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BioBreakfast: Is Victoria Cell Therapy Ready?
June 28, 2018 @ 7:30 am - 9:00 am AEST
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Cell and gene therapies are revolutionising healthcare and delivering outstanding outcomes for patients. The pipeline of products is growing, providing potential cures for previously intractable conditions and creating new business models for healthcare innovation companies.
The challenges in the production and manufacturing of these new therapies is a recognised bottleneck. Transformation of supply chains and the development of new therapeutic delivery systems will be required to embrace the economic and health opportunities that cell and gene therapies provide.
This event will explore Victoria’s manufacturing capabilities, clinical preparedness and infrastructure requirements to ensure Victoria is “cellular therapy ready”.
Date: Thursday 28th of June 2018
Time: 7:20am – Registration , 7:30am – Networking Breakfast, 8:00am – 9:00am – Presentation and Panel Discussion
Venue: The Cube, ACMI, Federation Square, Melbourne
Speaker:
Dr Dominic Wall, CSO, Cell Therapies Pty Ltd.
Dr Dominic Wall is the Chief Scientific Officer (CSO) for Cell Therapies Pty Ltd and the nominated Production Manager for the Centre for Blood Cell Therapies (CBCT) for the purposes of licensing by the Therapeutic Goods Administration (TGA). He also manages activities of the NATA certified Pathology services at the Peter MacCallum Cancer Centre.
Dr Wall graduated in Science (BSc (Hons) Applied Biology, UEL) in London in 1986, with training at the University of London School of Pathology at the Middlesex Hospital, followed by a University of Melbourne PhD in cancer research and a Founding Fellowship in the Faculty of Science of the Royal College of Pathologists. His interests are primarily in immunotherapy, regenerative medicine, cell therapy imaging and regulation of the emerging cell and tissue therapy field.
He has published more than 80 manuscripts, abstracts and presentations in these areas. In 1999 he developed the cell therapy program at Peter Mac and was a co-founder of Cell Therapies in 2001, leading it to becoming the first TGA licensed service in this field in Australia.
He has been the regional president of the International Society for Cellular Therapy (ISCT) for three terms and also leads the annual Global Regulatory Perspectives workshop at the ISCT annual meeting each year.
Chair:
Dr Tim Oldham, PhD; Executive Leader, Tijan Ventures
Panellists:
Prof. Alan Trounson – CEO and Executive Director, Cartherics
Anna Burgess, Director, Cancer, Specialty Programs, Medical Research and International Health at Department of Health & Human Services
Brent McPherson – ANZ National BD Manager, World Courier (Australia) Pty Ltd
Ms Jeanette Ripper – Production Manager, Cell Therapies.
Sponsor:
Bio: Tim Oldham , BSc(Hons), LLB(Hons), PhD; Executive Leader at Tijan Ventures
Tim Oldham, Executive Leader at Tijan Ventures, provides transformational and growth leadership to life sciences and healthcare companies with a current focus on cell and gene therapies. Dr Oldham brings global commercialisation experience in biosimilars, cellular therapies, generic and branded pharmaceuticals and medical/med tech devices built over 15 years of executive leadership and board roles at Mayne Pharmaceuticals Ltd, Hospira Inc, Cell Therapies Pty Ltd, Acrux Ltd and Respiri Ltd and diverse consulting experience. experience.
Bio: Professor Alan Trounson (CEO and Executive Director), Cartherics
Alan Trounson is Emeritus Professor Monash University and Distinguished Scientist, Hudson Institute for Medical Research, Clayton, Victoria, Australia.
He is the past President of the Californian Institute for Regenerative Medicine (2007-2014), the Californian state’s $3 billion stem cell agency driving research in stem cell biology and facilitating the translation of stem cell discoveries into clinical therapies.
He was a pioneer of human in vitro fertilisation (IVF) (1977-1996), introducing fertility drugs for controlling ovulation, embryo freezing techniques, egg and embryo donation methods, early sperm microinjection methods, initiated embryo biopsy, developing in vitro oocyte maturation methods and the vitrification of eggs and embryos.
He pioneered somatic cell nuclear transfer for embryonic stem cells in mice, led the Australian team cloning cattle for the Dairy Industry and was involved in developing artificial breeding of wombats, Black Rhinos and the frozen zoo for wild and endangered species.
He led the Australian team for the discovery of human embryonic stem cells in the late 1990’s and was awarded the first Australian Biotechnology of Excellence in 2003. He was the founding CEO of the Australian Stem Cell Centre.
He was Director of the Centre For Early Human Development (1987-2003) and Deputy Director Monash Institute Reproduction and Development (1990-2003). He founded the
Monash Immunology and Stem Cell Laboratories (120 scientists) at Monash University (2004-7).
He is presently the founding CEO/President of the start-up company Cartherics Pty Ltd., developing immune stem cell therapies for treating ovarian and gastric cancer sited at the Monash Health Translation Precinct, Hudson Institute, Monash Medical Centre, Clayton Vic.
He is the past President of the Californian Institute for Regenerative Medicine (2007-2014), the Californian state’s $3 billion stem cell agency driving research in stem cell biology and facilitating the translation of stem cell discoveries into clinical therapies.
He was a pioneer of human in vitro fertilisation (IVF) (1977-1996), introducing fertility drugs for controlling ovulation, embryo freezing techniques, egg and embryo donation methods, early sperm microinjection methods, initiated embryo biopsy, developing in vitro oocyte maturation methods and the vitrification of eggs and embryos.
He pioneered somatic cell nuclear transfer for embryonic stem cells in mice, led the Australian team cloning cattle for the Dairy Industry and was involved in developing artificial breeding of wombats, Black Rhinos and the frozen zoo for wild and endangered species.
He led the Australian team for the discovery of human embryonic stem cells in the late 1990’s and was awarded the first Australian Biotechnology of Excellence in 2003. He was the founding CEO of the Australian Stem Cell Centre.
He was Director of the Centre For Early Human Development (1987-2003) and Deputy Director Monash Institute Reproduction and Development (1990-2003). He founded the
Monash Immunology and Stem Cell Laboratories (120 scientists) at Monash University (2004-7).
He is presently the founding CEO/President of the start-up company Cartherics Pty Ltd., developing immune stem cell therapies for treating ovarian and gastric cancer sited at the Monash Health Translation Precinct, Hudson Institute, Monash Medical Centre, Clayton Vic.
Bio: Anna Burgess, Director, Cancer, Specialty Programs, Medical Research and International Health at Department of Health & Human Services
Anna Burgess is currently the Director, Cancer, Specialty Programs, Medical Research & International Health at the Department of Health & Human Services Victoria, and has held this role since January 2017.
In her current role, Anna is responsible for cancer service delivery, cancer research (including the Victorian Cancer Agency, specialty programs (including organ donation and transplantation, blood products, high cost pharmaceuticals, clinical genetics, genomics and new technology), health and medical research (including funding of medical research institutes and relationships with Victorian academic health science centres) and delivery of the Government’s strategies on international engagement in the health sector.
Anna has worked in the Victorian health sector for 30 years at the Department and in various executive roles in public health services.
In her current role, Anna is responsible for cancer service delivery, cancer research (including the Victorian Cancer Agency, specialty programs (including organ donation and transplantation, blood products, high cost pharmaceuticals, clinical genetics, genomics and new technology), health and medical research (including funding of medical research institutes and relationships with Victorian academic health science centres) and delivery of the Government’s strategies on international engagement in the health sector.
Anna has worked in the Victorian health sector for 30 years at the Department and in various executive roles in public health services.
Bio: Ms Jeanette Ripper – Production Manager, Cell Therapies.
Jeanette Ripper is the CTPL Production Manager, responsible for the quality of all GMP manufactured products and associated projects at Cell Therapies and is the nominee for production in all TGA / regulatory requirements.
Jeanette has extensive experience in the procurement and manufacturing of GMP compliant cells and tissues, oversight of the quality frameworks that support GMP manufacturing and advising on regulatory requirements for TGA, FDA &
PIC/S certified manufacturing environments, including quality requirements for clinical trial investigational products for human clinical trials.
Her most recent experience was as Principal Auditor at Clinical Network Services (CNS), where she performed GCP/GMP audits of Clinical Investigator Sites within Australia, New Zealand and South East Asia, to determine regulatory compliance to the applicable GMP and GCP guidelines (ICH), including compliance of investigational products manufactured using genetically modified organisms (GMOs).
Prior to this, Jeanette was the CTPL Quality and Regulatory Manager for three years, where she was responsible for the development and management of all dimensions of the Cell Therapies Quality Systems to international GMP benchmarks, for cell therapy products developed and manufactured on behalf of internal users as well as external commercial clients, for patients throughout Australia and Asia. Additionally, she was also directly involved in the development of the cGMP clean room facilities for the Victorian Comprehensive Cancer Centre (VCCC) in Parkville.
Jeanette has an international reputation in GMP, having spent 7 years as a lead GMP inspector at the TGA, within the Blood, Tissue and Cellular Therapy Products Inspection Group, of the Office of Manufacturing Quality and having had an important role in the team that developed the current cGMP that was issued by TGA for Human Blood and Blood Components, Human Tissues and Human Cellular Therapies in 2013.
Before joining the TGA, she was the Acting Scientific Director, and Production Manager for the BMDI National Cord Blood Bank at the Royal Children’s Hospital, where she was responsible for the management of the GMP manufacturing facility and the monitoring and oversight of the processing laboratory and cryostorage facility. She jointly lead the Cord
Blood Bank manufacturing to FACT and TGA accreditation and was the Production Nominee on the TGA GMP Manufacturing Licence.
Jeanette has extensive experience in the procurement and manufacturing of GMP compliant cells and tissues, oversight of the quality frameworks that support GMP manufacturing and advising on regulatory requirements for TGA, FDA &
PIC/S certified manufacturing environments, including quality requirements for clinical trial investigational products for human clinical trials.
Her most recent experience was as Principal Auditor at Clinical Network Services (CNS), where she performed GCP/GMP audits of Clinical Investigator Sites within Australia, New Zealand and South East Asia, to determine regulatory compliance to the applicable GMP and GCP guidelines (ICH), including compliance of investigational products manufactured using genetically modified organisms (GMOs).
Prior to this, Jeanette was the CTPL Quality and Regulatory Manager for three years, where she was responsible for the development and management of all dimensions of the Cell Therapies Quality Systems to international GMP benchmarks, for cell therapy products developed and manufactured on behalf of internal users as well as external commercial clients, for patients throughout Australia and Asia. Additionally, she was also directly involved in the development of the cGMP clean room facilities for the Victorian Comprehensive Cancer Centre (VCCC) in Parkville.
Jeanette has an international reputation in GMP, having spent 7 years as a lead GMP inspector at the TGA, within the Blood, Tissue and Cellular Therapy Products Inspection Group, of the Office of Manufacturing Quality and having had an important role in the team that developed the current cGMP that was issued by TGA for Human Blood and Blood Components, Human Tissues and Human Cellular Therapies in 2013.
Before joining the TGA, she was the Acting Scientific Director, and Production Manager for the BMDI National Cord Blood Bank at the Royal Children’s Hospital, where she was responsible for the management of the GMP manufacturing facility and the monitoring and oversight of the processing laboratory and cryostorage facility. She jointly lead the Cord
Blood Bank manufacturing to FACT and TGA accreditation and was the Production Nominee on the TGA GMP Manufacturing Licence.
Bio: Brent McPherson - ANZ National BD Manager, World Courier
Worked in the freight and international logistics industry for over 20 years, I have been fortunate to work for several multinational logistics companies, running operations and service departments for many local and international clients. Previously a Global Account Manager for the healthcare sector, in the APAC region. A graduating member of the European Logistics Association. Currently head of development for World Courier in ANZ, where we support the health sector with vital end to end supply chain solutions, for both their research and commercial needs.
