Merck & Co., Inc., West Point, PA

Andre Raw, PhD, Acting Senior Scientific and Policy Advisor, Office of Pharmaceutical Quality/Office of Lifecycle Drug Products, US Food and Drug Administration, Silver Spring, MD

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

Wayland Rushing, PhD, Director, Scientific Affairs, EAG Laboratories, Columbia, MO

James M. Schmidt, Senior Scientific Advisor, EAG Laboratories, Columbia MO

Paul Schwartz, PhD, Director, Division of Post-Marketing Activities II, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, MD

Mark Schweitzer, PhD, Global Head, Analytical Science and Technology, Novartis, Green Oaks, IL

Pamela Sheaff, MS, PMP, Senior Research Scientist, Physical and Chemical Charactarization, PPD, Middleton, WI

Weixian Shi, PhD, Principle Scientist, Drug Product Science and Technolog, Bristol-Myers Squibb, New Brunswick, NJ

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

Dan Tang, BS, Senior Research Scientist, Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ

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

Harley Wilcox, Senior Scientific Advisor, EAG Laboratories, Columbia, MO

Peter Wunderli, PhD, Associate Director, Biopharmaceuticals,  PPD, Middleton, WI

Jayne Zimmerman, Scientific Director, NCE analytical R&D, Drug Product Development, AbbVie Inc., North Chicago, IL

Planning Committee

Elizabeth Hewitt, MS; Takeda Pharmaceuticals, Cambridge, MA, Conference Chair
Ivelisse Colón-Rivera, PhD, Vertex Pharmaceuticals, Boston, MA, Immediate Past Conference Chair
Asha Rajapakshe, PhD, Merck & Co., Inc., West Point, PA, Chair for 2019
James E. De Muth, PhD, University of Wisconsin, Madison, WI, Conference Coordinator
Erik C. Burns, EdD, 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 Murphy, MBA, Meda Pharmaceuticals, Decatur, IL
Laura C. Pogue, PhD Food & Drug Administration, St. Louis, MO
George Reid, PhD, Cardinal Health Regulatory Sciences, Overland Park, KS
Stefanie Rentfrow, Perrigo, Allegan, MI
Tim Rhines, PhD, PharMEDium Serivces, Lake Forest, IL
Jason Rodriguez, PhD, FDA Division of Pharmaceutical Analysis, St. Louis, MO
Jasmine Rowe, PhD, Bristol-Myers Squibb, Princeton, NJ
Madhavi Srikoti, MS, Bristol-Myers Squibb Company, New Brunswick, NJ
Nathan Whitford, MBA, Eurofins Lancaster Laboratories, Inc., Portage, MI
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.

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

Fluno Center
(conference location)
601 University Ave
Madison, WI  53715
608.441.7148   877.773.5866
Price $143.00
Release Date: July 6, 2018
Booking link

Hampton Inn
(5 blocks away)
440 West Johnson St
Madison, WI  53703
608.255.0360
$169.00
Group Name: Land O' Lakes Conference August   Group Code: LLA
Release Date: July 6, 2018
Booking link

DoubleTree by Hilton

(4 blocks away)
 525 West Johnson St
Madison, WI  53703
608.251.5511
$159.00
Group ID: 314900   Group Code: PMA
Release Date: July 6, 2018
Booking link

Sponsors



EAG laboratories logo

Eurofins Lancaster Laboratories logo

 

Metric Contract Services Logo

 

AvistaPharma

PPD logo

usp

 

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