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"Ridley, Sarah"
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European priority review vouchers for neglected disease product development
IntroductionNeglected diseases are a significant global health challenge. Encouraging the development of therapeutics and vaccines for these diseases would address an important unmet medical need. We propose a priority review voucher programme for the European Union (EU). The developer of a drug or vaccine for a neglected disease would receive a voucher for accelerated assessment of a different product at the European Medicines Agency (EMA).MethodsThis study uses retrospective observational data to estimate the potential commercial value of the proposed voucher programme using a five-step approach: (1) estimating the time saved in the EMA accelerated regulatory review; (2) gauging time reductions in accelerated pricing and reimbursement decisions by EU member states; (3) selecting 10 high-revenue products launched between 2015 and 2020 representing typical voucher users; (4) analysing IQVIA MIDAS sales data for the selected products and (5) calculating the net present value (NPV) of the voucher based on the 10 products.ResultsThe accelerated EMA review would reduce regulatory time by an average of 182 days. Additionally, products could save more than a year in many member states through an expedited 120-day pricing and reimbursement review. The estimated NPV of regulatory acceleration by two quarters would be €100 million. In addition, if France, Italy and Spain reviewed pricing and reimbursement in only 120 days, then the value would double.ConclusionAn EU voucher estimated at more than €100 million, coupled with a US$100 million counterpart, offers a meaningful incentive for novel product development. However, the voucher programme should be part of a comprehensive strategy for tackling neglected diseases, rather than a standalone solution.
Journal Article
Life in Viking times : discover how the Vikings lived, played, worked, and fought
\"Find out about everyday life in Viking times in this fact-packed book that combines photographs of actual objects with full-color illustrations and fascinating text.\"--Page 4 of cover.
Book
\That Every Christian May Be Suited\: Isaac Watts's Hymns in the Writings of Early Mohegan Writers, Samson Occom and Joseph Johnson
This thesis considers how Samson Occom and Joseph Johnson, Mohegan writers in Early America, used the hymns of English hymnodist, Isaac Watts. Each chapter traces how either Samson Occom or Joseph Johnson's adapted Isaac Watts's hymns for Native communities and how these texts are sites of affective sovereignty.
Dissertation
Life in Roman times
\"Find out about everyday life in ancient Rome in this fact-packed book that combines photographs of actual objects with full-color illustrations and fascinating text.\"--Page 4 of cover.
Book
Towards a new business culture for tourism and hospitality organizations
Identifies hospitality and tourism themes that have been followed
in the International Journal of Service Industry Management and
Service Industries Journal between 1989 and 1994. Highlights
points of interest. The themes come under the headings of: structure of
the tourism industry; quality; consumer orientation; employees; and
strategic options, and follow the managerial practices that
organizations are concerned with in order to gain competitive advantage.
Journal Article
Life in Ancient Greece
This volume gives young readers an insider look at the everyday lives of ancient Greeks, providing a relatable way for them to learn about the history of this ancient culture.
Book
MURDER SUICIDE OF FAMILY TO ESCAPE 'THE EVIL IN WORLD'
Kristi died of a combination of drugs and her husband Benjamin died from toxic levels of heroin, according to a report from the Utah State Medical Examiner's Office.
Newspaper Article
Life in ancient Egypt
How did the ancient Egyptians farm? What were their houses made from? What did they put in their tombs? Find out about everyday life in ancient Egypt in this fact packed book.
Book
Kissed back to life! Man has heart attack in club full of nurses
The nurses, from Blackpool Victoria Hospital bowel cancer screening programme, then continued with their efforts until an ambulance arrived at the town's Sands venue.
Newspaper Article