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Advisory Committee on Biologicals (ACB)
Role of the ACB
The Advisory Committee on Biologicals (ACB) was formed in January 2012 to provide independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) in relation to the safety and efficacy of biological products ("biologicals").
The Committee is established under Regulation 39C of the Therapeutic Goods Regulations 1990. Members are appointed by the Minister.
Membership comprises of professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to cell and tissue products.
Dr Kenneth Micklethwaite is a clinical haematologist and Deputy Director of the Sydney Cellular Therapies Laboratory, Westmead Hospital. He studied at the University of New South Wales and is a Fellow of the Royal Australasian College of Physicians and the Royal College of Pathologists Australasia. Dr Micklethwaite was also the Lung Foundation Australia Clinical Research Fellow, the Cancer Institute New South Wales Clinical Research Fellow and the recipient of the George Santos Award from the American Society for Blood and Marrow Transplantation. Dr Micklethwaite obtained his PhD in medicine from the University of Sydney and completed his post-doctoral research at the Centre for Cell and Gene Therapy at the Baylor College of Medicine. Dr Micklethwaite provides expertise in the field of cellular therapies, including tissue engineering.
Associate Professor Daniel Chambers is a thoracic transplant physician at Prince Charles Hospital, Brisbane. He is co-chair of the Scientific, Programming and Education Committee of the Transplantation Society of Australia and New Zealand. He is also Associate Director of the World Lung Transplant Registry and sits on the Pulmonary and Programming Committees of the International Society for Cellular Therapy. His area of particular interest and expertise is the clinical development of new therapies including advanced biologics for lung disease, rejection, cancer and drug-refactory viral infection. Associate Professor Chambers provides expertise in the field of cellular therapies including tissue engineering.
Dr Brian Creese spent 16 years as a nonclinical reviewer with the TGA. He subsequently worked for 11 years with Australian biopharmaceutical companies and a global clinical research organisation, specialising in preclinical drug development and early-stage clinical trials. He is currently based in Brisbane and works as a self-employed toxicology and drug development consultant. He is a member of the Bellberry Human Research Ethics Committee. Dr Creese provides expertise in the field of toxicology.
Dr Marisa Herson is a plastic and reconstructive surgery specialist. Dr Herson has a PhD in bioengineered skin and the engagement in all aspects of human cell and tissue donation, graft manufacturing and transplantation. She was Head of the Donor Tissue Bank of Victoria, Melbourne. She is now an Honorary Associate Professor in Health Ethics and Professionalism at the School of Medicine at Deakin University. Dr Herson has contributed to the field as an academic, through professional leadership, and in diverse national and international advisory roles. Dr Herson provides expertise in the fields of tissue products and cellular therapies including tissue engineering.
Professor Paul Johnson is an infectious diseases physician in clinical practice who is currently the Deputy Director of the Infectious Diseases Department at Austin Health. He was trained at the Austin Hospital Clinical School and Fairfield Infectious Diseases hospital before moving to the Department of Microbiology at the Royal Children's Hospital. Here, he commenced a research program on the diagnosis, transmission and environmental reservoir of Mycobacterium ulcerans infections. Professor Johnson continues his clinical role at Austin Health and is conjointly Director, World Health Organisation Collaborating Centre for Mycobacterium ulcerans. Professor Johnson provides expertise in infectious diseases.
Professor Alejandro Lopez is a trained physician and has 32 years' experience as an immunologist. Professor Lopez has focused on transnational research in the areas of prevention or treatment of cancer and infectious diseases. He has co-organised the clinical testing of various biologicals including a synthetic peptide, adjuvants and dendritic-cell based immunotherapy against cancer (melanoma, prostate, glioblastoma). He has also conducted contract research for various natural and pharmaceutical products modulating the immune response. Professor Lopez provides expertise in the field of cellular therapies, including tissue engineering.
Dr David Morgan OAM graduated with degrees in medical science, medicine and surgery from the University of Queensland. In 1985-1986 he was the Sir Robert Menzies Memorial Scholar in Oxford and has been an Associate Professor at the University of Queensland in orthopaedic surgery since 1994. His past presidencies include the Asia Pacific Association of Surgical Tissue Banks, the Medical Device Evaluation Committee Device Tracking Subcommittee of the TGA, the Medical Advisory Committee of the Brisbane Private Hospital, the Medico-Legal Society of Queensland, the Hip Clinical Advisory Group for the Commonwealth Department of Health and Ageing, the Prosthesis List Advisory Committee for the Commonwealth Department of Health and Ageing and the Arthroplasty Society of Australia. Dr Morgan provides expertise in the field of orthopaedics.
Mr Nichalas Nuttall obtained his undergraduate degree in science and medical science. His post graduate qualifications are in management and public health. He is a medical scientist with 25 years' experience in pathology testing (microbiology, biochemistry, haematology) and 11 years in organ and tissue donation. Mr Nuttall is a part-time lecturer in clinical microbiology (Griffith University) and tissue bank management (Universitat de Barcelona). Mr Nuttall is currently the Director of Queensland Tissue Bank. Mr Nuttall provides expertise in the fields of blood products; tissue products; infectious diseases and epidemiology or biostatistics.
Ms Jebby Phillips has been a consumer representative in the health sector since 2011. She sits on the Medical Board of NSW, the NSW Agency for Clinical Innovation Neurodegenerative and Neuromuscular Governance Group, Cancer Australia's Breast Cancer Risk Factors Expert Reference Group, North Sydney Local Health District Consumer Advisory Committee and the Hornsby Ku-Ring-Gai Hospital Consumer Participation Committee. Ms Phillips provides expertise in the field of consumer health issues.
Adjunct Professor Marian Sturm is Facility Director of Cell and Tissue Therapies Western Australia, Royal Perth Hospital and Associate Professor with the Centre for Cell Therapy and Regenerative Medicine, School of Medicine and Pharmacology, University of Western Australia. She has extensive experience in the manufacture and regulation of clinical products for transplantation. Associate Professor Sturm provides expertise in the fields of tissue products and cellular therapies, including tissue engineering.
Associate Professor Erica Wood who holds an honorary appointment at Peter MacCallum Cancer Centre is head of the Transfusion Research Unit at Monash University, and is a consultant haematologist at Monash Health. She is vice-president of the International Society of Blood Transfusion, President of the International Haemovigilance Network, a member of the World Health Organization Expert Advisory Panel in Transfusion Medicine, and past President of the Australian and New Zealand Society of Blood Transfusion. Associate Professor Wood has served as Chief Examiner (Haematology) for the Royal College of Pathologists of Australasia and chair of the Joint Specialist Advisory Committee in Haematology. Associate Professor Wood provides expertise in the field of blood products.
2018 ACB proposed meeting dates
|Meeting no.||Meeting dates|
|11||8 March 2018|
|24 May 2018 (postponed)|
|6 September 2018 (postponed)|
|12||22 November 2018|
Contact details for the ACB
|Phone||+61 2 6232 8665|
|Mobile||+61 468 609 842|
|Fax||+61 2 6203 1250|
|Postal Address||Advisory Committee on Biologicals
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Attn: Scheduling & Committee Support Section, MDP 122