Codeveloping Targeted Therapies and Diagnostics: What's in It for Me?

Drug-test (RxDx) companion products pair a drug and a diagnostic test that can tell physicians which patients will benefit most from treatment with the drug. This report examines whether it is appropriate to ask pharmaceutical/biotech and diagnostics companies to develop these products when they may question what benefi t they will receive from such development; after all, these companies are already developing good drugs and good tests to treat many people. We examine the FDA's efforts to encourage development of RxDx products, possible incentives to both drug and diagnostics companies, the companies that we believe are currently suited to fi nd success, and what factors will likely play into this success. Get the Answers You Need to Shape Your Strategy The benefits of RxDx companion products could be very high for individual patients and society. However, decisions in the drug and diagnostics industries are based on economics.What will development of such tests cost? How will companies know when it makes financial sense to develop them? Technology now exists to exploit the information in human genes to make better medicines that treat not just large patient populations but also individual patients through personalized medicine. How can drug and diagnostics companies best benefit from this new knowledge? How can they strike a balance between public benefi t and company profit? Try as the FDA might to encourage the codevelopment of RxDx products, a lack of obvious economic benefit to the pharmaceutical and diagnostics industries has caused these industries to drag their feet in the development of personalized medicine and RxDx products specifically. What incentives are being considering to encourage development of these products? Can the cost of development be decreased? Should pricing/reimbursement for RxDx products be increased? What other incentives are reasonable? Please note, the PDF e-mail from publisher version of this report is for a global site license.

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Companies
Abbott
Applera
Arup Laboratories
AstraZeneca
Bayer
BioGenex
Biogen Idec
Bristol-Myers Squibb
Celera Genomics
Chugai
Clinical Data
Dainippon Sumitomo
Dako
Elan
Eli Lilly
Genentech
Genomic Health
Genzyme
Genzyme Genetics
GlaxoSmithKline
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Hoffmann-La Roche
ImClone
Johnson & Johnson
MedImmune
Merck KGaA
Novartis
Merck & Co.
Perlegen
Pfi zer
PGx Health
Prometheus Laboratories
Riken
Roche
Schering AG
Schering-Plough
Serono
Tanabe
Ventana Medical Systems
Vysis
Wyeth
Zenyaku