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Pharmacogenetics and the immunogenicity of protein therapeutics

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Figure 1: Schematic of a proposed decision tree for the evaluation of immunogenicity in individual patients or populations.
Figure 2: Estimating potential ADA responses to factor VIII in individual patients.

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Acknowledgements

We thank C.K. Sarfaty and B. Golding for helpful comments during discussions and G.S. Pandey for editorial assistance. This work was supported by funds from the Center for Biologics Evaluation and Research, Food and Drug Administration's Modernization of Science program (ZES). The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.

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Authors and Affiliations

  1. Program in Computational Biology, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA

    Chen Yanover

  2. Division of Hematology, Clinical Review Branch, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA

    Nisha Jain

  3. Biogen Idec Hemophilia, Waltham, Massachusetts, USA

    Glenn Pierce

  4. Department of Pathology and Laboratory Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA

    Tom E Howard

  5. Division of Hematology, Laboratory of Hemostasis, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA

    Zuben E Sauna

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  1. Chen Yanover
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  2. Nisha Jain
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  3. Glenn Pierce
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  4. Tom E Howard
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  5. Zuben E Sauna
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Corresponding author

Correspondence to Zuben E Sauna.

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Competing interests

G.P. is an employee of BiogenIDEC.

Additional information

C.Y. analyzed the data, generated Figure 2 and contributed to the writing of the manuscript. G.P. wrote the section on the clinical development and regulatory requirements for developing a personalized approach to protein replacement therapy. T.E.H. and N.J. provided the discussion of the clinical and regulatory issues, respectively. Z.E.S. was responsible for conceptualizing this project and overall writing of the manuscript.

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Yanover, C., Jain, N., Pierce, G. et al. Pharmacogenetics and the immunogenicity of protein therapeutics. Nat Biotechnol 29, 870–873 (2011). https://doi.org/10.1038/nbt.2002

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