A/Prof 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).
Dr Wendy Fleming – Director of Production
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 – Director of Quality
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.