The Weiner lab has an ambitious goal: to develop a nasal vaccine that will prevent and reverse the progression of Alzheimer’s disease.
Their recent work in preclinical models has been encouraging, demonstrating an ability to prevent the accumulation of amyloid-beta plaques – the hallmark of the disease – and dramatically reduce the burden of these plaques in older mice, among other promising measures.
“We felt it was time to translate this work into people,” said Howard Weiner, MD, of the Ann Romney Center for Neurologic Diseases. “In our lab, we like to borrow the phrase from hockey of ‘shots on goal.’ Doing a clinical trial and getting a treatment into people that works, that’s how you score. Of course, not every shot works – most don’t. But to paraphrase Wayne Gretzky, you miss 100 percent of the shots you don’t take. We wanted to take this shot.”
It was at that time that Weiner connected with the newly established Translational Accelerator – a resource and team at the Brigham designed to help researchers take those shots on goal.
Like many researchers, Weiner’s team had the data and the scientific knowledge to drive things forward. But getting a clinical trial off the ground can be a complex process to navigate, even for experienced investigators. That’s where the Translational Accelerator comes in. The group includes a core team of BWH Research leaders and more than a dozen highly skilled, internal advisors who offer rigorous scientific and strategic advisement on projects, particularly those with commercial potential.
For Weiner’s lab, working with the Translational Accelerator team has provided the infrastructure, support and advisement to give them the best chance of making their shot count.
Building Bridges, Making Connections
The Translational Accelerator provides researchers with access to business and scientific advisors, project management help, contact with visiting entrepreneurs, connections with external investors, business development resources, financial coaching, and guidance on clinical trial design and execution. In collaboration with the Partners HealthCare Innovation team, the group also provides intellectual property management and tech transfer support.
In addition to its Entrepreneurship & Innovation services, the Translational Accelerator aims to revolutionize translational medicine by advancing next-generation clinical trials. Next-generation clinical trials are those that can match patients with the treatments and tests that may be most effective for them, given their particular genetic and physical makeup. This potentially allows a trial to be conducted with fewer patients and a higher likelihood of success.
“We believe the Translational Accelerator is a critical resource for our entire faculty – both early-career investigators who may be conducting a clinical trial for the first time as well as seasoned experts who have plenty of personal experience, but who can benefit from having an infrastructure of support for launching innovative trials,” said Allison Moriarty, MPH, vice president of Research Administration and Compliance and a member of the accelerator team’s advisory committee.
Researchers can also draw from the team’s expertise in using existing scientific and clinical resources, such as IT infrastructure or data from more than 9 million patients.
“Across our research community, BWH has tremendous breadth and depth of knowledge on all aspects of getting a clinical trial off the ground, but unless an individual investigator is incredibly savvy, it can be hard to leverage disparate expertise and resources effectively,” Moriarty said. “The Translational Accelerator is designed to build bridges and help investigators navigate, and optimize use of, these resources.”
The Entrepreneurship & Innovation team of the Translational Accelerator began working with Weiner six months ago, just as his lab was beginning to design the clinical trial phase of their project. Together, they thought through the manufacturing process to make sure that the drug would be ready in time; tracked the different components needed for Federal Drug Administration approval; developed a business plan; and helped usher the project through all necessary steps for Institutional Review Board approval.
Weiner anticipates that if all goes smoothly, clinical trials for the nasal vaccine for Alzheimer’s could begin next year.
“I’ve been involved in translating basic research into the clinic for the last three decades,” said Weiner. “I have a lot of translational research experience, but I can’t do this alone. I needed the Translation Accelerator’s structure and support – that team has been crucial for this project, and we’re now working on other projects with them as well.”
Learn more at bwhtranslation.org.