Challenges and approaches for the development of safer immunomodulatory biologics

Jean G. Sathish; Swaminathan Sethu; Marie Christine Bielsky; Lolke De Haan; Neil S. French; Karthik Govindappa; James Green; Christopher E M Griffiths; Stephen Holgate; David Jones; Ian Kimber; Jonathan Moggs; Dean J. Naisbitt; Munir Pirmohamed; Gabriele Reichmann; Jennifer Sims; Meena Subramanyam; Marque D. Todd; Jan Willem Van Der Laan; Richard J. Weaver; B. Kevin Park

doi:10.1038/nrd3974

Challenges and approaches for the development of safer immunomodulatory biologics

Jean G. Sathish, Swaminathan Sethu, Marie Christine Bielsky, Lolke De Haan, Neil S. French, Karthik Govindappa, James Green, Christopher E M Griffiths, Stephen Holgate, David Jones, Ian Kimber, Jonathan Moggs, Dean J. Naisbitt, Munir Pirmohamed, Gabriele Reichmann, Jennifer Sims, Meena Subramanyam, Marque D. Todd, Jan Willem Van Der Laan, Richard J. WeaverB. Kevin Park

Research output: Contribution to journal › Article › peer-review

Abstract

Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions-including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity-pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics.

Original language	English
Pages (from-to)	306-324
Number of pages	18
Journal	Nature Reviews Drug Discovery
Volume	12
Issue number	4
DOIs	https://doi.org/10.1038/nrd3974
Publication status	Published - Apr 2013

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Sathish, J. G., Sethu, S., Bielsky, M. C., De Haan, L., French, N. S., Govindappa, K., Green, J., Griffiths, C. E. M., Holgate, S., Jones, D., Kimber, I., Moggs, J., Naisbitt, D. J., Pirmohamed, M., Reichmann, G., Sims, J., Subramanyam, M., Todd, M. D., Van Der Laan, J. W., ... Park, B. K. (2013). Challenges and approaches for the development of safer immunomodulatory biologics. Nature Reviews Drug Discovery, 12(4), 306-324. https://doi.org/10.1038/nrd3974

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title = "Challenges and approaches for the development of safer immunomodulatory biologics",

abstract = "Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions-including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity-pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics.",

author = "Sathish, {Jean G.} and Swaminathan Sethu and Bielsky, {Marie Christine} and {De Haan}, Lolke and French, {Neil S.} and Karthik Govindappa and James Green and Griffiths, {Christopher E M} and Stephen Holgate and David Jones and Ian Kimber and Jonathan Moggs and Naisbitt, {Dean J.} and Munir Pirmohamed and Gabriele Reichmann and Jennifer Sims and Meena Subramanyam and Todd, {Marque D.} and {Van Der Laan}, {Jan Willem} and Weaver, {Richard J.} and Park, {B. Kevin}",

note = "G0700654, Medical Research Council, United KingdomG0800766, Medical Research Council, United Kingdom",

year = "2013",

month = apr,

doi = "10.1038/nrd3974",

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Sathish, JG, Sethu, S, Bielsky, MC, De Haan, L, French, NS, Govindappa, K, Green, J, Griffiths, CEM, Holgate, S, Jones, D, Kimber, I, Moggs, J, Naisbitt, DJ, Pirmohamed, M, Reichmann, G, Sims, J, Subramanyam, M, Todd, MD, Van Der Laan, JW, Weaver, RJ & Park, BK 2013, 'Challenges and approaches for the development of safer immunomodulatory biologics', Nature Reviews Drug Discovery, vol. 12, no. 4, pp. 306-324. https://doi.org/10.1038/nrd3974

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AU - Sathish, Jean G.

AU - Sethu, Swaminathan

AU - Bielsky, Marie Christine

AU - De Haan, Lolke

AU - French, Neil S.

AU - Govindappa, Karthik

AU - Green, James

AU - Griffiths, Christopher E M

AU - Holgate, Stephen

AU - Jones, David

AU - Kimber, Ian

AU - Moggs, Jonathan

AU - Naisbitt, Dean J.

AU - Pirmohamed, Munir

AU - Reichmann, Gabriele

AU - Sims, Jennifer

AU - Subramanyam, Meena

AU - Todd, Marque D.

AU - Van Der Laan, Jan Willem

AU - Weaver, Richard J.

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Challenges and approaches for the development of safer immunomodulatory biologics

Abstract

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