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The Lock and Key of MedicineMonoclonal Antibodies and the Transformation of Healthcare$
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Lara V Marks

Print publication date: 2015

Print ISBN-13: 9780300167733

Published to Yale Scholarship Online: January 2016

DOI: 10.12987/yale/9780300167733.001.0001

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Blockbuster Mab Drugs

Blockbuster Mab Drugs

(p.184) Chapter Nine Blockbuster Mab Drugs
The Lock and Key of Medicine

Lara V. Marks

Yale University Press

This chapter explores the development of rituximab and infliximab, two of the best-selling monoclonal antibody (Mab) therapeutics today. The evolution of these drugs not only illustrates how a single Mab therapeutic came to be used for multiple indications, but shows the significant role that Mabs have played in fostering new understandings of the causes of cancer and autoimmune disorders, thereby opening avenues to more effective care. Their stories also show how the development of Mab drugs shifted from prioritizing rare diseases to treating more lucrative common illnesses. Although each drug took a different path to the clinic, they encountered similar hurdles along the way. These included not only the challenge of scaling up production for newly engineered antibodies, and getting Mabs through clinical trials and regulatory approval, but also securing enough funding. All of this required a complex alliance among academic researchers, industry leaders, and financiers as well as the consent of patients.

Keywords:   rituximab, infliximab, Mabs, monoclonal antibodies, Mab drugs, drug development, anti-cancer drugs, autoimmune disorders

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