Resources for Medical Education and Collaboration Inc

Filing Period

Jan 1, 2012 to Dec 31, 2012

Signed

Feb 28, 2013

Return Version

2012v2.1

Gross Receipts

$350,251

Major Activities

Activity 2

BIOLOGICS COLLABORATIVE PROGRAMSSUMMARY: The Biologics Collaborative includes Jeffrey C. Wang, MD, Howard S An, MD, Wellington K Hsu, MD, Jay R Lieberman, MD, and S Tim Yoon, MD. The Collaborative is currently supported by Resources for Medical Education and Collaboration (RMEC) and RMEC Board Members, Jim A. Youssef, MD and Darrel S. Brodke, serve as liaisons to the Collaborative. The group first met in May 2011 to chart out the development of a biologics registry. In the last year and a half, we have been successful in raising awareness around the need for data and supporting greater education surrounding biologics use in spine surgery by: hosting a new annual meeting in our second year this year (2nd Annual Biologics Collaborative, October 6, 2012 Santa Monica CA), publishing a paper in the Global Spine Journal, applying to two OREF grants with a 50% success rate, critically evaluating the prospects of a biologics registry, and taking a strong step towards improving data available on biologics. In our work, we have recognized that the registry space is increasingly competing for resources and there is a strong need for collaboration in order for data collection to be efficient and meaningful. As such, in September of this year we began reaching out to fellow organizations that have established registries or study groups with data platforms; these groups include the Association for Collaborative Spine Research (ACSR), North American Spine Society (NASS), Society of Lateral Access Surgery (SOLAS), the Spine Research Foundation (SRF), and the Society for Minimally Invasive Spine Surgery (SMISS). Other groups that were not contacted and are also pursuing databases in this area include the Association of American Neurological Surgeons (AANS), which has developed a comprehensive quality improvement effort. Data points of interest that were sought to be included in partnering registries have been determined and our outlined in the program files.The Biologics Collaborative has developed a generous donor base for its annual meeting and was in the process of developing strong relationships with key donors in developing a database. Amid concerns around the funding model, bias, and a starting point that would enable a sustainable project, we began to focus on supporting key studies that would serve as pillars in the area of biologics, given the paucity of data. These studies are currently being defined by the group.

Activity 3

SUPPORTING RESEARCH ACTIVITIES IN CLINICAL MEDICINETHE OSTEOBIOLOGICS REGISTRYEvidence-based medicine is at the forefront of healthcare reform. The need for evidence is preceded by the need for data. Specifically, RMEC has identified a need to gather data surrounding the use of osteobiologics in various surgical spine procedures. To address this need, we are developing the Osteobiologics Registry, a platform designed to collect multisite data surrounding the application of osteobiologics in spine surgery. This project has been on the RMEC radar since 2009, and in 2011 we made substantial progress on the establishment of the Osteobiologics Registry.Background on OsteobiologicsOsteobiologics are classified as autogenous bone graft substitutes, extenders, or enhancers; types of osteobiologics include demineralized bone matrices (DBM), allografts and allograft formulations, synthetic bone grafts, bone morphogenic proteins, bone marrow aspirate systems, and platelet-rich plasma systems.New types of osteobiologics, such as stem cell therapies, are continually being developed and introduced to the market. Given the number and range of biologics on the market in the United States, comparative clinical effectiveness research is important to improve treatments and outcomes for patients electing for spine surgery. Evidence across the diverse classifications of osteobiologics is notoriously lacking; many products pass through the FDA as "minimally manipulated human allograft" and/or are used off-label.To this end, an effective means of collecting standard of care data, encouraging research, and disseminating evidence is required; the Osteobiologics Registry will address this void by assembling uniquely qualified clinicians, including novices and leaders in the research realm to participate in registry data collection and enable tools and resources to promote the dissemination of findings through publications and presentations. Accomplishments Towards the Goal of Establishing the Osteobiologics Registry:The development and oversight of the Osteobiologics Registry is helmed by five clinicians, each with a unique ability to provide insight and direction to the project. Jeffrey C Wang, MD presides over the advisory board. This study is a prospective, multi-center, longitudinal, observational study designed to collect data surrounding the application of osteobiologics in spinal fusion surgery. Institutional review board (IRB) approval will be pursued for the prospective database with the intent to perform retrospective studies. Data will include demographics, surgical details including osteobiologic product use, clinical and radiographic follow up, and patient reported ODI, VAS, and EQ-5D.The Osteobiologics meeting was an important accomplishment towards establishing the registry and educating surgeons in this area.

Filer

EIN

26-2617823