Symposium 10: The changing landscape of drug development and early phase Clinical Trials
Tracks
Track 2
| Friday, December 12, 2025 |
| 11:00 AM - 1:00 PM |
Details
Early-phase clinical trials remain a pivotal way of capturing pharmacological data in humans. However, as technologies evolve, the previous ways of developing drugs and conducting clinical trials may not be suitable for newer therapies. This symposium will discuss some of the new technologies that are being encountered in current early phase trials – including the use of psychedelics, monoclonal antibodies and siRNAs - the difficulties encountered with designing and evaluating such trials, and the novel ways of capturing useful outcome data for progression of study. The symposium will have speakers with interests in clinical trials with specific examples of “new” study designs for emerging therapies (eg, psychedelics, monoclonal antibodies, siRNAs) and will finish with a discussion about the technical aspects of modern study design and the future of study design for emerging therapies.
Speaker
Dr Tom Polasek
Clinical Pharmacologist
CMAX Clinical Research; Monash University
Novel Therapeutic Modalities
Biography
Dr Jonathan Brett
Clinical Pharmacologist
Unsw/st. Vincent's Hospital
The challenges of conducting psychedelic clinical trials
Biography
Dr Jonathan Brett is a senior staff specialist in clinical toxicology and addiction medicine at St. Vincent’s Hospital, Sydney, clinical director of the Psychiatry and Non-Prescription Drug and Alcohol Unit and a clinical toxicologist with the NSW Poison’s Information Centre. He has fellowships with the Royal Australian College of Physicians in clinical pharmacology, toxicology and addiction medicine. He is a conjoint Professor with St. Vincent’s Clinical School, UNSW and a Senior NHMRC Research Fellow with the Medicines Policy Unit of Centre for Big Data Research in Health, UNSW. He is president elect of the Royal Australian College of Physicians Chapter of Addiction Medicine. He completed his PhD in biostatistics in 2018 with a focus on the use of big data measure the quality use of psychotropics in mental health and has a research interest in psychopharmacology.
Dr Millie Wang
Research Physician
New Zealand Clinical Research
Challenges of conducting trials with Complement inhibitors
Biography
Millie Wang is a research physician at New Zealand Clinical Research, where she has worked as a collaborative investigator in more than 100 clinical trials. Her key research interests are in first-in-human / early phase clinical research, with a particular focus on immunology and metabolic studies.
She graduated from the University of Auckland in 2011 with a Bachelor of Medicine and Bachelor of Surgery and obtained her Fellowship of the Royal Australasian College of Physicians in 2022, specialising in general and acute care medicine. She has since embarked on her clinical pharmacology training and is due to complete this in 2026.
Prof Sepehr Shakib
University of Adelaide; Northern Adelaide Local Health Network; CMAX Clinical Research
Technical aspects of modern early phase study design – what does the future of early phase clinical studies look like?
Biography
Chair
Angela Molga
Head of Unit, Clinical Pharmacology
Central Adelaide Local Health Network
