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Lecture 7

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BIOL 1010
James Cheetham

Lecture 7: Biotechnology and the Pharmaceutical Industry-Wednesday, October 27, 2010 - look at American TV channel and count the number of drug company ads - marketing of pharmaceuticals - At least a third, especially during Superbowl - In terms of sales, only company that tops out in terms of total gross sale revenue is Japan tobacco company - Then Johnson and Johnson, Merca, Visor (pharmaceuticals) - Changed by biotechnology since we discovered how to use recombinant proteins - Genentech was bought out by a pharmaceutical company - Lots of money to be made in this field - large-scale production of drugs came after discovery of antibiotics - usually drugs deal with small molecules (small number of atoms- Aspirin) - Big companies like small molecules- easy to make, can study how body metabolizes easier - Small companies like big molecules like proteins - Therapeutic hormones- Humulin made in 1982 o If desperate, people would have to extract insulin from human cadavers o Biggest biotech therapeutics on the market - First time in NA, person tested positive for Human Growth Hormone- difficult to test for this unless person tests for several standard deviations above normal o 2010- British apprehended rugbee player o Unintended consequence of developing therapeutic- for short or fragile elderly (reduces chance of breaking bones) o Whole Hollywood subculture about HGH, led by Sylvester Stallone- saying people should take it to feel younger o Interesting spin-off of something designed for therapeutic use - Pharmaceutical: small-molecule drugs (Aspirin, prozac) - Biopharmaceutical: proteins, drugs produced by microscopic organisms (bacteria, yeast), or animal cells in culture, or transgenic animals o HGH, insulin- act like natural compound in body using recombinant DNA technology o Usually identical to natural compount - Whole field of antibody production- blood test for drug (diagnostics) - Bacteria- zone of inhibition where antibiotics are put o Still gets done in clinical labs o If you think you have some infection, nurse takes swab from throat, plates bacteria on dish with different antibiotics- determine which antibiotic would help infection o *Pharmagenomics- tailoring medication to your genome, like tailoring medication to particular infection you have - Ancient Egyptians o Idea of using fungus as antibiotic- mouldy bread on wounds o *Chinese: mouldy soybean curds for infection - After WWI, dawn of antibiotics- Julius Wagner-Jauregg o Syphillis parasite sensitive to heat- could be cured with high fever o Treatment: give people malaria- high fever- killed off syphillis o Malaria could be treated with quino (drug available at the time) o Turns into neurosyphillis and kills - Ironically, year after he got Nobel Prize (1927), Fleming (1928) discovered penicillin (antibiotics) so he could cure syphillis without giving malaria o First real antibiotic o Microorganisms produce these things- compete for a niche- different species of bacteria competing for same place- dump out substances that would kill the others o Selection for bacteria that produce these antibiotic substances o Was doing experiments- thought his nasal mucus had antibacterial effects- smeared a plate with staphylococcus aureus and pneumonia o 1928- smeared plate with staph., left, lab below was working on fungus called penicillium o Returned, his plates were messed up, then saw that clear halo around fungus that contaminated- fungal spore flew in and landed in dish- had chance to grow up before bacteria did, so it could produce antibiotic and bacteria could grow in circle around it o First to recognize importance of his findings- chance favours the prepared mind - Florey and Chain could scale up production of fungus (penicillin) o Got Nobel Prize along with Fleming o Could produce lots in time for WWII - Start of large-scale pharmaceutical production o Companies like to make lots of money making drugs that you use for the rest of your life, rather than antibiotics o Less appealing financially - Insulin is protein (not small-molecule drug)- but still one of big pharmaceutical discoveries o Treatment for diabetes used to be starving the person- but it would take longer to starve to death than just take the sugar o Hard to purify the insulin- pancreas produces digestive enzymes to go into intestines- when you try to purify insulin, gets broken down by enzymes - Banting and Best o Extracts of pancreas, in dogs o Purified insulin from pancreas o Controversial in their time- treating people for diabetes with something purified from dog pancreas o Public has trouble accepting these things o Governor (NY?) Hughes had daughter Elizabeth, with diabetes, tried to get them to test his daughter, she lived. Because that happened, she became famous patient and it was accepted. - Chemically synthesized from individual amino acids in 1963, by Linus Pauling - Boyer (recombinant DNA) - Swanson (business guy) o Excited by Boyer and Cohen’s discovery o Contacted Boyer o Genentech o Moving technology from lab bench to clinic - Pharmaceutical industry and biotechnology industry interactions o Biotech is good at finding things, but can’t go through clinical trials and bring it to markets o Need infrastructure (for testing, doctors, etc.) o Partnered with pharm. Industries (Lilly) to bring it to market - Hoffman- another pharm. Comp - Access to Excellence- lots of tutorials and info about biotech - Genomics: o Recombinant systems produced from microorganisms o Etc. - Modern biotech: genomics and proteomics important - A lot more drugs coming out now - Don’t need to memorize the top ten biotech proteins, but important to keep in mind - Epoetin alpha- synthesize red blood cells- helps with renal disease (kidney disease) - Over half of new biotech drugs targeted towards treating cancer - Lots of biotech companies have partnered with pharm. Companies because of the complexity and costs of clinical research - Also very stringing regulations in all countries- gov. policies - Pricing- money used to develop makes them expensive - High-risk investment- most drugs don’t make it to market- but it pays off when it’s in market - Phase I- safety- first time it’s tried in humans (does it kill a person?) - Phase II- define the dose o Difference in the way each person metabolizes drugs - Phase III- have to pay nurses, doctors, statisticians, etc. - Phase IV- can be used for more than one thing - Takes less time if it treats fatal disease (HIV) - Can be over $1 billion for a drug - Have to show that drug benefits individual o Lowers cholesterol- so what? o Do longer studies - Colon cancer- modern treatment (with recombinant drugs)- $250,000 - Politicians and other people should ask whether it’s worth the $20,000/extra month - This is all an industry- want to ensure future investments o Favourable cost-effective analysis- make sure the thing works o Drug costs still lass than 10% of total costs of healthcare- main thing is salaries o Should prices be based on cost of production? What is value of drug? Why are prices lower in other countries? Ask yourself. - Insurance companies- co-pays (you pay part and they pay part) - We don’t really have legislation on this stuff - U.S.- biggest place for patents in the world o Biggest pharm. Market o Patent agent gives you right to sue someone if they steal your invention o Copyright- physical manifestation of the idea - US patent, European Union Patent, Rest of World patent - Patent expires- generic drug makers take over- patent companies try to do patent extension to not lose all that money - Market risk- someone else will have come up with better idea • Movie with Harrison Ford and Brendan Fraser- Extraordinary Measures - brewery- vats for yeast- same thing as bioreactors - Milwaukee- became biotech centre o Breweries dying out in ‘70s and ‘80s, bought by biotech companies o Converted fermenters into something to grow industrial enzymes in - Things like EPO are more expensive to manufacture because you grow them in mammalian cells - One of biggest countries for vaccine production- Cuba o Lots of countries had been producing lots of vaccines before Soviet Russia collapsed o They picked up the slack- vaccines for developing world - We don’t have many antiviral drugs o Virus mutates so fast - Also don’t have many antifungal drugs - Vaccines treat virus infections before they happen - Vampire bat- blood clots and saliva pushes it back to unclotting o Lives on blood, evolved effective enzyme o Recombinant tPA or tPA - tPA: causes blood clot of damaged tissue to break up- plasminogen gets activated to plasmin, fibrin of clot breaks down, clot dissolves - *Urokinase inhibits, streptokinase activates it (this is the standard treatment) - Myloloma cell line=cancer cell line - Can harvest broth they’re growing in, purify it o CHO cells are used a lot in biotech o CHO cells make t-PA and dump it out into cell culture o These become transgenic cells (CHO) o Use recombinant DNA to make it- rtPA - First example of protein produced using pharming technique - Murine Whey Acid Protein Promotor- DNA tells gene to only express if it grows in milk - LA- long acting- protein’s been engineered to work better o Glycosylated- sugars added o Stays in blood longer - Zygote from goat- inject in vector DNA (designed to only express in goat’s milk) o Some in nucleus o A few incorporated into chromosome o Both daughter cells will get it- have altered germline o Only cells that produce milk can express the protein o Recombinant zygote implanted into goat- gives birth to baby goat- baby produces milk- tPA - Argument: this is natural product- FDA refuses at first - Should companies produce drugs that are marginally more effective and maximally less expensive? - US patent for tPA- suing-o-rama o Genentech sues Wellcome and another group for collaborating to create tPA, etc. o Lawyers make a lot of background, especially with science background - Is cost of making recombinant products the most useful use of resources- big issue - Genomics helps biotech identify drug targets o If you’re going to develop recombinant protein, must have target it mind o Find out what genes are involved o Find it in mice, remove gene from mouse (knock-out) o So much redundancy in mammals- still live o Helpful for learning about function of gene o We do inducible knock-outs- before, genome would be turned off throughout entire lifetime- now, gene functions fine, give it drug with gene turned off and see how it reacts - Need research to identify how patients respond to things- some people have really bad reaction to general anaesthetic, for instance o Some people with mutation in mitochondria have near fatal reaction to general anaesthetic o Tailor a treatment to individual based on genome: Phamacogenomics  To do that, need DNA profile - Pharmacogenomics o In order to tailor treatment to individual, need
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