Recent Articles by Speakers:

Jill Conner, Director of Global Specialty Medicines, Teva Pharmaceuticals, will present  a “Case Study: Impact of Immunogenicity on Safety, and Regulatory Considerations for Complex Drugs.”

1.  Examination of the UPDRS Bradykinesia Subscale: Equivalence, Reliability, and Validity
Buck, P.O., Wilson, R.E., Seeberger, L.C., Conner, J.B., Castelli-Haley, J. (2011). Journal of Parkinson’s Disease, 1: 253-258.

2. Rasagiline: Time to Onset of Antiparkinson Effect is Similar when Used as a Monotherapy or Adjunct Treatment
Wilson, R.E., Seeberger, L.C., Silver, D., Griffith, A., Conner, J.B., Salzman, P.M. (2011). The Neurologist, 17: 318-324.

3. Improving Asthma Management: The Case for Mandatory Inclusion of Dose Counters on All Rescue Bronchodilators
Conner, J. B. & Buck, P.O. (2013). Journal of Asthma, Early Online April 29, 2013.

Kyra J. Cowan, Scientist, BioAnalytical Sciences, Genentech, will present “Integrated Immunogenicity Data Analysis from Clinical Trials.”

1. On Assay Robustness: The Importance of Early Determination and Science-Driven Decision-Making
Cowan, KJ (2013) Bioanalysis 5(11), in press.

2. HGF as a Circulating Biomarker of Onartuzumab Treatment in Patients with Advanced Solid Tumors
Penuel, E, Li C, Parab V, Burton L, Cowan KJ, Merchant M, Yauch RL, Patel P, Peterson A, Hampton GM, Lackner MR, Hegde PS (2013) Mol Cancer Ther. March 2013 (epub ahead of print).

3. Utilizing Design of Experiments to Characterize Assay Robustness
Cowan KJ, Erickson R, Sue B, Delarosa R, Gunter B, Coleman D, Gilbert H, Song A, Fischer SK (2012) Bioanalysis 4(17), 2127-2139.

4. Pharmacokinetics and Biodistribution of a Human Monoclonal Antibody to Oxidized LDL in Cynomolgus Monkey using PET Imaging
Kamath AV, Williams S, Bullens S, Cowan KJ, Stenberg Y, Cherry SR, Rendig S, Kukis DL, Griesemer C, Damico-Beyer LA, Bunting S (2012), PLoS One 7(9), e45116.

Melody Sauerborn, Senior Expert in Immunogenicity and Bioanalysis at TNO, a Netherlands Applied Research Centere, will present “Novel Platform Using LC-MS and Ligand Binding Assays for Characterizing PK and Immunogenicity of ADCs.”

1.  Is the Tiered Immunogenicity Testing of Biologics the Adequate Approach in Preclinical Development?
     Melody Sauerborn, Bioanalysis (2013) 5(7), 743–746

Zuben E. Sauna, Principal Investigator of Haematology at CDER/FDA, will present on “Pharmacogenetic Approaches to Immunogenicity with a View to Overcoming Attrition Owing to Development of Anti-Drug Antibodies, Using Factor VIIa as a Model.”

1. Understanding the Contribution of Synonymous Mutations to Human Disease
Z. E. Sauna and C. Kimchi-Sarfaty, Nat. Rev. Genet. 50, 683-691, 2011.

2. Pharmacogenetics and the Immunogenicity of Protein Therapeutics
C. Yanover, N. Jain, G. Pierce, T.E. Howard and Z.E. Sauna. Nat. Biotechnol. 29, 870-873, 2011.

3. Observations Regarding the Immunogenicity of BDD-rFVIII Derived from a Mechanistic Personalized Medicine Perspective
Z.E. Sauna, A. Ameri, B. Kim, C. Yanove, K.R. Viel, R. Rajalingam, S.A. Cole, T.E. Howard. J Thromb Haemost 10, 1961-1965, 2012.

4. Pharmacogenetics and the Immunogenicity of Protein Therapeutics.
G.S. Pandey and Z.E. Sauna. J. Interferon & Cyto Res. In Press. 2013.

5. Polymorphisms in the F8 Gene and MHC-II Variants as Risk Factors for the Development of Inhibitory anti-Factor VIII antibodies During the Treatment of Hemophilia A: A Computational Assessment.
G.S. Pandey, C. Yanover, T.E. Howard and Z.E. Sauna. PLoS Comput. Biol. In Press. 2013.

Marta Starcevic Manning, Ph.D., Principal Scientist, Clinical Immunology, Amgen, will present on “Immunogenicity Assessment for Antibody-Drug Conjugates.”

Immunogenicity Testing Strategy and Bioanalytical Assays for Antibody-Drug Conjugates
Hoofring SA, Lopez R, Hock MB, Kaliyaperumal A, Patel SK, Swanson SJ, Chirmule N, Starcevic M. .
Bioanalysis. 2013 May;5(9):1041-55. doi: 10.4155/bio.13.10.

Li Xue, Principal Scientist in Pharmacokinetics Dynamics & Metabolism, Pfizer, will present on “The Evaluation of Immunogenicity Risk of Biotherapeutics Targeting Dendritic Cell Receptors.”

1. Pre-existing Biotherapeutic-Reactive Antibodies:  Survey Results within the American Association of Pharmaceutical Scientists
Li Xue, Michele Fiscella, Manoj Rajadhyaksha et al. The AAPS Journal (# 2013) DOI: 10.1208/s12248-013-9492-4.

2. Evaluation of Pre-existing Antibody Presence as a Risk Factor for Post-treatment Anti-Drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics
Li Xue, Bonnie Rup. Accepted for publication in The AAPS Journal.