In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
|Articles|April 2, 2020
Zymewire Launches Directory Of Drug Development Experts With Services Available To Fight COVID-19
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Zymewire has announced the launch of CovidCollaborators.org, an online directory of expert, pro-bono, and discounted clinical development services being offered in the fight against COVID-19. Some of the services being offered include clinical research, clinical software, EDC, manufacturing, investigator training, patient recruitment, and more.
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Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.
A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.
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In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
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