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A Discussion of Biotechnology – The Future of the Pharmaceutical Industry? A Discussion of Biotechnology – ..................................................................................1 The Future of the Pharmaceutical Industry?.......................

...........................................1 Background and Sco e...................................................................................................! Pharmacogenetics and Pharmacogenomics....................................................................! "ecom#inant Proteins.....................................................................................................$ %accines.........................................................................................................................& Thera eutic Anti#odies................................................................................................1! Stem 'ells....................................................................................................................1( The Future of Biotechnology in the )*.......................................................................1+

it is remarka#le that such de/elo ment has occurred in this field. such as D8A forensics. Pharmacogenetics and Pharmacogenomics Pharmacogenetics is the study of ho0 an indi/idual<s genetic make=u affects the res onse of the #ody to drugs. 8ot more than forty years since 9atson and 'rick announced they had cracked the code of life.hi#iting this en>yme are du##ed Bslo0 acetylators. The 2uman 3enome Pro4ect has im lications in many fields. ressed roteins@en>ymes resulting from D8A damage. not 4ust a fe0 indi/idual cases. For e. 2istorically. the recommended dose 0as not ade5uate enough to treat the condition. 8aturally. already on the market are Bsmall interfering . For some. It 0as found that the en>yme ?i/er 8=acetyltransferase 0as res onsi#le for the drug<s meta#olism and further study re/ealed that the en>yme e. ad/ances in this field 0ere largely due to mistake . The aim of this ro4ect 0as to identify and se5uence all the some !6666 – !7666 genes that make u human D8A.t 5uestion 0as. as #iotechnology and harmaceutical com anies de/elo drugs that interact 0ith D8A.C Incidences like the isonia>id case and many others lead to a greater understanding of the role genetics lays in drug res onse. the recommended dose resulted in a manifestation of to. a significant ro ortion of the o ulous e.ed drug res onse #eha/iour in atients. legal and social issues 0ith any genetic mani ulation. the t0o olymor hs of li/er 8= acetyltransferase lead to the different res onses to the drug.am le. For e. The 2uman 3enome Pro4ect ser/ed to dee en this le/el of a0areness and no0 the study of harmacogenetics is 0ell esta#lished. Ane olymor h meta#olised the drug too 5uickly for any thera eutic affect to #e noted= indi/iduals e. In the case of isonia>id. thus leading to a #uild u that conse5uently lead to the re/iously mentioned to. of course. licitly 0ith the harmaceutical industry. The ne. since it is not the ur ose of this iece of 0riting.ic effects= indi/iduals e. This essay 0ill not address any of these issues.hi#it the olymor hism. 0ill concern itself e.Background and Sco e In the last millennium .sometimes /ery gra/e mistakes-. Instead.and stretching into this one-. agriculture and anthro ology: this essay. ho0e/er. Polymor hisms are 0ell esta#lished differences in en>yme structure and function i.e. there are many ethical. a great /enture 0as undertaken #y colla#orati/e la#oratories in eighteen countries1 The 2uman 3enome Pro4ect. it 0ill focus on the strategies used in the harmaceutical industry to use gene technology in the attem t roduce safer and more efficacious medicines. 0hat can #e done a#out it? Pharmacogenomics is the ractical element of using genetics in drug design and holds the romise tailor=made drugs may one day #e a#le to #e rescri#ed to #est suit an indi/idual #ased on the atient<s genetic make=u . This is not to #e confused 0ith truncated or ill=e.am le.isted in t0o olymor hs. ressed in more than one form.C The other olymor h did not meta#olise the drug fast enough. each form differing #y erha s a fe0 amino acids. Polymor hism is a henomenon 0here an en>yme is e. For others. This notion is already #eginning to #ecome a reality.hi#iting this en>yme are du##ed Bfast acetylators.ic effects. it 0as found that treatment of tu#erculosis 0ith the drug isonia>id lead to mi.

The gene is cut /ia restriction en>ymes that lea/e Bsticky ends.0ill gro0.molecules. the to layers of cells adhere to a late and are sim ly transferred. enicillin and tetracycline-. The gene and lasmid are then mi. Ane the gene has #een cut it is re licated #y some form of D8A am lification rocess. The #acteria are then cultured on gro0th media im regnated 0ith the anti#iotic that the lasmid contains the resistance gene for. such as the P'" ."8AC . The /ector lasmid is often synthesised to also incor orate an anti#iotic resistance gene for reasons that 0ill #e discussed later. Sometimes. each for a different anti#iotic . The host cell can then roduce that rotein 0here it could not #efore.e. These are the Bsticky endsC and the gene can #e incor orated into a /ector<s D8A. only host cells that ha/e taken u the lasmids .and therefore the gene. that target areas on D8A to halt transcri tion of certain genes 0here it may #e desira#le to do so. Ad/antages of using recom#inant roteins are1 • • • • • Proteins can #e roduced #y organisms that are easy to culture 2igh yielding Dasy to reco/er 'ost effecti/e Safer than using nati/e roteins First. Ance the host cells ha/e #een cultured on the first gro0th media 0ith anti#iotic to 0hich all lasmids contain the resistance gene. Plasmids are circular segments of D8A often found in rokaryotic cells. thus interru ting it. a small sam le of the cells are transferred to a second gro0th media im regnated 0ith the second anti#iotic. 'ells that gro0 on the second media contain lasmids 0ith the intact gene for resistance to the second anti#iotic= these only contain recom#ined lasmids . ty ically #acteria . The t0o media can then #e com ared. This is often done /ia /el/et lating: here.although not al0ays-. Aften. e. This essay 0ill no0 go on to look at some of these com ounds and strategies that are used to synthesise them. 2o0e/er. #ut the colonies are in the same osition. The #asic strategy is to recom#ine D8A from one s ecies 0ith a host cell<s D8A.si"8A.g.ed in the ho e that some lasmids 0ill incor orate the gene. ression of the desired rotein must #e identified and isolated. "ecom#inant Proteins "ecom#inant roteins are so named as they are synthesised from recom#inant D8A. Af course. not all lasmids in this rocess 0ill result in ha/ing the gene. In this 0ay. the lasmids are synthesised to ha/e t0o genes for anti#iotic resistance.citing ne0 com ounds are gri ing the harmaceutical industry<s attention that can mani ulate and use D8A to the atient<s ad/antage. a lasmid is used as a /ector. they cut the D8A in such a 0ay that single sense or anti=sense strands are left un aired. Some 0ill merely re=seal themsel/es at the stage 0here the gene is introduced. olymerase chain reaction-. The lasmid is engineered so that the gene is incor orated in the middle of the second resistance gene. The lasmid is cut 0ith the same restriction en>yme to yield com limentary sticky ends. In summary. the correct gene that is res onsi#le for e. The /ector is then inserted into host cells.C "estriction en>ymes recognise se5uences of D8A that #racket genes and catalyse the hydrolysis of the nucleotides either side of the gene.

added to nutrient #roth and allo0ed to gro0.1666 – 166666 ?.16 – 166 ?. therefore. If the rotein is intracellular. 'hromatogra hical methods in use are1 • • • • Ion e. This essay 0ill detail the most 0idely used techni5ue1 the a lication of chromatogra hy to urify the rotein.fermentor and the culture is gro0n to a s ecific density. 2ar/esting and Purification Ance the ure culture of cells that contain the recom#inant D8A /ector is o#tained. The rotein of interest is generally resented as a lo0 concentration 0ith a 0ide range of contaminants.clusion chromatogra hy 2ydro ho#ic interaction Affinity chromatogra hy . 'ells that cannot gro0 on the second media ha/e taken u lasmids that ha/e the anti#iotic resistance gene interru ted and so do contain the desired gene. This is termed the roduction scale fermentor.g.change chromatogra hy Si>e e. Fermentation. the medium is discarded and the cells are 0ashed and then lysed to release their contents. roduction of the desired rotein is initiated #y acti/ating the e. The cellular de#ris is then filtered and the filtrate is rocessed for reco/ery.e.heat and@or chemicals-. If the desired rotein is e. ranging from small molecules such as anti#iotics and sol/ents to large #iological macromolecules such as other host cell roteins and car#ohydrates.API-. 9orking cell #anks of smaller sam les are then generated from the master cell #ank #efore the cultures are remo/ed to ferment industrial /olumes of the acti/e harmaceutical ingredient . small scale fermentor are transferred to a large scale . This is termed the rimary culture hase Seed culture is transferred to a small scale . must #e urified and concentrated.tracellular. Eany techni5ues can #e em loyed to urify the rotein such as ultracentrifugation and electro horesis. the material is fro>en in glycerol and stored in a master cell #ank at tem eratures lo0er than =176 o'.and not the desired gene. The desired rotein. ression romoter . Ance the a ro riate cell density is achie/ed. All stages must o Be erformed under sterile conditions o Be monitored throughout o Adhere closely to /alidated rocedures • At the end of fermentation. This is termed the seed fermentation hase The contents of the rimary. centrifugation-. the cells are har/ested .fermentor and allo0ed to gro0. the cells are discarded from the centrifuged solution and the su ernatant medium is rocessed for reco/ery. 2ere are details of the fermentation rocess1 • • • The am oule is remo/ed from the 0orking cell #ank.

. thus achie/ing se aration. loiting differences in charge. Strongly charged molecules 0ill #ind more strongly than 0eakly charged molecules.Ion Exchange Chromatography (IEX) IDF se arates the desired rotein #y e. Smaller molecules are hindered #y the orous #eads and take longer to ass through the column than larger molecules. loiting difference in si>e. Size Exclusion Chromatography (SEC) SD' se arates the rotein of interest from other im urities #y e.

g. The formulation needs to consider the route of administration. 5uality.am le1 • • • To ical1 the su#stance is re5uired directly to 0here the action is re5uired e. oral anti#iotics-. it needs to #e formulated rior to resentation and use.Affinity Chromatography (AC) A' is a highly s ecific techni5ue that utilises rotein s ecific ligands to effect se aration. Eany rocessed no0 use A' as a single ste urification rocess and is highly cost effecti/e.non=local-: the su#stance is gi/en /ia the digesti/e tract . Parental1 the desired effect is systemic: the su#stance is gi/en #y routes other than the digesti/e tract .e.g. Formulation is a critical stage in the manufacture of #io harmaceuticals as it ensures the efficacy. sta#ility and safety of the roduct rior to reaching the atient. intra/enous anti#iotics-. . Formulation Ance the API is urified.e. sul#utamol for asthma inhalers Dnteral1 the desired effect is systemic . for e.g.

in AIDS- Case Stu y ! Somatotropin (Human "ro#th Hormone) Somatotro in deficiency can arise from se/eral human illnesses such as1 • • • • Turner<s syndrome1 artial or com lete a#sence of an F chromosome in females S2AF deficiency1 chromosomal gene deletion 2ormone deficiency1 malformation of hy othalamus. coli Ieast Animal cells E. coli Animal cells Eammalian cells Eammalian cells Application Dia#etes 3ro0th hormone 'ancer Eyocardial infarction@ ulmonary em#olism 'arcinoma@ melanoma 2aemo hilia Anaemia . Protein Sta#ility Proteins ha/e oor hysical and chemical sta#ility. Then.free>e dryingPD3lyation .- .somatotro in for in4ection. in 1&+7. coli E. coli #y Dli ?illy. e/en 0hen refrigerated or fro>en.0as marketed #y Dli ?illy L com any.the attachment of a fle. unusual cases of 'reut>feldt=Jaco# disease .am les of "ecom#inant Protein Products The first commercial a lication 0as the roduction of human insulin from E.a degenerati/e neurological disorder.i#le strand or strands of olyethylene glycol . The en>yme used to #e isolated from the ituitary glands of cada/ers and 0as /ery e. coli E. T0o methods are used to im ro/e sta#ility1 • • ?yo hilisation .D. Somatotro in has recently #ecome the first B#iosimilarC to #e a ro/ed for use.PD3.am les are1 Protein 2uman insulin 2uman somatotro in Interferon G!a@ G!# Tissue lasminogen inacti/ator Interleukin ! Factor %III Drythro oietin Year 1&+! 1&+7 1&&! 1&+H 1&&$ 1&&! 1&+& Host E.to a rotein. Ather e. ituitary gland or trauma2y o ituitarism1 non=functioning ituitary gland Patients 0ith these conditions are una#le to roduce sufficient 5uantities of nati/e gro0th hormone and therefore re5uire re lacement thera y. In 1&+7. 2umatro eK . ensi/e. coli deri/ed recom#inant en>yme. an E. Based on the assum tion that infectious rions 0ere resent in the cada/er=deri/ed 232. it 0as remo/ed from the market.0ere re orted in indi/iduals 0ho had recei/ed cada/er=sourced somatotro in treatment ten to fifteen years re/ious. coli E.

enses 2o0e/er.$yophilisation Ad/antages1 • • • Einimal damage and thus minimal loss of acti/ity ?o0 finial moisture content of roduct. Princi les1 . the ad/antages out0eigh the disad/antages. therefore longer shelf life Dase of reconstruction Disad/antages1 • • Slo0 2igh o erating e.

osure of the immune system to antigens leads to roduction of anti#odies . 0eight. D. This resulted in arents making the otentially dangerous decision to refuse to ha/e their child /accinated. This immunisation is often only tem orary and can #e thera eutic or ro hylactic. Antisera are anti#ody containing serum re arations from animals that react 0ith a circulating antigen.s arked fears of an autism connection 0ith the EE" /accine. a a er u#lished #y the ?ancet . EE" 'ontro/ersy In 1&&+.PE"lyation The si>e.ic Am ho hilic PD3lyation roceeds /ia co/alent #onds #et0een a s ecific acti/e grou on the rotein and a chemically reacti/e grou on the PD3 PD3lyation can #e either linear or #ranched 'urrently a/aila#le PD3lyated drugs include1 • • • PD3interferon – anti/iral agent PD3figrastim – chemothera eutic PD3adenosine isomerase – en>yme re lacement %accines Immunity Ac%uire Immunity D. cholera and tetanus /accines. Immunisation may #e either thera eutic or ro hylactic. As a result.9akefield et al.to stimulate anti#ody roduction. %accination uses modified antigens .IgB#y B lym hocytes M ac5uired immunity. sha e and the linkage used to connect the PD3 strand to the molecule determine the im act PD3lyation has on1 • • • • • Delayed a#sor tion Decreased roteolysis Increased circulation lifetime Slo0ed renal clearance "educed immunogenicity Im ortant notes on PD3s1 • • • • 8on=to. s ider anti/enins.to reduce clinical risk. . D. Passi&e Immunity Introduction of anti#odies into the system confers assi/e immunity 0hich is transient.am les1 EE".am les1 snake /enom antisera.

?AI%-. This . Ty es of %accines T0o con/entional ty es of /accines are a/aila#le1 • • 9hole cell /accines o ?i/e@attenuated /accines o *illed /accines Su#unit /accines "esearch continues into recom#inant /accines and D8A /accines. 'hole Cell (accines Feature Dose 8o. IgB Poor Im ossi#le *illed /accines1 • • Pertussis . A %irus=?ike Particle %accine . #ut does not carry any of the genes that allo0 for /iral re roduction or infection.0hoo ing cough'holera Case Study – Flu Vaccine Influen>a kills hundreds of thousands of eo le er year 0orld0ide. "ecent re orts ha/e refuted 9akefield<s claims and the 3E' ha/e recently charged 9akefield 0ith Serious Professional Eisconduct. Flu /accines are made seasonally using three strains chosen #y the 92A 3lo#al Influen>a Sur/eillance 8et0ork.am les1 ?i/e@attenuated /accines1 • • • • EE" Polio /irus Iello0 fe/er B'3 Live/attenuated vaccines ?o0 Single 8o Eany years IgB 3ood Possi#le Killed vaccines 2igh Eulti le Ies ?ess IgA. Doses Ad4u/ant needed? Duration of immunity Anti#ody res onse 'ell mediated immunity "e/ersion to /irulence D.incidences of measles ha/e #een on the rise since 1&&+. Flu /accines are a/aila#le #oth as an in4ection of killed /irus and as a nasal s ray of li/e attenuated influen>a /irus .%?P.is a three dimensional mimic of the /irus.

Pneumococcal Vaccines Streptococcus pneumoniae is the largest re/enta#le killer in children under fi/e. #acteraemia. ressing genes for influen>a /irus haemagglutanin. ression 0ithin the host has im ortant immunological conse5uences. • *ther (accines Recombinant Vaccines These are created #y utilising #acteria or yeast to roduce large 5uantities of a single /iral or #acterial rotein.g. A single recom#inant Vaccinia /accine e. Case Study.P'%-1 o Eanufactured using ca sular olysaccharides from H /irulent strains con4ugated 0ith di htheria '"E1&H rotein. sinusitis. This rotein is then urified and in4ected into the atient and the atient<s immune system makes anti#odies to the disease agent<s rotein: thus rotecting the atient from natural disease e. resulting in the s ecific immune acti/ation of the host against the gene deli/ered antigen. ?i/e recom#inant Vaccinia /iruses ha/e #een constructed conferring immunity to diseases in e. S. . Initial results sho0 that this form of /accine may #e /ery effecti/e. children under t0o years old-. 3ardasilN for 2uman Pa illoma/irus . /irus glyco rotein confers immunity to all three diseases in monkeys.g. • !$=%alent Pneumococcal Polysaccharide %accine . pneumoniae is also the most common cause of #acterial meningitis in adults and children. %?P /accines can #e mass= roduced 5uite effecti/ely.stimulates the immune system against a ossi#le later emergence of the authentic /irus.2P%-. erimental techni5ue used to efficiently stimulate immune res onses to rotein antigens. endocarditis and #rain a#scesses.PP%-1 o Eanufactured using ca sular olysaccharides from !$ /irulent strains o 2ighly effecti/e in those older than ! years H=%alent Pneumococcal 'on4ugate %accine . o Eore effecti/e for immune res onse in toddlers under ! years old. The organism causes many ty es of infection such as neumonia.i. meningitis.e. otitis media. erimental animals.e. Su)unit (accines These are ty ically com rised of surface antigens or #acterial olysaccharide ca sule fragments that are immunogenic. he atitis B ma4or surface antigen and her es sim le. the antigen-. The direct in4ection of mani ulated gene material into the host results in a small amount of its cells roducing the induced gene<s roducts . DNA Vaccines D8A /accination is an e. The foreign gene e. Eany /accines are con4ugated into roteins to increase the o/erall immune res onse in those 0ith 0eaker rimary immune systems .

Eonoclonal= A ure #reed anti#ody that is s ecific to a single e ito e. the thera eutic anti#ody can #lock the gro0th of a tumour and@or recruit the #ody<s immune system to attack the target an can also sensitise a cancer cell to chemothera y. Anti#odies may #e1 • • Polyclonal= A mi. can #e used alone. in com#ination 0ith chemothera y or as a carrier of su#stances such as to.ture of anti#ody molecules secreted against a s ecific antigen.Thera eutic Anti#odies Thera eutic anti#odies are la#oratory=engineered anti#odies that recognise and #ind to a rotein antigen on the surface of a cell. After #inding to the targeted site. each recognising a different e ito e.ins or radiation. Dach anti#ody is made u of t0o identical light chains and t0o identical hea/y chains. Dach thera eutic anti#ody recognises a different antigen and. 8otes on Anti#odies Anti#odies are roteins that #ond /ery tightly to their target antigens. in general. Polyclonal Anti)o ies .

cloned anti#ody roducing cell. it is ossi#le to roduce a o ulation of cells.+onoclonal Anti)o ies A mouse is immunised #y an in4ection of antigen F to stimulate the roduction of anti#odies targeted against F. . Eonoclonal anti#odies are roduced #y fusing these single anti#ody=forming cells to tumour cells gro0n in culture. each of 0hich roduces identical anti#ody molecules. The resulting cell is called a hy#ridoma. it can #e used as a s ecific ro#e to track do0n and urify the s ecific rotein that induced its formation. Dach hy#ridoma roduces relati/ely large 5uantities of identical anti#ody molecules. By allo0ing the hy#ridoma to multi ly in culture. These anti#odies are called monoclonal anti#odies #ecause they are roduced #y the identical offs ring of a single. Ance a monoclonal anti#ody is made. The anti#ody forming lym hocyte cells are then isolated from the mouse<s s leen.

The mA# selecti/ely #inds to human immunoglo#ulin D . 3enetic engineering has allo0ed the generation of chimeric. Eode of action1 . "ypes o# !onoclonal Antibodies Eouse hy#ridoma technology generates mouse monoclonal anti#odies . there are differences. In contrast to chimeric mA#s.regions using genetic engineering. The human immune system hence recognises murine anti#odies as foreign. only the com lementarily=determining regions .are of mouse origin in humanised mA#s. Examples of . A solution to this ro#lem 0ould #e to generate human anti#odies directly from humans.IgD-. humanised and human mA#s.Problems wit !urine !onoclonal Antibodies Although murine anti#odies are /ery similar to that of human<s. ra idly remo/ing them from circulation and causing systemic inflammatory effects. antigen s ecificity can #e conferred #y grafting a ro riate murine 'D"s onto human /aria#le .%.mA#s-. 0hich form the anti#ody=#inding site. IgD is commonly in/ol/ed 0ith allergies 0hen resent in high amounts in the #ody. Therefore.'D"s.herapeutic Anti)o ies $olair% FolairK is a monoclonal anti#ody made #y 8o/artis and used mainly in allergy= related asthma thera y 0ith the ur ose of reducing allergic hy ersensiti/ity. The /aria#le domains of anti#odies contain three such hy er/aria#le 'D"s.

&erceptin% 2erce tin is a humanised mA#. It #inds to 2D"!.that is found on some tumour cells . To date. a rece tor for e idermal gro0th factor . 2erce tin seems to #e the only mA# effecti/e on solid tumours.D3F.some #reast cancers. lym homas-. Eode of action1 .

0ith the otential to roduce o/er !66 different ty es of cells in the #ody. cornea. kidney.#.self rene0al"emain uns ecialised 0ith no s ecific function or #ecomeO S ecialised . #one marro0.are used in regnancy testing kits.left o/er from I% fertilisation in the la#oratory or .from a#orted foetuses. Directed against 'arcinoma= associated antigen 2uman carcino= em#ryonic antigen 2uman cardiac myosin Disease/ condition Small lung cell carcinoma 'olorectinal cancer Eyocardial infarction imaging Antibody 8ofetumo#a# Type Eurine Fa# fragment Arcitumo#a# Eurine Fa# fragment Imicroma# enetate Eurine Fa# fragment Stem 'ells Stem cells are e. li/er. . 9estern Blotting and D?ISA techni5ues.ReoPro% This is manufactured using the antigen #inding fragments and inhi#its the clum ing of latelets #y #inding to the rece tors on their surface that are normally linked together #y fi#rinogen. Adult stem cells1 Stem cells ha/e #een found all o/er the #ody including the #lood. It is therefore hel ful in re/enting reclogging of the coronary arteries in atients 0ho ha/e undergone angio lasty. #rain.2'3. to.ins or roteins1 • • • EA#s to human chorionic gonadotro in . um#ilical cord.traordinary #ecause1 • • • They can di/ide and make identical co ies of themsel/es o/er and o/er again . Dia'nostic mAbs Anti#odies are used in se/eral diagnostic tests to detect small amounts of drugs. There are t0o ty es of stem cells1 • • Dm#ryonic1 from inner mass if #lastocysts . Diagnosis of certain cancers in tissue #io sies. skin. dental ul .a. sali/ary glands etc. muscles.differentiated.

adult stem cells1 Embryonic Pluri otent1 can #ecome almost any cell Sta#le1 can undergo many cell di/isions Dasy to o#tain #ut #lastocyst is destroyed Possi#ility of re4ection Adult Eulti otent1 can #ecome many cells #ut not all ?ess sta#le1 ca acity for self rene0al is limited Difficult to isolate in adult tissue 2ost re4ection minimised .Dm#ryonic %s.

Eean0hile. or less. a osition a er u#lished 0ith the )*. Added to this 0ere continuing e.are currently #eing treated 0ith stem cells. Bioscience !617 0as u#lished shortly #efore the introduction of the BD) 'linical Trails Directi/eC issued after the T38 1Q1! Anti#ody 'T Study. Stem cell thera y also has the otential to regenerate tissues@ organs and cure more diseases such as dia#etes and multi le sclerosis. . genetics and #iotechnology are fuelling a mood of great o timism a#out the sector<s future. financial conditions ha/e 0orsened in recent years and in/estors are #ecoming increasingly reluctant to in/est in emerging #ioscience com anies and the u#lic markets are all #ut closing do0n.t fe0 years. 2o0e/er. The )*<s artici ation in glo#al clinical trials dro ed from (R in !66! to !R in !66(. "ather than harmonising clinical trials acti/ity across Duro e. coincided 0ith the 76 th anni/ersary of the u#lication of the structure of D8A: 0ith a flood of media ieces on genes. This is cou led 0ith an increasing recognition that it must look to third arties to hel re lenish its i eline. ectations on 0hat the 23P announced in !666 could deli/er for human health. the Directi/e has had the o osite effect 0ith different mem#er states im lementing its re5uirements more.Stem 'ell Treatments 2uman diseases such as Parkinson<s disease and leukaemia .as #one marro0 trans lants. The Future of Biotechnology in the )* Bioscience !617. It must #e re/ie0ed to ensure consistency and to re/ent Britain ricing itself out of drug de/elo ment. stringently. 8either the go/ernment nor the #ioscience industry has #een a#le to re/ent this financial free>e. the harmaceutical industry faces its o0n issues 0ith a atent BcliffC e5ui/alent to P1Q6 #illion in sales as se/eral #lock#usters come off atent in the ne.

Ea4or de/elo ments in the )S highlight one of the most im ortant issues facing harmaceuticals and #iotechnology data1 drug ricing. " L D is increasingly e. .including the cost of failures-. ensi/e: studies ut the cost of utting a ne0 drug for ma4or chronic diseases onto the market at u 0ards of P+66 million .