Drug Discovery and the Pharmaceutical Industry Louis Lu Douglas Brutlag Genomics and Medicine 12/3/09Copyright 2002, Douglas Kalish. All Rights ReservedGene Sequencing Human Genome Project Library of DNA sequencesTarget ID Pick a disease target Proteins or mRNA expressed or notTarget Validation Involvement of protein Understand pathways and interactionsLead Discovery Evaluate leads Replacing protein? Anti-sense RNA Antibodies Stimulate protein synthesisPre-Clinical Animal Tests Toxicity EfficacyClinical Phase I Small group of healthy volunteers (10’s) Safety Toxicity Sometimes use target group patients Example of Gleevec (Chronic Myeloid Leukemia)Clinical Phases II and III Phase II: (100’s) of patient population, Phase III: (1000’s) of patient population Determine Efficacy Dosage Safety Side EffectsManufacturing/Distribution FDA Approval Scale up quantities Detailing, advertising, distribution Insurance company acceptance (Exqmple of Vioxx)Pharma Value ChainTime ScaleBenefits of Genomics • Decreases Cost • Decreases TimePharmaceutical Companies http://www.duke.edu/web/soc142/team2/shifts.htmlWhat’s the Industry Like Today? Time to develop a drug = 10 to 15 years Cost to develop a drug 2006 = $1.3 billion 2001 = $800 million 1987 = $318 million Drugs and Biologics approved in 2008 = 31 Only 2 out of every 10 marketed drug ever return revenues that match or exceed R & D costs This year, 2,900 medicines are currently in developmentBibliography www.phrma.org/files/PhRMA%202009%20Profile%20FINAL.pdf http://www.pauljstabile.com/SpanningthePharmaceuticalValueChain.jpg/SpanningthePharmaceuticalValueChain-full.jpg
View Full Document
Unlocking...