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Advisory Committee on Medicines (ACM)

31 August 2020

Role of the ACM

The ACM provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on issues relating to the safety, quality and efficacy of medicines supplied in Australia including issues relating to pre-market and post-market functions for medicines.

The Committee is established under Regulation 35 of the Therapeutic Goods Regulations 1990. Members are appointed by the Minister.

The ACM was established in January 2017, to encompass pre and post-market advice for medicines, following the consolidation of the previous functions of the Advisory Committee on Prescription Medicines (ACPM), the Advisory Committee on the Safety of Medicines (ACSOM) and the Advisory Committee on Non-Prescription Medicines (ACNM).

Membership comprises of professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to medicines.

Membership

Chair

Associate Professor Geoffrey Herkes is a Senior Staff Specialist in neurology, and previous Head of Department, at the Royal North Shore Hospital in Sydney and Clinical Associate Professor of Medicine at the University of Sydney. He has a long interest in medicine regulation and safety and was the last chair of ADEC (2008-2009), first chair of ACPM (from 2010), and served with the TGA as a committee member from 1999. Associate Professor Herkes conducts research in neuropharmacology and epilepsy. In 2016, he was awarded the ANZAN (Australian and New Zealand Association of Neurology) medal for outstanding service to neurology nationally and internationally. He also serves as Chair of the NSLHD Human Research Ethics Committee. Associate Professor Herkes provides expertise in the field of neurology.

Members

Dr Janice Fletcher is a paediatrician, biochemical geneticist and genetic pathologist. She is the current Clinical Director of Genetics and Molecular Pathology, responsible for the provision of laboratory genetics services for South Australia. She is the pathologist responsible for the South Australian Newborn Screening Service and the National Referral Laboratory for the Diagnosis of Lysosomal and Peroxisomal disorders. Dr Fletcher provides expertise in the field of paediatrics, genetics and inborn errors of metabolism.

Dr Marion Kainer is an infectious diseases physician and epidemiologist. She has been the Director of the Healthcare Associated Infections and Antimicrobial Resistance Program at the Tennessee Department of Health and an Assistant Clinical Professor of Health Policy at Vanderbilt University School of Medicine since 2003. She obtained her medical degree at the University of Melbourne, a Master of Public Health from Monash University and trained in infectious diseases at Fairfield Hospital and the Austin Repatriation Medical Center. She served as an Epidemic Intelligence Service Officer at the Centers for Disease Control and Prevention in Atlanta. Dr Kainer provides expertise in the field of infectious diseases and antimicrobial resistance.

Professor Stewart J Kellie is a full-time paediatric oncologist and neuro-oncologist at the Children's Hospital at Westmead, Sydney, and Clinical Professor in the Discipline of Child and Adolescent Health at the University of Sydney. Professor Kellie was previously the chair of the University of Sydney Human Research Ethics Committee and was the chair of the 16th International Symposium on Paediatric Neuro-Oncology. Professor Kellie provides expertise in the field of oncology.

Dr Debra Kennedy is the founder and current Director of Mothersafe, (the NSW Statewide Medications in Pregnancy and Lactation Advisory Service). She has background in the areas of clinical teratology and pharmacology as well as paediatrics and clinical genetics. Dr Kennedy provides expertise in the field of medicines in pregnancy.

Professor Steve Kisely is trained in psychiatry, public health and addiction medicine. He is a Professor at the University of Queensland and Director of Research for Metro South Addiction and Mental Health Services in Brisbane. He has previously been on the TGA’s Psychiatric Drug Safety Expert Advisory Panel and Advisory Committee on the Safety of Medicines. His research interests are in non-communicable disease epidemiology using administrative data. Professor Kisely provides expertise in the field of psychiatry.

Professor Robyn Langham is the Head of the School of Rural Health at Monash University, a practising nephrologist and general physician. Her expertise lies in renal disease and organ transplantation and immunology, along with knowledge of endocrine and cardiovascular disease therapies. Professor Langham also has research experience in drug development. Professor Langham provides expertise in the field of renal disease.

Ms Alison Marcus has been actively involved in representing health consumers' interests since 2003, and was a member of the Advisory Committee on the Safety of Medicines. She is involved in community organisations and is interested in fostering opportunities for consumers and carers to improve health literacy, and ensuring that information is credible and readily available. She is a registered nurse who has worked in metropolitan, regional and remote health services in the public and private sectors, and in a range of community health and tertiary specialty clinical areas. Ms Marcus provides expertise in the field of consumer health issues.

Dr Maya Latimer is a senior Consultant Haematologist at the Canberra Region Cancer Centre, Canberra Hospital. She is the current Chair of the ACT Health Multi-Disciplinary Team (MDT) for lymphoma, participates in the Leukaemia MDT and is one of the supervising haematologists for human genomics (cytogenetics and molecular haematology) at ACT Pathology. She is active in the Australasian Leukaemia and Lymphoma group, participating in the high grade lymphoma (NHL and Hodgkins), CLL, low grade lymphoma, CML and myeloproliferative neoplasm subgroups. Dr Latimer is also a member of the Australasian Lymphoma Alliance and the eviQ reference committee. Dr Latimer provides expertise in the field of internal medicine, particularly haematology.

Professor Geoffrey McColl is Executive Dean of the Faculty of Medicine at the University of Queensland. He is a medical practitioner with a speciality qualification as a rheumatologist. Professor McColl brings considerable clinical and research experience in the areas of rheumatology and immunology. He was a member of the Pharmaceutical Benefits Advisory Committee and a previous Chair of its Drug Utilisation Sub-Committee. Professor McColl provides expertise in the field of rheumatology.

Associate Professor Wendy Munckhof is an infectious diseases physician and clinical microbiologist at the Gold Coast University Hospital and Wesley Hospital, Brisbane and an Associate Professor in the Department of Medicine, University of Queensland. She has a PhD in antimicrobial pharmacodynamics. Her research interests are antimicrobial pharmacodynamics, antimicrobial stewardship and the epidemiology and management of Staphylococcus aureus infections. She has previously been secretary of the Australian Society for Antimicrobials, Councillor of the Australasian Society for Infectious Diseases, and a member of the expert writing group for Therapeutic Guidelines: Antibiotic. Associate Professor Munckhof provides expertise in the fields of infectious diseases, clinical microbiology and antimicrobial therapy.

Professor Michael Peek is Associate Dean (Health Precinct Planning) and Professor of Obstetrics and Gynaecology at the Australian National University. He is also a subspecialist in Maternal Fetal Medicine at the Centenary Hospital for Women & Children within Canberra Hospital & Health Services. His research interests are centred around medical disorders in pregnancy. Professor Peek was a previous Federal Council Member of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and a past President of the Australasian Society for the Study of Hypertension in Pregnancy. Professor Peek provides expertise in the field of medicines in pregnancy, obstetrics and gynaecology.

Dr Stephen Phillips OAM is a General Practitioner with a long interest in standards and quality, particularly in relation to medicines, therapeutics and public health. Dr Phillips has actively participated on many committees, professional and public health organisations and was previously a member of the Australian Drug Evaluation Committee. He was awarded the Medal of the Order of Australia for his services as a promoter of the safe and effective use of medicines. Dr Phillips provides expertise in the field of general medical practice in Australia.

Associate Professor Peter Pillans is a specialist in clinical pharmacology, Associate Professor in the Department of Medicine, University of Queensland and was previously the Director of Clinical Pharmacology and a specialist physician at Princess Alexandra Hospital. He has a particular interest in drug safety, and served on the New Zealand Medicines Adverse Reactions Committee and the Australian Adverse Drug Reactions Advisory Committee for many years. He was also a member of Advisory Committee on Prescription Medicines. Associate Professor Pillans provides expertise in the field of clinical pharmacology.

Professor Philip Robinson is currently head of the Department of Respiratory and Sleep Medicine at the Royal Children's Hospital, in Melbourne. He also heads a drug trial research team at the Murdoch Children’s Research Institute involving paediatric lung conditions. His main clinical interest is in supportive lung disease, including CF and PCD as well as chronic lung disease of prematurity. Professor Robinson provides expertise in the field of respiratory disease.

Clinical Associate Professor Rashmi Sharma has wide-ranging experience working in clinical practice. Her interest in medicines also covers implementation of Quality Use of Medicine and she has worked with the Royal Australian College of General Practitioners, the Pharmaceutical Society of Australia and National Prescribing Service on various projects such as dispensing in general practice, development of opioid prescribing resources, antimicrobial resistance and inter-professional teaching. Clinical Associate Professor Sharma chaired the Medicines Advisory Committee in the ACT. She has extensive experience serving on government advisory boards, including the Professional Services Review Board and the Pharmaceutical Benefits Advisory Committee. Clinical Associate Professor Sharma provides expertise in the field of general medical practice in Australia.

Dr Kee Meng Tan completed his neurology training at Royal Brisbane & Women's Hospital and the Mayo Clinic, Rochester, with fellowships in Clinical Neurophysiology and Autoimmune Neurology. He joined the Comprehensive Epilepsy Program at Royal Melbourne Hospital and then the Director of Neurology at Gold Coast Hospital and Health Services. He recently assumed the role of Clinical Director of Diagnostic and Subspecialty Services at GCHHS. Throughout his career, he has taken on key advisory roles in clinical education in hospitals, medical schools and the Royal Australasian College of Physicians. Dr Tan provides expertise in the field of neurology.

Professor Duncan Topliss is the Director, Department of Endocrinology and Diabetes at the Alfred, Melbourne, and Professor of Medicine, Monash University. He is a past President and Life Member of the Endocrine Society of Australia. He has a wide expertise in clinical endocrinology including thyroid disease, diabetes, osteoporosis, pituitary and adrenal disease, and endocrine hypertension. Professor Topliss provides expertise in the field of endocrinology.

Professor Euan Walpole is currently the Medical Director for Cancer Services and Cancer Stream Leader at Princess Alexandra Hospital, Queensland. He is responsible for cancer clinical service delivery, safety, and financial outcome and research agendas. Other current positions held by Professor Walpole include honorary associate of NHMRC clinical trials centre, visiting medical officer at Mater Private hospital, ICON@South Brisbane and Brisbane Private Hospital and a pre-eminent medical specialist at Queensland Health. Professor Walpole provides expertise in the field of internal medicine, particularly medical oncology.

Associate Professor Dominica Zentner is an adult cardiologist at the Royal Melbourne Hospital with a PhD on cardiac changes during normal human pregnancy. Her clinical practice encompasses general clinical cardiology, adult congenital heart disease, the management of women with cardiac disease during pregnancy, genetic cardiology and echocardiography. She is involved in clinical research in these areas. Associate Professor Zentner provides expertise in the field of cardiology.

2019-2020 ACM proposed meeting dates

Meeting no. Cut-off date for pre-ACM response Meeting dates
18 19 November 2019 5-6 December 2019
19 21 January 2020 6-7 February 2020
20 17 March 2020 2-3 April 2020
21 19 May 2020 4-5 June 2020
22 21 July 2020 6-7 August 2020
23 15 September 2020 1-2 October 2020
24 17 November 2020 3-4 December 2020

Contact details for the ACM

Email acm@health.gov.au
Phone +61 2 6232 8665
Mobile +61 468 609 842
Fax +61 2 6203 1250
Postal Address Advisory Committee on Medicines
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Attn: Scheduling & Committee Support Section, MDP 122