The Problem
A multi-disciplinary collaboration between industry and a university on a long-acting anti-retroviral program was jeopardized when the acting Sponsor needed to withdraw its participation just as the COVID-19 epidemic began. Our team was engaged to help ensure a smooth transition of regulatory Sponsorship, to support the design and development of both the implantable device and the device delivery system, and to manage communication on clinical development plans with key stakeholders, including FDA and NIH/NIAID.
Our Actions
Our team collaborated with multiple contract research organizations and teams within the university to execute the following key deliverables:
- Our team completed a comprehensive gap analysis to support seamless transfer of the IND to the University, including a review of the prior Sponsor’s regulatory communications and current FDA and NIH advice on anti-infective product development.
- We supported the study team in the evaluation, interpretation, and design of ongoing and prospective in vitro and non-clinical studies to enable the development of a regulatory strategy to accelerate the program into a first-in-human clinical study.
- Our team jointly managed the key vendor responsible for the manufacture of the drug-eluting device, including participation in design activities, development of testing protocols, and supporting intellectual property prosecution arising from these activities.
- We identified and managed a medical device engineering vendor for the design, development, and testing of a custom device delivery system, demonstrating suitability for the clinical deployment of the drug reservoir.
- Although the prior Sponsor had held their pre-IND meeting in the weeks before the COVID-19 epidemic, our team successfully sought a Type-B interaction to provide a thorough program update, which resulted in an unusual invitation from FDA to submit a new pre-IND meeting request prior to initiation of clinical trial-enabling studies to ensure that the program remained aligned with FDA’s evolving approach to vaccine products.
Outcome
With our team’s support, our client was able to wrest control of a stalled anti-retroviral combination product program through a forthright evaluation of all parties. Our team then led a challenging dialogue with FDA that resulted in the Agency not only providing a clear path forward, but also emerging as a willing partner to further this important program.
In partnership with 
