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Bio Technology : October 2009
8 Australasian BioTechnology Volume 19 • Number 3 • October 2009 A global regulatory strategy: Maximising the potential in the Asia Pacifc market for the international regulatory arena. in harmony with local experts in the region. Capitalising on the potential of Asia Pacific requires an integrated, independent and objective assessment of the potential for harmonising the global regulatory needs of the various authorities; quality of the components of the various technical data needed for a successful regulatory program; and the ability of chosen sub-regions to provide them. Only through such an assessment and harmonisation of needs and supply can a medical product that is discovered, developed or produced in the Asia Pacific environment be approved, registered and/or and licensed. The application of appropriate resources to these tasks through the use of internal and external expertise will aid in designing a product development program that fits the product's particular strengths and makes the most efficient use of intellectual capital, natural resources, the local economy, training and experience of workers, and quality/ availability of facilities. The regulatory climate in the West is not very forgiving of poorly developed data; however it is more than willing to embrace high-quality intellectual property, new technology, and promising new products from the Asia Pacific region, provided the data (eg that derived from efforts in the chemistry, manufacturing and controls, pre-clinical/non-clinical, clinical, and biocompatibility areas), generated are also of high quality and well-documented. A developmental profile for a new product should be initiated from the onset of early discovery work and the historic orientation towards this type of profiling, along with formal reporting of protocols, results obtained, objective decision making ('go/no-go decisions') and prospects for moving forward, may vary widely in sub- regions of the area. A training program with consistent goals, harmonised to bridge the gap of technology, Asia Pacific know-how, resources and regulatory needs can bring about a revolutionary development of new In diffcult economic times, many sponsors are exploring the promises and opportunities available in the Asia Pacifc region. This region comprises a vast geographical, educational, cultural, economic and procedural diversity. This diversity provides a manifest source of leadership and support for development of life-saving and enhancing biotechnology products for the benefit of humankind on a global basis as well as within the region itself. The Asian Pacific region also represents a generous source of intellectual property from an expanding university and corporate infrastructure and this is expected to lead to a new pipeline of medical products in the decades to come. A growing availability of pre-clinical/non-clinical facilities and animal supply, at competitive prices and of growing quality should help provide the biotechnology industry with the generation of top-quality data in support of human clinical trials. This capability will need to be managed carefully to meet the ever-tightening require- ments of regulatory authorities. The large population base of the region and need for new therapeutic modalities allows the Asia Pacific region to provide an expanding source of potential patients for clinical trials of new biotechnology products. This must be handled carefully so as to meet ethical and scientific standards for support of these products. Likewise, a growing capability for manufacture of pharmaceuticals, biologics, medical devices and combination products with relatively inexpensive labour can dovetail with the growing needs of sponsors of such products for both testing and commercial production. Identifying the opportunities and assessing prospects is challenging and sponsors benefit from assistance from experts in medical product development, who can work AusBioFEATURE --- AusBiotech 2009 By Dr Evan B Siegel, President and CEO, Ground Zero Pharmaceuticals Presenter at AusBiotech 2009 4.00pm – 5.30pm, Thursday 29 October Global Regulatory Challenges and Opportunities