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The Pharmaceutical Industry and The Process of Drug Discovery What is a Drug? Types of Pharmaceutical Products What are the Important Disease Targets?

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Presentation on theme: "The Pharmaceutical Industry and The Process of Drug Discovery What is a Drug? Types of Pharmaceutical Products What are the Important Disease Targets?"— Presentation transcript:

1 The Pharmaceutical Industry and The Process of Drug Discovery What is a Drug? Types of Pharmaceutical Products What are the Important Disease Targets? How the Industry Has Evolved Drug Discovery and The Process of Getting a Drug to Market - an overview

2 What is a drug? “ A Chemical Substance that Interacts with a Living System and Produces a Biological Response”

3 What is a drug? “ A Chemical Substance that Interacts with a Living System and Produces a Biological Response”

4 Good and Bad Drugs? Safe Drugs? What is a drug? “ A Chemical Substance that Interacts with a Living System and Produces a Biological Response”

5 Good and Bad Drugs? Safe Drugs? What is a drug? “ A Chemical Substance that Interacts with a Living System and Produces a Biological Response” Morphine (bad?) vs. penicillin (good?) Curare vs. paracetamol

6 Classification of Drug Types Ethical drugs Generic drugs (no longer under patent) “Prescription Only” vs “Over the Counter” “Off Label” applications Orphan drugs Biotechnology products Counterfeit drugs Street drugs!

7 What criteria MUST new drugs meet? Drugs must address a new need or provide a significant “added benefit” over an existing medicine Drugs must also meet five criteria: Must be safe, effective, of high quality …cost effective (1980s) ……….affordable (1990s) ……………REALLY affordable (2000+)

8 Major Therapeutic Targets  Infectious disease – anti-infectives Anti-bacterial, anti-viral, anti-parasitic drugs  Metabolic disease cancer, cardiovascular, diabetes, inflammation, high blood pressure, neurological disease, pain  Other aspects of health care Hormonal treatments, contraception, vaccines, immunosuppresents, anaesthetics, nutraceuticals, “life style” drugs

9 A History of the Pharmaceutical Industry  The early days - Egyptians, Greeks, Arabs, China, India  Plant-derived medicines morphine (1805), quinine (1819), colchicine (1820), pilocarpine (1875)  Hormones insulin (1921), estradiol (1929), testosterone (1931), “the pill” (1960)  Antibiotics, Psychoactive drugs (post-1945 to 1960’s) penicillin (1944), streptomycin (1944), valium (1963)  Treatment of metabolic disorders (1960’s to current day) Ventolin (1969), Lipitor (1997), Viagra (1998), Avandia (1999), Vioxx (1999), Gleevec (2001) Search for gene therapies (1990), stem cell-based therapies Stem-cell replacement of a trachea (2008)

10 Some Important Events  American Civil War  Legislation – UK Cruelty to Animals Act (1876); US Federal Food and Drug Act (1906)  World War 1 - Development of UK regulatory rules  World War 2 – antibiotics  Vaccines – Smallpox: Jenner (1796) – eradicated in 1977  Thalidomide (1960) – report adverse drug reactions  AIDS (1980s) – fast track approval, “buyer power”  Viagra (1998)  Tamiflu – H1N1 (swine flu) pandemic (2009)  NICE (1999) – the affordability factor  Vioxx – anti-inflammatory – due to litigation  Avandia – Type 2 (non-insulin dependent) diabetes also due to litigation

11 How do drugs work?  The Biological Target - enzyme or receptor  Where is the target - part of “us” or elsewhere  Paul Ehrlich, Nobel Prize 1908, salvarsan;  blood-brain barrier; “Lock and Key” hypothesis; chemotherapy and “magic bullet” The Lock - Active Site of Enzyme/Receptor The Key - the Drug

12 The “Lock and Key” analogy Lock Key Binding  Here the KEY is the natural substrate  Binding of the KEY to the LOCK (an enzyme or a receptor) then causes a response – a shape change in the protein/receptor

13 The “Lock and Key” analogy Lock Key BindingBiological Response  Here the KEY is the natural substrate  Binding of the KEY to the LOCK (an enzyme or a receptor) then causes a response – a shape change in the protein/receptor

14 Binding of Drug is preferred vs. Biological response is altered OR shut down But when an effective drug is present  Drug may bind preferentially to the “active site” Antagonist – binds and BLOCKS Agonist – binds and ACTIVATES Partial agonist – induces a partial response

15 Who discovers drugs? Doctors?  Identify biological target - biology  Prioritise/ validate target – pharmacology and chemistry  Identify and optimise lead molecules – chemistry/pharmacology  Preclinical studies – chemistry/pharmacology/ toxicology  Formulation - pharmaceutical sciences  Clinical evaluation – medicine  Manufacture - chemical engineering

16 Getting a drug to market  Disease target - possible drug candidates  Pre-clinical testing; R&D (1-3 yrs)  Toxicology, “ADME”  Clinical R&D (2-10 yrs; Av. 5yrs) Phase 1 – healthy volunteers Phase 2 – small patient group Phase 3 – larger patient group  Regulatory approval (2-10(!) yrs) Market Phase 4 – long term monitoring

17 The Gamble - wastage and timescale  For EACH DRUG approved, an average of 7500 compounds will have been made  Of this 7500, an average of 21 will be tested for subacute toxicology, 6.5 will be tested in humans and 2.5 will reach Phase 3 – 1 then gets to market………  Entire process takes on average 12 years  Costs $138M (1975); $800M (2000); $1.6Bn (2008)  Development costs do NOT include pre-launch marketing which can DOUBLE costs

18 The “Pay Off”……to the companies  Typical R&D budget: 33% R and 67%D  R&D = 15 to 25 % of sales turnover  Patent protection – 20 years from filing  On average, 11yrs. of productive market life Losec – $2.7Bn in 1998; Nexium (single enantiomer) $7.7Bn in 2008 Lipitor - $1Bn in 1998; $13.8Bn in 2008

19 The “Pay Off”…….to us  Massive contributions to health, quality of life, reduced child mortality, life expectancy  Vaccines have eradicated major disease – smallpox; vaccines for malaria and pneumonia soon……..?  But costs and accessibility to healthcare are becoming major social and geopolitical issues  And, is there something seedy about making money out of illness?  What will happen into the future?

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21 The Companies in 2010

22 Major Therapeutic Targets

23 Top 10 Therapies - sales in 2008 (US$Bn) 2008 sales% share Oncology agents Lipid regulators Respiratory agents Acid pump inhibitors Antidiabetics Antipsychotics Angiotensin antagonists Antidepressants US$227.8Bn32.1%

24 What makes a good drug? Lipinski's rules (Chris Lipinski – 1997) In general, an orally active drug will meet most of the following: Not more than 5 hydrogen bond donors (nitrogen or oxygen atoms with one or more hydrogen atoms) Not more than 10 hydrogen bond acceptors (nitrogen or oxygen atoms) A molecular weight under 500 daltons An octanol-water partition coefficient log P of less than 5

25 Case Study Cimetidine (Tagamet) First lead Burimamide Cimetidine Into volunteers UK US Programme starts H 2 blocker; anti-ulcer/heartburn 1983 First drug to reach $1Bn Cleared for OTC in 1995

26 What is a drug? “ A Chemical Substance that Interacts with a Living System and Produces a Biological Response”


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