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Land O’ Lakes 23rd Annual Bioanalytical Conference

14 Presentations 0 Sections



The Annual Land O’ Lakes Bioanalytical Conference discusses innovations, challenges, and applications associated with the analysis of xenobiotics, metabolites, biologics, and biomarkers in biological matrices.

This year, the conference explores the extension of foundational principles to accommodate new technologies, modalities, and ways of working that support innovative modalities and programs. Attendees will discuss challenges and solutions related to the analysis of new therapeutic modalities (gene and cell therapy, multi-domain therapeutics, nucleic acids, encapsulated products, etc.); technology platforms; sample collection techniques; and the associated regulatory aspects that come from novel research applications.

Conference Objectives:

  • Share best practices and case studies for designing a successful bioanalytical plan with limited precedent
  • Discuss strategies for overcoming assay challenges and engaging scientists from multiple disciplines in troubleshooting
  • Share examples and suggestions for how to design appropriate validation experiments in the absence of formal guidance through case studies
  • Highlight new considerations for assay life cycle management

Programming Committee
Stephanie Cape, Ph.D., Labcorp Drug Development (Chair)
Vibha Jawa, Ph.D., Bristol-Myers Squibb Company, (Vice Chair)
Chad Briscoe, Ph.D. BioAgilytix (Past Chair)
Sanjeev Bhardwaj, Ph.D., Janssen/Johnson & Johnson
Eric Buxton, Ph.D., University of Wisconsin-Madison
Todd Lester, B.S. Biological Sciences, BioAgilytix
Sriram Subramaniam, Ph.D. U.S. Food and Drug Administration (FDA)
Martin Ullmann, Ph.D., Fresenius-Kabi
Catherine Vrentas, Ph.D., Pharmaceutical Product Development (PPD)
Christine Weisshaar, MS, Spark Therapeutics

This content is FREE to AAPS Members.
Click here to become an AAPS member and have unlimited access to this and other AAPS programming.

$1,695.00
Non-Member
$1,695.00
Items Included in the Purchase of this Event

Morning Plenary: Bioanalytical Planning - Applying Foundational Principles to Non-Standard Cases - PART 1

Presentation: Stephanie Cape, Ph.D., Boris Gorovitz, Ph.D., Cynthia Inzano, Ph.D., Vibha Jawa, Ph.D., William Quinn, Ph.D., 110 min 9 sec

Morning Plenary: Bioanalytical Planning - Applying Foundational Principles to Non-Standard Cases - PART 2

Presentation: Stephanie Cape, Ph.D., Diaa Shakleya, Ph.D., Christine Weisshar, Ph.D., 43 min 13 sec

Afternoon Plenary: Bioanalytical Planning - Applying Foundational Principles to Non-standard Cases, Continued

Presentation: Dan Dreyer, Leo Kirkovsky, Ph.D., Carla Mejia, Christine Weisshar, Ph.D., 75 min 41 sec

Rapid Fire Session 1

Presentation: Sebastian Guelman, Reid Kuen, Shane Needham, Ph.D., 50 min 32 sec
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Chalk Talk: Utilization of HRMS for Assay Development for Oligonucleotide Drugs - Sponsored by SCIEX

Presentation: Shane Karnik, 29 min 28 sec
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Chalk Talk: Cellular Immunogenicity for Cell and Gene Therapies: Bioanalytical Strategies - Sponsored by BioAgilytix

Presentation: Lynn Kamen, Ph.D., 35 min 55 sec

Morning Plenary: Immunogenicity - PART 1

Presentation: Todd Lester, Sofie Pattijn, MS., Kelli Phillips, Brian Roberts, Ph.D., 89 min 3 sec

Morning Plenary: Immunogenicity - PART 2

Presentation: Amy Lavelle, Ph.D., Amy Rosenberg, MD, 69 min 1 sec

Afternoon Plenary: Supply Chain Management and Reagent Consistency

Presentation: Marina Ichetovkin, Elizabeth Groeber, Patrick Lynch, Ph.D., Martin Ullmann, Ph.D., 94 min 46 sec

Rapid Fire Session 2

Presentation: Clark Fjeld, MS, Ph.D., Ching-Ha Lai, Ph.D., Hiren Patel, Ph.D., Cathy Vrentas, Ph.D., An Zhao, 60 min 53 sec
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Chalk Talk: Considerations Regarding Transfers of Validated Methods Between Sites and Organizations - Sponsored by Labcorp Drug Development

Presentation: Mark O'Dell, 17 min 54 sec

Morning Plenary: Data Application and Regulatory - PART 1

Presentation: Mark Arnold, PhD, Vibha Jawa, Ph.D., Steve Piccoli, Ph.D., 53 min 2 sec

Morning Plenary: Data Application and Regulatory - PART 2

Presentation: Andrew Byrnes, Ph.D., Sean Kassim, Ph.D., 46 min 50 sec

Morning Plenary: Data Application and Regulatory - PANEL DISCUSSION

Presentation: Mark Arnold, PhD, Andrew Byrnes, Ph.D., Sean Kassim, Ph.D., Steve Piccoli, Ph.D., 98 min 59 sec
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