PAREXEL has appointed four former senior executives from the U.S. Food and Drug Administration (FDA) to its Regulatory Consulting group. 

The new additions join more than 60 former global regulators in the group and will be focused on helping companies understand and work within the current FDA and global regulatory climates to optimize drug development and mitigate risk of unnecessary delays.

The additions to PAREXEL’s team have broad experience in policy making, including current regulations and guidance specific to biosimilars, cell and gene therapy, and product safety and manufacturing.

Kurt Brorson, Ph.D. joins PAREXEL following 26 years with the FDA, primarily in the Center for Drug Evaluation and Research (CDER). A recognized expert in viral safety of biopharmaceuticals and clearance during manufacturing, Dr. Brorson brings expertise in Chemistry, Manufacturing, and Controls (CMC) review and inspections for biopharmaceuticals, including biosimilars, as well as policy development within CDER’s scope. At PAREXEL, Dr. Brorson will be focused on supporting clients in the development and regulatory strategy for biosimilars and biotech products.

Changting Haudenschild, M.D. brings to PAREXEL in-depth, cross-disciplinary regulatory expertise and over 12 years of experience with the Office of Tissue and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER), FDA. Dr. Haudenschild’s regulatory expertise includes clinical safety and efficacy and biomarker/surrogate endpoint development and utilization. She also has significant experience avoiding and resolving issues that often arise and stall development programs for cell and gene therapy products for treatment of a wide range of clinical indications. Based in Europe, Dr. Haudenschild will be responsible for strategic, scientific, clinical, and regulatory support during all stages of product development to help companies achieve their objectives.

Mohammad (Mo) Heidaran, Ph.D. is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the FDA’s CBER, 15 years of biotech industrial experience in research, product and intellectual property development, and 9 years at the National Cancer Institute. In his role, Dr. Heidaran will provide clients strategic CMC technical and regulatory support during all stages of cell and gene therapy product development.

Mwango Kashoki, M.D., MPH brings over 16 years of drug review, development and regulatory experience at the FDA, with cross-disciplinary expertise in all phases of drug development from preclinical development through marketing application and post-approval assessments. At PAREXEL, Dr. Kashoki will provide strategic and technical guidance on various regulatory and clinical aspects of drug development, leveraging her expertise in clinical review as well as pharmacovigilance and other post-approval safety requirements.

“As promising new innovations, such as regenerative medicines, use of real-world evidence, and patient-centric approaches to clinical and product development continue to advance in the industry, it will be essential for sponsors to have the expertise to navigate the changing regulatory environment,” said Dr. Paul Bridges, worldwide head of PAREXEL Regulatory Consulting. “With these new additions to our Regulatory Consulting Services team, PAREXEL will deepen its leadership and expertise in areas that are priorities of the FDA, and are critical to our clients on their journeys to deliver important new treatments to patients in need across the globe.”