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Genentech Case

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Genentech Case
Probleemstelling
Avastin wordt momenteel gebruikt voor de behandeling van gemetastaseerde colorectale tumoren bij de mens. Indien echter uit de lopende klinische proeven blijkt dat Avastin ook ingezet kan worden voor de behandeling van andere neoplasieën (borst-, long-, ovariële tumoren, …), kan dit een toename in de vraag naar Genentech’s geneesmiddelen veroorzaken, waardoor het bedrijf mogelijks zal moeten uitbreiden. David Ebersman, “de senior vice president of product operations” bij Genentech, heeft binnenkort een discussie gepland om te evalueren of het bedrijf reeds moet investeren in een bijkomende productie-eenheid (CCP3), met als hoofdzakelijk doel de productie van Avastin. Eberman moet zijn conclusie omtrent een potentiële uitbreiding begin December 2004 overbrengen aan de overige kaderleden.
De bouw van een bijkomende productie-eenheid duurt echter gemiddeld 4,5 – 5 jaar en vergt $ 600 miljoen. Indien Genentech beslist om een nieuw bedrijf op te richten en Avastin niet succesvol blijkt te zijn voor de behandeling van andere neoplasieën, gaat een aanzienlijk deel van de bedrijfswinst verloren (dat eventueel op een andere manier kon besteed worden, zoals in R&D). Daarnaast heerst er ook onzekerheid over de producten die Genentech’s concurrenten in de toekomst zullen uitbrengen. Indien het bedrijf beslist om uit te breiden, kan dit verder ook leiden tot andere problemen zoals een gebrek aan overkoepelende controle en een verlies van zowel engagement als commitment onder Genentech’s werknemers. Ebersman speelt daarom met de gedachte om de output van het bedrijf te verhogen zonder de bouw van een nieuwe productie-eenheid, via een hervorming van huidige productie processen. Dit laatste kan echter gepaard gaan met bijkomende problemen, zoals een geweigerde goedkeuring door de FDA.
Doelstelling
Evalueren of Genentech al dan niet een nieuwe productie-eenheid (CCP3) moet opstarten.
Methode
Met behulp van een excel-template werd de jaarlijkse totale productiecapaciteit van Genentech berekend, waarbij telkens rekening werd gehouden met het al dan niet opstarten van CCP3. Deze resultaten werden vervolgens getoetst aan de verwachte jaarlijkse totale vraag, die varieerde naargelang het vooropgestelde succespercentage van Avastin in de verscheidene klinische proeven.

Analyse en resultaten
Vervolgens zullen enkele situaties geschetst worden, waarbij telkens de totale productiecapaciteit en de verwachte jaarlijkse totale vraag aan elkaar getoetst worden. Bij deze berekeningen wordt telkens van de veronderstelling uitgegaan dat de bouw van CCP2 beëindigd zal zijn in 2009 en CCP2 in productie kan gaan in het daaropvolgende jaar, namelijk in 2010. Tevens wordt van de veronderstelling uitgegaan dat de bouw van CCP3 de periode 2006-2010 zal bestrijken en CCP3 in productie kan gaan vanaf 2011. In de situaties waar CCP3 deel uitmaakt van de productiecapaciteit van Genentech, wordt allereerst uitgegaan van een productiecapaciteit van 200000 L bestaande uit 8 tanken van elk 25000 L. Vervolgens wordt een situatie geschetst waarbij CCP3 over een productiecapaciteit beschikt van 192000 L, bestaande uit 16 tanken van elk 12000 L. Bijkomende uitleg is terug te vinden in de besluitvorming.
Situatie 1: klinische proeven 100% succesvol, CCP3 niet opgestart
(Berekeningen zie bijlage 1)

Voor de periode 2007-2009 en 2011-2015 zal de totale verwachte vraag de totale productiecapaciteit overtreffen. Enkel in de jaren 2005, 2006 en 2010 zal Genentech voldoende kunnen produceren om aan de totale verwachte vraag te voldoen. Wanneer rekening gehouden wordt met een standaarddeviatie van 0.25 in de totale verwachte vraag, zal het bedrijf enkel in 2005 aan deze vraag kunnen voldoen.

Situatie 2: klinische proeven 100% succesvol, CCP3 wel opgestart, 200000 L
(Berekeningen zie bijlage 2, CCP3 200000

In de jaren 2005 en 2006 zal de totale productiecapaciteit de totale verwachte vraag overtreffen. Hetzelfde geldt voor de periode 2010-2015. Enkel in het jaar 2005 en de periode 2011-2013 zal Genentech kunnen voldoen aan de totale verwachte vraag, indien rekening wordt gehouden met een standaarddeviatie van 0.25 in de totale verwachte vraag.
Situatie 3: klinische proeven 50% succesvol, CCP3 niet opgestart
(Berekeningen zie bijlage 3)

Enkel in de periode 2008-2009 zal Genentech niet kunnen voldoen aan de totale verwachte vraag. Wanneer rekening wordt gehouden met een standaarddeviatie van 0.25 voor de totale verwachte vraag, zal Genentech hier enkel aan kunnen voldoen in de jaren 2005, 2006 en in de periode 2011-2015.
Situatie 4: klinische proeven 50% succesvol, CCP3 wel opgestart, 200000 L
(Berekeningen zie bijlage 4)

In de periode 2008-2009 en de periode 2014-2015 zal Genentech niet kunnen voldoen aan de totale verwachte vraag. Wanneer rekening wordt gehouden met een standaarddeviatie van 0.25 in de totale verwachte vraag, zal Genentech enkel in de periode 2005-2006 kunnen voldoen aan de totale verwachte vraag.

Situatie 5: klinische proeven 100% succesvol, CCP3 wel opgestart, 192000 L
(Berekeningen zie bijlage 5) Enkel in de periode 2007-2009 zal Genentech niet aan de totale verwachte vraag kunnen voldoen. In het jaar 2005 en in de periode 2011-2013 zal Genentech aan de totale verwachte vraag kunnen voldoen, indien rekening wordt gehouden met een standaarddeviatie van 0.25 in de totale verwachte vraag.
Vanaf 2010 overtreft de totale verwachte vraag naar Avastin slechts in beperkte mate de totale productiecapaciteit van CCP2 (zie bijlage 2).
Situatie 6: klinische proeven 50% succesvol, CCP3 opgestart, 192000 L
(Berekeningen zie bijlage 6)

Slecht in 2008 en 2009 zal Genentech niet in staat zijn om te voldoen aan de totale verwachte vraag. Indien echter rekening wordt gehouden met een standaarddeviatie van 0.25 in de totale verwachte vraag, zal Genentech enkel in de periode 2007-2010 niet hieraan kunnen voldoen.
Vanaf 2010 zal de totale capaciteit van CCP2 ruimschoots de totale verwachte vraag naar Avastin overtreffen.

Besluitvorming en aanbevelingen
Indien Genentech niet beslist om een nieuwe productie-eenheid op te starten, zal het bedrijf vanaf 2011 niet langer kunnen voldoen aan de totale verwachte vraag. Om hierop in te spelen, kan het bedrijf enerzijds bijkomende allianties aangaan met andere ‘contract manufacturers’. Hierin schuilt echter het gevaar dat deze partner(s) potentiële nieuwe concurrenten kunnen worden. Anderzijds kan het bedrijf beslissen om via herstructureringen de capaciteit op te drijven. Hierin schuilt echter het gevaar dat de FDA dit niet zal goedkeuren, of dat het bedrijf lang zal moeten wachten op een goedkeuring door de FDA. Een andere oplossing is het opstarten van een nieuwe productie-eenheid (CCP3). Deze optie geniet mijn voorkeur.
Bij de berekeningen werd telkens uitgegaan van de veronderstelling dat de bouw van CCP3 gestart wordt in 2006 en CCP3 in productie kan gaan vanaf 2011. Hierdoor beschikt het bedrijf in 2005 enerzijds over het eerste resultaat van een klinische proef met Avastin, alvorens de bouw te starten en is het bedrijf anderzijds nog net op tijd om te kunnen voldoen aan de totale verwachte vraag. Mijn persoonlijke voorkeur gaat uit naar een productiecapaciteit van 192000 L, bestaande uit 16 vaten van elk 12000 L, vermits CCP2 reeds vanaf 2010 kan instaan voor het leeuwendeel van de vraag naar Avastin. Bijgevolg zijn geen grote tanken van 25000 L nodig om deze tekorten op te vullen. Daarnaast hebben kleine tanken van 12000 L ook het voordeel dat ook andere producten van Genentech hierin kunnen geproduceerd worden.
Bij deze berekeningen werd echter geen rekening gehouden met een mogelijks gedaalde vraag naar Avastin. Dit kan onder andere het gevolg zijn van het uitbrengen van succesvolle producten door concurrerende bedrijven. Verder heerst ook onzekerheid over de dosis Avastin bij de behandeling van andere neoplasieën, waardoor de totale vraag naar Avastin ook kan schommelen.…...

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