Barbara Kienast

Head of Clinical Operations & Regulatory Affairs at Graythan Regulatory Services

Speaker

Head of Clinical Operations and Regulatory Affairs, Graythan Regulatory Services (GRS)

GRS is a Brisbane, Australia-based regulatory consulting firm founded in 2017 specialising in pharmaceutical, biotechnology, and gene technology development. GRS has been involved in many of the commercial gene technology approvals in Australia.

Her expertise spans clinical operations, regulatory affairs, and quality assurance, with particular depth in GMO frameworks, TGA processes (CTN, SAS Category B), IBC governance, and GMO licensing. She has led signature gene therapy studies, leading to Breakthrough Therapy designation by the US FDA. In her most recent CRO role, she was responsible for two global studies spanning 12 countries with a combined budget exceeding $USD 80 million, and a team of 70 people.

With a background in Chemical Engineering with a PMP certification, Barbara brings a rigorous, solutions-oriented approach to clinical and regulatory development. She is trilingual (English, French and German), and has lived and worked in five countries, bringing genuine international development perspective to her work. Barbara is passionate about building Australia's profile as a destination for international clinical research.