Dawn Driscoll, PhD MBA – Chief Executive Officer
Dawn Driscoll is the CEO of Cell Therapies, appointed October 2017. Dawn has over 20 years of experience in the biotechnology industry globally, with expertise in cell therapy, licensing, acquisitions and commercialisation. Dawn has previously managed global technical teams in clinical development, regulatory affairs, marketing and pharmaceutical product launches.
Dawn has held senior roles in Johnson & Johnson, Wyeth (Pfizer) Pharmaceuticals, and managed DCi Biotech, an international consultancy focused exclusively on the commercialisation of cell & gene therapies, for over 10 years.
Dawn holds a Bachelor of Science in Marine Biology, a PhD in Biochemistry and Molecular Biology, and a MBA from the Isenberg School of Management, University of Massachusetts.
“I am delighted to be working with the world-class team at Cell Therapies! I look forward to the next exciting phases of growth for both the company and the field of cell and gene therapies, which hold so much promise for so many patients.”
Dr Dominic Wall – Chief Scientific Officer (CSO)
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.
Mr Sven Straub – Chief Financial Officer
Mr Sven Straub was appointed as Chief Financial Officer in August 2014. He has more than 18 years of finance leadership and corporate governance experience gained in Australia, UK and Singapore for FTSE listed companies (Associated British Foods, PZ Cussons and G4S), as well as Novartis (8 years).
His most relevant experience includes business acquisitions, company start-ups, process development and improvement, long-term financial planning & analysis and multiple I.T. system implementations.
Mr Straub graduated from RMIT in 1989 (Ba Bus), and completed his CPA qualification in 1993, followed by a Masters in Business Administration at Deakin University (2009).
Ms Jeanette Ripper – Production Manager
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.
Dr Wendy Fleming – Production Manager
In her role as Cell Therapies’ Production Manager, Dr Wendy Fleming is responsible for the delivery of projects manufactured within the Cell Therapies cGMP facility.
Wendy graduated from the University of Western Australia with a Bachelor of Science in Microbiology and Pathology with Honours, and worked at the Western Australian Institute of Medical Research prior to undertaking a PhD in Molecular Biology at the University of Queensland in conjunction with the Queensland Institute of Medical Research. After completing her postgraduate degree Wendy went on to further her career working at cGMP facilities in academic research institutes before moving to Melbourne in 2010 to take up her position at Cell Therapies.
In addition to the many projects she has managed in Australia, Wendy has also successfully managed client projects in South East Asia, and in particular, was the Project Manager responsible for the design and specification of a cGMP PIC/S Clean room facility in Kuala Lumpur, Malaysia. As part of this project, Wendy implemented a TGA compliant quality system, conducted training for manufacturing staff and facilitated the commencement of a Phase I clinical trial. The facility has since been accredited by the national regulatory agency.
Wendy’s main interests are process development, continuous improvement strategies and technology transfers. Her other interests include the design, specification and commissioning of cGMP facilities and was directly involved in the development of the cGMP clean room facilities for the Victorian Comprehensive Cancer Centre (VCCC) in Parkville.
Mr Nathan Smith – Project Portfolio Manager
Mr Nathan Smith is the Project Portfolio Manager responsible for the delivery of all external projects, including apheresis management, consulting services, and Japanese affiliated projects. His role also oversees business development activities and management of the Cell Therapies client pipeline. He has over 15 years’ experience within CMC, operations and project management, including expertise in technical transfer, cell culture, cGMP clinical and commercial manufacturing, and contract manufacturing management (both internally and externally).
Mr Smith graduated from Pennsylvania State University with a BSc in Chemical Engineering. He worked at GlaxoSmithKline’s U.S. Biopharmaceuticals facility, participating in multiple technical transfer projects and successful FDA pre-approval inspections. He then joined BioReliance, where he developed and grew the cell banking business to meet EMA GMP certification requirements, engaging clients and developing their cell banking service line. Mr. Smith subsequently worked at Mesoblast, managing all external contract manufacturing activities, process development, and clinical product support of phase II and III clinical trials for an allogeneic cell therapy product. Finally, Mr. Smith worked at Genzyme as the Associate Director of Global Cell Banking Operations prior to joining Cell Therapies Pty Ltd.
Mr Gerry McKiernan – Quality Manager
Mr Gerry McKiernan is the Quality Manager covering activities of Cell Therapies Pty Ltd and its affiliated units at the Peter MacCallum Cancer Centre. Mr McKiernan has over 14 years’ experience in Quality roles in research and development and cGMP manufacturing in both Europe and Australia.
He is tertiary qualified in Applied Chemistry from the Institute of Technology Tallaght, Ireland. Since graduating, Mr McKiernan’s career has included biotechnology, pharmaceutical and medical device industries.
His experience includes Quality systems leadership at a regional level for vaccine development and clinical trials, Quality oversight for Class III medical device product development and validation which achieved registration in Europe and laboratory leadership for pharmaceutical product development in a contract manufacturing setting. Mr McKiernan has overseen the quality strategy for the expedited release to market of a cell derived recombinant protein antigen to address the emerging threat of the Hendra virus in Australia by achieving cGMP licensing for a R&D pilot facility and subsequent release approval. He has also overseen the implementation of a quality management system and compliance structure for a new vaccine research and development facility in Beijing.
Mr McKiernan is passionate about continuous improvement and has successfully implemented continuous improvement cultures within regulated industries.