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Kazakova, S. V. et al. N Engl J Med 2005;352:468-475

Kazakova, S. V. et al. N Engl J Med 2005;352:468-475. Epidemic-Curve Graph (Top) and Field Position Diagram (Bottom) of Cases of MRSA Infection among St. Louis Rams Football Players in 2003. The New Campaign. The New Campaign. Customer Centric. Establishing the product blueprint.

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Kazakova, S. V. et al. N Engl J Med 2005;352:468-475

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  1. Kazakova, S. V. et al. N Engl J Med 2005;352:468-475 Epidemic-Curve Graph (Top) and Field Position Diagram (Bottom) of Cases of MRSA Infection among St. Louis Rams Football Players in 2003

  2. The New Campaign

  3. The New Campaign

  4. Customer Centric Establishing the product blueprint • Must place market needs as the focal point • “as articulated by the customer.” • Attributes • Features • Performance • “I need a moisturizer that is better than the leading brand” Meeting Product Guidelines • Innovative formulation • Novel vehicles • Clinical assessment • Commercialization The Otx Sales Process 1. Meeting an unmet need 2. “Cahiers Des Charges” 3. Product Development 4. Marketing Brand Plan Outcome Driven

  5. FMF TRAPS HIDS MWS/FCU CH Inherit AR AD AR AD AD Chrom 16p13 12p13 12q24 1q44 19p13.3 Gene MEFV TNFRSF1A Mevalonatekinase CIAS1 Ela2 Protein PyrinMarenostrin TNFR type 1 Mevalonatekinase Cryopirin Neutro. elastase Ancest Jewish,Turkish, Arab, Armenian Scottish, Irish Dutch French German, English, French, N. Am. None Familial Periodic Fever Syndromes

  6. Distribution of Child Care US Data from Children’s Defense Fund. CDF Publications 1998 CCC = Child care center CCH = Family CCC

  7. ~7.5% meningococcal sepsis can be attributed to rare mutations at TLR4 locus Rare Tlr 4 Mutations Are AssociatedWith Meningococcal Susceptibility Smirnova I, et al. Proc Natl Acad Sci USA. 2003;100:6075-6080.

  8. West Nile Virus (WNV) http://www.dierentuin.net/pictures/huismuis.jpg anatomy.ucsf.edu/Pages/mouseclub/mousejournalclub.html wildlife.usask.ca/WestNileAlertHTML/viron.jpg

  9. A stop codon in exon 4 of the interferon response gene, 2’-5’-oligoadenylate synthetase/L1 isoform (Oas1) may be responsible for susceptibility to WNV and other flaviviruses Perelygin AA, et al. Proc Natl Acad Sci USA. 2002;99:9322-9327. Mashimo T, et al. Proc Natl Acad Sci USA. 2002;99:11311-11316.

  10. 20% symptomatic 1/150 with meningitis or encephalitis Relevance to Humans? • 20% symptomatic • 1/150 with meningitis or encephalitis WNV

  11. Men B Vaccine: A Genomic Approach • 600 potential vaccine candidates identified • 350 proteins expressed in E. coli • 344 proteins used to immunize mice • 355 sera tested • 91 novel surface-exposedproteins identified • 29 novel proteins induce bactericidal activity 18 months 24 months Scale-up GMP / IND 1 year 5 vaccine candidates Clinical trial

  12. Primary Efficacy End Point Posttreatment Response Rate PASI 75 Responders IV = 14% IM = 21% IV = 11% IM = 7% IV = 25% IM = 28% + First Course Alefacept in Psoriasis Phase 3 Efficacy Results Weeks 1–12 Dosing Weeks 13–24 Follow-up Placebo Alefacept 7.5 mg Weeks 2 4 6 8 10 12 14 16 18 20 22 24 Krueger GG, et al. J Amer Acad Dermatol. 2002;47:821-833; Lebwohl M, et al. Arch Dermatol. 2003;139:719-727.

  13. Linezolid for MRSA pneumonia? Clinical cure rates for linezolid and vancomycin therapy in patients with Gram-positive, nosocomial pneumonia Wunderink, R. G. et al. Chest 2003;124:1789-1797

  14. Mechanism of Action Domain V Domain II Site of methylation Telithromycin binds 10X more strongly than macrolides because of its better domain II contact Binding sites for both macrolides & telithromycin Douthwait et al Mol Micro 36:183, 2000

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