Contract research organisations (CROs) are evolving. No longer content with individual research projects, they are moving further into mainstream pharmaceutical activities. Sean Ottewell looksat recent developments and finds many CROs are reorganisingin anticipation of a blurring of differences between them and traditional pharmaceutical companies.
As the announcement of a merger between SmithKline Beecham and GlaxoWellcome has highlighted, the discovery and development of new therapeutic compounds is an increasingly expensive and global business.
However, while the prospect of a multi-billion Euro R&D budget signals a bright future for many of the merged company's own scientists, it is also likely to be good news for contract research organisations (CROs).
CROs originally emerged to take the strain off pharmaceutical companies by carrying out pre-clinical and clinical drug development. Later, as the same companies looked to outsource more of their drug development and other functions while cutting in-house costs, the role of CROs became even more important. Some estimates suggest that up to 40 per cent of R&D could be outsourced by 2005.
Today CROs provide almost identical functions to atraditional' pharmaceutical companies, right down to drug discovery. Often the only way to spot the difference is that CROs are not active in the sales or marketing of drugs. However, even that is changing now.
As recent developments among the largest CROs show, they are busy reorganising in anticipation of the differences between them and pharmaceutical companies being blurred to extinction over the next few years.
A customer focus
With 20 000 employees worldwide and offices in 31 countries, Quintiles is the market leader in providing a full range of integrated product development and commercialisation solutions to the pharmaceutical, biotechnology and medical device industries. It is also a leader in electronic transactions processing and informatics for the healthcare sector and provides healthcare policy consulting to governments and other organisations worldwide.
On 10 January Quintiles announced a change in its operating structure to enhance customer focus and efficiency. Its three service groups now have six lines of business, with each unit being headed by an executive reporting directly to chairman and ceo Dennis Gillings.
"Our new structure reflects key drivers in our industry the need to rapidly assess the viability of the burgeoning number of new drugs, cost-effectively accelerate development of the most promising drugs, quickly launch new medicines and evaluate their impact on healthcare,“ he said.
The six lines of business are: early development and laboratory services, clinical development services, integrated strategic solutions, commercialisation, informatics and electronic transactions processing.
In another show of how the role of CROs is growing, on 11 January the company signed a collaboration agreement with the US Association of Community Cancer Centres (ACCC) granting Quintiles exclusive rights within the CRO industry to use and promote the central clinical research capabilities of the Association's collaborative research group.
The collaboration is designed to streamline the start-up and completion of cancer clinical trials and bring the latest in cancer therapeutics to patients receiving care by community oncologists.
"This agreement will give our collaborative research group easy access to Quintiles resources, technology and expertise to improve the quality and efficiency of clinical trials. This collaboration should help speed the delivery of new cancer treatments to patients in need,“ said ACCC executive director Lee Mortenson.
Client research
Another company which is reorganising itself in anticipation of a busy future is Parexel. Over the past 15 years, Parexel has developed significant expertise in many areas including clinical trials management, data management, biostatistical analysis, industry training and other drug development consulting services. It has about 4400 employees at 46 locations in 29 countries around the world.
Parexel has reorganised its contract research services business into discrete operating units know as client research units (CRUs). Each CRU is led by a general manager responsible for its activity worldwide and includes personnel for client-focused project management, clinical monitoring and data management.
"As we continue to innovate and build on the excellence of our core clinical research activities, this organisation allows us to optimise our global resources to meet the expanding needs of our clients and positions us for client-focused growth,“ said chairman and ceo Josef von Rickenbach.
The realignment also included the creation of two additional operating units designed to provide drug development and therapeutic expertise, advanced technologies and clinical trial optimisation services to the CRUs.
Parexel is also the first major CRO to develop a paediatric clinical research initiative. On 10 January the company entered into a collaborative agreement with Paediatric Clinical Trials International (PCTI) to offer paediatric clinical research services to pharmaceutical and biotechnology companies worldwide.
As part of the deal, Parexel will support joint research initiatives through its knowledge of worldwide drug development, specifically its expertise and capabilities in the design and management of clinical trials, biostatistical services, regulatory affairs, patient recruitment, contract medical marketing and other drug development services.
To develop and oversee collaborative relationships with children's academic research centres, the company has appointed Ronald Keeney as head of paediatric academic alliances. "Both PCTI and Parexel initiatives are focused on improving the health of infants and children. This initiative will offer expanded access to some of the best clinical research in the world,“ he said.
Strategic relationships
With 7700 people employed in 17 countries around the world, Covance aims to lead advancements in drug development through science, service and shaping solutions.
Last year this company began a reorganisation to both strengthen its management team and enhance its ability to form strategic relationships with the world's leading pharmaceutical companies. This involved establishing a set of core activities which represent the leading areas of drug development outsourcing by the pharmaceutical industry: early development, clinical development and support services, commercialisation, and biomanufacturing.
It also announced the formation of a technology services group, including web-based capabilities, that together with process innovations and support services can accelerate drug development and lead to greater productivity and cost efficiency.
"By continuing to align our organisation more directly with their outsourcing needs, Covance will be positioned to forge stronger relationships with this key customer group,“ noted chairman and ceo Chris Kuebler.
Drug discovery
One other major player is PPD, a leading global provider of contract and consulting research and development services for pharmaceutical and biotechnology companies. PPD offers innovative technologies, therapeutic expertise and comprehensive resources for drug discovery, Phase I-IV clinical development and post-market support.
At the end of last year, the company announced that its virtual drug development services division PPD GenuPro had retained the rights to further develop dapoxetine, an anti-premature ejaculation genitourinary compound licensed from Eli Lilly. Formed in 1998 from a collaboration between the two companies, PPD GenPor is now evaluating other strategic partners for further development and has received numerous enquiries from potential partners.
"We believe that there is a significant market for a compound such as dapoxetine, which has shown promise using PRN or aas needed' dosing,“ said PPD ceo Fred Eshelman.
While it remains to be seen how far CROs eventually cross-over into traditional pharmaceutical company territory, there is no doubt that they have changed the way that R&D is carried out forever.
