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PPD Creates New Unit to Focus on Evidence-Based Drug Services

By Barry Teater, NCBiotech Writer

Wilmington-based Pharmaceutical Product Development (PPD), a global contract research organization, has created a new unit combining its medical affairs research operations team with Evidera, a company it acquired in August 2016.

The new dedicated unit, retaining the Evidera name, will provide biopharmaceutical customers with global services, PPD said in a news release.

Those services will now include modeling and simulation, interventional studies (including expanded access/compassionate use and extended access), observational studies (including registries), health economics, outcomes research, market access, epidemiology, real-world evidence, safety, and risk management.

“Our clients are seeking better evidence to satisfy the requirements of both regulators and payers, and we have a tremendous opportunity to meet that need by delivering real-world evidence that bridges the gaps between efficacy, safety and value,” said William Sharbaugh, chief operating officer.

“Through this new business unit we will be able to help our clients seamlessly integrate and align regulatory and peri- and post-approval research efforts, improving their ability to meet the evidence demands of both regulators and payers.”

PPD acquired Evidera in 2016 for its expertise in providing “evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products.”

Evidera, headquartered in Bethesda, Md., has over 400 employees in North America and Europe. It was created in 2013 as an independent company under the ownership of Symphony Technology Group (STG) following the acquisition of long-standing health economics, outcomes research, market access, epidemiology and data analytics practices from United BioSource Corp.

The new business unit will retain the executive and scientific leadership of both the Evidera and PPD organizations. Jon Williams, president and CEO of Evidera since 2013, will lead the new unit.

“Bringing together Evidera’s scientific and consulting expertise with PPD’s global operations infrastructure creates an unparalleled ability to partner with and serve our clients in optimizing their product value and market access,” Williams said.

Evidera staff members will continue to be based in their current locations around the world, including at PPD’s North Carolina operations in Morrisville and its headquarters in Wilmington, said Randy Buckwalter, senior manager of corporate communications. “They will not be consolidated into a central location, so there will be no real impact on any of our locations,” he said.

PPD has about 3,500 employees at the two North Carolina locations, Buckwalter said.

Two hired in product development

PPD also announced it recently has added two new leaders in product development, strengthening its therapeutic expertise in neuroscience, pediatrics and rare diseases.

Stephen Peroutka, M.D., Ph.D., will serve as vice president of global product development and therapeutic area head for neuroscience.

Horacio Plotkin, M.D., FAAP, will be vice president of global product development in the pediatrics and rare diseases therapeutic area and also serves as medical lead for the Rare Disease and Pediatric Center of Excellence.

“PPD’s global team of scientific, medical and strategic experts provides our clients expertise that helps reduce the cost and time associated with bringing medicines to market,” said Rob Dow, senior vice president of medical affairs for PPD. “By joining this team, these leaders deepen our expertise in neuroscience, pediatrics and rare diseases – areas that are very important to PPD and our customers.”

Peroutka has served as an advisor and consultant to several biopharmaceutical companies. He previously served as chief medical officer at Semnur Pharmaceuticals and as chief medical officer and executive vice president of NeurogesX.

Plotkin most recently served as global clinical development lead at Shire. Previously, he spent three years as chief medical officer of Retrophin, and held medical director positions at Alexion Pharmaceuticals, Enobia Pharma and Genzyme. He spent 20 years as a practicing pediatrician in the field of pediatric rare diseases.

PPD provides comprehensive, integrated drug development, laboratory and lifecycle management services to clients and partners including pharmaceutical, biotechnology, medical device, academic and government, academic and government organizations.

The privately held company was established in 1985 by Fred Eshelman, Pharm.D., as a one-person consulting firm. Today PPD has offices in 47 countries and more than 19,000 employees worldwide.

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