Pharmaceutical Technologist - May 2008 - (Page 23)

SMEs versus CROs the top tier CROs through quality, customer care, flexibility/adaptability and scientific excellence. Each of the four categories listed will be evaluated to demonstrate how the one-stop-shop of the global CRO doesn’t always meet what the customer is looking for. It is in this landscape that the SME finds itself, but there are a number of ways it can differentiate itself from the full-service providers to carve a niche in which to operate and flourish. Quality The concept of quality in the pharmaceutical industry is the most basic of building blocks and should be integral to all scientific processes. Patient safety must be at the centre of all activities undertaken in support of the drug development pipeline, and there are regulatory bodies within countries or continents that set levels of expectation and then monitor compliance with these standards. There is the expectation that every modern CRO possesses demonstrable compliance with either good laboratory practices (GLPs), current good manufacturing practices (cGMPs) or good clinical practices (GCPs) or, more likely, a combination of all three operating under a GxP banner. It is taken for granted that CROs will be either inspected by Medical and Healthcare Products Regulatory Agency or FDA, and that the quality system of the CRO will be able to withstand both regulatory and customer scrutiny to the finest level of detail. With the resources that are available to the multinational CRO, how can an SME compete? The concept of compliance must be taken as granted to be either a preferred supplier or to be listed on a licence. Prior to the commencement of any projects, audit inspections and due diligence will have assessed whether all or any of the The global market It is a common misconception that outsourcing is a recent phenomenon that has rapidly developed into a multibillion dollar industry as the concept of outsourcing can be traced back to the middle ages to the construction industry. Today, the total market revenues from CROs in the drug development sector are valued at $18.2 billion (€11.5 billion), with estimates for 2010 approaching $23.7 billion (€15 billion), a 30% increase in a 24-month period.1 This market is traditionally segmented into three regions: the US, Europe and Asia Pacific. With in excess of 1000 CROs operating across the globe, it is conceivable to believe that no one company would have dominance in the marketplace, but that there would be a greater division (though not an equal proportioning) of the share of the revenues. As it stands, 45% of the total market share is dominated by 0.5% of the available CROs. To meet the expectations of shareholders and investors, global CROs are continuously expanding their portfolios of available services and attempting to differentiate themselves from the competition. For many full-service CROs, differentiation is the Holy Grail of today’s market, which fuels acquisition over organic growth as the CRO behemoths compete to gain market share through the size of service offerings and the strategic fit with all and any outsourcing party. Outsourcing drug development pipeline is an established and mature marketplace. Price competition is commonplace, and the client’s expectation of what activities and level of support will be included in the package is ever increasing. With large resources and a significant reach in the marketplace, the global CRO has the ability to sweep aside all that comes before it. aforementioned quality systems have been practically demonstrated. The answer, however, lies in the concept that quality should not only be restricted to regulatory compliance, but that it must be an integral part of every aspect of the company; effectively a thread that runs through every facet of the business and that is demonstrably visible to the customer. From the manner that telephones are answered to elements such as invoicing and nonscientific or nonproject queries, the customer must be presented with an absolute feeling of quality in the service. The concept of quality in the pharmaceutical industry is the most basic of building blocks and should be integral to all scientific processes. As we are reminded so often by our quality managers, quality must be built into processes and products, and should be an integral component of everything we do. This is true now more than ever, and for the SME it should extend beyond the laboratory into every aspect of the business and customer interface. Customer care It is an old adage, but it is one that is still used today: the customer is always right; it is the customer who best understands their product, how it performs and what they are looking for. However, it is also the role of the On the go ● ● ● ● ● Through strategic M&As, many CROs are trying to be a ‘one-stop-shop’ for customers. The outsourcing marketplace is rapidly becoming larger and the key to success is to differentiate yourself from the competition. Both CROs and SMEs must provide quality, customer care, flexibility/adaptability and scientific excellence. For SMEs, offering a more unique, specialized service can be beneficial as the SME may possess insight or expertise that the CRO lacks. Although there is a growing number of CROs, they cannot meet all the needs for pharma, biopharma and biotechnology companies, creating an opportunity for the SME. www.ptemagazine.com 23 http://www.ptemagazine.com

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Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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