Outsourced contract research continues its move upstream

Outsourcing research and development is nothing new to pharmaceutical companies. However, the range of services being offered by contract research organisations continues to grow and the differences between client and customer are becoming even more blurred. Sean Ottewell outlines recent developments in this burgeoning sector.

As pharmaceutical companies expand the testing of drugs to new global markets and more diverse patient populations, their clinical trials are becoming increasingly complex. Today's greater emphasis on drug/drug interactions and the need for a deeper understanding of the role pharmacogenesis plays in drug development has lead to increasing demand for clinical bioanalytical services.

The result has been a 20 per cent per year growth in the market for outsourced bioanalytical services over the last three years. This market is now thought to be worth in the region of US$500 million.

In an effort to grab a larger slice of this business, at the end of October worldwide contract research organisation (CRO) Covance launched Biolink ­ its new bioanalytical service which promises superior data, faster turnround and new standards of process excellence.

Based at the company's site in Indianapolis, USA, Biolink is a major opportunity for Covance to provide the pharmaceutical industry with a more efficient way to manage clinical testing needs (Fig. 1). It builds on the company's current preclinical bioanalytical chemical business, providing testing services to determine the appropriate dose amount and frequency of a drug from late discovery evaluation to phase III clinical testing. Covance now claims to be the only CRO that provides these services on a full-service, global, integrated basis. In fact the company is so confident that the new laboratory can be doubled in size to 70000 square feet should demand outstrip supply.

Speaking at the Biolink opening, Covance corporate senior vice president and president of early development services Joseph Herring, said: "Covance has made a significant investment in technology, scientific and regulatory staff and a state-of-the-art facility to deliver a whole new bioanalytical standard to the pharmaceutical industry.“

This new standard includes more than 30 mass spectrometry instruments globally, providing sufficient capacity to meet deadlines and turnround times for large clinical sample sets. In addition, it is located next to the company's central laboratory which manages more than 4.5million medical samples from its yearly clinical trials.

Clinical pharmacology

Another worldwide CRO, Parexel, counts integrated services, therapeutic area depth, information technology, global drug development and product launch services among its key strengths. Like Covance, it provides solutions aimed at accelerating time-to-market and peak market penetration.

One of its key areas is clinical pharmacology and the company currently operates units dedicated to this in Washington DC, Berlin and Poitiers. The latest addition to this list came in early October with the announcement that Parexel had purchased a full-service clinical pharmacology unit in the UK from GlaxoWellcome. The unit is based at Northwick Park Hospital in Harrow and since 1991 has supported nearly all of the pharmaceutical company's first-in-human studies. "We appreciate the trust that GlaxoWellcome has demonstrated by selecting us to be their partner and this that this collaboration will greatly benefit both companies,“ explained Parexel chairman and chief executive officer Josef von Rickenbach. "The purchase of this high-quality, fully-operational clinical pharmacology unit enables us to address the needs of our clients based in the USA, Japan and other countries who have requested this type of service in the UK.“

Also keen to help Japanese pharmaceutical companies enter the European market is Quintiles Transnational Corporation. A global market leader in helping pharmaceutical, biotechnology and medical device companies develop and sell their products, in September Quintiles opened a Japan Pharma Centre at its site in Edinburgh, Scotland. The first such centre in Europe, it joins Quintiles' other Japan Pharma Centre which opened in Kansas City, USA, in May. Both centres are based on the ain-country caretaker' model which is popular in Japan. Just as Japanese in-country caretakers help foreign companies succeed in that market, Quintiles' Pharma Centres support Japanese pharmaceutical companies ­ especially medium-sized and emerging firms ­ who wish to establish an effective market presence in Europe and the USA. With its full range of products and services in pharmaceutical product development ­ spanning preclinical to regulatory approval as well as marketing, commercialisation and healthcare information ­ Quintiles aims to help the Japanese companies achieve their goals with a minimal investment.

"Quintiles is the ideal choice for such companies seeking an entryway into the European market ­ our track record with Japanese pharmaceutical companies goes back nearly a decade. Both the US and European Japan Pharma Centres will allow us to strengthen partnerships with Japanese pharma companies over the long term,“ said Derek Winstanly, President, Quintiles Japan and South Korea.

Edinburgh was chosen for the Centre partly because of the ongoing pharmaceutical research collaborations between Scottish universities and Japanese companies. Since 1995, the Edinburgh facility has had a growing reputation as one of Europe's premier pharmaceutical development hubs.

In mid-November, PPD ­ a leading global provider of discovery R&D resources for pharmaceutical and biotechnology companies ­ showed how blurred the distinction is becoming between CROs and their customers. Its drug discovery technology subsidiary PPD Discovery announced the first research milestone and the expansion of its functional genomics alliance with Aventis Pharma for the development of new therapeutic agents in oncology, inflammation, cardiovascular disease and central nervous system disorders.

The two companies announced the start of a four-year alliance in December 1998. Completion of the first phase of the alliance included a technology transfer from the PPD Discovery to Aventis Pharma for the research programme and prioritisation of the new candidate therapeutic targets using PPD Discovery's proprietary functional genomics platform ­ the GSX system. This isolates functional inhibitors called genetic suppresser elements (GSEs) of any gene responsible for a disease pathway. GSEs are small gene fragments that when expressed in cells inhibit the production or activity of the corresponding target protein.

With the achievement of the first milestone the alliance is being expanded to increase personnel resources assigned to the project. "The GSX system is adding an important new dimension to our core genomics research programme,“ said Emmanuel Conseiller, head of genomics and molecular biology for the oncology disease group at Aventis Pharma.

Under the terms of the joint research programme, Aventis Pharma is funding scientists from both companies to develop the cellular models and to select the GSEs. Aventis Pharma is initiating its drug discovery based on the human gene targets being identified through the collaborative programme. In addition to research support, PPD Discovery receives R&D milestone payments, the first of which was allocated with the completion of this phase of the alliance.

Aventis Pharma has the worldwide rights to the resulting therapeutic products, while PPD Discovery will receive royalties on sales of the Aventis products resulting from the collaboration. PPD Discovery will have worldwide rights to commercialise products for diagnostic applications as well as the rights to rights to develop therapeutic products against targets that Aventis Pharma elects not to pursue. Aventis Pharma will have the first option to license such products in addition to receiving development milestone payments and royalties on sales of the PPD Discovery products.

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