Topics
           Introduction of pharmaceutical industry 
           Drug development process and clinical trials.
           Biostatistics in clinical trials:
            ◦ Study design
            ◦ Clinical data
            ◦ Statistical modeling
           Other topics
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           Drug
            Drug definition: 
               according to the Food, Drug, and Cosmetic Act (FD&C Act):
               (1): a substance recognized in an official pharmacopoeia or formulary 
               (2): a substance intended for use in the diagnosis, cure, mitigation, 
               treatment, or prevention of disease 
               (3): a substance other than food intended to affect the structure or function 
               of the body 
               (4): a substance intended for use as a component of a medicine but not a 
               device or a component, part, or accessory of a device Novartis (60.9B), 
               Simple version: A Chemical Substance that Interacts with a Living System 
               and Produces a Biological Response
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           Drug
           “New Drug” vs “Generic Drug”
                New Drug patents expire 20 years from the date of filing. Many other 
                   factors can affect the duration of a patent. 
                      Since the company applies for a patent long before the clinical trial to assess a drug’s 
                      safety and efficacy has commenced, the effective patent period after the drug has finally 
                      received approval is often around seven to twelve years.
                New drugs (brand names) and generic drugs have the same 
                   pharmacological effects (dosage, intended use, effects, side effects, 
                   route of administration, risks, safety, etc.) and pharmacokinetics.
                For example: Glucophage vs. metformin. 
           “Prescription Only” vs “Over the Counter”
           Other drugs (orphan drugs), medical devices, vaccine
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           Pharmaceutical Industry
            List of 2013 top biotech and pharmaceutical companies (Revenue): 
               Johnson & Jonson (71.3B), 
               Novartis (60.9B), 
               Roche (52.4B), 
               Pfizer (51.6B), 
               Sanofi, Merck, GlaxoSmithKline, AstraZeneca, Eli Lilly, Abbott Lab.
           List of 2013 top biotech and pharmaceutical companies (Net income): 
               Pfizer (US, 22B), 
               Johnson & Jonson (13.8B), 
               Roche (Switzerland, 12.B), 
               Novartis (Switzerland, 9.5B), GlaxoSmithKline (UK, 9B), Sanofi (France, 
               5.1B), Amgen (US, 5.1B), Eli Lilly, Novo Nordisk, Merck.
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           Pharmaceutical 
           Industry: Drug
            Example of Blockbuster drugs from AstraZeneca: 
                AstraZeneca's Nexium (heartburn and acid reflux medication)
                Sale: 5B (2009), 5B (2010), 4.4B (2011), 3.9B (2012), 
                         6.14B (2013, the top 2nd)
                Patent expired May 2014. AstraZeneca will not release an OTC drug.
                AstraZeneca's Crestor (indication: cholesterol)
                Sale:  5.3B (2013, the top 4th). Patent is going to expire in 2016.
            Example of Blockbuster drugs from Pfizer: 
                Lipitor (Pfizer, indication: cholesterol) had sale Q3/2012 as $0.186B. The 
                patent expired in November, 2011. 
                Lipitor sales in 2010: $10.7B for the year.
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