Do companion diagnostics make economic sense for drug developers?

New Biotechnology
Amit Agarwal

Abstract

Drug developers are grappling with the impact of personalized medicine on their portfolios. The combination of molecular diagnostics with targeted biologic therapies has been hailed as a recent innovation with few historical analogs to guide behavior. However, if the definition of companion diagnostics is broadened to include any drug whose FDA approved label requires diagnostic testing before prescription then over 50 drugs across multiple therapeutic areas arise. Most importantly for current drug developers, these drugs represent a wide variety of market situations and with sufficient historical data to evaluate different commercialization strategies for the combination. Included in these examples are drugs which were not initially launched with companion diagnostics but were required to implement companion diagnostics after they were on the market for a period of time. The historical case studies demonstrate that companion diagnostics are neither a universal panacea nor an unmitigated disaster for drug developers but require an understanding of specific situations to determine the utility of companion diagnostics. Numerous case studies highlight how companion diagnostics have been a boon to drug developers including Iressa, ...Continue Reading

References

Jan 23, 1999·JAMA : the Journal of the American Medical Association·E A SteinG J Gormley
Jun 19, 2003·The Journal of Clinical Investigation·Daniel J RaderHelen H Hobbs
Sep 6, 2003·Lancet·Paul Durrington
Dec 11, 2003·Chest·Kristin B HighlandKit N Simpson
Nov 4, 2004·Journal of the American Academy of Dermatology·Joel M GelfandDavid J Margolis
Mar 3, 2005·Journal of the National Cancer Institute·Hisayuki ShigematsuAdi F Gazdar
Aug 21, 2009·The New England Journal of Medicine·Tony S MokMasahiro Fukuoka
Mar 13, 2010·Journal of the American College of Cardiology·Hans J AvisEvan A Stein

❮ Previous
Next ❯

Citations

Jan 9, 2014·Clinical Pharmacology and Therapeutics·W D DotsonM J Khoury
Apr 29, 2016·Journal of Medicinal Chemistry·Maria Laura BolognesiElisa Uliassi
Oct 27, 2017·Expert Review of Molecular Diagnostics·Paul Hofman
Oct 20, 2012·Clinical Chemistry and Laboratory Medicine : CCLM·Graham H Beastall
Apr 25, 2019·Expert Review of Molecular Diagnostics·Paul Hofman, Fabrice Barlesi

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antipsychotic Drugs

Antipsychotic drugs are a class of medication primarily used to manage psychosis (including delusions, hallucinations, paranoia or disordered thought), principally in schizophrenia and bipolar disorder. Discover the latest research on antipsychotic drugs here

Birth Defects

Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.

Antipsychotic-Induced Weight Gain

Antipsychotic-induced weight gain (aiwg) is a common adverse effect of this treatment, particularly with second-generation antipsychotics, and it is a major health problem around the world. Here are the latest discoveries pertaining to AIWG.

Allergy and Asthma

Allergy and asthma are inflammatory disorders that are triggered by the activation of an allergen-specific regulatory t cell. These t cells become activated when allergens are recognized by allergen-presenting cells. Here is the latest research on allergy and asthma.