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Challenges and Solutions for Budget Impact Analysis of Gene Therapies

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Neil McAuslane PhD, MSc, BSc. Scientific Director of the Centre for Innovation in Regulatory Science (CIRS) overseeing the scientific content of both CIRS regulatory and HTA programmes. Key research areas of work include regulatory strategy and strengthening, building quality into regulatory processes, the utilization of decision frameworks and the development of multistakeholder workshops which bring companies, patients, and agencies (Regulatory and HTA) together to discuss major areas of interest.
Prior to joining CIRS, Neil completed a PhD degree in Clinical Pharmacology from the University of Edinburgh, having gained an MSc in Toxicology at the University of Surrey and a BSc in Pharmacology from Dundee University. He joined the CMR International (now CIRS) in 1988 as a Postdoctoral Fellow in affiliation with the Division of Clinical Pharmacy, University of Wales, Cardiff, and became a permanent member of staff in 1991.
Neil has also supervised PhD students undertaking research in both the HTA and regulatory areas. He is currently involved in specific research on how best to measure the performance of agencies, risk-based approaches in the assessment of new medicines, building quality into the review process, decision making and HTA and regulatory alignment. He has edited and co-authored several publications and reports covering both regulatory and HTA topics.
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