Judy has broad experience in product development having worked across the AsiaPac region in her role as Senior Director, Consulting at Kendle International (now INC Research) and pharmaceutical companies Faulding (now Hospira) and CSL.
Her experience includes clinical development planning, regulatory strategy and submissions, medical writing, medical information and pharmacovigilance.
Prior to joining the industry, Judy was Director of Pharmacy at Peter MacCallum Cancer Centre.
Judy has a Bachelor of Pharmacy from Monash University, is a Fellow of the Society of Hospital Pharmacists of Australia and has a Masters in Health Science from Latrobe University. She is a Graduate of the Australian Institute of Company Directors, formerly Director ARCS Australia and Executive Director Easington Pty Ltd.
Brian has over 30 years experience in preclinical drug development, including 16 years as a preclinical reviewer with the Australian Therapeutic Goods Administration and 7 years with small biopharmaceutical companies (Progen Pharmaceuticals and Implicit Bioscience).
Brian's extensive experience within a regulatory agency is complemented by industry experience designing and managing preclinical studies, and conducting GLP-compliant bioanalytical studies. He also has experience in drug discovery in academia and big Pharma, early clinical development (design and management of phase I and II clinical trials), and regulatory affairs (pre-IND and IND).
Brian has provided independent toxicology and preclinical development advice to biopharmaceutical companies in Australia and the US.
Jurgen has extensive experience in the manufacture and regulation of therapeutic goods from early drug development stages through to commercial manufacture, with a focus on quality management and compliance. Over the last 30+ years he has held several scientific and senior management positions in both academia and in the biopharmaceutical industry.
His experience includes implementation and maintenance of GMP/ISO 9001/ISO13485 compliant Quality Management Systems, with a product range including small molecules, peptides, proteins, vaccines, cell based therapies and in vitro diagnostics.
Jurgen graduated from the University of Heidelberg (Germany) with a PhD in Neurosciences. He has been a committee member of the RACI Pharmaceutical Sciences Group (NSW) for over 20 years, and was a founding member of the Active Pharmaceutical Ingredient Manufacturer's Association of Australia (APIMAA). In his position as the Executive Secretary of APIMAA he is a member of the TGA-Industry working group on GMP.