PPD has set up a network of sites across North America for conducting phase I trials in patients to meet growing demand for early-phase services that can give sponsors answers about their drug candidates more quickly.
The global contract research organization (CRO) will hire senior project managers to oversee the development of its networks and manage phase I trials conducted through the sites. PPD plans to add more phase I sites to its North America network and also expand overseas by adding locations in Central and Eastern Europe and the Asia-Pacific region.
While PPD has run a 300-bed phase I clinic for healthy volunteers in Austin, Texas, for the past 25 years, the preferred partnerships give the CRO a new ability to recruit patient volunteers for phase I studies in a range of therapeutic areas. “This is a new area for us,” said Cindy Doerfler, vice president of PPD’s phase I clinic. “We want to be the sole solution for all of our clients and be able to deliver an integrated offering that spans preclinical, phase I, proof of concept, phase II-IV and late stage. One component that we hadn’t invested our time in was phase I patients. We started to see a lot of our regular clients asking us for access to phase I sites that have expertise in different therapeutic areas.”
Demand for phase I services has grown in recent years as drug sponsors, under pressure to control costs and improve efficiencies, want to understand not only the benefits, but also the liabilities of their compounds as early in the development timeline as possible. In addition, the percentage of phase I work outsourced to CROs has increased as many large pharmaceutical companies have closed their clinical research units in order to decrease fixed overhead costs. According to Jefferies & Co., the phase I outsourcing market is estimated at $2.3 billion in 2010, with an expected compounded annual growth rate of 6% during the next five years.
While phase I trials typically enroll healthy volunteers, drug sponsors increasingly want to include patients in these studies in order to determine early proof of concept for their compounds. Doerfler said patient volunteers now account for about 40% of all participants in phase I studies. “Everyone is looking to shorten their development timeline,” she said. “As soon as you get your first-in work done and you’ve got an idea of what your doses are going to be, you can move right into that patient study. We hope to be able to save our clients time and money by getting the patient trial lined up and ready to enroll while we are still working on the single and multiple ascending dose studies.”
The preferred partnerships increase PPD’s ability to recruit patients for phase I trials across a broad range of therapeutic areas including cardiovascular, metabolic, respiratory, central nervous system, renal/hepatic disease and biologics.
