Drug Discovery and the Pharmaceutical Industry Louis Lu Douglas Brutlag Genomics and Medicine 12 3 09 Copyright 2002 Douglas Kalish All Rights Reserved Gene Sequencing Human Genome Project Library of DNA sequences Target ID Pick a disease target Proteins or mRNA expressed or not Target Validation Involvement of protein Understand pathways and interactions Lead Discovery Evaluate leads Replacing protein Anti sense RNA Antibodies Stimulate protein synthesis Pre Clinical Animal Tests Toxicity Efficacy Clinical 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 Effects Manufacturing Distribution FDA Approval Scale up quantities Detailing advertising distribution Insurance company acceptance Exqmple of Vioxx Pharma Value Chain Time Scale Benefits of Genomics Decreases Cost Decreases Time Pharmaceutical Companies http www duke edu web soc142 team2 shifts html What 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 development Bibliography www phrma org files PhRMA 202009 20Profile 20FINAL pdf http www pauljstabile com SpanningthePharmaceuticalValueChain jpg SpanningthePharmaceuticalValueChain full jpg http biochem118 Papers Drug 20Discovery Pharmaceutical pdf
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