690 Pages Closer to a Cure for HIV
By now you’ve probably heard about the $32 million, five-year federal grant awarded by the National Institutes of Health to researchers at the University of North Carolina to develop a cure for HIV. The researchers are working on ways to purge the virus that continues to hide in the immune systems of patients taking antiretroviral therapy. David Margolis, M.D., professor of medicine, microbiology and immunology, and epidemiology at the UNC School of Medicine, is leading the effort, called the Martin Delaney Collaboratory. It is named after a noted HIV activist who died in 2009 and who was a co-author with Margolis and others of a seminal article calling for the formation of such an initiative.
As this news has made headlines, it seemed fitting to ask how investigators bring such big ideas to fruition and win grants of this size. Where did the project have its genesis and what resources did the research team need to pull together the 690-page grant application – besides more than a ream of paper and a robust FedEx budget?
By now you’ve probably heard about the $32 million, five-year federal grant awarded by the National Institutes of Health to researchers at the University of North Carolina to develop a cure for HIV. The researchers are working on ways to purge the virus that continues to hide in the immune systems of patients taking antiretroviral therapy. David Margolis, M.D., professor of medicine, microbiology and immunology, and epidemiology at the UNC School of Medicine, is leading the effort, called the Martin Delaney Collaboratory. It is named after a noted HIV activist who died in 2009 and who was a co-author with Margolis and others of a seminal article calling for the formation of such an initiative.
As this news has made headlines, it seemed fitting to ask how investigators bring such big ideas to fruition and win grants of this size. Where did the project have its genesis and what resources did the research team need to pull together the 690-page grant application – besides more than a ream of paper and a robust FedEx budget?
“A smaller group of us in this field were frustrated about the difficulty of making progress in eradication of HIV,” explained Margolis. “The idea that the project was really too big for a single investigator, or even a small group of investigators, came up at a meeting. That led to publication of an opinion piece in Science in 2009, which explains essentially the idea of the collaboratory.”
Meanwhile, NIH was undergoing significant budget cuts due to the Great Recession. Nevertheless, NIH put out a request for proposals a year later, in June 2010, with a due date of November 4.
“I think it was a pretty heroic effort by NIH to put together funding of this new initiative in a time when everything else was getting cut or flat-funded,” said Margolis.
Though previous HIV funding initiatives have focused on prevention and vaccine development, this is the first ever large-scale effort whose stated goal is to eradicate HIV. The UNC-led collaboratory is by far the largest of three programs established by the NIH awards and includes 19 collaborators from a total of nine U.S. institutions, plus the pharmaceutical company Merck, which will not receive federal funding. The other two collaboratories will be housed at the University of California, San Francisco and the University of Washington, Seattle.
The grant, funded through the National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health, was awarded to the North Carolina Translational and Clinical Sciences (NC TraCS) Institute at UNC. Grant funds will be shared among the 19 investigators at the nine universities and Merck. NC TraCS is home to UNC’s Clinical and Translational Science Awards, funded by NIH in 2008 to accelerate the translation of research results into health improvements as part of a nationwide consortium of 60 institutions.
Margolis recalled that when the application came out, they decided as a group to try to collect all the best experts in the field and invite them to join together to achieve the goal envisioned in that Science paper. That’s how they identified the list of 19 collaborators from nine institutions. The actual count is higher, he said, because of additional people working on the grants at each of the institutions, calling them “collaborators of collaborators.”
In summer 2010, Margolis contacted Marschall Runge, M.D., Ph.D., then the new director of NC TraCS, about putting together the grant proposal.
“He didn’t blink. He just said, ‘Sure, here, go for it,’” said Margolis of Runge’s reaction. “He made some critical resources available early on so we could bring people together – the resources to have a meeting and teleconferences – and the infrastructure to create the grant.”
As Margolis described the process, the group asked each member to contribute something from their area of strength where they have a strong research track record. Through a face-to-face meeting and several teleconferences, they fleshed out a plan for how each of their proposals would contribute to the research agenda of the entire collaboratory. They created timelines, set up a members-only website using Microsoft SharePoint to share documents during development of the application, refined their proposed research and began to actually write their individual research project proposals.
Throughout the summer and into the fall, NC TraCS provided key administrative support to accomplish the many phases of proposal development. Staff helped arrange the investigator meeting held in Chapel Hill in August 2010. Grant accounting staff worked for two months to orchestrate solicitation, receipt and correction of the nine subcontracts from the collaborating institutions. IT staff developed the SharePoint website, which now serves as the front door of the collaboratory to the public. Additional staff tracked and edited the many parts of the application as they arrived, including the 19 research proposals, 35 NIH biographical sketches, numerous resources documents and letters of support, as well as the subcontract budget packages. One staff member estimates she fielded 750-1,000 emails during the process.
Since the grant’s home institution would be UNC, staff prepared the entire budget for submission to UNC’s Sponsored Programs Office for approval. Finally, over a day and a long night, NC TraCS assembled all the pieces into one mammoth, coherent grant proposal ready for shipping.
Going forward, NC TraCS will continue to provide administrative support, such as subcontract negotiation, accounting, budgeting and human resources. They will also coordinate and plan meetings – both virtual and face-to-face – to facilitate communication between the many sites involved in the project. NC TraCS IT staff will provide ongoing support to establish an effective collaboration platform for the multi-institution investigative team, including implementation of research data sharing capabilities and support for the virtual ad hoc meetings needed to accelerate the research.
Margolis said the notion of this collaboratory is necessary because at present there is no known pathway for conducting this type of research through traditional pharmaceutical industry business models. The field is still too new and the scientific work needed at the moment doesn’t fit the typical pathway of animal testing, clinical trials and bringing a drug to market.
“Part of the goal of our collaboratory is to try to create those systems as we discover approaches to eradicate infection,” said Margolis.
