Parexel appoints two FDA luminaries, Dr Lola Fashoyin-Aje, and Dr Tala Fakhouri to its Consulting team
These strategic appointments will bolster the company’s regulatory expertise
Parexel announced two Food and Drug Administration (FDA) luminaries have joined Parexel’s Consulting team – Dr Lola Fashoyin-Aje, Sr VP, Head of Regulatory Oncology, Cell & Gene, and Dr Tala Fakhouri, VP Consulting, AI & Digital Policy, Real-World Research.
These strategic appointments will bolster the company’s 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, informs a statement for the company.
The statement also informed Dr Fashoyin-Aje is an 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. In this role, she provided strategic oversight of clinical development programs evaluating cell, gene, and tissue therapies across all indications. This included providing advice to pharma and biotech companies developing these products on clinical trial designs for Phase I-IV studies, advising on clinical endpoints, intended use population, dose optimisation and the use of medical devices in these programs. She earned a medical degree from the University of Rochester, School of Medicine and Dentistry, a master’s in public health from Yale University, and completed both her residency and medical oncology fellowship at Johns Hopkins.
Dr Fakhouri has 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 optimise 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 Consulting team, which comprises more than 1,300 regulatory experts, including more than 50 former regulators.