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Download - Society of Economic Geologists

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APRIL 2006 • No 65 SEG NEWSLETTER 11TABLE 2. The Drug Development Process: What Happens and When, Compared with the Exploration and Discovery Process (Source:Pharmaceutical Research & Manufacturing Association)CLINICAL TRIALSEarlyFDAResearch/ReviewPreclinicalProcess/Testing Phase I Phase II Phase III Approval On Market Phase IVYears 6.5 1.5 2 3.5 1.5 Took 15 yearsto get HERETest Test Tube 20-80 100-300 1000- PatientsPopulation and animal healthy patients 3000studies volunteers patientsPurpose Look for Determine Evaluate Confirm Postsafety, safety and effectiveness, effectiveness, marketingdesired activity dosage for look for look for surveillancenext phase potential side effects <strong>of</strong> the patientstoxic side from long term to look foreffects use potentialproblemsSUCCESS 5000 5 compounds 1RATE Evaluated enter clinical trials COMPOUND APPROVEDMINING EXPLORATION PRE-FEASIBILITY POSITIVE ECONOMICFEASIBILITYMINEbusiness, it is no more so than otherindustries. Therefore, it is worth consideringwhat innovative approachesother R&D sectors have used toincrease their chances <strong>of</strong> success.WINNOWING AWAYIdeas succeeding at each new product-development stageProjects succeeding at each new discovery-development stageRAWIDEASUNWRITTENIDEASSUBMITTEDSMALLPROJECTS1 2 3 4 5 6 7The first-generation biotechnologyfirms revolutionized how drugs weremade and also created a new kind <strong>of</strong>company environment. The focus wason productivity, not established1. Entry into country or region 5. Definition drillingLARGEDEVELOPMENTSMAJORDEVELOPMENTS2. Regional exploration 6. Pre - feasibility study50001000500100501051LogScale3. Drill targets 7. Positive feasibility study4. Follow - up drilling after initial favourable resultsLAUNCHESSUCCESScorporate behavior. Scientists were supportedby management and touted asthe key ingredient for success. Thebiotechnology industry showed itself tobe extremely adept at creating newways to support the front end <strong>of</strong> theprocess—discovery. The industrybecame so successful that the largepharmaceutical companies now devotea hefty share <strong>of</strong> their R&D budget tosupporting research within thesesmaller biotechnology companies(Robbins-Roth, 2000). It has long beenrecognized that managing R&D at acorporate scale <strong>of</strong>ten does not produceresults proportional to the expenditure—youcan’t just throw money atit—and that smaller R&D companiesare far more successful in this regardbecause they are motivated andfocused. However, the same caveatapplies, that exploration success willnot necessarily be proportional to thelarge increase in spending in the juniorsector (Metals <strong>Economic</strong>s Group,2005a).In addition to investing in thebiotechnology sector, the major pharmaceuticalcompanies have tried toemulate their success by copying theirstructure and splitting their R&D intosmaller, competitive divisions. Pfizer,the largest pharmaceutical company inthe world with a £4.3 billion($7.7 billion) R&DFIGURE 2. Winnowing away. Risk in all industries compared with risk in exploration and discoveryin the mining industry. Adapted from Industrial Research Institute, 1999. to page 12 ...

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