Wilmington-based Pharmaceutical Product Development LLC on Tuesday announced a project to consolidate its efforts in the rare disease and pediatric drug markets.
The Rare Disease and Pediatric Center of Excellence will “oversee all rare disease and pediatric-related drug development activities” for the company, according to a news release.
The center’s team, a group of pharmaceutical and clinical research professionals with experience in the areas, will focus on “addressing the specific challenges presented by the small, widely dispersed populations of rare disease and pediatric patients,” the release stated. “This group of functional experts has been assembled to support end-to-end clinical trial solutions in such areas as feasibility strategy, clinical information, biostatistics, pharmacovigilance, lab operations and business analytics.”
The announcement was made Tuesday to coincide with the national awareness campaign Rare Disease Day.
The team members are based at the contract research organization’s various locations, with the center’s head, PPD Senior Vice President Karen Kaucic, working out of its Rockville, Maryland, office.
“The team will come together at regular intervals to meet face to face, with annual meetings planned at our Wilmington headquarters to align with the annual Rare Disease Day,” PPD spokesman Randy Buckwalter said. “There are six members on the steering committee and 23 members of the full center of excellence with global representation.”
Though the center is new, PPD has logged experience in the two areas, conducting more than 220 rare disease studies with more than 50,000 patients in the past five years, according to company officials.
In the U.S., a disease is considered rare if it affects under 200,000 people. Europe defines it as a disease affecting no more than five in 10,000 people.
“In the U.S. and Europe alone, as many as 60 million individuals are affected by one of the more than 6,000 identified rare diseases,” the news release stated.
And in the area of pediatric drug development, PPD has conducted more than 400 clinical trials during the past five years, enrolling more than 97,000 patients.
There also is overlap between the two patient populations, company officials said.
“With a great majority of rare diseases touching children,” Kaucic said, “we believe our approach will enable us to be a more connected and active partner.”
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