Parexel expands global regulatory services team

US-based biopharmaceutical services company Parexel has bolstered its regulatory services team with the addition of three senior executives from the FDA and pharma.

Robert Iser joins Parexel as its vice president of regulatory consulting service from his post as director of the Food and Drug Administration’s (FDA) Office of Process and Facilities.

With more than 14 years’ experience with the US regulators, Iser reviewed product quality and assessed manufacturing processes and pre-approval inspections, and was responsible for developing and implementing CMC guidance.

Prior to joining the FDA, Iser spent seven years in the pharmaceutical industry managing quality systems, and supporting manufacturing process development, scale-up and validation.

His new role will see him focus on helping clients avoid market delays due to compliance or quality problems.

Meanwhile, Parexel has also appointed Dr Bob Desai as its vice president of consulting, technical oncology. He brings a decade of experience leading global oncology and biologic drug development programmes for Astellas, Pfizer, Hospira, Abbott and AbbVie.

His previous work has extended to all phases of oncology drug development and product classes from chemical compounds to recombinant biologics.

Dr Chang Lee takes up the position of vice president of consulting, APAC, bringing both industry and regulatory agency experience to his new role. He has previously worked for the likes of Novartis, Igenix and the FDA.

Dr Paul Bridges, worldwide head of Parexel consulting, said: “These new team members will contribute to our mission of helping clients take their products through development swiftly, successfully, and profitability, and ultimately, to the patients who need them most.”