University of Wisconsin–Madison

Meet the 2018 July Land O’ Lakes Speakers

The Land O’ Lakes Conference series is well known for being the premier teaching conference for pharmaceutical scientists. The conference topic for the 19th Annual Bioanalytical Conference is “Emerging Therapeutic Paradigms: Supporting the Next Generation of Biomarker and Bioanalytical Research and Understanding the Shifting Regulatory Landscape.” Meet the 2018 July Land O’ Lakes Speakers and their topics. Here is a small sampling of what you can expect at this highly acclaimed conference.

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Navigating Bioanalytical Assay Requirements and Issues in Support of Biosimilar Development

(Optional Short Course)

Portrait of Dominique Gouty

I am looking forward to participating as a presenter at this year’s Land O’Lakes Conference. Join me on July 9th at 1:00 PM for a presentation on biosimilar development the best bioanalytical approaches for evaluating differences between an original compound and biosimilar. An increasing number of patents for originator biologic products are due to expire, creating more industry opportunity in the area of biosimilars, and it is therefore important that we all align on best practices for their development. I’m looking forward to seeing everyone at the event.

Dominique Gouty
Senior VP of Business Operations

Mass Spec Analysis of siRNA and Metabolites to Support Alnylam Investigational RNAi Therapeutic Development

I have worked on the LC/MS bioanalysis of siRNA to support siRNA based drug development from pre-clinical and clinical stages in the past 9 years. I will be talking about the mass spec analysis of siRNA and metabolites to support Alnylam investigational RNAi therapeutic development at the “July 2018 Land O Lakes Conference on July 9th”. I am really excited to be presenting this topic because LC/MS analysis of siRNA and metabolites is very new and challenging. It is a great opportunity for siRNA analysis discussion and learning. I look forward to seeing you there.

Ju Liu
Principal Scientist
Bioanalysis Science Group

Portrait of Ju Liu


Portrait of Wei Song

I have been working on every stage of bioanalytical support of nanoparticle drug quantitation for the last 5 years in Pfizer’s first nanoparticle project! I will be talking about challenges in developing a robust quantitative assay to determine concentrations of released nanoparticle drug in biological matrix at the 2018 Land O’Lakes Bioanalytical Conference in July. I am excited to present this topic because nanoparticle drugs continues to play an important role in oncology drug delivery and the bioanalysis of nanoparticles provides a great opportunity for learning and discussion among bioanalytical scientists. I look forward to seeing you in Madison, WI in early July.

Wei Song
Scientist – Medicine Design
Pfizer Inc. 

Towards Global Harmonization of Bioanalytical Method Validation – ICH M10

ICH took up Bioanalytical Method Validation for harmonization in June 2016. This was timely and welcomed by the bioanalytical community. Members of the AAPS, European Bioanalysis Forum (EBF) and Japan Bioanalysis Forum (JBF), organized two workshops, “the sister workshops,” as a venue for bioanalytical scientists to discuss and achieve industry consensus in areas where harmonization is most desired. As one of the organizing members for the sister workshops, I will share the readout and discuss some of the challenges we face in our goal for harmonization.

Faye Vazvaei
Sr. Principal Scientist
Pharmaceutical Research and Early Development
Pharmaceutical Sciences/DMPK & Bioanalytical R&D
Roche Innovation Center

Portrait of Faye Vazvaei

Strategies for Successful Development, Validation and Transfer of Flow Cytometric Methods

Portrait of Virginia Litwin

Building measurement assurance in flow cytometry requires proper controls and standards, e.g. particles for instrument calibration, performance characterization, and standardization, biological cell reference materials, and validated measurement procedures. In the past few years, significant progress has been made in all three areas due to the efforts of NIST, FDA, AAPS, ISAC and ICCS An update on progress and on-going efforts will be presented.

Virginia Litwin
Vice President, Immunology
Caprion Biosciences

Procedure to Tactical Execution

I have been involved with PK assay development for large and small molecules for over 15 years in the pharmaceutical industry. At the June 2018 Land of Lakes Conference on July 11th, I’m excited to discuss the challenges in developing and utilizing  robust , reliable assays to support regulated bioanalytical work for ever more complicated drug candidates. I will show several case studies to illustrate the importance of tactical execution. Sponsors, clinics, and CROs need precise workflows and good communication channels to ensure sample quality during collection, enable successful assay transfer across laboratories, and manage shifting technology, business, and regulatory landscapes
Melanie Anderson
Principal Scientist
Merck Research Labs
Portrait of Melanie Anderson


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