Accelerated regulatory pathways: Vaccines for tropical diseases

Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.

Despite advancement in global pharmaceutical research, nearly one billion individuals are affected by tropical diseases yearly, according to World Health Organization. The development of new treatments for tropical diseases remains difficult and this report will explore how human challenge trials can support the development of treatments and vaccines for these diseases and accelerate their regulatory approval.[1]

A number of regulatory agencies have put in place programmes to stimulate the development of therapeutics for tropical diseases, for example, the FDA `Neglected Tropical Disease Priority Review Voucher Program’.

hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.

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