78Pharma Focus asia
ISSUE - 6 2008
Companies need to identify the situations where PAT investmentis most likely to be cost-effective and be clear about the purposeand scope of the project as well as how it helps the company to achieve its longer term manufacturing vision and strategy. Thefollowing series of questions can help in such identification:
– How does the PAT project fit with the company’swider product and manufacturing strategy? Also, what are theproject’s specific R&D or manufacturing benefits, such asoperational savings, faster time to market, increased machineavailability, less waste etc?
– How much investment, including capitalexpense, planning and deployment, training, and ongoingmanagement and support, will the project require?
– What are the expected financial returns of theproject, including ROI, savings and what is the payback period?
Key rOi Qesos
– How will the PAT project contribute tooverall enterprise efficiency? Is the enterprise and knowledgearchitecture in place to capture these gains?
– What are the potential risks associated with the project?How likely are they and what contingencies need to be in place?What would be the impact on the financial return and strategicgains?
Coptiti ad rptatioal ipact
– What competitiveadvantage can be gained? What are the reputational implicationsof investing or not investing in PAT? How does the proposedinvestment compare with competitor’s PAT plans?
Accotability ad owrhip
– Who is accountable for theproject’s success? Is the project owned by top management? Is there sufficient leadership to deliver the change in working methodsand culture that will be needed for the project to be successful?
implemented (Figure 1), not just look-ing at quality and process control butgoing ar beyond this to consider regu-latory relationships, the needs o health-care organisations and, ultimately, thelinks with patients. An important parto the US Food and Drug Administra-tion’s vision or PA, or example, is thatthe adoption o the technology by thepharmaceutical industry will help closethe gap between drug product develop-ment and the patient. In the uture,it is hoped that PA will be part o aeedback loop that can enable compa-nies to take account o how a specicdrug is perorming in specic patientcontexts and adjust ormulations andmanuacturing accordingly.In addition to these uture visions,the development o PA and decisionsabout the best roll-out o the technol-ogy needs to be taken in the contexto a company’s current and projecteddrug portolio, reecting the dierentmanuacturing needs o products thatare in the pipeline. In other words,decisions on PA cannot be takenaway rom the context o the threekey major elements—the company’suture business and product strategy, itsorganisational setting and external envi-ronment. However, in my experience,this consideration o wider external orinternal context oten does not takeplace when it comes to PA projectsin pharmaceutical companies. Compa-nies requently view PA in exactly theopposite way, deciding to buy a coupleo tools to replace existing lab measure-ment methods and see where that leadsthem.Tis consideration o contextoutlined in Figure 1, in turn, leads tosome o the parameters or the ROIanalysis both on the cost and thebenets side. For example, investmentin PA should be expected to delivertangible perormance improvementsin R&D and manuacturing processes,such as reduced waste, aster through-put times and, ultimately, the potentialor real-time product release. At thesame time, there will be wider company implications, such as retraining or rede-ployment whose costs will need to beully actored in.
Rooting ROI in strategic ambition
Te design and extent o the ROIanalysis will be largely determined by the extent o strategic ambition behindthe PA implementation. Tere isa big dierence between a company that is seeking to develop PA in agreeneld setting, aiming or ull real-time product release, and a company that is seeking to improve an existingaspect o manuacturing, perhaps on asingle unit operation such as drying. Inmany situations, companies can start with a small application o PA onone part o the production process, orexample on a single unit operation suchas drying, beore moving on to a moreglobal view. A typical start point, orexample, might be the establishment o an end-point detection or a dryer orgranulator. Indeed, in our experience,the most common applications o PArelate to online monitoring o blending,drying and granulation steps.In all instances, the goal should besome clearly identiable perormanceimprovement. However, as discussed,many companies do not even startby identiying such clear change butinstead all into the trap o seeing PAmerely as an alternative to existingactivities, or example investing in anin-line process analyser as a replacement
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