Clinical Research: Phase 1 - Phase 4

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal candidate inside the FDA.

Dr. Lisa Pitt was a senior regulatory project manager at the agency, evaluating drugs for inherited metabolism disorders, prior to joining Premier Research as Vice President of Global Regulatory Affairs. “Small biotechs lead the development of innovative new compounds, and it’s important that we have the hands-on knowledge to shepherd them through the rigors of the regulatory process in markets around the globe,” said Dr. Colin Hayward, the company’s Chief Medical Officer.

“How successful we are in improving patients’ lives depends largely on how effective we are in helping our customers navigate the complexity of the development and regulatory process,” Hayward said. “Dr. Pitt brings a rare combination of scientific and regulatory experience that make her a major asset to the biotech and small pharma pioneers that are doing the most exciting and innovative work in our industry.”

Pitt leads a regulatory team that is expanding to better support customers through each phase of drug development across a wide range of therapeutic areas, specializing in rare diseases, oncology, pediatrics, neuroscience, and analgesia.

“Regulatory requirements should be at the forefront of due diligence investigations and risk mitigation strategies for the companies developing today’s novel therapies,” Pitt said. “Our regulatory team will evaluate the development program components to ensure they are in agreement with registration requirements and prior health authority recommendations.”

As Premier Research’s top regulatory official, Pitt provides strategic guidance and oversees the company’s regulatory affairs service offerings. In addition to her work with the FDA, she has more than two decades of experience in the pharmaceutical and contract research industries and extensive expertise in small-molecule and biologic pharmaceutical product development, from early phase through registration and post-marketing.

About Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.