title: Development and regulatory strategies for drug and diagnostic co-development.
abstract: At the 5th FDA-Drug Industry Association (DIA) Workshop on 'Pharmacogenomics in Drug Development and Regulatory Decision Making', track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and their companion diagnostic products. Identification and validation of genomic and other biomarkers are becoming important components of drug-development strategies, and recent successes show the power of personalized approaches to change the benefit-risk paradigm for new drugs.
authors.affiliation: Novartis Pharmaceuticals Corp., East Hanover, NJ 07939-1080, USA. lois.hinman@novartis.com
authors.forename: Lois M
authors.initials: LM
authors.lastname: Hinman
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Carl
authors.forename: Brian B
authors.initials: BB
authors.lastname: Spear
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Salerno
authors.forename: Robert L
authors.initials: RL
authors.lastname: Becker
authors.forename: Brian M
authors.initials: BM
authors.lastname: Abbott
authors.forename: James F
authors.initials: JF
authors.lastname: Kelly
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mansfield
authors.forename: Russell G
authors.initials: RG
authors.lastname: Katz
authors.forename: Courtney
authors.initials: C
authors.lastname: Harper
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Day
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pacanowski
authors.forename: William
authors.initials: W
authors.lastname: Pignato
mesh_terms: D054316:Biomarkers, Pharmacological / Q000032:analysis; D019937:Diagnostic Techniques and Procedures / Q000592:standards; D015195:Drug Design; D004345:Drug Industry / Q000592:standards; D033161:Government Regulation; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054316:Biomarkers, Pharmacological