B21. Clinical-Regulation considerations when conducting cell therapy clinical trials
Tracks
Clinical & Regulation
| Wednesday, June 4, 2025 |
| 4:30 PM - 5:30 PM |
| Parkside 1 |
Chair & Speakers
Ms Joanne Amies
Consultant
Wedgetail Regulatory Affairs
B21 Clinical-Regulatory considerations when conducting cell therapy clinical trials
Abstract
This session will cover specific regulatory considerations for Australian clinical trials of cellular therapies, including TGA GMP requirements and ongoing compliance obligations to ensure your product continues to meet OGTR GMO and TGA CTN criteria. Understanding these regulatory considerations is crucial as they directly impact the planning and execution of your clinical trials. By attending this session, you will gain valuable insights that can help streamline your processes and ensure compliance with regulatory standards. Case studies highlighting regulatory opportunities and “pitfalls” will be presented.
Biography
Joanne Amies is an experienced Regulatory Affairs Professional with over 20 years of expertise in regulatory affairs, particularly in the fields of haematology and oncology. She has played a significant role in the approval of groundbreaking therapies in Australia, including CAR T-cell therapy and gene therapy for SMA.
Hiram Chipperfield
Senior Manager - Regulatory Affairs
Vaxxas
B21 Clinical-Regulatory considerations when conducting cell therapy clinical trials
Abstract
This session will cover specific regulatory considerations for Australian clinical trials of cellular therapies, including TGA GMP requirements and ongoing compliance obligations to ensure your product continues to meet OGTR GMO and TGA CTN criteria. Understanding these regulatory considerations is crucial as they directly impact the planning and execution of your clinical trials. By attending this session, you will gain valuable insights that can help streamline your processes and ensure compliance with regulatory standards. Case studies highlighting regulatory opportunities and “pitfalls” will be presented.
Biography
Hiram Chipperfield is a life sciences professional with a focus on therapeutic product development and regulatory affairs. He holds a Ph.D. in Cell Biology from the University of Queensland which was followed by academic and commercial cell therapy research.
Throughout his career, Hiram has worked across a range of therapeutic product development projects, from diagnostics to cell therapies. His expertise spans preclinical development, clinical strategy, product registration, and post-market reimbursement applications.
His professional interests include the development of cell and gene therapies. As an IBC member and Chair, Hiram has reviewed over 20 GMO projects from first-in-human clinical studies through to commercial applications. In the field of cell-based therapies, he has leveraged a practical approach to regulations to support a range of therapeutic programs.
Hiram has held senior roles in a diagnostics company and supported early-stage sponsors through consulting roles in several clinical CROs. He currently holds the position of Senior Manager – Regulatory Affairs at Vaxxas.
