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Pharmaceutics 734 FALL 2008
2) CLASS SCHEDULE 9/02 LECTURE: INTRODUCTION TO PHARMACOGENOMICS. HOMEWORK 1: 1. Look over the syllabus. 2. Read The Case for Personalized Medicine. 3. Read FDA's critical path report. 4. Read PriceWaterhousCooopers Pharmacogenomics report 5. TURN IN ASSIGNMENT #1 DUE NEXT CLASS:Answer the questions below. a) The average cost of developing a drug today is $__________________ b) True or False: A major problem in drug discovery today is the lack of biological targets for therapeutic agents. c) If a phase II clinical trial costs $10 million, how much money on average is spent on phase II clinical trials per successful drug product._____________ d) True or false: Bioinformatics, Clinical Informatics, Biomarkers are important areas of research opportunities recognized by the FDA’s Critical Path Initiative? e) True or false: The use of genetic tests to rescue drugs that are withdrawn from the market is an important research opportunity recognized by the FDA’s critical path initiative? f) True or false: The NIH Roadmap is a major NIH program established based on recommendations of the Personalized Medicine Coalition? g) According to the Critical path initiative, what is the estimated success rate for a drug candidate in phase I clinical trial?________________ h) True or false: Based on documents cited by the critical path initative, the development of in silico screening/predictive toxicology technologies could lower drug development cost by 50%, being at least as important as the use of biomarkers for lowering the cost of drug development? i) True or False: The Critical Path Report indicates that changing the current paradigm of drug therapy from reaction to prevention is key to address some of the modern limitations of drug therapy. j) Please indicate which presentation topic/date you prefer, followed by your 2nd, 3rd, 4th, 5th and 6th choice. 9/09 LECTURE:INTRODUCTION TO PHARMACOGENOMICS. LECTURE: The Practice of Personalized Medicine: The individualization of 6MP Therapy Discussion: How will personalized medicine vs. other technologies affect the Critical Path? HOMEWORK 2. 1. Read C&EN article about Pharmacogenomics. 2. TURN IN ASSIGNMENT #2 DUE NEXT CLASS: What has happened to the different companies quoted in the C&E Pharmacogenomics article since 2001? Make a “then and now” table explaining (in one or two sentences) what the companies were doing in 2001 and what they are doing today, and turn it in class. 9/16 LECTURE: Cellular and molecular mechanisms of variability in drug response LECTURE: Genetically Individualized therapies: Better Medicine? Discussion: What is the current state of Pharmacogenomics today in relation to the predictions of the 2001 article. 1) Arrange a day to meet with Prof. Rosania to discuss paper presentation and organization (the first week of October). 2). Read Eichelbaum and Evans and Evans&Relling reviews 3) TURN IN ASSIGNMENT #3 DUE NEXT CLASS. From published reviews and research articles, find TEN candidate gene:drug associations affecting interindividual variability in drug response or drug toxicity. Explain the mechanisms behind these associations (in a couple of sentences).
9/23 LECTURE: The foundation of PG: Genome sequencing and SNP detection Discussion: Brain storming: Searching for new candidate gene:drug associations. HOMEWORK 4. 1) Read Nature article about new sequencing technologies 2) Read Wired article about George Church. 3) TURN IN ASSIGNMENT #4 DUE NEXT CLASS: Visit webpages of Navigenics, 23andMe, DecodeMe, and figure out what these companies do. Answer the following questions: 1) what service is provided by these companies? 2) how much does each company charge for its services? 3) how are the results provided by each company (format)? 4) What kind of information/counseling resources are provided by the companies in terms of interpreting the significance of the test results? 5) How are websites like SNPedia related to the services provided by Navigenics, 23andMe or DecodeMe? 9/30 LECTURE: Predictive biomarkers for tailoring drug therapy. Lecture/ Discussion: Personal Genomics and the $1000 genome Homework #5: 1) Read article about Genome-wide association studies 2) TURN IN ASSIGNMENT #5 DUE NEXT CLASS: Find five or so articles about gene:drug associations that you may want to present in class, and meet with Prof. Rosania to figure out which article you will present. 10/07 INVITED LECTURE: Kerby Shedden – Statistical challenges of using SNPs to predict drug response. 1) Read FDA pharmacogenomics guidance and IVDMIA guidance 2) Read warfarin NEJM article. 10/14 LECTURE: Recent Pharmacogenomic Advances and achievements: Warfarin, Irinotecan, Abicavir; Social, Ethical, Economic issues of Pharmacogenomics. Alternative technologies Discussion: Does the FDA pharmacogenomics guidance address the challenges of using genetic testing for drug discovery and development? Would a pharmaceutical company invest in marrying a drug to a genetic test vs. a second generation drug that would not require a genetic test? 10/21 FALL STUDY BREAK 10/28 LECTURE/DISCUSSION: Finding candidate new gene-drug associations potentially determining interindividual variability in drug response (for example, biochemical assays of drug transport and metabolism using cloned transporter or metabolic enzymes, or microarray/proteomic experiments identifying variations in genes associated with variations in drug response. 11/4 Research Article Presentations: Validating candidate gene-drug associations with experiments in knock-out or transgenic mice models. Saadet Albayrale Noha Salama (tentative) 11/11 Research Article Presentations: Determining the degree of variability of drug metabolizing/transporter gene structure or function in a human population. Byumseok Koh Yanke Yu 11/18 Research Article Presentations: Determining if variability in drug metabolizing/transporter genes is associated with variability in drug transport or metabolism. Bryan Newman Newaj Abdullah 11/25 Research Article Presentations: Determining if variability in drug metabolism/transporter/other-drug-response genes is associated with differences in clinical drug response/adverse drug reactions. Ronak Shah Bei Yang 12/2 Research Article Presentations: Determining if adjusting dose or drug therapy based on genes associated with drug response leads to therapeutic improvements. Steve Stout Kyoung Ah Min 12/9 Research Article Presentations: Contradictory research findings on the effects of genes on drug efficacy and toxicity. Kelan Thomas Noha Salama (tentative) 12/18 FINAL ESSAY Due: NOON (12 PM)--Thurs DEC 18TH.
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