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ARRRR! Drug Development and Discovery

ARRRR! Drug Development and Discovery. Access to Essential Medicines De-Cal Fall 2006- Week 2. Happy International Talk Like a Pirate Day!. Drug companies make medicines that cost “ lots o' doubloons”

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ARRRR! Drug Development and Discovery

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  1. ARRRR! Drug Development and Discovery Access to Essential Medicines De-Cal Fall 2006- Week 2

  2. Happy International Talk Like a Pirate Day! Drug companies make medicines that cost “lots o' doubloons” My favorite pirate pick up line: Avast, me proud beauty! Wanna know why my Roger is so Jolly?

  3. Roadmap • Evolution of the pharmaceutical industry • Research & development pipeline: • Identifying compounds • Pre-clinical and clinical trials • Production and distribution • Marketing and sales • The reality of Pharma

  4. Evolution of Pharma • Previously unregulated • Huge gains in basic scientific understanding the 1950s and 60s • Modern drug industry is centralized in about ten major companies Then Now

  5. R&D Pipeline The Players: Contract Research Organizations Basic research institutions FDA Small Biotech firms Big Pharma

  6. R&D Pipeline • Step 1: Basic laboratory research • Step 2: Preclinical testing after a promising compound is found • Step 3: Investigational New Drug filing with FDA • Three phases of clinical trials • Step 4: New Drug Application (NDA) • Step 5: Sale

  7. Clinical Trials Phase I Phase II Phase III Non-blind experiments for dosing Single blind experiments for efficacy Double blind experiments for efficacy

  8. Less of a pipeline, more of a funnel . . .

  9. Production and Distribution • Developing production methods and creating facilities • Distribution • Enormous marketing expenditures

  10. The $800 million pill?

  11. Important concepts • Generic drug manufacturers • New Molecular Entities (NMEs) • Bioequivalency • Me-too drugs • Lifestyle drugs • Second indications • Pharma companies are ruthless profit maximizers

  12. The Politics of Pharma • Organized into PhRMA (Pharmaceutical Research and Manufacturers of America • Huge political lobby: • In 2001 Name-brand pharma spent $75.4 million on lobbying • That same year generics spent $2.4 million • The providers for a society that increasingly relies on drugs

  13. The Good • In 2004 name-brand pharmaceutical firms spent approximately $53 billion on R&D • New medicines generated 40% of the two-year life expectancy gain in 52 developed countries* * F.R. Lichtenberg, The Impact of New Drug Launches on Longevity, National Bureau of Economics Research Working Paper No. 9754 (June 2003).

  14. The Bad • In 2001 an estimated 1.9 to 2.2 million people were driven in personal bankruptcy by health care costs* • In 2004 pharma spent approximately $1.25 billion per NME; in 1995 that number was $317 million+ * Health care costs main cause of bankruptcy, study finds, The New Standard, at http://newstandardnews.net/content/?action=show_item&itemid=1439 +R&D spending per NME Declines, Drugresearcher.com, at http://www.drugresearcher.com/news/ng.asp?id=61610-r-d-nme-spend

  15. The Questionable • Decline in the efficiency of R&D (i.e. less NMEs per R&D $ spent) • Mergers of big companies hurting R&D • The cost of marketing of pharmaceuticals • Direct to consumer advertising • Me too and lifestyle drugs Arrr! That be questionable, matey

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