University of Wisconsin–Madison

Annual Bioanalytical Conference (July Land O’ Lakes)

Emerging Therapeutic Paradigms: Supporting the Next Generation of Biomarker and Bioanalytical Research and Understanding the Shifting Regulatory Landscape

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

Land O' Lakes Pharmaceutical Bioanalytical Conference

The Land O’Lakes Conferences are recognized worldwide as one of the premier teaching conferences for pharmaceutical scientists. The July Land O’Lakes Bioanalytical Conference is a three-day conference is to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program is a mixture of lectures, interactive discussions and a poster session.

Second Annual July 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: Jul 11, 2018
Course date:Jul 9, 2018 - Jul 12, 2018
Location:

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

Course fee:

$1075
$1375 after 6/25/2018
$850 Government and Academic Rate

$175 Optional Short Course

Registration fee includes the opening dinner and all receptions.

Course Objectives

Overall Goal:

The 19th Annual Bioanalytical Conference provides an educational forum to discuss issues and applications related to the analysis of overall approaches associated with Biomarker validation, stability and the associated regulatory concerns that come from this growing area of research and application.

Conference objectives:

  1. To provide a better understanding of the bioanalysis of biologic therapeutics, small molecule xenobiotics, biomarkers and immunogenicity in biological matrices and cutting edge techniques for bioanalysis of leading drug therapies such as CAR T-Cell Therapy;
  2. To gain insight into problems and issues encountered during the drug discovery process and the interface between drug discovery and development;
  3. To discuss current global regulatory issues affecting bioanalysis;
  4. To identify processes for improving the identification and quantification of successful drug candidates and their measurement, including in vitro/in vivo implications;
  5. To discuss analytical issues relating to drug metabolism and pharmacokinetics and their applicability in drug development activity;
  6. To discuss issues associated with information management, data handling and automation in bioanalytical laboratories;
  7. To gain insight into various perspectives on the drug development process, including industry, academia and regulatory agencies;
  8. To evaluate the harmonization of methods validation, quality control and set standards for drug metabolite identification in studies involving bioanalysis; and
  9. To 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 19th Annual Land O’Lakes Bioanalytical Conference invites interested parties to submit research poster abstracts for the 2018 Conference Poster Session on Wednesday, July 11, at the Fluno Center, Madison, Wisconsin.

All abstracts must be submitted via email to the University of Wisconsin by Friday, May 8, 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 June 24.  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  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 11, 2018.

Call for Posters July 2018

Previous Poster Abstracts-2017

Course Outline

Monday, July 9, 2018
1:00 pm - 4:30 pm

Optional Short Course:

Navigating Bioanalytical Assay Requirements and Issues In Support of Biosimilar Development

(see below for additional information)

1:00:  Introduction Biosimilar development and how to approach Bioanalytics (differences between original compound vs biosimilar)
Speakers: Eric Fluhler, PhD, Glenmark Pharmaceuticals and
Dominque Gouty, PhD, BioAgilytix

1:15: PK Assays for Biosimilars
Speaker: Ron Bowsher, Phd, B2S Life Sciences

1:45: Immunogenicity Assays for Biosimilar Programs
Speaker: TBA

2:15 Break

2:30: Nab Assay Development and Implementation for Biosimilar Programs
Speaker: Dominque Gouty, PhD

3:00: Regulatory Expectations around the World
Speaker: TBA

4:00: Learning from Past Failures and Success: Case Studies
Speaker: Bruce Stouffer, Executive Director Immunochemistry, PPD

5:00 pm Registration for Conference
5:00 pm

Opening Reception

Sponsor: citoxlab

6:00 PM

Opening Dinner

Sponsorship available

6:30 pm

Opening Remarks and Evening Presentation:
Erik Burns, MBA, EdD

Invited Speaker: Laura Sepp-Lorenzino, PhD, Vice President, Head Nucleic Acid Therapies, Vertex Pharmaceuticals 

Title: Emerging Modalities of Gene Therapies

Tuesday, July 10, 2018
7:30 am Continental Breakfast
8:00 am Welcome and Conference Overview
Eric C. Buxton, PhD, DPPD Division Chair
 

Plenary Session 1: Biomarkers in Drug Development (BM FOCUS)
Moderator: Lakshmi Amaravadi, PhD, Global Head, Bioanalytical & Biomarker Development, Shire

8:15 am

Overview of Biomarker and Bioanalytical Strategy: Development and Implementation of Biomarker Strategy During Drug Development from R to D and Post Marketing
Speaker: Anahita Bhathena, PhD, Head, Translational Oncology, AbbVie

9:00 am FDA/C-Path Initiative on Biomarker Qualification: The Process & Recommendations
Speaker: Chris Leptak, PhD, US Food and Drug Administration
9:30 am BM Qualification with the FDA/C-Path Initiative
Speaker: Steve Piccoli, PhD, CEO and Founder at Neoteric Consulting
10:00 am Networking Break
10:15 am PD Biomarkers: Bioanalytical Strategies for Early Development and Case Studies
Speaker: Mark Arnold, PhD, Director, Site Lead, Covance
10:45 am

Pharmacodynamics Biomarker Assays in Early Drug Development: Opportunities and Challenges
Speaker: Yan Zhang, PhD, Director, Bristol-Myers Squibb

11:15 am

Panel Discussion

Speakers: Mark Arnold, PhD, Anahita Bhathena, PhD, Chris Leptak, PhD, Steve Piccoli, PhD, Yan Zhang, PhD,Brian Furmanski, PhD, John Kadavil, PhD, Kara Scheibner

12:30 pm Lunch
 

Plenary Session 2: Emerging Modalities: From Gene Therapy to Nanoparticles
Moderator: Stephanie Pasas-Farmer, PhD, President, BioData Solutions

1:30 pm

Metabolite Profiling and Bioanalysis of siRNA by High Resolution Mass Spectrometry
Speaker: Ju Liu, PhD, Principal Scientist, Alnylam

2:00 pm

CAR-T Cell Characterization in Clinical Trials by Flow Cytometry: Hurdles and Successes
Speaker: Shyam Sarikonda, PhD, Associate Director, Flow Cytometry, Navigate Biopharma Services-A Novartis Subsidiary

2:30 pm

Nanoparticles
Speaker: Wei Song, Medicine Design, Pfizer Worldwide Research & Development

3:00 pm

Topic: Ultrasensitive Detection of Proteomic and Genomic Biomarkers using SIMOA (Single Molecule Array)
Speaker:
Dan Sikkema, PhD, Vice President, Quanterix

3:30 pm

Networking break

3:50 pm

Tech Showdown #1: An Efficient, Automated, Hybrid Immunoaffinity LC-MS/MS Workflow for the Preclinical analysis of monoclonal antibody drugs
Speaker: Mike Rosenblatt, PhD, Group Leader Mass Spec, Promega Corp.

4:40pm

Panel Discussion

Speakers: Ju Liu, PhD, Shyam Sarikonda, PhD, Wei Song, Brian Furmanski, PhD, US Food and Drug Administration, John Kadavil, PhD, US Food and Drug Administration, Kara Scheibner, US Food and Drug Administration

5:45 pm

Reception

Sponsorship available

7:30 pm Evening free to explore Madison
Wednesday, July 11, 2018
7:30 am Continental Breakfast
  Plenary Session 3: Emerging Bioanalytical Challenges, Solutions and Harmonization of BA Guidance
Moderator: Eric Fluhler, PhD, Glenmark Pharmaceuticals
8:00 am

Announcements

8:15 am Towards Global Harmonization of Bioanalytical Method Validation - ICH M10
Speaker: Faye Vazvaei, MS, Senior Principal Scientist, DMPK and Bioanalytical R&D, Roche
9:00 am

Immunogenicity and Cut-Point Analysis
Speaker: Ron Bowsher, PhD, Partner & CSO, B2S Life Sciences

9:45 am What is the Deal with ADA and Target Interference in PK Assays?
Speaker: Michael Partridge, PhD, Senior Staff Scientist-Assay Development, Regeneron Pharmaceuticals
10:15 am

Networking Break

10:30 am

Panel Discussion

Speakers: Ron Bowsher, PhD, Michael Partridge, PhD, Faye Vazvaei, MA, Brian Furmanski, PhD, US Food and Drug Administration, John Kadavil, PhD, US Food and Drug Administration, Kara Scheibner, US Food and Drug Administration

 

Tech Talks: Paths to Success in Bioanalysis
Moderators:
Stacy Ho, PhD, Sanofi-Genzym
Melanie Anderson, PhD, Merck Research Labs

11:00 am Strategies for Successful Development, Validation and Transfer of Flow Cytometric Methods
Speaker: Virginia Litwin, PhD, Caprion Biosciences, Inc.
11:20 am Procedure to Tactical Execution
Speaker: Melanie Anderson, PhD, Merck Research Labs
11:40 am High-Level Overview of what is needed for IND and NDA filing from a Regulatory Perspective
Speaker: R. John Stubbs, PhD, Stubbs and Hensel Pharma Consulting, LLC
12:00 am LCMSMS Meets Ligand Binding: Reagent Characterization and Management to Ensure Consistency Throughout the Life of a Ligand Binding Assay
Speaker: Matt Sciscione, Research Scientist, Syneos Health
12:30 pm Lunch and Poster Reception
1:30 pm

Afternoon Social Activities
TBA

3:00 pm

Solution Seminar

This workshop will seek to explore collaborative solutions through in-depth discussion and working groups and moderators with subject matter expertise.

Working Topics Will Include:

  • LC-MS/MS and LBA – How to present data from both platforms to the agency in a NDA or BLA application
  • When there is no true PK?  Implication for the importance of biomarker analysis (PD) and the regulatory requirements for these assays.
  • Emerging modalities of gene therapies

Workshop will be led by:
Leo Kirkovsky, PhD, Director, Clinical Assay Group (CAG), Pfizer
Moderators:
Laura Sepp-Lorenzino, PhD, Vice President, Head Nucleic Acid Therapies, Vertex Pharmaceuticals
Stephanie Pasas-Farmer, PhD, President and Principal, BioData Solutions, LLC
Jeff Moran, Senior Director, Early Phase Operations, Clinical Division, Syneos Health

6:00 pm

Dinner
Tech Showdown #2: Targeted Pathway-directed Analysis in Multi-omics Research
John Sausen, MBA,  Director of Strategic Initiatives-Mass Spectrometry, Agilent Technologies
Tech Showdown #3: Red String Theory: Navigating the Maze of BioAnalytical Data
Stephanie Pasas-Farmer, PhD, President and Principal, BioData Solutions, LLC

Thursday, July 12, 2018
7:30 am Continental Breakfast
 

Plenary Session 4: Integration of PK/PD Immunogenicity Data to Support Drug Development-Developing Novel Approaches
Moderators: John Stubbs, PhD, Stubbs and Hensel Pharma Consulting, LLC

8:00 am

Announcements

8:15 am

How does all the PK/ADA and Biomarker Data Come Together in Drug Devleopment and New Approaches
Speaker: Balaji Agoram, PhD, Forty-Seven, Clinical Pharmacology and DMPK, Forty Seven, Inc.

9:00 am

Emerging Approaches in Systems Pharmacology Modeling and Data Utilization from Modeling Perspective
Speaker: Karim Azer, PhD, Sr. Director and Systems Pharmacology U.S. Head, Interdisciplinary Pharmacometrics Program, Sanofi

9:45 am Networking Break
 

Plenary Session 5:
Ask a Regulator: Bring your questions for discussion on Guidances on "Method Development/Validation for Immunogenicity Testing", "Bioanalytical Method Validation" and "Note for Guidance on Toxicokinetics" and other related regulatory topics.
Moderators: Qin Ji, PhD, Bristol-Myers Squibb Company

10:15 am

Panel Discussion
Moderators:
Michael Day, PhD, Cardinal Health Regulatory Sciences
Brian Furmanski, PhD, US Food and Drug Administration
John Kadavil, PhD, US Food and Drug Administration
Kara Scheibner, US Food and Drug Administration

11:45 am Closing Remarks
2019 Chair Stephanie Pasas-Farmer, PhD
12:00 pm Conference Adjournment

 

Navigating Bioanalytical Assay Requirements and Issues In Support of Biosimilar Development

Pricing pressures continue to impact the pharmaceutical industry and this is clearly evidenced by the growing number of generic small molecule medicines available to patients.  Large molecule biopharmaceuticals have not been immune to these pressures, as governments have been encouraging the development of cheaper biosimilar products for years.  In concert, regulatory agencies have begun to develop guidance documents to establish the regulatory expectations for demonstrating the similarity of innovator and biosimilar products. To date, however, a detailed regulatory guidance on Bioanalytical Method Validation (BMV) for biosimilar compounds has not been released.  While existing final and draft guidance’s provide considerable detail on validation expectations for innovator PK and ADA assays, the validation of bioanalytical methods for biosimilar products introduces a number of unique challenges. 

In this course we will review these challenges and describe recommendations and best practices for BMV of biosimilars. For PK assays, issues such as whether to develop one single assay or two assays for the innovator and biosimilar will be addressed. How to demonstrate similarity in the assay(s) with respect to sensitivity and performance (precision and accuracy) will also be discussed.  For immunogenicity assays, best practices related to the selection of appropriate positive controls, comparison of assay cut points and drug tolerance will be reviewed.  The importance of appropriate decision making and defining appropriate assay characteristics will be exemplified through numerous case studies.

 

Instructors

Balaji Agoram, PhD, Forty-Seven, Clinical Pharmacology and DMPK, Forty Seven, Inc., San Francisco, CA

Melanie Anderson, PhD, Merck, Philadelphia, PA

Mark Arnold, PhD, Director, Site Lead, Covance, Trenton, NJ

Karim Azer, PhD, Sr. Director and Systems Pharmacology U.S. Head, Interdisciplinary Pharmacometrics Program, Sanofi, Bridgwater, NJ

Anahita Bhathena, PhD, Director, Translational Oncology, AbbVie, Chicago, IL

Ron Bowsher, PhD, Partner & CSO, B2S Life Sciences, Indianapolis, IN

Michael Day, PhD, Director, Chemistry, Manufacturing and Controls, Cardinal Health Regulatory Sciences, Kansas City, MO

Erik Fluhler, PhD, Glenmark Pharmaceuticals

Brian Furmanski, PhD, Senior Clinical Pharmacology Reviewer, US Food and Drug Administration, Silver Spring, MD

Dominque Gouty, PhD, Bioagilytix

Chris Leptak, PhD, US Food and Drug Administration, Silver Spring, MD

Virginia Litwin, PhD, Caprion Biosciences, Inc.

Ju Liu, PhD, Principal Scientist, Alnylam, Boston, MA

Michael Partridge, PhD,  Senior Staff Scientist - Assay Development, Regeneron Pharmaceuticals, Tarrytown, NY

Steve Piccoli, PhD, CEO and Founder at Neoteric Consulting

Mike Rosenblatt, PhD, Group Leader Mass Spec, Promega Corp., Madison, WI

Shyam Sarikonda, PhD, Associate Director, Flow Cytometry, Navigate Biopharma Services, a Novartis Subsidiary, San Diego, CA

John Sausen, MBA,  Director of Strategic Initiatives-Mass Spectrometry, Agilent Technologies, Milwaukee, WI

Kara Scheibner, US Food and Drug Administration, Silver Spring, MD

Matthew Sciscione, Research Scientist, Syneos Health, Philadelphia, PA

Laura Sepp-Lorenzino, PhD, Vice President, Head Nucleic Acid Therapies, Vertex Pharmaceuticals 

Dan Sikkema, PhD, Vice President, Quanterix, Lexington, MA

Bruce Stouffer, Executive Director Immunochemistry, PPD, Richmond, VA

Faye Vazvaei, MS, Senior Principal Scientist, DMPK and Bioanalytical R&D, Roche, New York, NY

Yan Zhang, PhD, Director, Bristol-Myers Squibb, Pennington, NJ

Planning Committee

2018 Planning Committee:

Lakshmi Amaravadi, PhD, Shire, Boston, MA, Conference Chair

Erik Burns, MBA, EdD, University of Wisconsin, Madison, WI, Conference Director

Melanie Anderson, Merck Research Laboratories, West Point, PA

Mark Arnold, PhD, Covance Clinical Labs, Trenton, NJ

Patrick Bennett, Executive Director, Biomarker Lab, PPD

Chad Briscoe, PhD, PRA Health Sciences, Lenexa, KS

Eric Buxton, PhD, University of Wisconsin, Madison, WI

Joy Davis, American Association of Pharmaceutical Scientists (AAPS), Arlington, VA

Raj Dhodda, PhD, AbbVie, North Chicago, IL

Stephanie Pasas-Farmer, PhD, Bio Data Solutions, Inc, Eagleview, PA, Co-Chair

Eric N. Fluhler, PhD, Glenmark Pharmaceuticals, Mahwah, NJ

Brian Furmanski, PhD, Center for Drug Research and Evaluation, FDA, Silver Spring MD

Randall H. Guthrie, Pyxant Labs, Inc. Colorado Springs, CO

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

Priya SriRaman, PhD, Celgene Corporation, Summit, NJ

John Stubbs, PhD, Stubbs and Hensel Pharma Consulting, LLC, Blue Bell, PA

Douglas J. Turk, PhD, McKinley Scientific, Erin, Ontario, Canada

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
Rate: $139.00
Event Title: UW School of Pharmacy - July Land O Lakes Conference
Booking link

Fluno Center
(conference location)
601 University Ave
Madison, WI  53715
608.441.7148
Price $143.00
Booking link

Hampton Inn & Suites Madison/Downtown
(5 blocks away)
440 West Johnson Street
Madison, WI  53703
608.255.0360
Rate: $169.00
Event Title:  Land O Lakes July Conference
Group Name: Land O'Lakes Conference July  Group Code: LLJ
Booking link

DoubleTree by Hilton
(4 blocks away)
525 West Johnson Street
Madison, WI  53703
608.251.5511
Rate: $149.00
Group ID: 314899  Group Code: BIO
Booking link

Sponsors

 

PPD logo

Promega logo

Program Coordinator

Erik Burns, MBA, EdD

Course Coordinator
Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 262-3130
erik.burns@wisc.edu