Working document is here: https://docs.google.com/document/d/1ll2vme6DXfxK-bT3inMbuYCHsTBM_11CH_rVnXPEdFc/
Context and targeted barriers
Many open source or open science pro bono projects have proliferated during the pandemic. Professionals have volunteered countless research hours towards developing solutions, but few of these ideas or projects ended up creating medical or biomedical interventions that could assist people in the real world. To a large extent this is due to the unique challenges of operating in a highly regulated environment, which is normalised to large financial investments in order to translate ideas into biomedical products. While the current pandemic is a particularly acute situation at the moment, it is also a long-standing problem. We propose to work towards establishing a new path to accelerate progress in biomedical science besides institutional science and corporate innovation: Community-driven innovation.
Just One Giant Lab (JOGL)
JOGL is a non-profit platform building and supporting a large open community of scientists, engineers and clinicians that has worked on several affordable open source solutions to fight the pandemic, such as diagnostic tests. We have been at the forefront in trying to translate open source community-driven innovations into clinical products, and we have become familiar with many of the barriers.
Creation and funding of a legal entity, that can be the facilitator and chaperone of open source biomedical technology solutions through the regulatory environment and into the clinic has the potential to be very beneficial to patients and the biomedical establishment in general.
Navigating the healthcare regulation and economical field can be a true hardship without appropriate counsel, for that reason we wish to create a non-profit agency whose mission will be to chaperone promising impactful community-driven innovations installed on the JOGL platform and bring them to the market to fully realise the vision behind their existence.
Because of their community-based nature, where core contributors don’t wish to change life to become entrepreneurs, these innovations currently face two major problems:
- They are not represented by a formal entity capable of dealing partnerships and providing an economical workflow.
- They are mostly doomed to remain at the proof of concept step.
To solve this, this agency will have for mission the following objectives:
- Be a pipeline from initiative groups to industrial partners in order to bring community-driven open source solutions in the real world
- Create and animate a chaperoning program for community-driven open source innovations
- Run an open Institutional Review Board (IRB) to...
- Provide counsel, resources and funding to the selected projects
- Be the formal representative person for the selected projects in front of (1) the public health agencies in charge of medical innovation certification and of (2) the manufacturers and distributors.
- Establish a bridge between the projects and the public to create engagement and support
We have named this initiative “Fitz” in remembrance of John G. FitzGerald, a Canadian physician and public health specialist who was instrumental in the control of diphtheria in the early 20th century by producing and freely distributing antitoxin in order for it to be “within reach of everyone”. FitzGerald was also instrumental in facilitating the first tests of insulin, and a pioneer in the making of accessible medicine and medical tools. Fitz is going to pursue such efforts thanks to the JOGL community.
We will be providing assistance to the projects in regards to the following:
The regulatory landscape is an important aspect of biomedical science, although many non-experts in that field do not realise this. When you engage with real-world clinical practitioners you realise that regulatory issues are some of the most important things. Such issues as developing a trusted relationship with regulators are the main priority of our project. Regulators require legally responsible entities with whom to engage, and our new legal entity will enable regulatory authorisations for biomedical devices & products.
Clinical validation is vital, and clinical trials may be necessary for certain types of products. Open science initiative groups cannot easily approach clinicians. Therefore, one of the key tasks of JOGL FITZ will be creating a rich international network in order to provide infrastructure for mutual fruitful collaborations for clinical validation and potentially clinical trials of pathfinder projects.
We will create the necessary QA/QC processes to fulfill regulatory requirements. We can assist manufacturers with manufacturing & scale up issues.
Legal support by this entity to allow freedom to operate and protect from patent trolls etc would be vital.
The creation of an entity that can assist in taking open source work and moving it through pathways above with trusted clinical partners on each avenue would be very beneficial. In essence we would become the custodian and clearing house of endeavours where open science seeks to move into the real world.
The heart of our offering is the Open Science community developing the actual technological implementations. We want to drive the creation of a vibrant community that will continue to feedback state-of-the-art tweaks and new concepts to the underlying initial technology so that it continues to improve. Much akin to how contributors to computer programming projects contribute via websites like GitHub, we intend to set up a free and open-source version control (eco)system for biochemistry and molecular chemistry projects.
Pic 1. FITZ’s missions
Pic 2. FITZ’s role to enable an interface between the community-driven projects and the partners capable of manufacturing and distributing the products.