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The Pharmaceutical Industry and The Process of Drug Discovery PowerPoint Presentation

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Description : This Pharmaceutical presentation titled "The Pharmaceutical Industry and The Process of Drug Discovery" talks about: - 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

Tags : Drug, Pharmaceutical, Pharmaceutical Industry, Drug Discovery

Published on : Jul 19, 2020 | Views : 1578 | Downloads : 11

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Slide 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
Slide 2-

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

What is a drug? “A Chemical Substance that Interacts with a Living System and Produces a Biological Response”
Slide 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”
Slide 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
Slide 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!
Slide 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+)
Slide 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
Slide 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)
Slide 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 – 1999-2004 due to litigation Avandia – Type 2 (non-insulin dependent) diabetes - 1999-2010 also due to litigation
Slide 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
Slide 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
Slide 13-

The “Lock and Key” analogy Lock Key Binding Biological 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
Slide 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
Slide 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
Slide 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
Slide 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
Slide 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
Slide 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?
Slide 20-

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Slide 21-

The Companies in 2010
Slide 22-

Major Therapeutic Targets
Slide 23-

Top 10 Therapies - sales in 2008 (US$Bn)
Slide 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 http://www.molinspiration.com/cgi-bin/properties
Slide 25-

Case Study Cimetidine (Tagamet) 1964 1966 1968 1970 1972 1974 1976 1979 H2 blocker; anti-ulcer/heartburn 1983 First drug to reach $1Bn Cleared for OTC in 1995
Slide 26-

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

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