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Advisory Committee on Biologicals (ACB)

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24 May 2019

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.

Membership

Chair

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.

Members

Professor David Brown is a clinical immunologist and immunpathologist who has expertise in the basic cellular pathways that many biologicals target, as well as significant experience in using these drugs in the treatment of a wide variety of diseases. He also has expert knowledge regarding the immunological tests used for the diagnosis of diseases leading to and resulting from the use of biological therapies. Prof Brown is the director of immunopathology at NSW Health Pathology-ICPMR and is a member of the NSW Pathology Immunology Advisory Clinical Stream. In addition, he has experience in the recognition and treatment of side effects of biological therapies. Prof Brown provides advice as a clinical expert.

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.

Professor Nick Di Girolamo is a distinguished academic with experience in ocular diseases, including successfully leading clinical trials on stem cells. He has experience chairing the Human Research Ethics Biomedical Panel and as a member of the Human Research Ethics Committee with the University of New South Wales, as well as a number of other research positions. He is also a peer reviewer on the editorial board of a number of medical journals. Prof Di Girolamo provides expertise in the field of cellular therapies, including regenerative medicine and tissue engineering.

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 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 Laurens Manning is an infectious disease physician with wide ranging research and clinical expertise. He has also implemented a number of service improvement initiatives in his work with WA Health. He has been appointed to two international working groups, is developing treatment guidelines for Papua New Guinea and is involved in facilitating infectious disease collaborative studies across Australia and New Zealand. In addition, his current work relates to the treatment of conditions using new tissue therapies and the establishment of a faecal microbiota transplantation (FMT) service in WA. Dr Manning provides clinical expertise in the field of infectious diseases.

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.

Associate Professor Helen Ritchie has a special interest in reproductive and developmental toxicology and serves as an Associate Professor in the discipline of Anatomy and Histology sciences within the Faculty of Medicine and Health at the University of Sydney. She has experience with laboratory research and has previously worked at the National Industrial Chemicals Notification and Assessment Scheme as a Senior Regulatory Scientist. Associate Professor Ritchie provides expertise in the field of toxicology.

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.

Professor Bernard Tuch is a translational endocrinologist and has been a well-respected and an active member of the stem cell sector in Australia for almost two decades, including in his current role as Director of NSW Stem Cell Network. He has carried out human trials with cells and medical devices, has clinical expertise and has extensive research experience with stem cell therapies and xenotransplants. Professor Tuch provides expertise in the field of cellular therapies, including tissue engineering.

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.

2019 ACB proposed meeting dates

Meeting no. Meeting dates
13 5 September 2019
14 18 November 2019

Contact details for the ACB

Email
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