Collaborative consortia, networks and learning communities
HHS is engaged in many collaborative activities with its stakeholders, covering a broad range of health and human service concerns. Over the past two years, since its first Open Government Plan was published, HHS has been building upon its interests in collaboration and co-creation in new ways. These include:
- creating “learning communities” where the experiences of collaborators are used to improve HHS programs;
- establishing training programs that leverage the “real-world” experiences of communities and use field training exercises as opportunities to improve the conditions of communities in need;
- realigning existing departmental programs to create new synergies among existing programs; and
- using new forums for the sharing of pre-competitive data.
Some examples of these activities and their near-term plans for growth include:
- Community Health and Service Missions
The United States Public Health Service’s (USPHS) Community Health and Service Missions (CHASM) program is designed to bridge the chasm of health disparities, protect the health of all Americans, and provide essential human services for those who are least able to help themselves. This program helps underserved and vulnerable populations by fostering collaborations among local, state, tribal, and federal governments with active participation from local volunteers and nongovernmental organizations. CHASM is particularly transformative because it creates the ability to bring in multidisciplinary experts from across federal agencies under one umbrella, enhancing knowledge and services provided. USPHS officers provide expertise in environmental health, epidemiology, toxicology, program administration and development, dental, veterinarian, nursing, primary care, mental health, preventive medicine, and applied public health care. USPHS found that the more involved the community is with determining and addressing their health care needs, the more successful the outcome of the mission.
CHASM meaningfully and purposefully incorporates technology, in the form of Responder eLearn, a web-based public health training platform. Responder eLearn is utilized in CHASM in order to increase stakeholder involvement in the development phase through the tool’s community forums, measure outcomes through survey distribution, as well as providing just in time training in the days prior to the mission. CHASM is highly innovative because it provides an avenue for USPHS officers to train for emergency response while also promoting and advancing health infrastructure in underserved communities. This initiative unites multidisciplinary USPHS officers to respond, collaborate, and participate with local, state, tribal, and NGO groups in an effort to address this nation’s most pressing public health needs. Upon return, these officers are able to share their newly acquired knowledge and leadership skills with their home agencies, which further facilitate interagency transparency. More information on the CHASM program can be found at: http://dcp.psc.gov/ccmis/CHASM.aspx
In early February 2012, CHASM convened a collaborative meeting with multiple federal agencies to discuss additional opportunities for partnership by identifying overlapping strategic goals that result in reducing health disparities and improving environmental health. One example of this collaboration is the use of USPHS officers to help meet the strategic goals of sister agencies while helping the USPHS meet its goal of emergency response training. In 2012 and beyond, CHASM will advance partnership opportunities with these federal agencies and collaborating in the Federal Interagency Health Equity Team.
- Collaboration Network for CMS Partners
CMS is developing an online collaboration network to support awardees, grant recipients, and other CMS partners who seek a web-based experience to share best practices, learning resources, and trends in the quality of the care they deliver among themselves. Aside from simple file-sharing and discussion threads, the site will allow CMS partners to track their own health care quality metrics. Through regular reports of aggregated anonymous quality metrics (e.g., percent of patients with bedsores over a preceding month) submitted online, users will see their own quality trends and can compare their trends with those of others. Major health care initiatives will use this space including the Partnership for Patients and Accountable Care Organizations (ACOs). CMS established the information technology infrastructure, and anticipate that by mid-2012, the collaboration network will be deployed to support the Pioneer ACOs and 500 Health Centers running a primary care demonstration.
- Innovation Pathway - End Stage Renal Disease Innovation Challenge
FDA’s Innovation Pathway is a streamlined review program for innovative medical devices that are intended to address unmet public health needs. Along with shortening the overall time it takes for the development, assessment, and review of breakthrough medical devices, one of the goals of the Innovation Pathway is to create a more collaborative and transparent experience for innovators and FDA working together. The program will introduce new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts.
In January 2012, FDA’s Center for Devices and Radiological Health launched the End Stage Renal Disease Innovation Challenge as a pilot program to test the tools and processes being developed for the Innovation Pathway. Since the launch, the Center has received interest requests from over 30 entities, over a dozen of which submitted completed applications.
Accepted applicants will undergo a “Collaboration Phase” with FDA. During this period, a team will be created consisting of both the FDA review staff and the company experts. This team is charged with collaboratively creating the regulatory pathway forward for the new technology, including identifying key scientific and regulatory hurdles. While FDA will retain the final authority in making all regulatory decisions, the intent is for these key decisions to be reached with agreement from both sides in a collaborative way.
The ESRD challenge was launched in January 2012 and will be ongoing. In March 2012, FDA publically announced the accepted applicants. By December 2012 FDA will complete the Collaboration Phase of the Innovation Pathway with all applicants. By January 2013 the group will publicly share lessons learned from the early ESRD experience. It is also expected that a narrative story will be generated that captures the intent and outcome of the Collaboration Phase for each company, and will be publicly posted on the Innovation Pathway website as case examples.
- National Center for Advancing Translational Sciences
NIH established a new center, the National Center for Advancing Translational Sciences (NCATS), to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS was created primarily by uniting and realigning existing programs that play key roles in translational science into one focused NIH effort. The decision to establish NCATS was motivated in part by the recognition that the process for translating scientific discoveries into new tools and treatments is ripe for innovation. It is well known that developing new diagnostics and therapeutics is a complex, costly, and risk-laden endeavor, demonstrated by the less than 1% of compounds initially tested actually making it into a patient’s medicine cabinet. For this reason, NCATS will focus on developing and testing new methods and tools to circumvent the greatest bottlenecks in translational science. By improving the diagnostic and therapeutic development, NCATS will make translational science more efficient, less expensive, and less risky. In this way, NCATS complements — and does not compete with — the work of the private sector and the other NIH Institutes and Centers. To accomplish its mission NCATS creates new synergies among existing programs by focusing on three broad research domains: clinical and translational science activities, rare diseases research and therapeutics, and re-engineering translational sciences. NCATS will also establish and administratively house the Cures Acceleration Network, which was authorized in FY 2012 to advance the development of “high need cures” by funding research projects in new and innovative ways while reducing barriers to translation, in areas the private sector is less likely to pursue. In early 2012, the NCATS leadership hosted a meeting and tour for leaders of stakeholder constituency groups as well as a webinar in partnership with FasterCures for approximately 1,000 NCATS stakeholders.
- Pediatrics Formulations Platform
This program, which is a collaboration between FDA and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), addresses the need for facilitating formulations for children so that they will take their medicines. Currently there is a lack of commercially available, age-appropriate, oral pediatric dosage forms for several critical diseases. In addition, there is no coherent approach to pediatric formulations development, by industry.
The Pediatric Formulations Platform initiative seeks to review, categorize, and describe the formulations in a manner that allows others to learn from prior successes and failures through an open-source, publicly available approach. This assessment will be posted on a Pediatric Formulations Platform and made available to sponsors, regulators, scientists, and anyone interested in knowing what approaches were successful for pediatric products with defined chemical characteristics. In addition, this initiative seeks to remove/lessen the technical barriers to production of pediatric formulations by determining and/or developing technologies to formulate medications in appropriate oral pediatric dosage forms, so that they are in an age-appropriate formulation and in the correct dosage amount for the youngest children in an open-source approach. For more information about the Pediatrics Formulations Platform see: http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/index.cfm
Several important milestones have been achieved to date, including an assessment of all commercially available products to determine which have pediatric formulations; and a determination of what technologies are publicly available, how these technologies have been used, and for what types of products. In 2012, FDA staff plan to use prototypical drug products and employ computational methods to characterize their molecular structure. Staff will also determine the best formulations technology for specific drug categories based on information previously identified. In 2013, staff will produce prototype batches of selected drug products with several taste-masking approaches. In 2014, staff will perform bioavailability of prototype products in appropriate preclinical models and standardize the prototype products and perform stability studies to determine shelf-life.
- Critical Path Institute Partnership with the Food and Drug Administration
FDA established a partnership with the Critical Path Institute (C-Path), an independent, publicly-funded institute, to “Conduct Essential Research to Spur Medical Innovation.” C-Path serves as the third-party neutral convener for the collaboration among multiple partners from government, the pharmaceutical industry, academia, patient advocacy groups, and research foundations. Since its founding, five consortia have been established including:
- Coalition Against Major Diseases
- Predictive Safety Testing Consortium
- Polycystic Kidney Disease Consortium
- Critical Path to Tuberculosis Drug Regimens Consortium
- Patient Reported Outcome Consortium
Ideas, expertise, and experience are leveraged to facilitate the development of drug development tools within these consortia. Their efforts demonstrate collaboration and data-sharing in the pre-competitive stages of research and development across multiple stakeholders to optimize drug development paradigms. Activities are ongoing with the expectation that multiple new packages for qualification of drug development tools will be submitted over the next few years. More information for each of these consortia can be found at: http://c-path.org/project-pipeline.cfm