Writing an Investigational New Drug (IND) application is a major hurdle for drug developers. It can take a team of specialists three to four months, and mistakes can trigger protocol amendments or clinical holds.
In June, we started working with Population Health Partners (PHP) to leverage specialized Kosmos Clinical Protocol Design (“CPD”) and Kosmos Regulatory Authoring (“RA”) products to support PHP’s process of IND preparation.
Since then, specially trained Kosmos products produced a first acceptable draft of the Nonclinical Overview in 4.2 hours, against 100 hours of expert time, flagged an error that roughly fifteen human reviewers missed, and authored 70% of the text in a Pre-IND Briefing Meeting Request submitted to FDA.
PHP is now bringing Kosmos products to a second program and expects to complete IND preparation in as little as 1 month, instead of the 4 month industry standard.
PHP's experts can spend their time reviewing and deciding, not just drafting. The time recovered by Kosmos products means that drugs could make their way to patients faster.