WILMINGTON, N.C.—Pharmaceutical Product Development LLC (PPD), a global contract research organization (CRO), announced the creation of a dedicated unit combining its medical affairs research operations (MARO) team and Evidera, a wholly owned subsidiary that provides evidence-based solutions to “demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products.” PPD acquired Evidera last year.
The new dedicated unit will retain the Evidera name, and it will provide customers with global comprehensive and integrated solutions, including 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 and safety and risk management.
As William Sharbaugh, chief operating officer of PPD, explained, “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. 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.”
The new business unit will retain the executive and scientific leadership of both the Evidera and MARO organizations. Jon Williams, who has served as president and CEO of Evidera since 2013, will lead the new unit.
In additional PPD news, the company announced that it launched a clinical research associate (CRA) apprenticeship program targeted to military veterans and military service members with medical backgrounds making a transition to the civilian workforce. PPD’s initiative, the first CRA apprenticeship program registered with the U.S. Department of Labor, began in North Carolina, Texas and California in the first quarter of 2017.
“PPD recognizes the need for highly skilled professionals to ensure the quality of clinical trials,” said Ed Murray, executive vice president and chief human resources officer of PPD. “With this program, PPD addresses one of the immediate needs of military veterans and personnel transitioning to civilian careers, while addressing a clear need to expand the talent pool of CRAs for the conduct of clinical research.”
PPD also announced the addition of two new leaders in product development. According to Rob Dow, the company’s senior vice president of medical affairs, “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. 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.”
Dr. Stephen Peroutka, vice president of global product development and therapeutic area head for neuroscience, has served as an advisor and consultant to several biopharmaceutical companies, including chief medical officer at Semnur Pharmaceuticals and chief medical officer and executive vice president of NeurogesX Inc. Dr. Horacio Plotkin, vice president of global product development in the pediatrics and rare diseases therapeutic area and medical lead for the Rare Disease and Pediatric Center of Excellence, most recently served as global clinical development lead at Shire. Previously, he spent three years as chief medical officer of Retrophin, Inc.
