Picking up the pace

WILMINGTON, N.C.—In the early months of this year, contract research organization Pharmaceutical Product Development LLC (PPD) has made several moves to expand relationships or services in areas as disparate as rare diseases, renal disease and HIV/AIDS.

On Feb. 28, Rare Disease Day, the company announced that it had established a Rare Disease and Pediatric Center of Excellence as a clearinghouse for all its rare disease and pediatric-related drug development activities.

“Our new center of excellence builds on PPD’s longstanding expertise and experience to address the special drug development considerations of rare diseases and pediatrics,” Dr. Karen Kaucic, PPD senior vice president and head of the center of excellence, said in a media release.

In the past five years, PPD has conducted more than 220 studies with more than 50,000 patients, and conducted more than 400 clinical trials, enrolling more than 97,000 patients across a wide range of therapeutic indications, including infectious diseases, respiratory, cardiology, oncology and immunology.

The new center will leverage the experience of Kaucic and her team of pharmaceutical and clinical research professionals in rare disease trial design and execution in such disciplines as product development, clinical operations, commercial strategy and early engagement. The team will work to address the specific challenges presented by populations of rare disease and pediatric patients, with support for end-to-end clinical trial solutions in such areas as feasibility strategy, clinical information, biostatistics, pharmacovigilance, lab operations and business analytics.

PPD also intends to use its pediatric investigator network to provide clients with faster trial startup, more predictable patient enrollment and higher-quality data. It will employ a framework built specifically for this center to ensure the application of best practices and develop a customized approach to address the unique needs of these trials.

“With a great majority of rare diseases touching children,” said Kaucic, “we believe our approach will enable us to be a more connected and active partner. Our clients can depend on us for the latest trial design innovations, the ability to navigate complex trial logistics and our keen understanding of customized patient access strategies in low-prevalence, widely dispersed patient populations.”

From diseases that touch only a few, to ones that touch very many, PPD has made a significant addition to its services in the area of kidney diseases, announcing in February that it has entered into a collaboration with Frenova Renal Research, a leading drug and medical device clinical development services provider dedicated exclusively to renal research.

PPD stands to benefit from this arrangement in two ways. First, Frenova offers an enormous cache of data and expertise to PPD and its clients. As part of kidney care and services company Fresenius Medical Care North America (FMCNA), which boasts a network of more than 2,200 dialysis centers nationwide, Frenova maintains a network of resources encompassing 260 research sites with 450 principal investigators and access to more than 183,000 active end-stage renal disease patients and 390,000 active patients with chronic kidney disease. FMCNA itself has collected data on more than 1 million patients, including data on more than 250 million dialysis treatments, more than 1 billion medication administrations and more than 1 billion laboratory results.

“The opportunity to collaborate with Frenova enhances our ability to connect our clients with researchers recognized as world leaders in the field of nephrology and further strengthens our industry-leading global site and patient capabilities by helping to deliver seamless access to patients, sites and data sources,” said Ulrich Zoeller, vice president of project management and general medicine for PPD. “Frenova’s access to more than two-thirds of all U.S. nephrology patients, coupled with the breadth of its resources and experience in renal research, will enable PPD to continue to build on its already strong presence in nephrology trials.”

In addition to this data and the therapeutic expertise of Frenova’s global nephrology experts, PPD will now be able to offer access to F1RST Up (Frenova Rapid STart Up), Frenova’s exclusive alliance of research sites designed to streamline, initiate and enroll clinical studies dramatically faster than industry norms with just-in-time patient recruitment. Fifteen of Frenova’s 260 research sites are proprietary F1RST Up sites, which use coordinated research processes that enable faster site startup and streamlined study execution.

The effectiveness of PPD’s services, and the longevity of their relationships, is evidenced by a third announcement, made in March, that its long-standing contract with the Division of AIDS of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), has been renewed for the fifth time. This contract was first implemented in 1990, and the renewal carries the relationship forward to 2024.

As part of the contract, PPD will continue to predict risks to clinical trial participant safety and data integrity based on measures of site performance and other known risk factors. The renewed contract covers support for a broad scope of research related to HIV or HIV co-infections that includes monitoring therapeutic trials, prevention trials and vaccines work.

“The extension of this contract will allow PPD to provide important comprehensive clinical site and study monitoring services to the NIH in some of the most pivotal and exciting directions in AIDS research,” commented William Sharbaugh, chief operating officer of PPD. “We are privileged to continue our collaborative relationship with the NIH, leveraging our considerable resources as one of the world's largest CROs, while capitalizing on our in-depth knowledge of infectious diseases.”