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Advisory Committee on Biologicals (ACB)

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2 June 2020

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 haematologist and physician scientist, actively working in cell and gene therapy of malignancy. He is the Medical Director of the Sydney Cellular Therapies Laboratory and the Clinical Lead for the CAR T-cell program at Westmead Hospital, the NSW Immune Effector Cell Translational Centre. He is active in the field of chimeric antigen receptor T-cells in Australia, developing novel new cell and gene therapies for haematological and solid organ malignancies. He has served as co-chair of the International Society for Cell and Gene Therapy Immuno-Gene Therapy Committee. Dr Micklethwaite provides expertise in the field of cellular therapies, including tissue engineering.

Members

Professor David Brown is a clinical immunologist and immunopathologist 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. Professor 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. Professor Brown provides advice as a clinical expert.

Professor Matthew Cook is Professor of Medicine at Australian National University (ANU), Director of Immunology at Canberra Hospital and Director of the Centre for Personalised Immunology. He is also medical director of Canberra Clinical Genomics, which is a NATA-accredited diagnostic genomics facility, established as a joint venture between ACT Health and ANU. He is a clinician-scientist with more than 20 years of experience using genetic analysis to elucidate disease pathways, focussing on autoimmune and immune deficiency diseases. He was elected as a foundation fellow of the RCPA Faculty of Science. Professor Cook provides expertise in the field of cellular therapies.

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 NSW, as well as a number of other research positions. Professor Di Girolamo provides expertise in the field of cellular therapies, including regenerative medicine and tissue engineering.

Professor John Hayball is Professor of Immunology at the School of Pharmacy and Medical Science, University of South Australia, and Chief Scientific Officer of Sementis Ltd, a privately held Adelaide-based vaccines biotechnology company. He leads a research team with diverse multidisciplinary capabilities ranging from basic organic, physical and protein chemistry, through to molecular and cellular biology, immunology, virology and vaccinology. Professor Hayball has expertise in immunological tolerance and immunity and the development of new immuno- and biotherapeutics using cutting edge genetic engineering technologies. Professor Hayball provides expertise in the fields of infectious diseases, vaccinology and immunology.

Dr Laurens Manning is an infectious disease physician with wide ranging research and clinical expertise. 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 Dental Council, the Sydney Adventist Hospital Foundation Board, North Sydney Local Health District Consumer Advisory Committee and the Hornsby Ku-Ring-Gai Hospital Consumer Participation Committee. She is a former member of the NSW Agency for Clinical Innovation Neurodegenerative and Neuromuscular Governance Group, and Cancer Australia's Breast Cancer Risk Factors Expert Reference Group. She is also involved with several community health groups in a volunteer role. 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.

Dr Deborah Verran is a Senior Specialist Transplant Surgeon. She has led organ donor surgical teams for 23 years and was the Clinical Resource Officer for DonateLife organ and tissue donation network, of the Australian Organ & Tissue Authority. She has knowledge and understanding of the current regulatory and governance requirements pertaining to the use of human tissue for therapeutic purposes. Dr Verran has also been an expert panel member for medico-legal groups, undertaken advisory roles with NSW Health and been a member of the NHMRC Research Ethics Subcommittee. Dr Deborah Verran provides expertise in the field of transplant surgery.

Professor Erica Wood is Head of the Transfusion Research Unit in the school of Public Health at Monash University. She is a consultant haematologist at Monash Health and holds an honorary appointment at Peter MacCallum Cancer Centre. Professor Wood is President-elect of the International Society of Blood Transfusion, a member of the World Health Organization Expert Advisory Panel in Transfusion Medicine, and past President of the International Haemovigilance Network. She is past-President of the Australian and New Zealand Society of Blood Transfusion and served as Chief Examiner (Haematology) for the Royal College of Pathologists of Australasia and chair of the Joint Specialist Advisory Committee in Haematology. Professor Wood provides expertise in the field of blood products.

2020 ACB proposed meeting dates

Meeting no. Meeting dates
14 21 February 2020
15 21 May 2020
16 3 September 2020
17 12 November 2020

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