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Parexel, a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry, has announced appointment of two Food and Drug Administration (FDA) personnel: Lola Fashoyin-Aje, as senior vice president, head of regulatory oncology, cell & gene, and Tala Fakhouri, 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, said the company.
Dr Paul Bridges, president, consulting, Parexel stated "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. Prior to joining Parexel, Dr. Fashoyin-Aje was director, office of clinical evaluation, Center for Biologics Evaluation and Research (CBER) at FDA.
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. 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 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, stated the company communication note.
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