Subject Matter
Publications and Presentations Update in process!
Speaker: Update on USP Chapters <1032>, <1033>, and <1034>. Informa's 9th Annual Biological Assays Conference, November 03-04, 2010, London England.
Speaker (General Chapter <1032>: Design and Devlopment of BIological Assays) and Chair of Planning Committee, 3rd Annual USP Biological Assays Workshop, August 11-12, 2010, USP headquarters, Rockville MD.
Speaker: Status of the USP Bioasssay Chatpers. IC 20th International Intensive Symposium on Biological Assay Development and Validation, May 13, 2010, San Francisco CA.
Speaker: Statistical Analysis using Parallel Lines or Curves, & To p or not to p: p Value or Equivalence Test. CaSSS Conference, Bioassays 2009: Scientific Approaches and Regulatory Strategies; November 2-3, 2009, National Institutes of Health, Bethesda MD.
Speaker: Status of the USP Bioassay Chapters. 8th Annual Informa Biological Assays Conference; October 13-14, 2009, Berlin, Germany.
Speaker: (1) Sneak preview of USP General Chapter <1032>, Design of Biological Assays: (2) Update on USP Bioassay Activities. 2nd Annual BEBPA (Biopharmaceutical Emerging Best Practices Association) Biological Assays Conference, September 30 – October 2, 2009, Rome Italy.
Program Committee, Session Chair, and Speaker: The USP Bioassay Chapter Suite. 2nd USP Bioassay Workshop, August 12-13, 2009, USP Headquarters, Rockville MD.
Course Organizer and Instructor, Statistics Module, USP Pharmaceutical Education Course: Bioassay Fundamentals. August 11, 2009, USP Headquarters, Rockville MD.
Speaker: DOE in Bioassay Validation. IBC 4th Annual BioProcess International Analytical & Quality Summit, May 04-06, 2009, La Jolla CA.
Speaker: The USP Suite of Bioassay Chapters - Specifically, General Chapter <111>, Analysis of Biological Assays. 2nd Annual IVT PharmSTATS Conference, April 27-28, 2009, Arlington VA.
Poster: Daclizumab exhibits efficacy in multiple sclerosis subjects positive for interferon-beta neutralizing antibodies. ECTRIMS 2008 World Congress on Treatment and Research in Multiple Sclerosis, September 17-20,2008, Montreal Canada
Speaker: Overview of USP Bioassay Chapters and Focus on Chapter <111>, Analysis of Bioassays. Inaugural USP Bioassay Workshop, August 13-14, 2008, USP Headquarters, Rockville MD.
In-Process Revision to USP General Chapter <111>, Design and Analysis of Biological Assays. USP Pharmacopeial Forum, Vol. 34 (3) [May-June 2008]
Speaker: USP Bioassay Guidance Update. IBC Life Science 2nd Annual Analytical and Quality Summit; June 6, 2007, San Diego, CA.
Hauck, W., Singer, R., Callahan, L. (2007) Summary of Planned Revisions to Chapter <111>, Design and Analysis of Biological Assays. USP Pharmacopeial Forum, Vol. 33(3) [May-June 2007].
Singer, R., Lansky, D., Hauck, W. (2006) Bioassay Glossary. USP Pharmacopeial Forum, Vol. 32(4) [July-August 2006].
Hauck, W., Singer, R., et al. (2005) Assessing Parallelism Prior to Determining Relative Potency. PDA Journal of Pharmaceutical Science and Technology, 59(2): 127-137.
Poster: Treatment with Visilizumab Causes Rapid and Reversible Increase in Circulating Levels in Selected Cytokines, Chemokines, and Growth Factors in Patients with Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). Digestive Disease Week Conference; May 14-19, 2005, Chicago, IL.
Speaker: Revision of USP Chapter 111: Design and Analysis of Biological Assays. IBC 8th International Conference on Well Characterized Biologicals; November 11, 2004, Washington DC.
Poster: Assessing Parallelism Prior to Determining Relative Potency. WCBP 2004, 8th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products; January 6-9, 2004, Washington D.C.
Speaker: Review and Discussion of ICH Q1E: Evaluation of Stability Data. 4th Annual IBC Biological Assay Development and Validation Symposium; May 6-8, 2002, San Francisco.
Workshop Instructor: Fundamental Concepts in Statistics for Biotechnology Scientists. 3rd International Conference on Strategic Use of Comparability Studies and Assays for Well Characterized Biologicals; September 18-21, 2000, Washington D.C.
Workshop Instructor: Statistics for the Statistically Challenged. 2ndAnnual IBC Symposium on Biological Assay Development and Validation, Techniques for Accelerating Product Approval; May 17-19, 2000, Washington D.C.
Poster: Application of Parallel Line Methodologies to the Measurement of Relative Potency. 4th Symposium on the Analysis of Well Characterized Biotechnology Products (IBC); January 9-12, 2000, San Francisco, CA.
Basi, G.B., Riggs, M.B., Nash, K., Singer, R. (1992) Antibodies to soluble Human T cell receptor beta chain recognize multiple epitopes on cell surface TcR. J. Immunol. Methods, Nov 1992, 155(2): 175-91.
Poster: Recognition of HIV gp120 by anti-idiotype antibodies to anti-CD4 monoclonal antibodies. National Institute of Allergic and Infectious Disease (NIAID) Conference on AIDS Vaccine Development; October 1989, Miami, FL.