How two recent projects by California’s stem cell agency are trying to help scientists move their discoveries forward
When baseball players are trying to improve their hitting they’ll use a pitching machine to help them fine-tune their swing. Having a device that delivers a ball at a consistent speed can help a batter be more consistent and effective in their swing, and hopefully get more hits.
That’s what we are hoping our new Translating and Accelerating Centers will do. We call these our “Pitching Machines”, because we hope they’ll help researchers be better prepared when they apply to the Food and Drug Administration (FDA) for approval to start a stem cell clinical trial, and be more efficient and effective in the way they set up and run that clinical trial once they get approval.
The California Institute for Regenerative Medicine (CIRM) Board, which is a taxpayer supporter initiative created in 2004 to fund Stem Cell Research, approved the Accelerating Center last summer. QuintilesIMS, a leading integrated information and technology-enabled healthcare service provider, is the home of the Accelerating Center.
The Accelerating Center will provide key core services for researchers who have been given approval to run a clinical trial, including:
- Regulatory support and management services
- Clinical trial operations and management services
- Data management, biostatistical and analytical services
The center also makes good business sense. CIRM will invest up to $15 million in funding to help the start-up of the center. In turn, CIRM is projecting a return on that investment within five years through discounts on services to CIRM projects.
The reason why these kinds of service are needed is simple, as Randy Mills, our President and CEO explains: “Many scientists are brilliant researchers but have little experience or expertise in navigating the regulatory process. This Accelerating Center means they don’t have to develop those skills, we provide them for them.”
The Translating Center is the second part of the “Pitching Machine”. This is an innovative new center that will support the stem cell research, manufacturing, preclinical safety testing, and other activities needed to successfully apply to the FDA for approval to start a clinical trial.
The Translating Center will:
- Provide consultation and guidance to researchers about the translational process for their stem cell product.
- Initiate, plan, track, and coordinate activities necessary for preclinical Investigational New Drug (IND)-enabling development projects.
- Conduct preclinical research activities, including pivotal pharmacology and toxicology studies.
- Manufacture stem cell and gene-modified stem cell products under the highest quality standards for use in preclinical and clinical studies.
Quintiles IMS also won that award and now will combine the two centers under one roof, helping researchers create a comprehensive development plan for every aspect of their project. City of Hope, a hospital in Los Angeles, is providing all of the stem cells and Charles River is doing all of the preclinical work.
For the researchers this is important in giving them the support they need. For the FDA it could also be useful in ensuring that the applications they get from CIRM-funded projects are consistent, high quality and meet all their requirements.
We want to do everything we can to ensure that when a CIRM-funded therapy is ready to start a clinical trial that its application is more likely to be a hit with the FDA, and not to strike out.
Just as batting practice is crucial to improving performance in baseball, we are hoping our “Pitching Machine” will raise our game to the next level, and enable us to deliver some game-changing treatments to patients with unmet medical needs.
An earlier version of this blog appeared in The Stem Cellar, the official blog of CIRM.