lecture_drug_dev_fall 08

lecture_drug_dev_fall 08 - The Drug Development Process...

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The Drug Development Process: Pharmaceutical Industry
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Drug Development Altruistic Objective : Offer the public a therapeutic chemical compound to prevent or alleviate disease symptoms. Commercial Objective : Cost-effectively discover and develop a potentially therapeutic chemical compound that generates adequate revenues to… 2) Sustain synthesis, distribution and marketing activities for drug. 3) Provide spending capital to fund new R&D activities.
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1. Corporate infrastructure and overhead. 2. Intellectual protection and litigation. 3. Biological research. 4. Chemical research. 5. Preclinical safety assessment (toxicology). 6. FDA relations 7. Clinical safety assessment (phase 1 clinical trials). 8. Clinical efficacy assessment (phase 2 clinical trials). 9. Large scale synthesis and formulations. 10.Distribution. Discovering and bringing one new drug to the public typically costs a pharmaceutical company nearly $1 billion and takes an average of 10 to 12 years .
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“Brand name manufacturers” are given 17 years of patent life and allowance for restoration of up to 5 years of lost patent time due to delays in the drug approval process. Drug Development Timeline Date of patent application “Launch” date (drug is marketed to public) Expiration of patent Cost Recovery Patent R&D Timeline
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Critical Stages of Drug Development (in chronological order) 1) Identification of drug “target” 2) Screening for chemical compounds that bind to “target” 3) Safety assessment (preclinical) 4) Safety assessment (clinical) 5) Efficacy assessment (clinical) 6) Clinical monitoring (post-launch) Utilization of computational methods are expected to… DECREASE TIME of development INCREASE probability of drug approval
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1) Identification of drug “target’ A drug target is the receptor or enzyme that the drug will bind to and inactivate. A) DNA microarray-based gene expression profiling in disease tissues to identify the genes (extrapolated to proteins) that show altered gene regulation in the disease state. B) Identification of SNPs (or mutations) that confer the disease state.
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2) Screening for chemical compounds that bind to “target” A) 3D characterization and modeling of the target enzyme or protein for the purposes of identifying a region or domain of the protein that a drug can bind to (with high affinity). B) Prediction of the molecular structure of a drug that will bind to the target. Use the principal components of this prediction to reduce the diversity (and number) of chemical compounds to be screened.
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Safety assessment (preclinical) A) DNA microarray focused on liver enzymes (metabolic enzymes) to characterize the response of the liver to the drug (in rats). B) DNA microarray-based expression profiling in the target tissue to
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This note was uploaded on 02/29/2012 for the course CNIT 458 taught by Professor Michaelkane during the Spring '11 term at Purdue.

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lecture_drug_dev_fall 08 - The Drug Development Process...

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