18-02-OpticNerve

Prototype Solutions for Optic Nerve Injury

The overarching goal of this program is to provide biomanufacturing for an emerging area of medical technology and innovation to support standard procedures toward a device, biologic, or combination prototype to maintain, re-establish or regenerate damaged visual pathways.

The Awardee will develop an innovative solution to a critical problem in visual loss. Applications were expected to address one or more of the following focus areas in nerve regeneration or end-organ health:

 

  1. 1. Enhance optic nerve regeneration.
  2. 2. Re-establish neuronal connections between retinal ganglion cells and the lateral geniculate nucleus with high efficiency.

This effort aims to promote highly innovative, groundbreaking research; high-impact research with near-term clinical relevance; multidisciplinary, synergistic research; and translational studies to support the fluid transfer of knowledge from basic principles to clinical solutions.

The research project award recipient was selected from the Offerors who responded to MTEC’s Request for Project Proposals (18-02-OpticNerve).


Preservation and Restoration of Vision in Optic Neuropathies: Porcine traumatic model for advancing neuroprotective and regenerative therapies towards human testing

 

Project Team: Stanford University
Award Amount: $3.00M
Project Duration: 36 months
Project Objective: Traumatic injury to the optic nerve, as can occur on the battlefield or in civilian life, results in permanent loss of vision, as do degenerative disorders such as glaucoma or ischemic optic neuropathy. The labs involved in this consortium have made enormous progress identifying pro‐survival and pro‐regenerative molecular pathways that lead to unprecedented levels of RGC survival and axon regeneration. However, movement towards human therapeutics has been limited by lack of data in a large animal model. We thus propose two major goals:

1. Achieve substantially greater levels of optic nerve regeneration through combinatorial therapies;

2. Validate rodent data in a large animal porcine model of traumatic optic neuropathy (TON). This second goal will be enriched by detailed structural and functional examinations similar to those usable in humans, further narrowing the gap between laboratory and human testing of successful candidate therapies. These data will provide both proof‐of‐concept and safety/toxicity data towards dissemination and commercialization of regenerative therapy(ies) for optic nerve.

Year One Accomplishments:

  • Assembled a group of subject matter experts, at the vice president or director level, from the health and non-health sectors to establish industry best practices for enterprise-wide integrated supply chain design and execution.
  • Characterized, in comparison to industry best practice (IBP) organizations, Defense Health Agency (DHA) on attributes of a Fully Integrated Supply Chain Organization. To accomplish this we:
    • Carried out interviews with entities across the DHA and interviews with non-military supply chain organizations.
    • Provided recommendations to advance DHA to IBP level or beyond.
    • Vetted the characterization with key MEDLOG stakeholders as well as with 14 members of the Arizona State University Flag Officer Advisory council.
  • Presented Year 1 activity summary at the Interim Progress Review (IPR) meeting held at Ft. Detrick on 23-Apr-2019.
  • Developed Phase 1 report, which elaborated on the Characterization report and assessed technologies and processes for consideration by DHA as it evolves into an enterprise level military logistics and supply chain organization.
  • Collaborated with DHA to identify a set of six fundamental FISCO functions and appropriate support functions for inclusion in a roadmap to bridge the gap between current DHA practices and IBP.
  • Developed a special topic report on supply chain risk management with focus on medical product recalls.