Developing a Single Product for Multiple Markets
Tuesday, October 25, 2011,
12:00 PM - 1:00 PM ET
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Meeting the manufacturing requirements of FDA, EMEA and TGA is a common challenge for those undertaking product development in the context of multicentre studies.
When optimising a product to ensure its commercial viability what can be done to pre-empt likely concerns of multiple regulators?
This webinar will take you through the common issues and points of difference between each regulator. As well as addressing the challenges and opportunities when using manufacturing sites on three continents.
At which point should automation and introduction of closed systems be optimally considered?
Dominic will also explore product development, biomaterials, comparability, stability and in process and release testing as well as product characterisation.
PhD FFSc (RCPA)
Dominic Wall has been directly involved in cell therapy manufacturing since the 1990’s and is currently the Chief Scientific Officer of Cell Therapies Pty Ltd as well as being the the operations director of the cell therapy services (and pathology services) at a comprehensive cancer centre (Peter MacCallum Cancer Centre). After completing his undergraduate education in London he completed a PhD at the University of Melbourne and obtained his Fellowship (FFSc) from the Royal College of Pathologists of Australasia in 2010. He currently administers three TGA issued cGMP manufacturing licences , on behalf of Orthogen Australia Ltd and Mesoblast Ltd (as well as Peter Mac). These services have been subjected to 13 medicines agency inspections over the last 10 years as part of their routine compliance activities. He is currently involved in commercial process development and manufacturing for numerous international clients of Cell Therapy as well as supporting novel research in in-vivo therapy imaging using PET and MRI, complex cell therapy trials (such as GMO T cell immunotherapy for acute leukemia) as well as a maintaining a core routine service for patients with cancer. He is the Regional (Australasia) Vice-President Elect for the International Society for Cell Therapy.
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