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Parexel announces appointments of two FDA luminaries - Lola Fashoyin-Aje, M.D., MPH and Tala Fakhouri, Ph.D., MPH - to its Consulting team, further strengthening regulatory, medical and AI expertiseDURHAM, N.C., July 01, 2025 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry, today announced two Food and Drug Administration (FDA) luminaries have joined Parexel’s Consulting team – Lola Fashoyin-Aje, M.D., MPH, as Senior Vice President, Head of Regulatory Oncology, Cell & Gene, and Tala Fakhouri, Ph.D., MPH, as Vice President Consulting, AI & Digital Policy, Real-World Research. These strategic appointments further bolster the company’s industry-leading regulatory expertise and add senior leaders to a Consulting team that supported nearly one-third of all sponsor NDA/BLA submissions approved by FDA in 2024. "We’re delighted and honored to welcome Dr. Fashoyin-Aje and Dr. Fakhouri to Parexel during a critical time for our industry and our customers,” said Paul Bridges, Ph.D., President, Consulting, Parexel. "As sponsors develop therapies that leverage complex drug modalities and employ innovative technologies, such as AI, they are the early innovators pursuing market approvals in an evolving regulatory landscape. These leadership appointments further demonstrate Parexel’s unrivaled regulatory expertise and our ability to help sponsors derisk their portfolios and navigate uncharted global regulatory processes, all while supporting patients in receiving these treatments sooner.” Dr. Fashoyin-Aje is a science-driven, board-certified internist and medical oncologist with a proven track record of accelerating drug approvals and developing and shaping innovative regulatory strategies. During her more than 30-year public health, medical and regulatory career, she has built extensive expertise in clinical development, regulatory policy and evidence standards, and collaboratively engaged stakeholders to drive innovation in drug across varied product classes and diverse therapeutic areas. Dr. Fakhouri is a strategic leader with extensive experience in regulatory affairs, AI-driven drug development, real-world data analytics and digital health technology. She has demonstrated success in developing and interpreting complex regulatory landscapes, providing strategic regulatory guidance, and fostering collaborations between regulators, industry and global stakeholders. Dr. Fakhouri has successfully led high-impact teams and managed complex initiatives to optimize regulatory decision-making and de-risk technology use in drug development. Formerly, Dr. Fakhouri was Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER) at FDA. Dr. Fakhouri managed a team tasked with developing, coordinating, and implementing medical policy with a focus on data science and the use of AI in drug development. She also contributed to the development of medical policy related to real-world evidence and the use of digital health technologies for medical product development. She earned a master’s in public health from Johns Hopkins University, was a postdoctoral fellow in Molecular and Cellular Biology at Harvard University and received a doctorate in Oncological Sciences from University of Utah. Dr. Fashoyin-Aje and Dr. Fakhouri join Parexel’s distinguished Consulting team, which comprises more than 1,300 regulatory experts, including more than 50 former regulators. This team leverages its extensive experience and deep insights to guide clients through complex global regulations across all stages of drug development – helping to accelerate drug development timelines and optimize paths to market access worldwide. About Parexel Media Addison Stallings ![]() |