University of Wisconsin–Madison

Annual Bioanalytical Conference (July Land O’ Lakes)

Innovation in Bioanalytical Research for Translational Medicine: New Modalities, New Technologies, and Evolving Regulations

Land O' Lakes Pharmaceutical Bioanalytical Conference

The Land O’Lakes Conference Series recognized worldwide as one of the premier teaching conferences for pharmaceutical scientists. The Annual Bioanalytical Conference is a three-day conference to discuss issues, innovations, and applications associated with the analysis of xenobiotics, metabolites, biologics an, biomarkers in biological matrices. This conference is designed to facilitate an open exchange of scientific and methodological applications for bioanalysis and provides a forum for interaction with regulators from multiple agencies. The program is an interactive mixture of lectures, panel discussions and a poster session.

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: Jul 15, 2019
Course date:Jul 15, 2019 - Jul 18, 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 1, 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 1, 2019. No refunds will be provided after that date.

 

Course Objectives

Overall Goal: The 20th Annual Bioanalytical Conference provides an educational forum to discuss issues and applications related to the analysis of overall approaches associated with New Modalities, New Platforms, Gene Therapy, Multiomics and the associated regulatory concerns that come from this growing area of research and application.

Conference objectives:

  1. Gain insight into problems and issues encountered during the drug discovery process and the interface between drug discovery and development
  2. Discuss current global regulatory issues affecting bioanalysis
  3. Identify processes for improving the identification and quantification of successful drug candidates and their measurement, including in vitro/in vivo implications
  4. Discuss analytical issues relating to drug metabolism and pharmacokinetics and their applicability in drug development activity
  5. Provide a better understanding of the bioanalysis of Gene Therapy development, digital PCR, Nab/companion Diagnostics, Vectors and branched DNA
  6. Discuss issues associated with information management, data handling and automation in bioanalytical laboratories
  7. Gain insight into various perspectives on the drug development process, including industry, academia and regulatory agencies
  8. Evaluate the harmonization of methods validation, quality control and set standards for drug metabolite identification in studies involving bioanalysis
  9. Provide a platform for learning, networking, and exchanging ideas and solutions on bioanalysis of small and large molecule

Poster Session:

The Planning Committee for the 20th Annual Land O’Lakes Bioanalytical Conference invites interested parties to submit research poster abstracts for the 2019 Conference Poster Session on Wednesday, July 17, at the Fluno Center, Madison, Wisconsin.

All abstracts must be submitted via email to the University of Wisconsin by Monday, May 20, 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 June 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 registration deadline of July 1  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 June 17, 2019.

Call for Posters 2019 Bioanalytical Conference

Poster Abstracts 2018 Bioanalytical Conference

Course Outline

Monday, July 15, 2019
1:00 pm - 4:30 pm

Optional Pre-Conference Short Course:

Gene Therapy Fundamentals
Speaker: Krishanu Shaha, PhD, Assistant Professor, Biomedical Engineering, University of Wisconsin-Madison

5:00 pm Registration for Conference
5:00 pm

Opening Reception

Sponsored by: Citoxlab

6:00 PM

Opening Dinner

Welcome: Erik Burns, MBA, EdD, Conference Program Director, Director, Corporate Engagement, AAPS
Associate Professor, University of Wisconsin, School of Pharmacy, Division of Pharmacy Professional Development

Sponsored by: TBA

6:30 pm

Evening presentation: "CRISPRi in Bacterial Pathogens: Fighting Antibiotic Resistance with Broken Scissors"

Speaker: Jason M Peters, PhD, Assistant Professor, Pharmaceutical Science Division, University of Wisconsin School of Pharmacy, Madison WI

Tuesday, July 16, 2019
7:30 am Continental Breakfast
 

First Plenary Session: Gene Therapy

Moderator: Lakshmi Amaravadi, PhD, Global Head, Bioanalytical & Biomarker Development

8:15 am

Welcome and Conference Overview

Erik Burns, EdD, MBA, MA, Conference Program Director

8:30 am

Regulatory for Gene Therapy

Speaker: Patrick Bennett, MS, Executive Director, Biomarker Lab, PPD

9:15 am

Overview Discussion of Vectors

Speaker: Glen Banks, PhD, Bristol-Myers Squibb

9:45 am

Bioanalysis of Nanoparticles

Speaker: Qin C. Ji, PhD, Bristol-Myers Squibb

10:30 am Networking Break
10:45 am

Branched DNA-Gene Therapy

Speaker: TBA

11:15 am

Implement qRT-PCR Methods to Support PK/TK, Drug Mechanism of Action, and PD (mRNA knockdown) to Advance RNAi Therapeutic Development 

Speaker: Elena Castellanos-Rizaldos, PhD, Senior Scientist,  Alnylam Pharmaceuticals

11:45 am

Nab-Companion Diagnostics

Speaker: Joe Bauer

noon Panel Discussion
12:30 pm Lunch/Networking
 

Second Plenary Session: Patient Centric Bioanalysis

Moderator: Mark Arnold, PhD, Director, Site Lead, Covance Clinical Labs

1:30 pm

Digital Health: Data Capture Component, At Home Data Collections

Speaker: Lisa Shipley, PhD, Vice President, Digital and Analytics Technology, Merck

2:00 pm

Realizing Patient-centric Blood Sampling with Tasso-Connect

Speaker: Erwin Berthier, PhD, CTO Tasso, Inc., Affiliate Professor of Chemistry, University of Washington

2:30 pm

Successful Implementation of Patient-Centric Self-Sampling Technologies; Observations, Consideration and Pitfalls

Speaker: Russ Grant, PhD, Strategic Director and National Director of Mass Spectrometry, LabCorp

3:00 pm Networking Break
3:20 pm

Regulatory Perspective on Patient-Centric Concerns

Speaker: Brian Booth, PhD, Deputy Director of the Division of Clinical Pharmacology V, Office of Clinical Pharmacology, CDER, FDA

3:40 pm

Microsampling Technologies; Current Perspectives from Industry and Regulators

Speaker: Enaksha Wickremshinhe, PhD, Research Advisor, Eli Lily and Co.

4:00 pm

Tech Showdown #1

4:25 pm

Tech Showdown #2

4:50 pm

Tech Showdown #3

5:30 pm

Evening Reception

Sponsors: TBA

8:00 pm Evening free to explore Madison
Wednesday, July 17, 2019
7:30 am Continental Breakfast
8:15 am Announcements
 

Third Plenary Session: Size Matters: Multiomics Miniaturization

Moderator: Melanie Anderson, Merck Research Laboratories

8:30 am

Integrating Pharmacoproteomics into Drug Development

Speaker: Jiang Wu, PhD, Director, Bioanalytical and Biomarker Development, Takeda

9:00 am

Laser Microdissection with Nanodroplet Sample Processing for Single Cell Proteomics

Speaker: Ryan Kelley, PhD, Associate Professor, Department of Chemistry and Biochemistry, Brigham Young University

9:20 am

LC/MS-based Bioanalysis in Biopharmaceutical R&D: Microsampling, Automation, Micro and Nano Flow Chromatography, and Integrated Data Analytics

Speaker: Dan Spellman, PhD, Director, Discovery Bioanalytics, Merck Research Laboratories

10:00 am

Networking Break

10:30 am

Ion Mobililty Proteomics

Speaker: Catherine E. Costello, PhD, Director, Center for Biomedical Mass Spectrometry, Boston University School of Medicine

11:15 am

Neogenomics - An Integrated Approach of Immuno-phenotyping Rare Ovarian Granulosa Cell Tumor FFPE Samples by MultiOmyx™ Multiplexed Protien Assay and Nanostring PanCancer Gene Expression Profiling Assay

Speaker: Anna Juncker-Jensen, PhD, Scientific Liaison NeoGenomics Laboratories

12:00 pm

Companion Diagnostics-Complimentary Diagnostics

Speaker: TBA

12:30 pm Lunch/Networking
 

Afternoon Session: New Technology

Moderator: Chad Briscoe, PhD, PRA Health Sciences

1:30 pm

Tech Showdown #4 - 2018 Conference Winner

Speaker: John Sausen, Agilent

1:55 pm

Tech Showdown #5

Speaker: TBA

2:20 pm

CyTOF - High Density Flow Cytometry

Speaker: TBA

3:00 pm Networking Break
3:30 pm

Scheduled Afternoon activities

6:00 pm

Exhibits, Poster Session and Reception

Sponsor: TBA

Exhibitors: TBA

8:00 pm Evening free to explore Madison
Thursday, July 18, 2019
7:30 am Continental Breakfast
8:15 am

Announcements
2019 Tech Showndown winner and 2019 Poster awards

Erik Burns

 

Fourth Plenary Session: Ask a Regulator

Moderator: Eric Fluhler, PhD, Glenmark Pharmaceuticals

8:30 am

ICH10 Meeting Summary Meeting of EBF

Speaker: Mark Arnold, Covance

9:15 am

Ask a Regulator about New ICH10 Guidance

Speaker: TBA

10:00 am Networking Break
10:30 am

Panel Discussion

Speakers: Mark Arnold and Brian Booth

11:15 am Closing remarks
2019 Bioanalytical Conference Chair: Melanie Anderson, MS, Merck

11:45 am Conference Adjournment

Instructors

Glen Banks, PhD, Bristol-Myers Squibb Co., Pennington, NJ

Patrick Bennett, MS, Executive Director, Biomarker Lab, PPD, Richmond, VA

Erwin Berthier, PhD, CTO Tasso, Inc., Affiliate Professor of Chemistry, University of Washington, Seattle, WA

Brian Booth, PhD, Deputy Director of the Division of Clinical Pharmacology V, Office of Clinical Pharmacology, CDER, FDA, Silver Spring, MD

Elena Castellanos-Rizaldos, PhD, Senior Scientist,  Alnylam Pharmaceuticals, Cambridge, MA

Catherine E. Costello, PhD, Director, Center for Biomedical Mass Spectrometry, Boston University School of Medicine, Boston, MA

Russ Grant, PhD, Strategic Director and National Director of Mass Spectrometry, LabCorp

Ryan Kelley, PhD, Associate Professor, Department of Chemistry and Biochemistry, Brigham Young University, Provo, UT

Qin C. Ji, PhD, Bristol-Myers Squibb, Richmond, VA

Anna Juncker-Jensen, PhD, Scientific Liaison NeoGenomics Laboratories, Orange, CA

Krishanu Shaha, PhD, Assistant Professor, Biomedical Engineering, University of Wisconsin-Madison, Madison, WI

Lisa Shipley, PhD, Vice President, Digital and Analytics Technology, Merck, Philadelphia, PA

Dan Spellman, PhD, Director, Discovery Bioanalytics, Merck Research Laboratories

Enaksha Wickremshinhe, PhD, Research Advisor, Eli Lily and Co., Indianapolis, IN

Jiang Wu, PhD, Director, Bioanalytical and Biomarker Development, Takeda, Cambridge, MA

Planning Committee

Link to comments from the 2018 Planning Committee

2019 Planning Committee:

Erik Burns, MBA, EdD, University of Wisconsin, Madison, WI, Conference Director
Melanie Anderson, Merck Research Laboratories, West Point, PA, Conference Chair
Lakshmi Amaravadi, PhD, Shire, Boston, MA
Mark Arnold, PhD, Covance Clinical Labs, Trenton, NJ
Patrick Bennett, Executive Director, Biomarker Lab, PPD
Chad Briscoe, PhD, PRA Health Sciences, Lenexa, KS
Raj Dhodda, PhD, AbbVie, North Chicago, IL
Eric N. Fluhler, PhD, Glenmark Pharmaceuticals, Mahwah, NJ
Stacy Ho, PhD, Sanofi, Waltham, MA
Qin C. Ji, PhD, Bristol-Myers Squibb Company, Princeton, NJ
Leo Kirkovsky, PhD, Pfizer Worldwide Clinical Assay Group, La Jolla, CA
Jeff Moran, inVentiv Health, Lincoln, NE
Stephanie Pasas-Farmer, PhD, Bio Data Solutions, Inc., Eagleview, PA,
John Stubbs, PhD, Stubbs and Hensel Pharma Consulting, LLC, Blue Bell, PA
Sriram Subramaniam, Food and Drug Administration, Silver Springs, MD
Meredith Voelkel, AAPS

Accommodations

Hotel accommodations are the responsibility of the registrant.

Fluno Center
(conference location)
601 University Ave
Madison, WI  53715
608.441.7148
Rate: $143.00
Booking link
Room block held until June 16

Hampton Inn & Suites Madison/Downtown
(5 blocks away)
440 West Johnson Street
Madison, WI  53703
608.255.0360
Rate: $169.00
Group Name: Bioanalytical Conference  Group Code: BIA
Room block held until June 15
Booking link

DoubleTree by Hilton
(4 blocks away)
525 West Johnson Street
Madison, WI  53703
608.251.5511
Rate: $179.00
Room block held until June 3
Booking link

Graduate Hotel
(3 blocks away)
601 Langdon Street
Madison, WI  53703
608.257.4391
Rate: $189.00
Room block held until June 14
Booking link

The Lowell Center
(3 blocks away)
610 Langdon Street
Madison, WI  53703
Rate: $115.00
Group code: LANDBIO
Rooms held until June 15
608.256.2621
Booking link

Sponsors

Citoxlab logo

Program Coordinator

Erik Burns, MBA, EdD

Director of Corporate Engagement
American Association of Pharmaceutical Scientists
(703) 248-4738 direct
(612) 695-2601 cell
BurnsE@aaps.org