Presentations and Posters
Abstract Presentations:
Effect of Different Vendors and Lots of Bovine Serum Albumin Upon Immunoassays to Support Immunogenicity and Pharmacokinetics of Protein Biotherapeutics
Jurgensen C., Spears A., Olech R., Brilando L., Kalensky C. and Rock M.
2011 AAPS National Biotechnology Conference
May 16, 2011
San Francisco, CA
Symposium Presentations:
Enzyme Biotherapeutics: Analytical Methods Requiring a Different Approach
Marie Rock
2011 AAPS National Biotechnology Conference
May 16, 2011
San Francisco, CA
Case Study: Biotherapeutic Reference Standards and the Adaptation of Immunoassays to Non-Clinical Dose Formulation Studies, Symposium Session (171)
Marie Rock
2011 AAPS Annual Meeting
October 11, 2011
Washington, D.C.
How does the Non-clinical Dose Formulation Analysis (NCDFA) Acceptance Criteria for Biotherapeutics Differ from Small Molecules NCDFA?
Marie Rock
2011 AAPS Annual Meeting
October 27, 2011
Washington DC
Antibody Drug Conjugates: Don't You Just Love Them- A Selection of Case Studies
Marie Rock
2011 AAPS Annual Meeting
October 27, 2011
Washington DC
Perspectives on Ligand Binding Assays for Immunogenicity Assessment
Marie Rock
Immunogenicity Summit
November 16, 2011
Bethesda, MD
Training Presentations:
Pharmacodynamics of Monoclonal Antibody Biosimilars: Bioanalytical Considerations, Webinar on Biosimilar Drug Development - The Impact of Draft CHMP Guidelines
Marie Rock
February 21, 2011
Development of Ligand Binding Analytical Methods to Support Immunogenicity Testing: Theoretical to Practical Considerations, Two Day Training Course, American Association of Pharmaceutical Sciences
Marie Rock
2011 AAPS National Biotechnology Conference
May 14-15, 2011
San Francisco, CA
Analytical & Bioanalytical: What Is It We Really Need? Study Director Workshop
Michael Schlosser
Global Preclinical Training
June 13-15, 2011
Lake Tahoe, CA
Benefits and Risks of the Competitive Ligand Binding Assays for Evaluation of Neutralizing Antibody Activity
Marie Rock
Immunogenicity Summit
November 16, 2011
Bethesda, MD
Book Chapters
Schlosser MJ, Farabaugh CS. In Vivo Genetic Toxicology: Application to Cancer Risk Assessment. New Horizons in Predictive Toxicology, ed. Wilson, Royal Society of Chemistry, Cambridge, United Kingdom In press 2011
Development of Ligand Binding Analytical Methods to Support Immunogenicity Testing: Theoretical to Practical Considerations, Two Day Training Course
Marie Rock
2010 AAPS National Biotechnology Conference
May 15-16, 2010
San Francisco, CA
Impact of the Variability of Ligand Binding PK Assays on the Outcome of Comparability Assessments for Follow-on Biologics
Marie Rock Moderator and Organizer
2009 AAPS National Meeting
November 10, 2009
Los Angeles, CA
Assessment of Immunogenicity of Biotherapeutics
Marie Rock
Japanese Society of Xenobiotics Annual Meeting
November 28, 2009
Kyoto, Japan
Biomarkers - A New Look at Something Familiar
Marie Rock
Southern California Chapter of the Society of Toxicology 2009 Annual Meeting - Safety Biomarkers: Recent Progress and Current Initiatives
October 1, 2009, Session 2, 2:40-3:10 PM
Irvine, CA
BIOTEC Section & LBA Bioanalytical Focus Group WEBINAR
Application of Multifactorial DOE for the Ligand Binding Lab
Marie Rock
Presenters: Chad Ray, Franklin Spriggs and Vimal Patel
October 8, 2009, 12:30-2:00 PM EST
> download the LBABFG newsletter
Comparison of the Preincubation and Plate Incorporation Methods in the MicroAmes: Lessons for Drug Discovery Screening
Melissa Wells, Sandy Soelter and Michael Schlosser
2009 EMS Annual Meeting
October 24-28, 2009
St. Louis, MO
> download the full poster
The Effect of K3EDTA Plasma From Different Commercial Suppliers Upon ELISA Performance
Jason Zatkoff, Lia Tibavido, Catherine Jancila, Charles Kalensky and Marie Rock
2009 AAPS National Biotechnology Conference
June 21-24, 2009
Seattle, WA
> download the full poster
Development of Ligand Binding Analytical Methods to Support Immunogenicity Testing Theoretical to Practical Considerations
Course moderated by Marie Rock
2009 AAPS National Biotechnology Conference
June 25-26, 2009
Seattle, WA
The Effect of the Soluble Erythropoietin Receptor on EPO ELISA and ECL Assays for Antibody Screening and Blood Level Determinations
by Ruth Olech, Marie Rock and Charles Kalensky
2008 AAPS Annual Meeting
November 16-20, 2008
Atlanta, GA
> download the full poster
Absence of a Pressor Response to Oral Tyramine in Conscious Telemeterized Rats Treated with the Novel Oxazolidinone TR-701: Comparison to Linezolid
P.R. Atterson, K. Takacs and M.J. Schlosser
48th Annual ICAAC / IDSA 46th Annual Meeting
October 25-28, 2008
Washington, DC
> download the full poster
Validation of a MicroAmes Reverse Mutation Mammalian Microsome Screen using ICH-Compliant Salmonella and E. coli Tester Strains
by Melissa Wells, Sandy Soelter and Michael Schlosser
Environmental Mutagen Society 39th Annual Meeting
Gene's and the Environment: From Molecular Mechanisms to Risk
October 18-22, 2008
Rio Grande, Puerto Rico
> download the full poster
Miniaturization of the In Vitro Micronucleus Assay Using Human Peripheral Blood Lymphocytes: Application for Early Screening in Drug Development
by Sandy Soelter, Nina Sahay, Rachel Grau and Michael Schlosser
Environmental Mutagen Society 39th Annual Meeting
Gene's and the Environment: From Molecular Mechanisms to Risk
October 18-22, 2008
Rio Grande, Puerto Rico
> download the full poster
Analytical & Bioanalytical: What is it we really need?
by Michael Schlosser
Preclinical Training Institute
"Training Tomorrow's Experts...Today"
Study Directing: Principles & Practices 2008
June 8-11, 2008
Lake Tahoe, Nevada/California
Analysis of Samples from Non Clinical and Clinical Trials of Biotherapeutics Where High Dose Prozone Effects Are Present
by Chuck Kalensky, Michelle Stuart, Ruth Olech and Marie Rock
2008 AAPS National Biotechnology Conference
Tuesday June 24, 5-6pm
Toronto, ON
> download the full poster
Strategies for Early Toxicity Testing with Focus on Genotoxicity Evaluations
by Michael Schlosser
Molecular Medicine Tri-Conference
4th Annual Preclinical Development: How Can We Improve Prediction of Clinical Safety?
March 26-28, 2008
San Francisco, CA
Practical Applications in GLP Bioanalysis by Marie Rock
AAPS Workshop on Current Topics in GLP Bioanalysis:
Assay Reproducibility for Incurred Samples Implications of Crystal City Recommendations
February 7 - 8, 2008
Arlington, VA
> download the full poster
Toxicology Perspective: Successful Strategies for an IND Filing
Michael Schlosser
From Discovery to IND Scientific Strategies and Processes to Improve Your Chances of Success
March 13-14, 2007
Baltimore, MD
Evaluation of a MicroAmes Screen that is Fully Predictive for the Regulatory Salmonella/E. Coli Mammalian Microsome Mutagenicity Test
by Michael Schlosser, Sandra Soelter and Melissa Wells
Society of Toxicology, 46th Annual Meeting and ToxExpo
March 25-29, 2007
Charlotte, NC
> download the full poster
Application of the MicroAmes Screen and MultiCASE SAR for Assessing the Genotoxic and Carcinogenic Potentials of the Pharmaceutical Impurity, Difluoroaniline
by Melissa Wells, Sandra Soelter, Michael Schlosser
Society of Toxicology, 46th Annual Meeting and ToxExpo
March 25-29, 2007
Charlotte, NC
> download the full poster
Development and of Quantitative Validation of Ligand Binding Assays to Support Pharmacokinetic Assessments of Biopharmaceuticals
Module 1: Introduction to Biopharmaceuticals
by Marie Rock
2007 AAPS National Biotechnology Conference
June 24-27, 2007
San Diego, CA
Challenge of Method Validation (Large Molecule Perspective)
by Marie Rock
Eighth Annual Land O'Lakes Bioanalytical Conference
July 9-13, 2007
Merrimac, WI
Book Chapters
"Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis"
Marie Rock and Stephen Keller
Ligand Binding Assays, pp 239-264, Masood Khan and John Findlay, eds. John Wiley & Sons, Newark, New Jersey Inc 2009
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