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Drug Development and Discovery

Drug Development and Discovery. Access to Essential Medicines De-Cal Spring 2007- Week 3. Roadmap. Evolution of the pharmaceutical industry Research & development pipeline: Identifying compounds Pre-clinical and clinical trials Production and distribution Marketing and sales

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Drug Development and Discovery

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  1. Drug Development and Discovery Access to Essential Medicines De-Cal Spring 2007- Week 3

  2. 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

  3. 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

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

  5. 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

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

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

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

  9. Biologics- What are they? The FDA Says Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

  10. And that means . . . Biologic compound = Significantly more complex Traditional organic compound = Relatively simple Thalidomide Hemoglobin

  11. The $800 million pill?

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

  13. 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

  14. 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).

  15. The Bad • In 2001 an estimated 1.9 to 2.2 million Americans 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

  16. 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 • The pipeline isn’t sustainable Arrr! That be questionable, matey

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