The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

Printable Proposal Content with Comments

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Preparation and Presentation of an IND Application to the FDA

Proposal Status: 

James H. McKerrow PhD,MD

A major unmet need for the entire UCSF research community is a point person, or small team, that can aid individual investigators in the compilation and writing of an application to the FDA for an IND (investigational new drug). While some IND work has gone on at UCSF, primarily in collaboration with commercial entities, there does not exist an individual with the expertise to help an research investigators identify information that must be included in an IND application for a new small molecule drug, and subsequently to help prepare that application itself.


This shortcoming became clear through efforts of QB 3 personnel to assemble such an application for a newly discovered small molecule in collaboration with the UCSF Small Molecule Discovery Center in Byers Hall. While CTSI provided some information on ethics and individual IND components, there was no single individual who could coordinate such efforts and assist investigators in writing the proposal. In the end investigators on the Mission Bay Campus had to utilize the expertise of personnel in QB 3 who had previous experience in this arena while working in the biotech industry. Unfortunately those individuals have now left the University.


CTSI is the logical umbrella organization to sponsor IND support for research investigators at UCSF. An individual with experience in writing such a proposal and presenting it to the FDA should be recruited and made known to the research community at large. CTSI could use the experience of QB 3 personnel to identify the characteristics of such an individual, and the rich biotech environment surrounding UCSF should prove fertile ground for recruitment.


This individual would meet one-on-one with UCSF research personnel who find themselves at the translational end of a drug development process. They would look over the accumulated information on a drug candidate that the investigator has acquired, and counsel the investigator as to what additional studies the FDA would likely ask for. They would also assist the investigator in preparation of an IND application and presentation of this application at a pre-IND meeting with the appropriate FDA section. Currently, contract research organizations such as SRI international in Menlo Park offer this service at a considerable fee. It would therefore be logical for CTSI to recruit and sponsor such an individual as a member of the UCSF translational drug discovery and development community.


This is an excellent idea - a local point person or small team within CTSI to help UCSF researchers with FDA submissions. If this could be expanded to cover not only investigational new drugs (IND) but also the 510(k) and PMA processess that many UCSF researchers face with the development of new devices or drug-device combinations, this would be an even more powerful and helpful tool. When the head of the FDA devices division visited UCSF last year, he said there were no plans for FDA to have a local office here in San Francisco (similar to the new satellite patent office in Silicon Valley), but I wonder if we might propose to FDA to have a local participant or participants in this new effort. Having FDA involved locally through the application process could well be a model for greater efficiency in IND, 510k, and PMA processess that could later be disseminable to other universities or regions with outstanding track records of drug and device innovation.

Commenting is closed.

Digital Health Sciences Virtual Core

UCSF Digital Health Sciences Virtual Core

An Open mHealth-compatible Rapid Development Platform & Services

Problem Digital and connected health technologies promise to reduce health care costs and improve health outcomes. Many CTSA researchers have digital health ideas they want to pursue and test, but their institutions are not able to fully provide the resources and expertise they need to build initial prototypes and/or to conduct clinical research using digital technologies.

Solution: The UCSF Digital Health Sciences Virtual Core

The Virtual Core will be a joint effort of CTSI and the Center for Digital Health Innovation (CDHI) to provide “one-stop shopping” for researchers to quickly develop, prototype, field test, and evaluate digital health technologies. The novel technical approach that can be scaled across CTSAs and beyond is to exploit Open mHealth[1], an emerging standard for integrating mobile apps and data, and to build open source Open mHealth-compatible modules for clinical research. The Core will offer 3 major services on a recharge basis to UCSF, participating CTSAs, and other partners:

  1. Rapid Development Services – CDHI is currently choosing a rapid development platform, any of which can be “future-proofed” through use of Open mHealth and other standards. Researchers will work with UCSF developers to script user interaction (e.g., data capture screens, account setup, informed consent, protocol set-up (e.g., n-of-1), reminders, etc.). Development will leverage shared APIs and modules from the growing Open mHealth community, which includes companies (e.g., Qualcomm Life,, health systems (e.g., Kaiser), research centers (e.g., NSF-funded Calit2), and innovation projects (e.g., XPrize). This community is building open APIs to commercial data clouds (e.g., Jawbone, RunKeeper). Use of Open mHealth and other shared code will thus reduce unnecessary duplication while promoting reuse and rapid innovation.
  2. Hosting Services -- UCSF will host the development platform, server, and secure data store with full access control privileges for UCSF and external users. Partners may also host their own data store, platform, and/or server depending on local needs while still benefiting from shared software.
  3. Consultation, Grants, and Resources – The Core will partner with campus entities and other CTSAs to coordinate: 1) technical, design, and methodological consultation services; 2) pilot grants to UCSF researchers under the RAP and T1 Catalyst mechanisms; 3) recruitment assistance and opportunities (e.g., with SF HIP); and 4) streamlined processes (e.g., IRB templates, industry MOUs).

Partners: Potential UCSF partners include QB3, ITA, ISU, and many others. CTSA interest includes UC Davis (on participatory research and business processes), USC, and Cornell (they are hosting their own platform). Industry interest includes, and J&J, (which could link with the Clinical Trials Consortium). Connections to Qualcomm, Intel, etc. open opportunities around devices. From the community, Quantified Self is interested in collaborating around “citizen science,” which could involve SFHIP as well. While UCSF will lead the development of software and methods for core clinical research needs (e.g., recruitment, informed consent, n-of-1 studies, standardized variables, connection to EHRs), other partners can develop their own areas of expertise by contributing or curating open source code or research methods (e.g., mental health, health disparities, longitudinal studies, etc.). By design, this effort can be scaled across additional partners nationally and internationally (e.g., for global health).

Innovation: This proposal is unique in developing and disseminating reusable modules for digital health and clinical research while tapping into open resources from across the mHealth ecosystem. Northwestern’s Purple Robot also offers a scripting and sensor data acquisition platform, but is Android only and is a closed solution that does not ensure integrated mHealth solutions.  

Projected Impact: UCSF will establish clear leadership in the digital health sciences. It will likely lead to new academic-industry collaborations, and will increase the innovation and output of researchers across CTSAs. Finally, through Open mHealth, the resulting software, methodologies, and best practices will reach beyond academia to maximize CTSA’s and NIH‘s ultimate impact on human health.

[1] Open mHealth is a non-profit funded by RWJF and co-founded by Ida Sim, UCSF CTSI’s Co-Director of Biomedical Informatics.




I think I understand how this proposal describes a set of tools different from what is currently being developed at UCSF but could you discuss how you see the Virtual Core fitting into the current mHealth and Center for Digital Health Innovation initiatives. 


Education also has a strong interest in these areas and the School of Medicine's new Bridges Curriculum is being built around a core of quality improvement work in research and health care and are thinking about how all of our digital health work comes together to create a strong core. 



Hi Kevin,


This proposal is being developed in close coordination with CDHI. The technical services will be delivered through CDHI, the informatics and clinical research methodology from CTSI, and consultation services and other resources will be jointly delivered by CTSI and CDHI. We are working to streamline a single portal to help UCSF and external people easily navigate and access all digital health related services and resources, whether from CTSI, CDHI, or any other part of campus. It'll be a work in progress!


As for educational applications, the Virtual Core will certainly support educational solutions, and the support for prototyping and evaluation will offer opportunities for testing both educational and clinical solutions in training environments. We'd love to make deeper links with your office.


Thanks for your comments!


Ida - this is fabulous!  This infrastructure and support are critical to support rapid, thoughtful development of tools in the digital health space.  We will be somewhat novel in providing this service — overlap with the Center for Digital Health Innovation is big but funding to allow CTSI to build out the support and platform services (especialy the critical consultion service) will be critical.  I also recommend adding funding to expand the digital health portion of the T1 Catalyst program and awards for pilot funding.  Thanks - Leslee


Thanks, Leslee. I will include additional funding for pilot awards in this proposal, and consider additional mechanisms that would allow faculty to take the most advantage of this Core.

This sounds like a really interesting service!  If the goal is to bring in new investigators, it will be critical to provide some level of support outside the recharge system (e.g., 5 hours free consultation, free creation of first prototype). It also might be helpful to create a webinar or offer a class through CTSI for those who are new but interested to help them get started. 

In collaboration with CDHI, we are considering a series of short instructional videos on selected digital health topics, complemented by targeted webinars. These efforts would not be part of this proposal but would certainly dovetail with it.

Very exciting proposal! I am looking forward to discussing it further at the CTSI retreat. While this proposal describes some new and innovative approaches, I'm curious about how this program would work alongside the CDHI and mLabs. One issue, which I would love to see addressed/added is more design support for researchers and a discussion about the importance of considering a design strategy in the development of mobile tools.

I fully agree that good design is critical to successful solutions. We will work with CDHI and the Office of Technology, Innovation, and Alliances to develop a cadre of external design experts that faculty can easily work with through standing business agreements. Moreover, the Open mHealth community will be generating open source visualization modules that UCSF developers can reuse and customize. 

The idea of a digital health sciences virtual core is important and highly relevant to the proliferation of mobile devices and ubiquitous communications. As I understand it, the proposal centers the Core on the "ohmage" data management and mobile application platform, and considers "researchers" to be the target customer. 


1. Up front, it would be good to establish a customer focus by uncovering what researchers want or need in the way of development and support services. Then we can determine what unique contributions UCSF can make. The description of Rapid Development Services could then be more specific about what technical support UCSF would want to offer. For example, rapid development services could range from a software toolkit with an integrated development environment and necessary tools with a basic user guide, to an education program (classes, workshops) on best practices for developing digital health technology, to a technical support program for actual development and even a consulting service in architectural design. 


2. The proposal mentions prototyping, field testing and evaluation of digital technologies but subsequent services seem to be focused on software development assistance and application and data hosting. Prototyping and field testing would involve hardware, to start. 


a) To what extent would UCSF be involved in hardware design and prototyping, which would require hardware-related knowledge and expensive equipment and manufacturing facilities?


b) Does the proposal envision UCSF offering a field for testing, e.g., recruit participants?


c) Or does the reference to evaluation mean we would like to develop some sort of testing or certification program for digital health technologies? 


3. Because the mobile world changes extremely quickly, it would be good to consider other potential platforms or adopt a strategy capable of supporting other platforms as they develop. 


4. The concept of a Digital Health Sciences Resource Center seems to differ from that of the other two services in that it seems more of a referral center or clearinghouse, whereas Rapid Development and Hosting are directly related to the development of digital health technologies. Could it be a separate proposal?

Thanks, Greg. Great points.


1. There was a previous survey of the digital health development needs of UCSF staff, faculty, and students that informed this proposal. We should do another needs assessment in coordination with CDHI.


2a. This proposal was not envisioned to include hardware design and prototyping. We have many contacts to digital device companies that may be interested in providing sample units for testing. Those are business relationships that we can explore over time.


2b. Recruitment is always a challenge. We would work with Participant Recruitment Services in CTSI to identify opportunities. For cardiovascular projects, the Health eHeart project is a possible option as well. This work would be separate from this specific proposal. 


2c. CDHI is developing a program for field testing apps and solutions, catering mostly to external companies for starters. The Digital Health Sciences Core can support that work by providing reusable modules for "embedded evaluation" (e.g., informed consent, randomization, standardized symptom collection) of commercial apps/solutions.


3. The Open mHealth initiative is aimed at specifically the problem of rapid change and evolution: to provide a common open architecture for the digital health ecosystem that is future-proofed by design. The ISU development shop in the School of Medicine has evaluated a number of development platforms -- ohmage is only one of them but has the virtue of being Open mHealth compatible. The Core should certainly be designed to not be locked into ohmage or any other platform, and Open mHealth's open architecture would support such a platform-agnostic approach.


4. Good point. The Resource Center will be joint with CDHI also, and can be a separate but complementary effort (like recruitment, for example). For purposes of CTSA renewal, however, it may be strategic to show how Consultation Services from several CTSAs can be leveraged to enhance the impact of the Virtual Core for the wider CTSA consortium.    


The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

Digital Health Sciences Virtual Core

Ida Sim

1. Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

Many researchers at UCSF and beyond have digital health ideas they want to pursue and test, but their institutions are not in a position to fully provide the resources and expertise they need to build initial prototypes and/or to conduct clinical research using digital technologies


2.    Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

Virtual core will use ‘ohmage’ and openmHealth platforms to

  1. Provide framework for prototyping and field testing & rapid development services
  2. Consolidate consulting and other resources under a ‘resources core’.

 3.    What partners are involved in the solution?

Potentially other CTSAs – UC Davis & Cornell interested.  Industry, J&J and interested.

4.    What is the potential impact?

UCSF will establish clear leadership in the digital health sciences.

It will likely lead to new academic-industry collaborations, and will increase the innovation and output of researchers across the CTSA consortium.

Through Open mHealth, the software, methodologies, and research results facilitated by the Virtual Core will reach beyond academia to maximize CTSA’s and NIH‘s ultimate impact on health.

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad



1.     How do we maximize impact and broad applicability of the proposal?

Go beyond just the ohmage platform.

Communicate options that are available and how to get them. Navigation services type guidance.

Articulate what the assets are, what’s the faculty resource center and what can it do, what technologies are available, and how to get them. Make it one-stop-shopping.

Expand pilot awards from $30k to $100k and money to study the efficacy.

Create an app store for these technologies, develop knowledge store of technical and any policy best practices/lessons learned in digital health work with NIH and other governing bodies.

Share the model with other universities to start their own, then possibly partner with them.


2.     What foundation exists on campus already that will ensure success of the initiative?

 Center for Digital Health Innovation - 30 iPhone apps, two survey systems, 3M funding, resource center chancellor

Existing partnerships with companies like Genentech  Qualcomm for development and use of digital health apps for collecting study data.

Existing app store should be leveraged and communicated by CTSI.


3.     What creative and/or innovative partnerships could be leveraged to ensure success?

 Leverage programs like Catalyst to bring scientists and industry together. Leverage other contacts with researchers to funnel them to Digital Health Sciences Virtual Core.

Leverage relationships with other universities (CTSA, BRAID, Global Alliance on Genetics) to increase the pool of available development and application resources.

Get Mike Blum and Ida Sim together.

Innovation technology fund should also be leveraged.


"Get Mike Blum and Ida Sim together."  -- LOL :)  CTSI's on it...

The Virtual Core is envisioned to support early prototyping and testing of apps and solutions, drawing on a growing Open mHealth library of open APIs and reusable code. Once a solution is more finalized, it should be developed on a robust commercial platform if it is to be deployed in the marketplace. That going-to-market phase will needs support from UCSF  (e.g., app store, etc) -- any effort along these lines will be in conjunction with CDHI, T1 Catalyst, and QB3 and will be separate from this proposal. 


This Virtual Core will be working in very close coordination with all the campus and external entities mentioned in this very helpful comment. The Core is also structured to be exportable to other institutions (in fact, Cornell CTSA plans to do a version of this starting this fall). Thanks!


1. How do we maximize impact and broad applicability of the proposal?


Clarify that EMR, genomic data and desktop platforms are included in opportunities, not limited to mobile technologies; HOWEVER  a focus on mHealth might be attractive.


Clarify that the platform will strengthen the link between industry and academia; the “bridging environment”.


Describe that this core doesn’t own the projects, but “seeds” possibilities for success.  Another mechanism to help ideas get into the door could help.


How is the discovery distinguished to the individual, yet open to use by other investigators?  Breaking out the technology into components that are generalizable and can be used by others.  Open mHealth is a library with all of the components in it.  You may want to license some components and leave others open.


Examples of how patterns or components have been used could be powerful for providing exemplars, including in clinical research. 


Access to expertise and resources for developing apps is an attractive idea for investigators.  Perhaps SOS could help incentivize this; perhaps asking how people propose what piece of their code or technological innovation will be provided to the university or other sponsors in exchange for support.


Important to develop research methodologies and tools for supporting work in mHealth.  CDHI will support frontlines innovators, but there is growing interest in consultation—both getting and paying for. 


We lack evaluation tools for impact, usability, etc. of tools and methodologies.

The way we do science is different from how we develop software.  Some challenges: implementation science; not asking the right questions, for example. 


A year might be a reasonable timeline for developing a pilot iteration of the software development process.


Ohmage could provide a platform for gathering data re: behavior to influence development of mHealth innovations to predict how features will work with populations.


Part of the process should be to help build the connection to industry translation/ adoption to polish, be ready of use.

2.     What foundation exists on campus already that will ensure success of the initiative?


SFHIP can help support engagement with local community collaborators to identify apps that people want to use for improvement of community health.


Consultation services could help inform the development of this new service.


SOS can function to disseminate pilot funds




Catalyst Awards can help move successful prototypes beyond pilot phase


 3.     What creative and/or innovative partnerships could be leveraged to ensure success?


SFHIP can help support engagement with local community collaborators to identify apps that people want to use for improvement of community health.


Tapping expertise of other CTSAs via consultation.

Tapping recruitment services across other CTSAs.

Cornell, UCSD, UCSC are interested. UC Braid network or CTSA network. Corporations, or UCB could provide technical support, potentially.

Industry partners could provide support for development (pilot?) - There has already been an example of private industry interest in partnering for their clinical trials.

From today's panel discussion (8-2), it seems that CDHI is already providing rapid development services in a flexible, low-cost way. It is integrating software modules already available in the marketplace for researchers, and working with business technology partners to enhance existing software and develop new features. CDHI also seems well-funded and positioned to garner more funds.


CTSI need not duplicate these services. Our panel found opportunities for expansion by supporting CDHI's work, articulating it to UCSF researchers, outlining clear avenues for engaging with CDHI, and helping to broadcast its products. 


We also discussed capturing the CDHI "model" for possible use as best practices for organizations outside UCSF. 

The technical approach proposed here is fundamentally different from ISU's current services (ISU being the development shop aligned with CDHI), and shows far greater promise for leading to better integrated data and solutions for more effective health care and research (see This proposal is being developed with CDHI and ISU, and we will ensure that all services will be coordinated and complemented, not duplicated.  

The synergy between the CDHI and the proposed Digital Health Science Core are many.  While the CDHI was initiated with generous funding from the Chancellor and external donors, additional funding will be critical to provide ongoing and expanding services to the researchers, developers and clinicians who are well poised to develop and test digital health innovations.  I think we can use the CTSI-supported Core to expand the CDHI infrastructure, adding critical funding to develop MORE services that are more ACCESSIBLE to UCSF (and then extramural) researchers and clinicians.  


Specifically, we need to increase the staff of technology experts to guide our content and research experts (who may not yet be sophisticated in digital health) through the development and testing of new technology.   The consultation service is essential and critical.  Funding to provide staff for pre-award development is necessary so investigators can eventually bring in grant funding (to support the core/CHDI) and even royalties from sales.   I also recommend adding funding to expand awards for pilot funding (maybe add to the existing and successful digital health portion of the T1 Catalyst program). 


In addition to open standards, this proposed program (or perhaps others at UCSF) could give a focus to information security. Mobile devices are proliferating but their security frameworks, where they exist, and human behavior about deploying the devices expose risks to the data they store, transfer, and maintain.

Commenting is closed.

Systems Based Medicine Resource Group

Proposal Status: 


Scale and significance of the problem:  Presently it takes approximately 17 years on average for a physician to adopt a level 1 standard of care.  Part of this delay in adopting standards of care is the absence of a standardized method to disseminate tools for implementation.  The adoption of best practices may require tools, checklists, protocols, procedures, medical center memorandum, and computerized order sets. Currently, each hospital and clinic separately designs their own procedures (evidence and systems-based), protocols, tools and guidelines, which are rarely tested, validated, or optimized. Hundreds of man hours of clinicians’ time go into development of these tools. Often committees working on protocols run out of time, or energy, and the tool is lost. When tools are implemented at one facility, they are rarely validated, tested, optimized, maintained, or distributed to others.  While evidence-based and systems-based medicine may be optimal for patient care from the standpoint of safety and efficacy, the absence of a standardized method to implement, optimize, validate, maintain, and disseminate tools that are developed within a single hospital, renders use of such tools, best practice in concept only, wastes staff resources, and fails to provide the best care possible.


Current approaches (nationally) The VA System has 171 medical centers and more than 1000 clinical sites, with little sharing of protocols, checklists, and systems based medicine tools. VA Central Office will provide regulations on what must be accomplished  but the actual tools, checklists, and approaches are left to individual medical centers to develop.  Kaiser Permanente (KP) has 37 medical centers with a system to share systems based medicine tools. KP has a centralized library of validated order sets, checklists, and tools for systems based medicine.


Proposed approach and why it is innovative:  Establish a centralized systems based medicine resource group to optimize, validate, maintain, communicate, promote, distribute, and disseminate tools developed through systems-based and evidence-based medicine in the VA, KP,  and UCSF facilities, utilizing a central repository system. These tools would assist in the implementation of systems-based medicine.  These implementation tools may include protocols, checklists, Apps, memoranda, computerized order sets, and patient care practices. The medical protocols could be checked using epidemiologic analysis of computerized medical records for safety and efficacy. The cost to produce systems based medicine resources would be dramatically reduced by validating already available tools and then distributing them, rather than have each hospital in a system develop tools individually. In the VA, the work to produce a systems based medicine tool would be cut by a factor of more than 100 (1 protocol used in 171 hospitals, rather than each hospital developing their own independently).


Potential Partners:  The systems based medicine resource group could collaborate with Kaiser Permanente, the VA, and UCSF to share systems based medicine tools. KP has borrowed protocols from the SF VAMC. KP has an extensive library of these tools which could provide a basis for the library.


Projected impact, if possible, use back of the envelop calculation to provide quantitative support: A central repository system that effectively disseminates validated tools for implementing best practices would improve availability of evidence and system-based resources to clinicians,  reduce the time and cost for adoption of best practices thereby improving patient care.The result would be improvements in patient outcomes, reduction of mortality rates, reduction of operating costs, improved efficiency, and wider use of evidence and systems-based medicine. Use of individual protocols has reduced mortality rates by 35-50%. Cost savings in the VA are estimated to be a minimum of $1 billion dollars per year.


This is an excellent idea.  My only comment would be to consider a broader form of engagement that expands beyond UCSF/VA/Kaiser, to include critical stakeholders in other health care settings. Especially important are "safety net" settings such as SFDPH and federally qualified health centers across the SF Bay Area that serve diverse patient populations.  The CTSI Community Engagement Program has a practice-based research network (SF Bay CRN -- ) with strong a strong track record of working in these settings.  We would be eager to collaborate on this proposal with you.

That would a tremendous help. Developing systems based medicine tools is complex, takes substantial amounts of time, and requires effective testing and validation. The Systems Based Medicine Resource Group would provide the mechanism to collect, test, validate, and then disseminate systems based medcine tools to assist in implementation of systems based medicine. 

What types of tools are you thinking of?  Can you just give a couple of examples?

At present we are collecting protocols, checklists, templates, clinical reminders, medical center memoranda for clinical services, and software. The safety and efficacy of the tool will be tested using comparison to established guidelines as well as epidemiologic analysis of outcomes. 


We have also developed a clinical checklist tool that is able to create and edit checklists, store intermediate results, extract data from the CPRS/VISTA database, check the data using a logic editor for abnormal values, tests or documents out of date or range, then display either a single patient view and multipatient view. The tool allows one to manage panels of patients that need work ups over time. 


The Systems Based Medicine Resource Group will collect, test, validate, and then disseminate systems based clinical tools such as checklists, clinical reminders, order sets, protocols, and clinical software for systems based medicine. 

Commenting is closed.

The Global HCV Treatment Revolution: A Response Model for Future Challenges and Opportunities

Scale and significance of the problem

New pathogens and developments in diagnostics and therapeutics are transforming healthcare.  Comprehensive planning for paradigm-changing advances, when possible, can mobilize the full range of expertise available in a complex institution like UCSF and in our community partners. Systematic planning can identify new research opportunities, reduce institutional costs and improve patient care.

One healthcare challenge that can serve as exemplary for other implementation opportunities is the treatment of hepatitis C virus (HCV) infection. HCV is a large epidemic-more than 200 million cases worldwide- causing substantial morbidity and mortality. Current treatments have serious limitations but new drug development has been remarkable with soon-to-be-approved drugs achieving close to 100% cure rates after only 12 weeks of use with low toxicity. These drugs will cause an explosive increase in treatment volume over the next 1-2 years despite a high cost (est. $70,000).

Lessons learned in this demonstration project will apply to pending breakthroughs including the discovery of effective drugs to prevent or treat Alzheimer’s disease and the identification of genetic causes of common diseases with resulting targeted interventions.

Current approaches (nationally)

No comprehensive model of HCV treatment exists and no other attempts have been presented that approach this proposal in establishing a comparison for implementing efficient systems for other diseases and new challenges. HCV care is currently fragmented, delivered by hepatologists, infectious disease specialists of general internists with limited collaboration or involvement by teams as proposed here.

Proposed approach and why it is innovative

We will design optimized systems of care and research organization to monitor, evaluate and adjust the screening of patient populations, to stage underlying liver disease and to initiate therapy when indicated. As each of the three primary UCSF-related medical centers; Parnassus, San Francisco General Hospital and the VA Medical Center have large but demographically distinctive patient populations and payment systems, comparing experience through data sharing will enrich the development of the HCV response model and increase its generalizability. Linking the information collected across UCSF with data from the network of the five University of California medical centers through the UC BRAID system of CTSI with 12 million covered lives will further strengthen the lessons learned from this project, representing an innovative use of “big data” in healthcare.

The HCV model project will be dynamic. As drugs are approved and as demand for care increases, the team will monitor data from each medical center to compare population screening rates and success in each step of the treatment “cascade” familiar from the HIV experience.

The project will be innovative and outward looking in working from the start with community members and with experts at UCSF expert in engaging the very different communities most affected by the HCV epidemic.

The HCV project will continually attend to how the systems found effective might be similarly deployed against other health care imperatives, particularly as the entire structure of American healthcare adjusts to the rollout of the Affordable Care Act.

Potential partners

The project will build from an existing cross-campus planning group of clinicians, basic scientists and epidemiologists, adding information technology to created data linkages across the three UCSF medical centers and with UC BRAID and economists and pharmacists to model cost and policy implications. Community members and community engagement experts will increase project impact and broad participation. Implementation scientists will develop models which can inform other healthcare challenges an d global health experts will consider applications in resource-limited settings.

Projected impact (estimate resources needed)

HCV infects 200 million worldwide. Designing a coordinated and effective response to new curative treatments would have an immediate benefit to those affected, decrease further transmission and provide a crucial model for other emerging healthcare priorities.


Supporting Documents: 


Addressing the treatment of HCV in the era of upcoming newer and more effective but costly agents has a significant public health impact. A multidisciplinary approach proposed to address this issue and its impact not only  locally but also globally is of outmost importance and is certain to lead to further research and education opportunities. This is a very important and timely proposal.

The proposed project is very timely because, as a new era of treatment dawns and screening identifies more infected individuals, we have the opportunity to create large prospective treatment cohorts.  Such cohorts are needed to provide sufficient data on the earliest immunologic events needed for treatment-mediated clearance.  Knowledge gained from such data may in turn stimulate progress toward a prophylactic vaccine.

Very exciting.  The big issue here though is how to turn this on its head, describing it more as a model for integrating research at various levels (including implementation science) with policy and care to measurably improve health.  The model will be tested with HCV.... (something like that is more likely to be aligned with a CTSA submission - since the CTSA award is supposed to enable infrastructure, not directly fund the response to any specific disease)

I was just reading about a CTSA project - HCV Target 

Are there any synergies or intersections that can be leveraged or built upon here?



Summarize the problem being addressed. Please make sure this is NOT disease-specific.

  • Emerging healthcare imperatives demand a coordinated, effective response; and new tools may offset the challenge of resource constraints
  • HCV provides a model of large disease burden and demographically variable epidemiology and natural history; where dramatic treatment advances will cause predictable explosive increase in service demand 


Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases

  • Design a multisite and multidisciplinary team to address new demands using new HCV treatment advances as a model
  • Enhance scalability by data integration across sites with differing demographics (Parnassus, SFGH, VA), and Statewide through BRAID
  • Define implementation strategies though upfront inclusion of healthcare economics and community engagement


What partners are involved in the solution?

  • Existing planning group of clinician investigators, basic scientists and epidemiologists
  • Informatics (data sharing) and economists and pharmacists (payment strategies for expensive but curative new treatment regimens)
  • Implementation scientists, medical center, community engagement specialists (model adjustments, scalability), global health scientists


What is the potential impact?

  • HCV infects 200 million worldwide. Designing a coordinated and effective response to new curative treatments would have an immediate benefit to those affected, decrease further transmission and provide a crucial model for other emerging healthcare priorities
  • Success would further UCSF reputation in innovating comprehensive responses to most important emerging challenges locally, Statewide and abroad

Submitted on behalf of the retreat discussion team.

History: UCSF has history of epidemics and associated UCSF, e.g. HIV.  HCV treatment effective, toxic, curable and many new drugs now being produced/marketed. New therapies are coming that are less toxic, more effective. Need to bring together a “big tent” of people, including global health practitioners and policy makers, economists, health care practitioners. Identify community engagement.  If starting point is UCSF focus, then need to optimize the use of IT to identify patients in the UCSF system (UCSF, VA, SFGH) and statewide. Potential for immediate response to the release of these new, very expensive ($70K/yr) drugs. Currently is a very siloed therapy in the UCSF system (GI, ID). Goal of this proposal would be a national model for other emerging health care crises, over and above HCV. Adaptability to multiple emerging disease states would increase fundability of proposal.

Experience with HIV, both past successes and failures, including access to health care, expense, patient adherence. Community engagement key toward success of the proposal.

  1. How to maximize impact?

Proactive designed approach with a feasible economic model. Ideally engage with other countries with significant numbers of infected patients, i.e. not the U.S. (versus working within the UCSF system). Early interaction with policy makers, CMS, politicians all will maximize impact.

    2. What UCSF infrastructure already exists?

Heath economists (IHP), clinicians, CAPS, Kaiser, community engagement with CTSI, IT sharing agreements exist, implementation science. Good connections with pharma and biotech exist, but need strengthen.

    3. What creative/innovative partnerships?

Increased strengthening of relationships with pharma, increased community engagement (including infected patients in these early stages) with DPH, others. UC systemwide (UC BRAID) could potentially be a partner.  An early partnership with MediCal is needed to determine State of Calif accessibility, funding of new agents. Important to collaborate with employers, e.g.the Safeway model for its employees. ACOs important partnership as well….who pays for these agents?

Everyone agrees that this is an important infection and that emerging DAA treatments present a rare opportunity to develop/test new models for health care delivery.  A great start!  Leslie points to a well-established project (HCV-Target) and Maininder points out that the CTSA is intended to enable infrastructure rather than respond to a specific disease.  With each point in mind, it seems that focusing on modernizing models of health care delivery, using HCV as an example, could be an appropriate framework.  HCV-Target appears to focus on benefits and risks specific to HCV treatment, not models of care, so it would not overlap.  Moreover, there is potential to ask how new models could help health care delivery as well as health outcomes research (like HCV Target).  Perhaps new health care delivery models that (1) focus on responding to challenges through technology-based infrastructure, (2) are developed/tested by multidisciplinary teams, and (3) result in open-source programs that would benefit groups worldwide are worth considering.  I have not read the "Big Tent" technology posts, but maybe there are opportunities for overlap and/or synergy.

Commenting is closed.

Exchange Marketplace for Drug Discovery and Development Resources

Drug development is a complex and resource-intensive process, with few academic institutions able to provide its translational researchers with the all the necessary infrastructure and resources to advance promising targets or early-stage molecules to validation. We propose to create an Exchange Marketplace – a framework in which a university can offer its unique capabilities and core resources in drug development in exchange for those that are not readily available on that particular campus.  We propose to utilize the UC BRAID (Biomedical Research Acceleration, Integration & Development) network and the Drug and Device Discovery and Development (D4) workgroup within BRAID to engage the five participating UC campuses of BRAID into the Marketplace.


A recent summit of the BRAID D4 workgroup in April 2013 made it clear that no single campus has all the necessary core resources to do drug development in-house. The summit also helped identify some of unique drug development infrastructure and core resources on each of the D4 campuses which can be shared via the Marketplace.  For example, UCSF leads the group with a state-of-the-art small molecule screening facility and medicinal chemistry capability (SMDC), while UCSD can contribute access to its unique marine natural products library.  UCD can contribute its GMP manufacturing facility and UCLA its GLP Toxicology facility – such facilities are not available at any other D4 campus.  These aforementioned facilities are meant to be representative examples of unique resources on each campus, but they demonstrate the increased breadth of capabilities that immediately opens up to the research community once the campuses agree to the exchange.


We propose that each campus contributes a chosen $ amount of services, linked to specific cores, to be offered to other campuses.  In return, each campus will be eligible to receive the amount of services on the marketplace equal to its contribution.  A process will be set up to issue the awards (in the form of services) to the investigators of the participating campuses.  The awards can be issued through a multi-campus RFP process, with a review team comprised of representatives from each campus.  Alternatively, each campus can conduct its own evaluation of proposals and recommend projects to receive the awards. 


Exchange Marketplace for drug development resources brings together and leverages the strengths and capabilities of each of the participating institutions.  It provides the research community with the knowledge of the types of services available on sister campuses.  It can seed collaborations between researchers across campuses.  Exchange Marketplace can offer pre-negotiated rates on a fee-for-service model, removing the IP roadblocks to collaborations.  A planning grant through the Big Tent Open Proposal mechanism could allow us to evaluate the feasibility of establishing such marketplace, gathering campus-level support from the participants, and refining the list of cores and facilities interested in participating in the program.


The recent Institute of Medicine review of CTSA programs strongly emphasizes a need to engage in substantive and productive collaborations as well as develop and disseminate research resources while focusing and leveraging on individual CTSA institution’s strengths.   The Exchange Marketplace does precisely that by linking the resources of the 5 BRAID participants (UCSF, UCD, UCLA, UCI, UCSD) and making them available to the research community.  Once the program is established and successful, this platform can be extended to other areas of research and development (e.g. Device development) and/or to other institutions.  Initially, however, we believe that the network comprising the BRAID D4 provides a powerful foundation for establishment of the program. 



The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

Exchange Marketplace for Drug Discovery and Development Resources

Submitted by: Irina Gitlin

1. Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

  • No single academic institution has on its campus the necessary range of facilities and infrastructure to conduct drug development
  • Translational investigators need accessibility to a wide range of facilities/infrastructure to advance target discovery or early leads towards products

2. Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

  • Exchange Marketplace – a framework in which universities can offer its unique capabilities and core resources in drug development in exchange for others

3. What partners are involved in the solution?

  • Start with 5 UC BRAID campuses to set up and test the Marketplace.  The advantages of working initially through BRAID are having the faculty champions on each campus and existing precedence for collaboration.
  • Long-term: can be extended to other UC campuses or other universities

4. What is the potential impact?

  • Extend knowledge and accessibility of available resources across UC; leverage capabilities of each participating campus
  • Seed collaborations
  • Make academic drug development more effective and efficient


Notes from the small group discussion at the retreat:

1.     How do we maximize impact and broad applicability of the proposal?

  • To maximize impact, need to provide a continuum of support.  One missing piece in an academic setting is project management support.  Another is a ‘connector’ to industry, foundations, or government grants with translational focus who would help with securing larger $ to do product development. 
  • UC-wide collaborations could be lengthy to set up; could be easier to focus on UCSF, develop a streamlined model for academic drug development, then export to other campuses.
  • It would also be helpful to have a resource catalog that summarizes the resources of each school. 
  • Additional financial support to existing translational resources at UCSF is needed as well.


2.      What foundation exists on campus already that will ensure success of the initiative?

  • There are organizations at UCSF that address above-mentioned missing pieces.  A more unified strategy between the Grants office, Research Development office, CTSI, ITA and others could help with translational projects. 
  • Catalyst program is another program that addresses some of the researchers’ needs with respect to translation.

3.      What creative and/or innovative partnerships could be leveraged to ensure success?

  • BRAID is a foundation, and the success with IRBs shows that cross-UC collaborations can be done.



I'd like to supplement Irina's comments to the questions posed at the small group discussion (see above).

1.     How do we maximize impact and broad applicability of the proposal?

  • To maximize impact, need to provide a continuum of support.  One missing piece in an academic setting is project management support.  Another is a ‘connector’ to industry, foundations, or government grants with translational focus who would help with securing larger $ to do product development. A third element, that begins mid-stream and continues through Post-Marketing expansion, is Regulatory Support.  UCSF has a myriad of resources in this area that can be partnered in creative ways to provide regulatory guidance across the 5 campuses.  This type of guidance is vital to the IND application process, successful completion of Phase I-IV trials, New Drug review application, FDA approval and post-marketing activities.

2.      What foundation exists on campus already that will ensure success of the initiative?

  • CTSI Regulatory Knowledge and Support (RKS) and Human Research Protection Progam (HRPP) have expertise in IND applications, FDA regulations, monitoring, and preparation for FDA or Sponsor audits.
  • Participant Recruitment and Study Management Services (PRS) includes a Study Coordinator as well as a Regulatory Core whose staff are trained in the management of FDA-regulated clinical trials.

3.      What creative and/or innovative partnerships could be leveraged to ensure success?

  • BRAID is a foundation, and the success with IRBs shows that cross-UC collaborations can be done.  Their proven track record of collaboration between IRBs will be valuable and efficient in combining regulatory expertise and creating standard education materials/processes for FDA applications, Site Initiation Visits and monitoring plans.  BRAID’s Regulatory Initiative is already working on identifying infrastructure and processes that will reduce the barriers to regulatory approval.

Perhaps as a companion to the exchange, develop curriculum to teach business foundations of entrepreneurship for clinical researchers. Online, shared resources might include topics such as: finding commercial partners, marketing, finance, operations, sstrategy, building and investing in businesses, raising capital, evaluating business opportunities, creating business plans, etc. This has a different flavor than sharing access to facilities, but perhaps it would be useful for this audience of researchers.

Commenting is closed.

"Speed-Networking" to Drive Novel Translational Research Connections


Investigators lack opportunities for novel interactions with partners with whom they do not ordinarily collaborate, either because they haven’t had the opportunity to meet each other by virtue of operating in different disciplines or locations, or because there has been neither a straight-forward mechanism nor incentive to look outside one’s usual circle of  partners.



  1. Provide an opportunity for scientists to meet  research, community, and/or community partners outside their usual circle of collaborators in order to foster a broader network  partnership through a designated networking event;
  2. Provide seed-funding for up to three collaborative projects per event in the amount of approximately $5,000 each for feasibility pilot studies that encourage new collaborations, new methods, and/or innovative interdisciplinary research approaches to outstanding translational healthcare issues; and
  3. Aide in the transition of funded projects to further larger, enabling projects.



In an effort to encourage collaborations across disciplinary, geographical, or institutional boundaries, the Research Development Office (RDO) will facilitate a series of interactive events that will bring targeted investigators and community, affiliate, and/or commercial partners together and incentivize innovative collaborations.



These “Speed-Networking” events will provide a structured environment in which each researcher will have an opportunity to meet potential outside collaborators in a prescribed format.    Additional social interaction time will then allow interested parties an opportunity to continue specific threads of inquiry.   Potential partners will ultimately complete a card indicating their interest in speaking further with one or more of the participants.  The RDO will manage the follow-up from these events.


The particular focus area for any single event could be selected strategically to support larger campus initiatives or be uniquely chosen to “test the waters” for new areas of potential strategic importance.




Initially, ten separate Speed-Networking events will be planned over the course of a year.  The RDO will work with CTSI leadership to identify both the specific focus of an event and the cadre of participant researchers and outside partners.  The number of participants will be capped at 30 to ensure adequate interaction time.  The RDO will manage all the logistics, including invitations, securing meeting space, arranging food and beverage as needed, and setting-up the event space and materials.  The RDO will also lead participants through the event and manage all follow-up.



  • “Slush” Time (20 min.):  the success of this event in part depends on all attendees being punctual; light refreshments, therefore, will be available during this time to allow for casual conversation and serve as “slush” time for stragglers to arrive
  • Introduction (5 min.):  the RDO team leader will introduce the program, focusing on the intent, format, and financial incentive
  • Rotations (1 hr.):  four-minute rotations between each set of attendees, allowing all investigators to meet  all potential partners around a short set of pre-designed questions (e.g., who, what, what if, and how might we)
  • Free Association (20 min.):  people are able to reconnect with a partner with whom there is a “spark” and pursue their shared interest a bit more, potentially developing a more concrete vision of a collaborative project
  • Next Steps (10 min.):  each attendee will fill out a card identifying her/his top three choices for collaboration; the RDO  team leader will close the event by informing participants of next steps and timeline



After the event, “matches” will be identified by the RDO team based on participants’ mutual identification.  The RDO will reach out to these partners, inviting each “match” to prepare a simple, two-page proposal describing their feasibility or pilot project and associated budget needs of up to $5,000.  The target goal would be to have these due within three weeks of the event, if possible.   CTSI leadership, with the assistance of the RDO, will make the final funding decision, based on both the likelihood of project success and a fit with CTSI strategic goals.  The goal is to make these funding decisions within about five weeks of the event, if possible.  For projects not outlined or funded as a result of this event, it is important to note the tremendous value in the networking component for potential future collaborations and faculty satisfaction.  For funded projects and where appropriate, the RDO will collaborate with the Office of Innovation, Technology and Alliances (ITA), as well as the appropriate UCSF community engagement office, to foster success in the translation  of the idea.



There are three specific returns on investment of the Speed-Networking event that will be measured:  1) the number of researchers that participate in a networking event will be counted; 2) the direct benefit to future  collaboration activity made possible by supporting the generation of preliminary data and providing evidence of prior collaboration; this will be measured by following funded projects and capturing the percentage that go on to receive related funding from extramural sources, initiate new contracts, or otherwise move to further the collaboration; and 3) the participant satisfaction value, which will be measured through a short survey instrument sent at the end of each event.  The RDO will track and report these measures.



In the first year, we plan to facilitate ten speed networking events.  Each event will target 30 participants, leading to the funding of two or three $5,000 pilot proposals.  While the RDO will leverage resources from its Building Teams for Innovative Research (BTIR) program personnel for this Speed-Networking program, additional resources will be needed to facilitate the program at a rate of approximately one FTE per three events.  We also plan to minimize the logistical event costs by utilizing freely available facilities on campus wherever possible.  The anticipated costs are presented in Table 1 below.



Cost for 3 Events

Costs for 10 Events

Event logistics, including beverages, food, paper goods, copying (assuming ~$500 per event)



Pilot Proposal Award, assuming 30 awards per event, at $5,000 per award



Two FTEs, at $80,000 each



Total Annual Proposed Budget





The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

“Speed-Networking” to Drive Novel Translational Research Connections

Submitted by: Gail Fisher & Gretchen Kiser

1. Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

  • Investigators lack opportunities for novel interactions with partners with whom they do not ordinarily collaborate, either because they haven’t had the opportunity to meet each other by virtue of operating in different disciplines or locations, or because there has been neither a straight-forward mechanism nor incentive to look outside one’s usual circle of  partners.


2.    Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

  • Provide an opportunity for scientists to meet research, commercial, and/or community partners outside their usual circle of collaborators in order to foster a broader network of partners through a designated networking event;
  • Provide seed-funding for up to three collaborative projects per event in the amount of approximately $5,000 each for feasibility/pilot studies that encourage new collaborations, novel ideas, new methods, and/or innovative interdisciplinary research approaches to outstanding translational healthcare issues;
  • Aide in the transition of funded projects to further larger, enabling projects.

 3.    What partners are involved in the solution?

  • Internal:  1)  Research Development Office; 2)  CTSI; and 3)  ITA               
  • External:  1)  Commercial entities; 2) other research institutions; and 3) community groups

 4.    What is the potential impact?

  • Increase in new partnerships/collaborations between UCSF researchers and industry partners/community groups/partner institution researchers;
  • Development of innovative solutions and approaches to research questions, as well as to critical issues of translational importance, such as biomedical research-associated ethical, legal and social implications (ELSI), healthcare delivery or health policy.


  1. 1.     How do we maximize impact and broad applicability of the proposal?


Identify a theme (a plane or axis, to focus the potential collaboration) for each event to draw a variety of participants who may have some things in common but would not normally work together.


Select venue for events that will optimize the experience for participants


Use networking tools, i.e., UCSF Profiles, to identify possible matches and participants for each event


Ask participants to record a short video/pitch that can link to profile -  “Mission in a minute” – who are you, what do you do, and why does it matter.  Record pitches, add to profile short videos.

Look for ways to create unanticipated connections between people

Structure so that potential collaborators interact with each other for 10 minutes (as their speed date) suggested to establish rapport, exchange ideas.

Experiment, start small, try different approaches (and measure success), i.e., “fishbowl” approach, where experts are gathered to apply their expertise to a particular problem of question.

Get some high profile champions to draw a crowd

Think of examples of successful collaborations, get testimonials.

Follow up – send contact list to all participants

Think about expanding budget to hire trained facilitators to ensure success of events

Develop UCSF Profiles – expand to include wish list/magic want/interests – make this function searchable to help identify collaborators





  1. 2.     What foundation exists on campus already that will ensure success of the initiative?


Can draw upon existing examples in postdoc office, alumni relations, identify other places where examples of this type of event already exists, study what has been effective.




  1. 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

Include participants from a broad array, national labs, VA, SFGH, CHORI, Galdstone, LBNL, UC BRAID

Systemwide committee on research – end up writing a grant together.

Question 3 –

Try partnering with industry, hold events at their locations

Partner with industry,hold some events there – Genentech, or Onyx?


Other Notes (group ran out of time):

  • Need a way to create a kind of venn diagram of their own interests; so people aren’t too far way from each other
  • Gail: first event; invite very particular people
  • Target around specific problems – ideas would be up to participants
  • How do you select participants
  • Order of events
  • How to match people
  • Broad categories
  • Can profiles be used for this – use profiles to extend the circle; 50 names who are in  my outer circle;  what degree of separation do you want
  • People do speed dating; unpredicatability is crucial;
  • We wouldn’t math ourselves; but we would have [people involved who would be willing to give it a try
  • How would we maximize the impact of this; how to broaden beyond ucsf.
  • What sort of groups would be appropriate
  • Mission in a minute – who you are and why you do what do matters; distribute them in other ways and inlcue in Profile
  • Everyone records pitches; this could extend the reach
  • Need to think out of the box; mix people would not normally interact;
  • Maybe 4 minutes during initial exchange – or 10 minutes;
  • Way to connect afterwards
  • What kind of way to bring people together; how to categorize people; fundamental mechanisms; disease;   need to focus on translations aspects
  • Difficult to do unless across a disease; set up; how do you identify who would be an appopriate voice from community
  • E.g., diabetes; nurses; community people; lack of access to care; nutritionists; economists; scientists; is there any unifying single theme;
  • Public health problems – impacting population health; vested interest from different groups
  • Free form list of words
  • Theme could be community health – could come up with terms that are not necessarily a disease
  • Agree on a taxonomy for each event
  • Fishbowl – bring 3-4 people in different disciplines in middle of room; have expertise in dealing with the topic; people on outside in diff areas; what did you learn in approaching the problem; moderator; people on outside can ask questions; what are the lessons from your discipline bring to tis problem; very engaging start;
  • The answer could be in another industry
  • Diffusion expert; meteorology;
  • What would be the incentive for them to follow through: how do you foster continuing collaboration
  • Seed money $5000 to support subsequent team meetings
  • Univer Community partnership projects - $2500 given to 10 different partnerships
  • Any match would write a proposal – keith and Gretchen would decide or RAP would;
  • Criteria would ave to be clear
  • This is future looking; not past accomplishments; profiles now has “interests”
  • Where would you do this event
  • How do you insure that the right people in the room
  • What about a person’s home? An alum; would make it more intimate; chancellor’s residence;
  • What partnerships could be leveraged?
  • Would it be a good idea to have this facilitated? Could train people from UCSF to facilitate
  • Partner with Genentech or Onyx pharmaceuticals?
  • Could hire professional facilitators – need to be sure it is done professionally
  • There will be early adopters; get some high profile champions;
  • Need one example of how it works; have 3-4 collaborators about how they got together
  • Different ways to assess the quality of the event; diff ways to student this event;
  • All 4 schools and grad division included
  • How to go beyond ucsf; community groups; alumni; donors; populations = like patients and citizens
  • Start small and increase as we succeed
  • Include national labs, foundations, VA, SFGH, Childrens hospital of oak; lbnl; gladstone; UCBRAID;
  • Need to be specific about composition group
  • Alternate between MB and Parnassus
  • Chancellor dinners (Bishop) brought people
  • Could make groups based on their geography
  • Persuade alum to host meeting; they pay for it; and then
  • Opportunity to get $; prestige to get invited; social mingling; personal invitation; should be a host – a prestigious person;
  • Community health go to each dean; name people to participate;
  • Ice breaker part to prompt conversation
  • What could you leverage; Canadian medical anthropology;  already amazing openness to be part of this; people even outside of medical fields who are interested in this; 

Some thoughts from CTSI Retreat / Leadership panel with UCSF Deans:


Infrastructure is needed to facilitate faculty collaboration.   Can we find more efficient ways of connecting; are there are ways that UCSF Profiles could be leveraged to use data analytics to facilitate networking between the four schools and the graduate division.  One option is to promote lunches where guidance and potential funding opportunities could be presented.  Another suggestion was made to propose a research field and invite researchers from across the campus to attend focused meetings.  CTSI could help by facilitating collaborations, and recommending leading questions for interactions.  

Expanding Profiles to be a more active networking tool would be helpful.  A good example is Research Gate ( - this service automatically notifies an investigator (on a preset schedule) when a peer and published and when one of their articles is cited.  I find this very helpful to keep up with what my peers are doing and develop new collaborations (as well as have fun and enlightened conversations when we meet at events).   

Commenting is closed.

Improving Education and Treatment of Newborns with Disorders Detected in the California State Newborn Screening Program through Linking Resources of the CTSI with the State Genetic Disease Screening Program

Primary Author: Elliott Vichinsky
Proposal Status: 

The IOM has called for the CTSAs to expand research on children. The CTSI and the California Department of Public Health have a common vision of improving the health of children through newborn screening programs for genetic disorders. California has been a pioneer in developing new approaches to diagnosis, education, and treatment of disorders detected in the newborn period. Currently, several million newborns in California are screened for 21 genetic disorders each year. 

Overall, screening disorders are identified in 1 of every 500 births.  The data indicate hereditary disease expression is strongly affected by ethnicity/race. In California, there are 16 separate racial/ethnic groups at disproportional risk for specific genetic disorders.  For instance, 1 in every 80 Southeast Asians has a screening disorder.  Asian East Indians have the highest prevalence of endocrine disorders, Native Americans have a disproportional prevalence of cystic fibrosis, and metabolic disorders are highest in the Middle Eastern population.

Systematic problems, magnified by the diverse cultural and economic factors affecting the target population, impair the ability of the California State Newborn Screening Program to optimally reach its public health goals.  These goals include appropriate evaluation, performance monitoring, and access from birth through young adulthood to specialized treatment for all persons affected by screening disorders. Furthermore, significant numbers of families with affected newborns currently lack an informed provider in a medical home, do not have access to the latest therapy, and/or are not able to obtain counseling.

The goal of this proposal is to form an innovative partnership between the California Department of Public Health’s Genetic Disease Screening Program (CDPH BDSP) and the CTSI. The decision makers at the CDPH BDSP are “on board” and eager to have an opportunity to develop these ideas in a planning period.  Likely CTSI partners include the Comparative Effectiveness Large Dataset Analysis Core (CELDAC), the CTSI Community Engagement Program, CTSI Clinical Research Services, and the Children’s Hospital & Research Center Oakland, which runs the state screening program for hemoglobinpathies and has worked with the state screening program for many years. Other UCs are also potential partners.

This partnership will have several objectives:

(1)    Improve medical homes through provider education— The initiative will foster an active network of medical home physicians, and will develop provider education programs focusing on standard of care practice guidelines for each disorder, leading to better quality of care and improved guideline compliance. 

(2)    Develop a patient registry-- In collaboration with the medical homes, the initiative will develop an active registry of patients identified in the newborn screening program. These patients will receive educational services through multimedia approaches and have access to clinical trials.

(3)    Improve the infrastructure to conduct translational research-- The provider network and patient registry will provide a platform for conducting longitudinal studies for rare diseases, development of biomarkers, and a biologic bank for research, and will greatly facilitate access to patients and data for the development of new therapies.

Strategically combining resources of the CTSI and the CDPH BDSP will open up new and unprecedented research avenues from T1-T4.  California is uniquely positioned to utilize its screening registry for translational research purposes. We believe that a small planning grant will allow us to develop these ideas into a compelling project that would greatly strengthen the CTSI renewal and would ultimately serve as a model for other states. 

Commenting is closed.

Bay Area Nutrition and Health Initiative: A Novel Family and Community-Based Approach for Addressing the Gap Between Nutrition Science and Improvements in Nutrition-related Health Outcomes

Primary Author: Ronald Krauss
Proposal Status: 

Poor nutritional practices contribute inordinately to the major diseases affecting public health and hence the health care economy. Among these are obesity (recently classified as a disease in itself) as well as heart disease, hypertension, stroke, diabetes, and likely, some forms of cancer.  While weight loss has been a focus of trials aimed at improving disease risk, studies such as the recent report of the NIH Look Ahead trial have failed to demonstrate that diet-induced weight loss reduces disease outcome (in this case, cardiovascular disease). Notably, in the New England Journal of Medicine editorial accompanying this report (July 11, 2013), it was stated that "different and novel strategies [will be needed] to maintain initially large effects on weight and other risk factors over a period of several years".


To address this need, we propose developing and implementing an innovative family and community-based nutrition counseling and skills training program that is informed by our separate experiences with adults and children, but will now aim at working with families in a more integrated approach.  This novel program affords the opportunity to evaluate genetic and cultural influences on metabolic health and nutritional needs; to generate and apply new knowledge regarding effective and individualized nutritional guidance; and to evaluate the effectiveness of this approach vs. conventional practices on specific health-related outcomes (e.g., adiposity, blood pressure, metabolic profiles).  


Our proposed Bay Area Nutrition and Health Initiative (BANHI) will recruit families - as defined by at least one adult and one biological child - into a comprehensive clinical research program that provides regular health assessments, education and skills training, including mindfulness and food preparation, and a unique plan for long-term follow-up (at least 5 years). Key features of BANHI are: 1) it teaches skills to the unit, i.e. the family, which can most effectively implement behavior change; 2) it is simultaneously preventive and therapeutic; 3) it targets the lifespan, including the perinatal period; 4) it creates a research cohort that will be an invaluable resource for studies in the laboratory and the clinic aimed at increasing knowledge and evaluating the efficacy of therapies (nutritional and other) aimed at reducing risk of chronic disease and 5) it has the potential to generate laboratory and clinical data, as well as a biobank of archived samples, that may be used by investigators to understand the basis for inter-individual variation in disease risk and responses to dietary modifications.


Importantly, the BANHI embraces the entire translational spectrum (T1-T4) with participation of researchers, clinicians, and public health experts. It capitalizes on the combined scientific and core resources as well as expertise of Children’s Hospital & Research Center Oakland and UCSF (e.g. Clinical Research Services, Community Engaged Research and Participant Recruitment Services), as well as the UC Berkeley School of Public Health.  CHRCO, in particular, has access to a large number of at-risk families with diverse racial, ethnic, and cultural backgrounds that would benefit from this program. Furthermore, potential partnerships with other health organizations, including the Ethnic Health Institute at Alta Bates Summit Medical Center and La Clinica de la Raza, will allow for the Initiative to expand its reach to an even greater number of families of underserved communities throughout the Bay Area. BAHNI may serve as a model for other academic medical centers and national guidelines committed to achieving long-lasting improvements in the risk of nutrition-related chronic disease.


The approach to use the intact social network of families is an important idea especially since food has so many social and cultural components.


Nutrition/Diet is connected to many additional health outcomes including oral health (dental health). 

Commenting is closed.

UCSF Center for Innovation Practice: Dissemination and Diffusion

Proposal Status: 

1. Scale and significance: Creative and groundbreaking T-2-T-3 Innovations in health care and community delivery have been developed and tested within many UCSF settings. While some successes have been achieved, the campus has not been able to leverage the full power of these innovations; limitations in the scalability of even the strongest and best-tested innovations occur. Many of the innovations are disseminated and potentially exported externally to UCSF, but few systematic approaches exist to internally marshal innovation for internal consumption in potential “next circle” of settings for replications and further testing, adaptation, and cultural refinements. Few systematic approaches for collecting information on these “home-grown” initiatives exist, precluding “mindful” and meaningful expansion into other “neighborhoods”.

2. Current Approaches (nationally). Our “distributive” nature lends to lost opportunities for cross-fertilization, delays as new initiatives are tested, lack of recognition of previous institutional history that could help avoid common, but time- and expense-intense errors. National innovation “explosion” being tested nationally could have great utility for UCSF/UC-wide, in an effort to make information more readily available.

3. Potential Approach: Establish a campus-wide Innovation Bank. Readily available and consistent information on the innovations, including how they were established, funded, who was involved, how did the model evolve, outcomes, evidence of effectiveness (i.e., cost-savings, increased patient satisfaction, improved use of existing resources) has not been centralized as we aim to develop additional quality and cost-reduction improvements. Additional strategies are needed for sharing the results of the innovations: short videos, podcasts, retreat briefings, panels. A “concierge” element, matching individuals ready to implement new initiatives with those who might have had relevant experience. Evaluation of the process of matching, as well as utility of the repository, is needed. The clearinghouse could also help in the diffusion of practice for those interested in identifying “works in progress”, wherein the innovation is still in the initial process of implementation. “Crowd-sourcing” could be tapped, contributing to ideas, in real time.

4. Partners: An Advisory Board comprised of Clinical Chairs would guide the development and implementation of the repository; proposed activities would also coordinate with the Implementation Science endeavor, Center for Healthcare Value, etc. Other CTSA/UCOP could participate once the initial resource is launched at UCSF.

5. Projected Impact: A collective fund, supported in part by the Clinical Departments, Schools, and Medical Center, would help create an “incentive” matching fund to implement innovations (UCSF and elsewhere) that have been shown to have success in improving quality, safety, outcomes, cost containment, and patient satisfaction. A process for applying for funds (building on campus efforts in Implementation Sciences) will be established and a review panel will select prioritized innovations, continuing to monitor and provide oversight as the replications are implemented. Leveraging innovations that work could help reduce substantial medical costs.


What is the scale of budget and/or effort that might support this Center?

Commenting is closed.

Harnessing the Law for Translational Science: The UC Initiative on Translational Science and the Law (ITSL)

1. Scale and Significance: Law shapes the effectiveness and impact of research translation across the T1-T4 continuum. Effective T1 involves contracts and intellectual property; T2 researchers navigate human subjects regulation; healthcare policy shapes T3 impact; and law itself is a powerful lever for change at T4.

Recognizing law’s impact, we seek to accelerate research by providing tailored legal support at all points of the translational continuum. To do so, we propose a UC-wide Initiative on Translational Science and the Law (ITSL). This Initiative will enable investigators to more-readily address legal challenges to research translation and to recognize and leverage opportunities to use the law to enhance their translational impact.

2. Current Approaches: The Initiative on Translational Science and the Law (ITSL) extends the work of the UCSF/UC Hastings Consortium on Law, Science, and Health Policy – the only effort of its kind in the US, to our knowledge (see below). The Consortium has brought together health researchers at UCSF and law faculty at UC Hastings to address challenges and leverage opportunities at all four translational points.

  • T1: The Consortium sponsored a UCSF forum on gene patenting and is contributing to a precision medicine workgroup on regulation and policy.
  • T2: The Consortium is contributing to EngageUC, an NIH project that is leveraging UC BRAID to develop harmonized processes for biobanking.
  • T3: With CTSI pilot funding, the Consortium is working with health policy researchers to identify legal strategies to foster price transparency in healthcare purchasing.
  • T4: With CTSI pilot funding, the Consortium has brought together obesity researchers with local regulators and public interest lawyers to develop legal strategies to reduce the health burden of excess sugar consumption.

3. Proposed Approach and Why it is Innovative: ITSL will build on the success and structure of the UCSF/UC Hastings Consortium. First, we will establish a network of legal experts at multiple UC campuses and will make this expertise broadly available to translational researchers (see Potential Partners, below). Second, ITSL will perform outreach to health researchers throughout UC to raise awareness of this service. Proactive outreach – e.g. attending presentations where investigators discuss research with legal implications, leveraging information in CTSA Profiles, etc. – will be particularly important. Our Consortium experience suggests that researchers often recognize when they face legal challenges but may be unaware that their problem is actually solvable. Finally, once investigators recognize that help is available, ITSL staff based at the Consortium will field questions, clarify requests, work with Consortium faculty to identify appropriate ITSL-network experts, and propose tailored solutions. The Consortium has developed a range of such tailored solutions. Well-circumscribed questions, e.g. a human subjects question, may be solved via brief consultation. But ITSL will also be able to respond to ongoing needs, e.g. developing a legal core to bolster T4 translation in a multi-site public health intervention study.

A recent examination of CTSA law and policy initiatives found no partnerships similar to the Consortium or ITSL. All CTSAs help guide investigators across regulatory hurdles, but few make legal expertise available to accelerate translational research per se. It is likely that legal issues in research translation are currently siloed: T1 in technology transfer, T2 in ethics and compliance, and T3-T4 in policy and public health research. ITSL seeks to change that.

4. Potential Partners: The UCSF/UC Hastings Consortium will provide a foundation for ITSL. UC Hastings and CTSI connections with law schools and translational researchers, respectively, will allow ITSL to recruit experts and conduct outreach. On the legal side, the Program on Understanding Law, Science, and Evidence (PULSE) at UCLA School of Law and the Health Law Program at UC San Diego and California Western Law School offer strong partnership opportunities. On the translational science side, UC BRAID, EngageUC and precision medicine create teams of investigators whose research programs will benefit from ITSL support. Other CTSAs or networks, such as the eMERGE network of DNA biobanks, provide additional opportunities for partnerships nationwide.

5. Project Impact: The experiences of the UCSF/UC Hastings Consortium illustrate the potential impact of this initiative. The Consortium has contributed to NIH and private grants totaling more than $6 million in the last three years. The Consortium has sponsored 50+ lectures and symposia and contributed to over a dozen white papers and publications. Based on this experience, we project the potential impact of ITSL could be substantial.


Overview for CTSI retreat discussion:

Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

  • Legal barriers can slow translation across T1-T4 continuum, e.g. contracts, intellectual property, human subjects, healthcare regulation
  • Law can also accelerate translation, e.g. align incentives for quality or mandate reduced exposure to health harms
  • Researchers need help overcoming barriers & leveraging opportunities

Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

  • The UC Initiative on Translational Science and the Law (ITSL) will provide tailored legal support to researchers at all points of translational continuum
  • Assemble UC-wide network of appropriate legal experts (see Partners)
  • Outreach to researchers UC-wide (see Partners)
  • Provide scalable solutions based on size & scope of barrier/opportunity

What partners are involved in the solution?

  • UCSF/UC Hastings Consortium on Law, Science & Health Policy illustrates proof of concept and will provide coordinating center for ITSL
  • Legal experts: Health law programs at UCLA and UCSD/Western School of Law
  • Researchers: Outreach via UC BRAID, EngageUC, and precision medicine

What is the potential impact?

  • In 3 years, Consortium has helped support $6m+ of new NIH/other funding and produced 50+ symposia and 12+ white papers & publications
  • UC-wide scope gives ITSL higher potential for funding & dissemination impact
  • We know of no similar program in the US; further scaling nationwide may be possible, e.g. via CTSA Regulatory Knowledge KFC

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad


 1.     How do we maximize impact and broad applicability of the proposal?


  • Make research more relevant by engaging with the law. Hard to see relevance right at beginning for some researchers
  • Demonstrate an impact through policy
  • Make sure we span the continuum between T1-T4
  • Create some bridges between the IP folks
  • Bridge the group to individual divide (T1 problem)
  • T1 – people don’t always want their data stored, help them understand what it means to have biobanking
  • Apply proposal to all 12 CTSI programs, not just through the lens of one program (such as CEHP)
  • Disseminate examples of how the network could help researchers
  • Make sure proposal engages basic sciences
  • Stay away from buzz words if they trigger unintended outcomes
  • Explore how this proposal bears on child research
  • Accelerating discovery can’t happen without engagement with FDA
  • Science informing public policy, changing law
  • Overarching impact around patient-engaged research


 2.     What foundation exists on campus already that will ensure success of the initiative?

  • Expand UCSF/UC Hastings partnership following UC BRAID model (new 1 year degree)
  • What is out there? Outward-looking, establish point of perspective and legal system is one of those.
  • SFHIP provides example of working across many organizations, including SFPD
  • Clinical trials recruitment groups (e.g. Rena Pasick), also Participant Recruitment Service, ATHENA network
  • It’s about the populations you deal with, university has larger responsibility
  • Clinical research infrastructure advisory committee – partner on them, such as on biobanking and how do we do consenting?
  • Build on UC BRAID biobanking effort, common structures, common SOPs so that utility of that material is much higher. Can DNA be used in five years, for multiple studies
  • Work with regulatory groups across campuses

 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

  • Have advisory board that goes to different schools
  • UCB school of public policy
  • Engage with industry and their legal teams. How do their legal teams influence public policy?
  • Create infrastructure that is supportive of industry partnerships that are already happening and that ensure patient-engaged research, such as community panels



Perhaps one path for the ITSL to engage with researchers might be a model similar to CTSI's Consultation Services program ( Or better still, by partnering directly with CS, the ITSL may be able to reach more researchers on campus who are unaware there are legal & policy experts who wish to help. A goal might be to extend the CS model for the ITSL to include all 5 UC biomedical campuses. CTSI may be able to advise or actively participate in setting up a way for the ITSL to charge a subsidized rate for services to the 5 UCs (and other interested parties).



Commenting is closed.

Telemedicine and Translational Research

Primary Author: David Durand

Advancements in technology, greater acceptance of remote communication by patients and insurance providers, and a trend toward an  increasing demand for providers and cost effective approaches will ensure telemedicine will play a much large role in the future of healthcare delivery than it does currently.   T4 research on outcomes, efficacy, cost, quality of care, and patient satisfaction related to the various applications and potential applications of telemedicine has grown significantly over the past decade, and there are now two journals dedicated to telemedicine.   However, little research to date has been with the pediatric or diverse rural or urban underserved populations.  The Institute of Medicine recently published its report on advancing translational research among the CTSA programs and recommended a greater focus on both children and ethnic minorities.

Largely with federal funding, the California Telehealth Network has built an infrastructure of high-speed broadband throughout California.  With expertise in numerous pediatric specialties and diverse population populations and a progressive spirit, CTSI could be the hub of research at the forefront of telehealth research.

Studies on outcomes, patient satisfaction, cost effectiveness and ROI, and comparative effectiveness may be applied to timely topics such as but not limited to:


•             Tele-care coordination, home health 

•             Remote monitoring of persons nursing homes

•             Tele-care for persons in correctional facilities and other institutions

•             Telepsychiatry and behavioral medicine

•             Oversight of non-MDs if scope of practice bills pass (SB 491,SB 492, and SB 493)  

•             Access to specialty care in rural areas of California

•             Provider training


In addition to research on telemedicine, the utility of these new technologies within the research enterprise has barely been tapped. There are numerous applications and opportunities to both study and utilize new communication technologies within translational research to facilitate participant interaction and involvement and oversight more non-academic community research locations. 

A CTSI planning grant will allow a select group of researchers across partnering institutions to secure partners, define its goals, and narrow its focus.  Potential partners include the UCSF Telemed Dept., the CTSI Community Engagement Program, Children’s Hospital & Research Center Oakland, and the UC Davis Pediatric Telemedicine Project. Other potential partners include SF Bay CRN, UC Davis, UC Berkeley, and various organizations around the state.

A coordinated effort among and between UCs in California and community partners could serve as a national model and source of expertise for the study of telehealth clinical applications and the utility of telehealth applications within translational science. 


Most imperative piece is the identification of a long-term goal, with using the pilot funding to bring all the telehealth stakeholders to gain buy-in and develop a small,scalabile cohort study with metrics to support the initial pilot. 
  • How do we maximize impact and broad applicability of the proposal?
    • May be more specifically focuses. Beginning small and building on experimental success.
    • Transferability to other therapeutic areas. Scalability.
    • Where is demand coming from for this service?
    • Is this community need driven? Have we asked the questions to the partenrs?
    • Make certain that large institutions are all involved.
    • How do you loop in community provider?
    • Leverage the California bond; leverage the foundation.
    • Clinical service establishment; research examines the comparative effectiveness.
    • Narrow down; what is service/audience.
    • What is the research question? Clear who is targeted
    • Engage trainees throughout the process.
    • HIPPA compliant. What else is needed on other end? Translation
    • End users at the table.


  • What foundation exists on campus already that will ensure success of the initiative?
    • What is not on campus?
    • Infrastructure to perform research.
    • Practice based community health network.
    • Which partners would be beneficial at the table.  What current UCSF stakeholders should they engage?
    • Engaging David Durand
      • SF HIP
      • SFGH
      • Telemedicene department
    • Have a connector/facilitator connect the diverse stakeholders across campus.
    • Have the core set up infrastrucre; sharing SOP’s and allowing quick activation times.
    • Focus on specific area; specific performance metrics to measure success
  • What creative and/or innovative partnerships could be leveraged to ensure success?
  1. a.      Engaging local technology/industry companies. Apple, Google, Cisco, Facebook,
  2. b.      Learning lessons from Phase 4 Pfizer
  3. c.       Partner with ITA
  4. d.      Insurers/Payors
  5. e.      Schools
  6. f.        Cost effectiveness analysis
  7. g.      DPH- SF and Oakland
  8. h.      Collaboration across the state and CTSA’s


Chip Chambers

Courtney McFall

Cecily Hunter

Helen Loeser

Karen Hamblett

Kristin Chu

Nariman Nasser

David Haddick

Margaret Tempero

Michael Potter

Peter Becchetti

Jennifer Creasman
Era Whitaker 

Commenting is closed.

An initiative to expand CTSI Study Recruitment in the East Bay

Primary Author: David Durand
Proposal Status: 

The pace and efficiency of recruitment of participants into a study is typically the limiting factor for how quickly a clinical trial can be completed.  Maximizing the efficiency and scale of recruitment for a study means the study can be completed sooner, use fewer resources, and/or increase the study’s sample size, and therefore its utility to science.

The CTSI’s Participant Recruitment and Study Management Services (SRS) program aims to assist UCSF investigators with study recruitment, screening, and enrollment of participants into USCF clinical research services, as well as provide tools, education and outreach related to the recruitment of research participants. Despite these resources, recruitment in San Francisco can be especially challenging. In particular, there is simply a limited pool of children living in San Francisco for pediatric studies, as well as a limited pool of African Americans of all ages.

Fortunately there a population of more than 2 million individuals in the East Bay which, for the most part, has not been tapped for UCSF-based clinical trials. However, few investigators are familiar with how to access these communities, and in any case, the time and inconvenience of going into the city likely prevents the eager participation of most individuals outside of San Francisco.

The CTSI satellites sites at Children’s Hospital Oakland and Kaiser Permanente in Oakland have been utilized primarily by investigators based at those institutions. Very recently, there have been efforts to expand recruitment into the East Bay for trials originating with UCSF investigators, as well as hosting study visits at that locations. The positive impact on recruitment from these locations cannot be understated and has resulted in additional funding for UCSF.

CTSI’s goal with the renewal launch pad is “to involve the broadest community possible of UCSF faculty, affiliate organizations, community partners, etc. to help identify and plan activities that will substantially improve translational research at UCSF, regionally and nationally.”

The proposed initiative would serve to significantly strengthen translational research based at UCSF by facilitating the ability of investigators of clinical trials to outreach and enroll a “new” population of diverse children and adults, and to conduct study visits in the East Bay.  

Potential partners include CTSI SRS program, CTSI Community Engagement Program, Children’s Hospital & Research Center Oakland, Gallo Center, Kaiser Permanente, the Center for Information and Study on Research Participation (CISCRP), and the OmniScience Mobile. A planning grant would allow interested parties to develop these basic ideas into practical strategies. Over time a recognition among investigators to "think outside of SF" would become normalized. 

 Successful implementation of the proposed initiative in the next CTSI cycle has enormous potential to improve study efficiency, reduce costs, and increase sample size of scores of CTSI studies, as well as improve the competitiveness of future grant proposals.

A large scale, coordinated and strategic effort to expand the CTSI recruitment catchment area, particularly if successful (as early attempts have indicated it should be) could influence similar efforts at other CTSA sites and for research centers in general. 


Recognition of the important populations in the East Bay is critical for research to address disparities among African Americans.  Successful engagement there can build on the longstanding relationships established by UCSF researchers such as the Faith-based and Alameda-County Hlth Dept based program of the UCSF Cancer Center. 

San Francisco Bay Area Collaborative Research Network (SF Bay CRN) is CTSI's primary health care practice based research network ( ).  Our membership includes dozens of primary care practices and health centers in Alameda and Contra Costa counties, and extends into the Central Valley, as well.  Members of our steering committee include individuals located in East Bay health systems, such as Kaiser, Children's Hospital, Hill Physicians, Sutter Health, and a variety of FHQC community health centers.  While we have facilitated many practice-based research projects involving East Bay healthcare settings, our capacity to aid in these activities could certainly be expanded, and we would certainly welcome any new partnerships with the groups putting this proposal forward that might lead to greater use of our network for translational research in primary health care. 

Commenting is closed.

Poverty Matters: Incorporating Social Determinants of Health into the Medical Model

Proposal Status: 

Adverse social circumstances like community violence, unstable housing, food deserts and poverty can have dramatic, negative impacts on the health of vulnerable children. In safety-net settings, the prevalence of these adverse social circumstances is alarmingly high. A 2007 study in a pediatric emergency department demonstrated that over 97% of presenting families had at least one unmet basic social need; over 48% of families reported that within the last 12 months they had either been threatened with or experienced utility shut-offs; and over 30% of families said that they had either reduced the size of their meals or skipped meals because they did not have enough money for food. [1] These collective social needs, often referred to as social determinants of health, are well-documented to cause psychological stress in families.[2] [3]

There is an increasing body of literature that shows an association between aggregate psychological stress over the life course[4] and the risk for the development and severity of numerous chronic diseases[5]. The combined physiological response to environmental, social, and personal stressors is referred to as allostatic load[6]. Allostasis refers to the body’s ability to adapt to stress (physical, psychological, and social) through activation of the sympathetic nervous system, hypothalamus-pituitary-adrenal axis and metabolic system. As the allostatic load increases, this system breaks down and leads to the dysregulation of stress hormones, which causes disease or worsens disease states, and leads to behavioral/developmental and potentially lifelong psychiatric problems.

Correlating disease processes with adverse childhood experiences, and incorporating indicators of social stress and allostatic load into the medical model represents a new frontier in disease management.  There is a need for research to more firmly define the link between social stressors, disease, and the healing process, and to understand the impact of epigenetics on brain development and its relationship to the toxic stressors of poverty.

Incorporating a “Social Determinants of Health” framework into a mechanistic model of disease represents a new direction in disease prevention and management. It would necessitate building a new system of identifying patients’ needs, and would mandate including social determinants of health in disease prevention strategy. It would allow for new areas of drug development,  transform health care delivery systems, health care utilization and training of health care providers. The “Social Determinants of Health” approach has broad implications for both bench research and clinical trials at UCSF and throughout the country.  Moreover, allostatic load is a concept that is exceptionally well suited for T1-T4 research. A CTSI initiative investigating allostatic load would establish CTSI as a leader in this innovative approach to disease and help encourage a paradigm shift in translational research and medicine.

A primary partner on this project would be the UCSF Center for Genes, Environments & Health, which is already doing social and biologic research on allostatic load. In addition to the translational sciences research team, partners include Children’s Hospital & Research Center Oakland (CHRCO), which has a high volume of children significantly affected by social stressors. The Institute of Medicine (IOM) recently published its report on advancing translational research among the CTSA programs and recommended a greater focus on both children and ethnic minorities, with CHRCO this recommendation will be met. The proposed project will appeal to a diverse team from multidisciplinary backgrounds and we foresee the CTSI Community Engagement Program, other UC health care providers, epidemiologists, sociologists, anthropologists, public health experts, and national groups already addressing issues of poverty and health as potential partners.  Lastly, partnerships with community agencies will be essential in building a foundation for community-based participatory research. 

[1] Hanson M, Lawton E. Between a rock and a hard place: The prevalence and severity of unmet legal needs in the pediatric emergency department setting. Medical Legal Partnership for Children. 2007

[2] McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med 1998;338:171-9.

[3] Evans GW et al. The environment of poverty: multiple stressor exposure, psychophysiological stress, and socioemotional adjustment. Child Development 2003;73(4):1238-1248.

[4] Halfon N, Hochstein M. Life course health development: an integrated framework for developing health, policy, and research. Milbank Q 2002;80:433-79, iii


[5] Marmot MG et al. Health inequalities among Britist civil servants: the Whitehall II study. Lancet. 1991 Jun 8;337(8754):1387-93


[6] Wright RJ et al. Seeking an integrated approach to assessing stress mechanisms related to asthma: is the allostatic load framework useful? Am J Respir Crit Care Med 2013;187:115-6


Commenting is closed.

National Repository for Stem Cell Derived Neurons

Primary Author: Bruce Miller
Proposal Status: 

The failure of large clinical trials for Alzheimer’s disease (AD), frontotemporal dementia (FTD), amyotrophic lateral sclerosis and Parkinson’s disease (PD) are forcing the field to consider more targeted treatments for genetically homogeneous cohorts. Precision medicine approaches to the diagnosis and treatment of patients offer huge opportunities to advance the dementia field. New trials for AD patients with presenilin-1 mutations and FTD patients with progranulin and tau mutations have already been started or are being considered.  

Dr. Shinya Yamanaka brought a revolution to stem cell technology by delineating a method to convert skin cells to induced pluripotent stem cells (iPSCs).  This approach has facilitated development of new models of neurodegeneration for patients with FTD-related mutations of progranulin (1,2) or C9orf72 (3). Similarly, iPSC-based modeling of the detrimental effects of apolipoprotein E4 and the tau polymorphism A152T (Yadong Huang, personal, communication) is facilitating a precision medicine approach to the determination of disease effects of specific genes. Via iPSC technology, large quantities of neurons can be produced allowing exploration of the pathological consequences of genetic polymorphisms while simultaneously allowing drug screening of neurons from patients with genetically caused forms of dementia. (4)

We propose to create through UCSF’s CTSI a national core of neurons from patients with both sporadic and genetic forms of Alzheimer’s disease, frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson’s disease and other rare forms of dementia. Selected investigators will study and manipulate these neurons in order to develop model systems for the major mutations that cause AD, FTD, ALS and PD. Simultaneously, age-matched control neuronal lines would also be generated for comparison studies. Large numbers of these neurons would be created for and distributed to other CTSI sites investigators and scientists across the world, requesting the use of these valuable cells.  

Comprehensive clinical phenotyping would be performed on the participants in this project that would include clinical characterization (demographics, cognitive, motor and imaging data), and family history.  Whole genome sequencing of the cells would be performed at UCLA and transciptome analysis would be done at UCSB. The resulting multidimensional data would be incorporated into the UCSF Precision Medicine Knowledgebase, linking it with related neuroscientific datasets and analytic resources to maximize its value for the larger research community. The project would be led by UCSF’s Memory and Aging Center (Bruce Miller, Kate Rankin, Aimee Kao), the Gladstone Institute (Yadong Huang), the Broad Institute (Steve Haggarty), UCSD (Irene Litvan), and UCLA (Dan Geschwind and Giovanni Coppola). Partial support for the study will be supplied by three private foundations, the UCSF NIA supported by an Alzheimer Disease Research Center (Miller), and a grant supported by the NINDS (Huang).



1. Almeida S, Gascon E, Tran H, Chou HJ, Gendron TF, Degroot S, Tapper AR, Sellier C, Charlet-Berguerand N, Karydas A, Seeley WW, Boxer AL, Petrucelli L, Miller BL, Gao FB. Modeling key pathological features of frontotemporal dementia with C9ORF72 repeat expansion in iPSC-derived human neurons. Acta Neuropathol. 2013 Jul 9.

2. Almeida S, Zhang Z, Coppola G, Mao W, Futai K, Karydas A, Geschwind MD, Tartaglia MC, Gao F, Gianni D, Sena-Esteves M, Geschwind DH, Miller BL, Farese RV Jr, Gao FB.

3. Induced pluripotent stem cell models of progranulin-deficient frontotemporal dementia uncover specific reversible neuronal defects. Cell Rep. 2012 Oct 25;2(4):789-98.

4. Cenik B, Sephton CF, Dewey CM, Xian X, Wei S, Yu K, Niu W, Coppola G, Coughlin SE, Lee SE, Dries DR, Almeida S, Geschwind D, Gao FB, Miller BL, Farese RV Jr, Posner BA, Yu G, Herz J. Suberoylanilide hydroxamic acid (vorinostat) up-regulates progranulin transcription: rational therapeutic approach to frontotemporal dementia. J Biol Chem. 2011 May 6;286(18):16101-8.

5. Zhao WN, Cheng C, Theriault KM, Sheridan SD, Tsai LH, Haggarty SJ.  A high-throughput screen for Wnt/β-catenin signaling pathway modulators in human iPSC-derived neural progenitors. J Biomol Screen. 2012 Oct;17(9):1252-63.



Summarize the problem being addressed. Please make sure this is NOT disease-specific.

Given the paucity of effective therapies for clinically heterogeneous diseases such as neurodegeneration and psychiatric disorders, precision medicine approaches to the diagnosis and treatment of such disorders holds immense promise.  However, obtaining well-characterized neurons from patients with multigenic causes for these disorders is time consuming, expensive and requires a large infrastructure of clinical, laboratory and informatics expertise.

Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases

We propose to create a National Repository for iPSC-derived neurons in neurodegenerative and psychiatric diseases. Induced pluripotent stem cells (iPSC) technology revolutionized medicine by allowing the development of new cellular models of disease and facilitating a precision medicine approach to the determination of effects of specific genetic variants. Via iPSC technology, large quantities of human neurons can be produced to explore the pathological consequences of genetic polymorphisms and allow drug screening using disease-specific neurons.

What partners are involved in the solution?

The project would be led by UCSF’s Memory and Aging Center (Bruce Miller, Kate Rankin, Aimee Kao), the Gladstone Institute (Yadong Huang), the Broad Institute (Steve Haggarty), UCSD (Irene Litvan), UCSB (Kenneth Kosik), and UCLA (Dan Geschwind and Giovanni Coppola). Partial support for the study will be supplied by three private foundations, the UCSF Alzheimer Disease Research Center supported by NIA (Miller), and a consortium grant supported by the NINDS (Huang).

What is the potential impact?

Comprehensive clinical phenotyping (ie history, exam, imaging, cog testing) would be performed on the subjects in this project. Whole genome sequencing of the cells would be performed at UCLA and transciptome analysis would be done at UCSB. The resulting multidimensional data would be incorporated into the UCSF Precision Medicine Knowledgebase, linking it with related medical datasets and analytic resources to maximize its value for the larger research community. Selected investigators will study and manipulate the iPSC-derived neurons to develop model systems for the major mutations that cause neurodegenerative and psychiatric diseases. These invaluable neurons would then be distributed to other CTSI sites investigators and scientists across the world.

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad



1.      How do we maximize impact and broad applicability of the proposal?


  • Though it makes sense to “start with what we know”, i.e., developing neural progenitor cells (NPC’s), we will more explicitly build into the proposal the ways we are setting up the process/infrastructure to make this a “use case” for development/archiving of other types of cells derived from iPSCs (e.g., cardiac muscle, etc.).


  • We will be more clear about how the creation of the multilevel (i.e. iPSC/NPCs plus phenotype, genotype, genomic) dataset will facilitate/accelerate scientific discovery, vis-à-vis the knowledge network; be clearer about broader scientific applications (i.e., how is this scientific infrastructure)


  • We will also identify mechanisms for data linking across levels – should propose to have a data/bioinformatics core involved in building, quality control, and maintenance of the datasets


  • We will be more clear about how the currently diverse methodological approaches to development of NPCs will be managed, vis-à-vis validation (e.g., use 2-3 methods in parallel and compare?)


2.      What foundation exists on campus already that will ensure success of the initiative?


The team will leverage campus initiatives that are geared to foster efforts just like this

  • CTSI’s expertise and leadership in bioinformatics (from policy to tools, e.g. RedCap); wide array of consultation services
  • UCSF Precision Medicine Knowledgebase, linking it with related neuroscientific datasets and analytic resources to maximize its value for the larger research community.


3.      What creative and/or innovative partnerships could be leveraged to ensure success?


We will seek to leverage the many UC system-wide efforts that exist and poise this effort as a “use case” for the following initiatives:

  • UC BRAID including
    • UC ReX
    • IRB harmonization including use of the UC IRB MOU for multicenter studies and its effort to streamline processes and create a central system for SCRO
    • Engage UC and their work on global informed consent for biobanking including their robust effort in engaging the community
    • Biobanking and work on governance and operations of system-wide biorepositories
  • UC Share
    • we have already consulted with Laura Vant t’veer about this initiative and will leverage their work to create a system-wide resource for clinical genomics infrastructure

Commenting is closed.

Administrative Data Concierge Service

Challenge: Many UCSF researchers are interested in questions about human health and the delivery of health care services that could be studied using large administrative datasets, such as those generated by the Centers for Medicare and Medicaid Services (CMS), the California Office of Statewide Health Planning and Development (OSHPD), and agencies that collect vital statistics data (e.g., birth certificates, death certificates). While some UCSF researchers have conducted important research with these datasets, expanding the pool of researchers who work with them is challenging for several reasons. Organizations that produce these datasets often have difficulty responding to requests promptly due to limited resources and competing priorities. In addition, extensive programming is often required to transform the raw data into usable information. For some research questions, researchers also need to link vital statistics records with administrative data on the delivery of health care services. Because many of the publicly available versions of data sets are de-identified, linking such datasets typically relies upon probabilistic matching algorithms. The complexities and error-prone nature of probabilistic matching represents a barrier to the full exploitation of administrative and vital statistics data by researchers who are not experts in these techniques.

Solution - Data Concierge Service: Building upon resources for analysis of large, public datasets that are already available to UCSF researchers through the Comparative Effectiveness Large Dataset Analysis Core (CELDAC), this project would establish a concierge service that would assist UCSF researchers in accessing large administrative datasets. A ‘special access’ data manager who would simultaneously be employed by UCSF and agencies that collect administrative data (OSHPD, CA Department of Public Health, CMS) would link records across datasets. The data manager would have expertise in the use of deterministic and probabilistic matching algorithms to merge datasets using unique identifiers (where available) and other variables such as date, age, gender, and zip code. The data manager would generate customized datasets that are tailored to researchers’ specifications, create de-identified versions of them, and deliver them to requestors (probably through MyResearch). The data manager and CELDAC’s principal investigator would work with investigators to ensure they secure the approvals needed to analyze and report upon the data and serve as a liaison with data-providing agencies. This service could be funded in a manner similar to CTSI’s existing consultation services (CTSI subsidy for initial hour of consultation, recharge for subsequent hours of service). It could also be made available to researchers at other CTSAs to broaden the potential user base.

Potential Partners: Members of Stanford’s CTSA have expressed interest in collaborating with UCSF CTSI to enhance capacity to conduct research using secondary datasets. CTSAs at other UC campuses may be interested as may faculty and trainees in the School of Public Health at UC-Berkeley. The UC Research Exchange would be a valuable partner in this effort due to its experience in bringing UC campuses together to improve access to administrative data for health research. In addition, CELDAC’s principal investigator has good contacts with staff of OSHPD’s Healthcare Information Division who are interested in enhancing their ability to serve researchers and other customers.

Innovation: This proposal builds upon UCSF CTSI’s existing resources for conducting research with large administrative datasets by creating a data concierge service that would help UCSF researchers to more quickly obtain secondary datasets tailored to their specific research interests. If successful, CELDAC could be transformed from a conduit of information about datasets that other organizations generate to a concierge that works proactively with these organizations to help researchers at UCSF and potentially other CTSAs obtain the data they need for their research. Making requisite public data more accessible is expected to significantly expand the use of secondary data to address important hypotheses in public health and comparative effectiveness research. This innovation may be particularly valuable during the current contraction in national research funding.

Projected Impact: This project could enhance UCSF researchers’ ability to conduct timely research using large administrative datasets that would enhance our understanding of factors that affect human health. If successful, the project could serve as a model for other CTSAs.


this is an exellent idea to have someone with the expertise and security priveliges to create an honest broker system for many projects.

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad
Administrative Data Concierge
Submitted by Janet Coffman

  1. Summarize the problem being addressed.  Please make sure this is NOT disease-specific.
    • Researchers would benefit from improved access to large administrative data sets, including administrative data sets that are merged with each other (e.g., OSHPD, death records) and/or with investigators' primary data
    • Linking such datasets often requires probabilistic matching algorithms that are difficult to implement—imposing a barrier to research progress.
  2. Summarize the solution being proposed. Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.
    • Establish a concierge service with a 'special access' data manager who would
    • Access identified administrative data to allow for deterministic data merging
    • Use probabilistic matching algorithms to merge de-identified datasets
    • Create de-identified versions of datasets customized to researchers’ needs
  3. What partners are involved in the solutions
    • UCSF CTSI Comparative Effectiveness Large Dataset Analysis Core
    • CTSAs at other UCs (including UC Research Exchange) and Stanford CTSA
    • State and federal agencies that collect vital statistics and administrative data
  4. What is the potential impact?
    • Enhance UCSF researchers’ ability to efficiently leverage multiple existing data sources to conduct relatively low cost/high impact research
    • Improve understanding of factors that affect human health
    • Serve as a model for other CTSAs

Group 9-1

1.     How do we maximize impact and broad applicability of the proposal? 

Develop an Open Source catalog that is cheap, widely applicable, and easily accessible to a wide variety of large datasets.  The catalog must be a curated, searchable data dictionary. Identify experts and a way to network people with the data. 


 2.     What foundation exists on campus already that will ensure success of the initiative?


UCSF already has an inventory of datasets that can be leveraged.  Use Profiles website to connect investigators to data sets.  Expand UCSF Profiles to include data managers and other applicable individuals to connect expertise of how to access and link to Data Management tools.  Build network.  Identify databases, expand availability of data, match database to PIs.  Use CTSI design consultant service and leverage individual subject experts


 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

Leverage UC BRAID and other CTSAs.  Partner with NIH and congress, partner with dataset providers to develop a standard for how the data is entered.  Link with expert from industry, such as Google or Amazon web services, to create a searchable database to match data with investigators.  Connect to health industry exchanges, Create a template agreement with data set owners.

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad

Notes submitted on behalf of Group 9-2

How do we maximize impact and broad applicability of the proposal?

What types of data?  Vital stats, death records, hospital discharge records, ED dataset, medicare claims.  Curate data.  Make sure data answers question before starting.  Improve access to data. 


Develop an Open Source catalog that is cheap, widely applicable, and easily accessible to a wide variety of large datasets.  The catalog must be a curated, searchable data dictionary. Identify experts and a way to network people with the data. 


What foundation exists on campus already that will ensure success of the initiative?

UCSF already has an inventory of datasets that can be leveraged.  Use Profiles website to connect investigators to data sets.  Expand UCSF Profiles to include data managers and other applicable individuals to connect expertise of how to access and link to Data Management tools.  Build network.  Identify databases, expand availability of data, match database to PIs.  Use CTSI design consultant service and leverage individual subject experts


What creative and/or innovative partnerships could be leveraged to ensure success?

Leverage UC BRAID and other CTSAs.  Partner with NIH and congress, partner with dataset providers to develop a standard for how the data is entered.  Link with expert from industry, such as Google or Amazon web services, to create a searchable database to match data with investigators.  Connect to health industry exchanges, Create a template agreement with data set owners.

Some thoughts from CTSI Retreat / Leadership panel with UCSF Deans:


Data management and analytics needs are great and silos are difficult to overcome.  It is critical to enhance the institutional commitment to data analytics even though there are regulatory and security issues that present challenges.  A concierge service should focus on how any particular dataset is relevant to a PI or research area. We need an internal component to give faculty skills to navigate these databases.

Commenting is closed.

Precision medicine approaches to diagnosis of neurodegenerative disease

Proposal Status: 

Once considered rare, neurodegenerative diseases are now recognized as among the most common and devastating health problems of aging. However, the clinical symptoms and brain imaging signs on which current diagnostic criteria are based still rely heavily on subjective clinical interpretation.  As a result, diagnosis is often made relatively late in the clinical course, and is often inaccurate, particularly in community settings.  Clinical trials for potentially disease-modifying treatments are proliferating, but these are targeted to specific neuropathologies such as a-beta, tau, and progranulin. Early and accurate diagnosis is thus essential to move appropriate patients into clinical trials at the earliest possible stage and to start specific, disease modifying treatment as early as possible.

A precision medicine approach to neurodegenerative disease requires that all levels of the patient’s clinical system be represented, maximizing clinicians’ ability to identify interactions among key features of the genetic, genomic, metabolic, brain, and cognitive profile to correctly predict and treat disease.  However, before such multilevel interactions can be understood in an individual patient, clinical researchers must first identify them in large, comprehensively characterized cohorts of patients.  International efforts such as the Alzheimer’s Disease Neuroimaging Initiative (ADNI) have paved the way by gathering not only structural and functional brain images, but also genes, biological specimens, and comprehensive clinical data on large cohorts of patients.  However, there is still a pressing need to build such multilevel datasets from cohorts of patients with other neurodegenerative diseases.  The rapid proliferation of studies using ADNI data proves that when such a resource is made openly available to the research community, there is an exponential increase in the speed of discovery, leading more quickly to precise disease characterization and diagnosis.


While open sharing of data from carefully characterized neurodegenerative disease cohorts is key to accelerating scientific discovery, a second essential element in a precision medicine approach to these diseases is to build mechanisms that bring these scientific refinements back to the community. Currently, though a clinician might obtain a structural MRI as a standard part of their diagnostic evaluation, they often do not possess the level of expertise to accurately interpret that scan. If clinicians anywhere were able to access an automated resource that incorporated the most refined diagnostic approaches available for interpreting their patients’ MRIs, it would substantially reduce the chance of misdiagnosis and immediately translate to substantial benefit for the patient and their family.


Aim 1:  We propose to create a national web-resource for automated quantitative analysis of structural brain MRIs, designed to provide diagnostic differentiation across neurodegenerative diseases. The technology already exists to perform automated analysis of regional atrophy from structural MRI scans. Voxel-based morphometry combined with automated diagnostic algorithms derived from support vector machine (SVM) learning approaches have been effective in differentiating patients with Alzheimer’s disease, progressive aphasia, and frontotemporal dementia.  We propose to enhance and pipeline this process by
1) refining the SVM algorithms for all of the most common neurodegenerative diseases, including cross-validating algorithm accuracy on additional samples
2) determining and testing the quality control parameters involved in evaluating MRI scans from scanners with varying acquisition protocols, and
3) programming an online system that would accept uploads of MRIs from any center, automatically inspect the images for quality issues influencing interpretation, and generate a report providing probabilities of pattern-matching to different diseases.
Our collaborators for this project will include Kaiser Permanente, a rich source for well-characterized elderly patients with MRI and genetic data, as well as imaging/visualization specialists at Lawrence Berkeley National Labs, who have agreed to collaborate on development of algorithms for both quality control and interpretation, and the UCSF Center for Imaging of Neurodegenerative Disease, the lead site for ADNI.


Aim 2:  We will create and archive a multilevel precision medicine dataset carefully describing all aspects of clinical presentation and biology in this valuable cohort of patients with various neurodegenerative diseases, which will be made available to the wider scientific community for download and analysis. In the process of constructing and validating this tool for automated MRI interpretation, we estimate we will need to expand our cohort to a total of 1,000 neurodegenerative disease patients and 500 healthy older controls. This creates a unique opportunity to establish and disseminate a dataset that describes these patients at every key biological level from gene to cognition, making it possible to approach the diagnosis and treatment of these diseases from a systems perspective.
1) Though we will already have these patients’ brain scans and clinical phenotyping, we propose to also systematically perform assays of the specimens already collected from these individuals to more fully characterize their genetic, genomic, and metabolic profiles.
2) We will fully document, quality check, deidentify, and homogenize the data so it can be effectively but securely downloaded and utilized by the scientific community.

Commenting is closed.

Grants program for collaborative, multidisciplinary, translational research

Proposal Status: 

We recommend that the UCSF CTSI initiate a grants program to support collaborative, multidisciplinary, translational research (CMTR) at UCSF and, in future years, across the entire UC system.

      1. Scale and significance of the problem. Successful translational research requires the collaborative effort of individuals with expertise in a broad range of disciplines, including (among many) bench science, structural biology, chemistry, clinical medicine, and statistics. At UCSF, as at almost all academic research centers, collaboration among faculty and trainees is made difficult by the mechanisms of funding, which reward individual success, and by the measures of academic success, which do not sufficiently reward collaboration. Despite this, there is a strong tradition of collegiality at UCSF and we believe that support for collaborative translational research here will be rewarded with success. This effort can then be scaled to include the other UC campuses, to broaden expertise and access to patients. This would be facilitated by current initiatives to foster collaborations across UC medical centers (e.g., BRAID and UC ReX).

      2. Current approaches (nationally). The NIH has stressed the importance of translational research and academic centers have moved to meet this need in a variety of ways. Often, these approaches are “top-down,” including, for example, the creation of new departments or facilities to create lead compounds or to develop screening procedures for drugs. UCSF has in addition utilized “bottom-up” approaches, supporting investigators with concepts that may lead to new therapies, e.g., the T1 Catalyst program and the UCSF/Pfizer Center for Therapeutic Innovation. The CTSI has in particular supported the development of clinical researchers, with notable success. These efforts, however, have not yet succeeded in developing strong partnerships between clinical and basic sciences. Instead, at UCSF, as at most academic medical centers across the nation, basic scientists and clinical scientists work in different worlds, with little overlap. We believe that the CTSI has the power to help change this.

      3. Proposed approach and why it is innovative. We propose that the CTSI directly counter the barriers to collaborative translational research by supporting research that promotes synergy among investigators across highly disparate areas of research. Collaboration between clinical and basic science investigators would be especially encouraged. Awards would be for up to $100,000, spent over a period of up to two years. Criteria would include:  A. Goals that will advance the possibility of new therapies or diagnostics that will benefit humans with disease. Translation of discoveries made in UCSF laboratories would be given high priority; B. An operational plan that demonstrates how support will promote interactions and collaboration among investigators; C. A path to clinical implementation, even if this is not a goal of the grant. D. Explanation of how the studies will add value to the work such that it is more likely to generate support from other sources.

Applicants would be encouraged to make use of the CTSI resources, e.g., in statistics, study design, patient recruitment, etc. Applications would begin with a one-page pre-application. Selected pre-applicants would be invited to submit a 4-page application for review by a standing committee. Full applications would be accepted at least twice yearly.

During the first two years of the CMTR program it would be limited to UCSF, in order to test approaches and maximize success. In the third year, the program would be expanded to include all UC campuses, thereby enhancing the breadth of expertise as well as the number patients studied. Other UC campuses would be asked to contribute to the costs of the collaborative programs.

Even as we provide support for collaborative, multidisciplinary research, we would initiate programs to facilitate this. Possible approaches include:  (1) a research “exchange”, where investigators can post ideas, problems, and requests and where they can ‘recruit’ collaborators – like a Craig’s list for research, (2) work with the sponsors of the proposed “speed dating” approach to linking investigators, (3) leverage Profiles to identify researchers working on areas of possible common interest, (4) create a small leadership team with broad knowledge of programs and individuals at UCSF to serve as “matchmakers” for collaborative research, (5) strive to enhance the culture of collaborative research at UCSF by altering promotion criteria to favor it, and by educating faculty in opportunities for collaborative research, (6) as suggested by the review panel, planning for the CMTR program would benefit from input by non-health care partners regarding methods for fostering cross-disciplinary research, e.g., Technology (Google, Microsoft) or Energy (Schlumberger, Chevron), etc.

By supporting collaboration rather than individual effort, the CMTR program will tap into the great expertise in both clinical and bench science at UCSF. The innovation in this approach is its direct support of a bridge between these domains. Support for team research has long been the approach in industry, but it is little tested in academia.

      4. Potential Partners. The proposed program will benefit from several CTSI programs that already exist, including especially the Catalyst Award and the Annual Pilot Awards.  Indeed these have overlapping aims with the CMTR program.  The CMTR differs substantially in its emphasis on cross-disciplinary research, but there may be opportunity to wed the Catalyst program and/or other CTSI programs to the proposed CMTR program.  The CTSI will also be of direct scientific benefit because of its relevant programs for consultation in statistics, patient recruitment, data management, etc. 

Within UCSF, we will be assisted by recent efforts to standardize and centralize biobanking and to access information in the biorepositories.  We plan to partner with other UC campuses beginning in year 3, and we expect that this will increase funding. For the review of applications, we will use not only UC faculty but also representatives from Pharma, as well as from non-health care partners on methods for fostering cross-disciplinary research as noted above. Pharma is also an expected future partner for successful awardees, and is even a potential partner for the CMTR program itself. Although we do not plan to use patients or disease advocates in reviewing grants, we do plan to use them in reviewing the success and failures of the program.

      5. Projected Impact. Translational research inherently carries high risk, with a concomitant high payoff if successful. Because of this, it is our expectation that many of the projects will fail. If they do not, we are probably not assuming enough risk. But the payoff can be very large, as shown by the UCSF Program for Breakthrough Biomedical Research (PIBBR), which supports risky research but has brought in support that is many times greater than the investment.

This proposal is endorsed by:  Joe DeRisi (Biochemistry and Biophysics), John Fahy (Medicine), Kathy Giacomini (BioEngineering and Therapeutic Sciences), Steve Hauser (Neurology), Tippi MacKenzie (Surgery), Mike McCune (Medicine), William Seaman (Medicine), Kevin Shannon (Pediatrics), Kevan Shokat (Cellular and Molecular Pharmacology), Eric Small (Medicine) and Zena Werb (Anatomy).



Supporting Documents: 


I am looking forward to the discussion of this proposal at the retreat in light of the recent accomplishments of the Bixby Center for Global Reproductive Health and their successful NIH application to join the Contraceptive Clinical Trials Network:


Overview for CTSI Retreat Discussion:

1. Summarize the problem being addressed. Please make sure this is NOT disease-specific.

The problem is that translational research requires expertise from many domains, and many factors work to isolate investigators within their individual domains. These factors include the necessity for independent work in obtaining grants and in gaining academic promotion. Also, investigators in different areas lack a common ground for discussion. We wish to overcome these barriers to collaboration.


2. Summarize the solution being proposed. Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

We propose to overcome the barriers to collaborative translational research by allocating relatively small pilot grants (up to $100,000 over two years) in support of start-up collaborations between at least two departments, with emphasis on linking at least one clinical department and one basic science department. We would begin the program at UCSF and expand it to include all UC campuses.

3. What partners are involved in the solution?

All members of the faculty would be eligible to apply. Because of the inclusive nature of the program, it would apply broadly across the campuses, beginning at UCSF and expanding to include all UC campuses.


4.What is the potential impact?

All grants will have the important impact of creating new synergistic interactions in translational research. Expanding the program across the UC campuses will offer even broader opportunities for collaborative research. Nonetheless, start-up collaborations in translational research carry a high risk of failure. We accept this, because any successes have the potential for payoff in developing new therapies or diagnostics for patients.

How do we maximize impact and broad applicability of the proposal?
Grant making mechanism, speed dating, but moving toward an intervention to tackle the real barriers; application group use a means to identify what's work and we could help them

[re-word?] Clinical agency/site - worry about defining by departments; true multidisciplinary project

What foundation exists on campus already that will ensure success of the initiative?
Effort for biobanking at the Cancer Center
System for investigators to access information in the biorepository (Trial share infrastructure)
Profiles - people searching through CTSI
SOS - $1million dollars per year in 2 cycles, could give 3 - $100,000 grant per cycle, could we change REAC and RAP

Radical IDEA: Turn all grants into multidisciplinary grants...Jr. Faculty need to pick a team in order to move forward in advancement and promotion

Should SOS funds support infrastructure

What creative and/or innovative partnerships could be leveraged to ensure success?
Is there a place for industry?
Matching programs for funds for projects?
Plan to grow or start across institutions?
Spending money on logistics to solve problems across campuses?

Review committee: Create a creative review committee, adding a patient advocate


Thank you, Monica.  I have submitted a revised application, incorporating your suggestions.  I also appreciate the "radical idea," of turning all CTSI grants into multidisciplinary grants and having invesigators pick teams for their work!  (But I thought it would be going a bit far to put that as part of our aims.)

CTSI 2013 Retreat Workgroup Discussion Summary:

The workgroup unanimously agreed that the proposal is meritorious and will be a valuable component to the CTSI grant renewal. The workgroup, which consisted of individuals with broad experiences in the challenges and opportunities of translational research, proposed several important additions to the proposal to maximize its reach and impact.

1. How do we maximize impact and broad applicability of the proposal?

The workgroup suggests that the proposed grant mechanism should be bolstered by key enabling infrastructure, including tools to identify potential collaborators, enable input from external stakeholders (such as community advocates and industry), and train investigators in team science.

Specific suggestions include:

  • Leveraging Profiles to help identify researchers working on particular research areas and seeking potential collaborations
  • An exchange where researchers can ‘post’ problems and requests and ‘recruit’ collaborators - like a ‘Craigslist’ for research. Maybe including a ‘bartering’ system.
  • Including the voice of the patient/community and industry. This could be achieved either through a public Open Proposal system, or by inviting these stakeholders to the proposal review panel.
  • Identify and promote the use of existing UCSF and external tissue/information databases
  • Educating and training researchers on the value of team science

2. What foundation exists on campus already that will ensure success of the initiative?

UCSF Profiles succeeds in helping researchers identify experts and network with others in particular fields. Including tools that specifically promote collaboration may be useful - e.g. enabling researchers to ‘post’ requests for collaborators, or automatically suggesting potential collaborators through matching interests. There are a few other groups using software such as Chatter, Poster Listserv and Eagle Eye to accomplish this goal.

The Catalyst Awards program leverages public/private partnerships and seed funding to support translational research at UCSF. There is currently no emphasis on multidisciplinary teams, but more often than not, collaborations between a diverse researchers lead to the most successful projects. There may be a potential for leveraging the Catalyst mechanism to expedite the implementation of the proposed project.

3. What creative and/or innovative partnerships could be leveraged to ensure success?

Partnerships are a key aspect of maximizing the impact of the proposed project. Partners are critical as reviewers and potential research collaborators. Key partners include stakeholders such as:providers, payors and industry. The panel also suggested engaging with non-healthcare related partners with similar research challenges, to identify and leverage the tools and approaches that succeed in other industries - e.g. Technology (Google, Microsoft, etc.), Energy (Schlumberger, Chevron, etc...).

Thank you Kirsten and all members of the Retreat Workgroup for you extensive help.  I have posted a revised proposal, incorporating your suggestions, and I welcome any additional thoughts.

Some thoughts from CTSI Retreat / Leadership panel with UCSF Deans:


CTSI is well poised to facilitate multi-disciplinary collaboration opportunities.  There is a huge gap between basic and clinical researchers at UCSF, which could be helped if there were established opportunities for collaboration. The potential for success is greater if there is a financial commitment from CTSI as an incentive.    Dean Guglielmo noted that the problem of silos is universal in other CTSAs as well.  One suggestion to decrease disciplinary silos is to expose graduate students to clinical research early in their training. 

These comments are appreciated.  I agree with the suggestion at the end, which could be undertaken in conjunction with our  proposal (and our proposal might provide an incentive for graduate students to learn more about opportunities for collaborative research).

Commenting is closed.

Brain on Fire Network

Proposal Status: 

Problem: Rapidly progressive encephalopathies are diagnostically challenging and provide great potential for scientific and clinical advancement by harnessing the interdisciplinary resources and collaborative infrastructure of the CTSIs.We need systems to rapidly identify emerging infections and immunologically-mediated nervous system disorders and to investigate their causes and possible genetic contributors in order to provide rapid, efficient and cost-effective diagnosis, discover new diseases, and guide appropriate treatment.

A revolution has occurred in neurology and psychiatry with the identification of antibody-mediated neurological encephalopathies and psychiatric illness. A similar development has occurred in pathogen discovery with the use of high throughput techniques (many pioneered here at UCSF). As genome sequencing rapidly becomes more affordable, obtainable and powerful, it should provide new insights into the mechanisms and risk factors for these disorders spanning several medical disciplines.  

We propose to establish a “Brain on Fire” Network to actualize a vision of translational medicine by connecting the clinic to outstanding laboratory cores. The goal will be to create a pipeline for identifying whether patients with rapidly progressive encephalopathies or psychiatric disorders might have an infection or a primary immunological disorder, and if so, what are the genetic contributors. This network will link the clinic, research units, and high-throughput laboratory pipelines for pathogen discovery (requiring CTSI expertise/resources for coordinating, including engagement with research cores and appropriate public health labs, such as the CA Department of Health and the CDC), and CNS antibody discovery programs (utilizing CTSI expertise/resources to create and support national collaboration). This network will link investigators from a broad range of disciplines.

Antibodies against extracellular neuronal or other CNS cell antigens cause these syndromes. Unlike the known paraneoplastic antibody-associated syndromes, which were primarily due to intracellular antigens and were difficult to treat, these newer syndromes caused by antibodies against extracellular neuronal or other CNS cell antigens are readily treatable, even curable. They also are now at least five times more common than typical paraneoplastic antibody associated syndromes. The phenotypes often involve cognitive impairment, movement disorders, psychiatric disorders, seizures, or a combination of these symptoms. These disorders overlap multiple disciplines, including medicine (general, immunology, rheumatology, infectious disease), psychiatry, neurology and others. One common syndrome, which begins with psychiatric symptoms that progress to frank psychosis and then to violent movement disorders and pulmonary failure, is associated with antibodies to the N-methyl-D-aspartate receptor (NMDAR). For many years, these unfortunate patients were thought to have infectious encephalitis due to unidentified viruses; only with new immunological techniques and methods has the cause of these enigmatic disorders been identified. Other related disorders include voltage-gated potassium channel complex (VGKC encephalopathies), AMPAR encephalitis, GAD65 associated seizures, ataxia and/or encephalopathy. New syndromes are rapidly being discovered, making this one of the most exciting new areas of medicine.

Current approaches (nationally): Only a few centers in the world have the technical and clinical expertise to identify new syndromes and manage these patients. To our knowledge, only three laboratories in the world (Oxford, Mayo and Barcelona) are actively identifying novel antibodies and syndromes. Despite a few institutions working to identify these disorders, there is no consistent, multidisciplinary approach. As these syndromes are becoming more frequent, we need to develop a systematic network for surveillance, identification and study of these disorders.

Solution: Establish a network of centers with clinical expertise in identifying possible autoimmune mediated neurological, psychiatric, and “infectious” disorders. Asses and follow patients in a comprehensive, standardized, manner clinically, immunologically, radiologically, and genetically. Clinicians work closely with various CTSI basic science cores. Immunology cores will screen for known and novel antibodies and antigens. Genetic cores will assess various risk factors.

Potential partners: Various CTSIs, including our own, as well as Mayo and UPENN, already have some expertise in these areas. It would be important to train and incorporate other centers as well.

Projected impact: As these patients often require a long time for proper diagnosis, this system should greatly decrease the time to diagnosis and initiation of appropriate therapies and lead to significant cost savings to the medical system. Discovery of new diseases and disease mechanisms should have significant impact on public health, save millions of dollars annually and prevent unnecessary morbidity and death.

Commenting is closed.

Translating Neurobiological Knowledge into Psychosocial and Behavioral Interventions That can Prevent and Treat Stress-Related Illness

Proposal Status: 


 The Problem

               We live in a highly stressful world that has resulted in an unprecedented incidence of stress-related mental and physical illnesses. Research in the neurosciences has made significant progress in identifying the role of environmental stressors (e.g. violence, abuse, disasters, neglect, harassment, discrimination) in the development of illness. There is particularly striking evidence that one’s interpersonal environment can shape and modify neurobiological factors that subsequently result in health problems. There is also growing evidence to indicate the role of psychosocial and behavioral interventions in modifying these neurobiological factors. Yet little research has focused on translating this exciting knowledge into evidence-based interventions to prevent and treat adverse effects of stress on health.  Although highly relevant to adults, psychosocial/behavioral interventions for stress-related illness have particular importance for children whose brains and other organ systems are more vulnerable to adverse effects of biological treatments. In addition, early interventions with children have the potential to address emerging problems before they develop into more severe disease.  

Current Approaches

               The importance of stress reduction is widely recognized.  However, there is a significant gap between advances in the neurosciences regarding allostatic load, psychoneuroimmunology, or epigenetics and their application to the development and testing of psychosocial/behavioral interventions that can attenuate or modify the neurobiological effects of stress on the nervous system. Studies are needed to assess the impact of these interventions on neuroplasticity and to examine how neurobiological outcomes of these therapies relate to psychological and physical symptoms across stress-related disorders.

Proposed Approach

               The UCSF CTSI can create a targeted program that encourages the translation of basic neuroscientific knowledge into the development and testing of psychotherapeutic and behavioral interventions for stress-related illnesses. This would involve 2 key components: 1) develop a centralized infrastructure that will bring together investigators in the field to share their expertise and facilitate collaboration of researchers across stress-related health problems. This infrastructure could also include innovative subject recruitment programs, a sample repository specific to stress-related biomarkers, and a repertoire of interventions that show promise in enhancing therapeutic neuroplasticity and reducing stress-related neurobiological deficits or injury; and 2) provide funding for pilot studies to test psychosocial/behavioral interventions that build on neuroscientific findings and measure the impact of these interventions on biomarkers specific to these findings.

Potential Partners

               There are many opportunities for collaboration. One of our strong community partners - Children’s Hospital and Research Center in Oakland – is submitting this idea in collaboration with UCSF. There would also be interest from our partners at SF General Hospital, SF Child and Behavioral Health Services, and CHILD at UCB. On a national level, there could be collaboration with the National Network of Depression Centers (of which our UCSF Depression Center is a member) and their CTSIs/CTSAs. This initiative would have important links to many of our CTSI’s programs, including Recruitment and Study Management Services, Strategic Opportunities Support, Community Engagement and Health Policy, and Early Translational Research.

Projected Impact and Innovation

               The initiative will foster collaboration among different disciplines at UCSF, with our community partners, and with colleagues nationally to achieve a much greater impact than would the efforts of individual investigative teams. It could provide a model infrastructure for an innovative field of research that other CTSIs and research institutions could use to advance the prevention and treatment of stress-related illnesses. It will also provide support to interdisciplinary, investigative teams in conducting important pilot work that will serve as the basis for applications to acquire extramural funding.  The initiative is highly congruent with NIH interests in fostering multi-disciplinary and biobehavioral research.   




Commenting is closed.

Minimizing the CTSA carbon footprint

Proposal Status: 

How can we minimize our contributions to global warming in the operation of our CTSI and CTSA programs in general? An example of a high carbon activity are airplane flights. Are there ways to use alternative communication modalities to avoid taking more transcontinental flights than necessary for scientific meetings, administrative activities, etc? The challenge of this big tent proposal would be to perform an inventory of our CTSI carbon footprint and find ways to reduce it without compromising our programs.


Totally agreed, particularly now that we're past 400ppm CO2, and all the attendant public health impacts have become so much more clear. I've spent the past 3 years doing writing and advocacy (1, 2, 3) around the climate impacts of the dirty aviation industry, which is responsible for ~5% of the human impact on the climate, and is one of the biggest sources of emissions by people and institutions who otherwise think of themselves as being green. I'd love to brainstorm this further.

Commenting is closed.

Open data

Proposal Status: 

Academic institutions, civic agencies at all levels, and NGOs of all kinds have joined what’s being called a “data revolution” by making the information they collect and use publicly available. How can this “open data” movement advance and accelerate clinical and translational research to improve health and eliminate health inequities? The CTSI Open Data Initiative will bring together under one umbrella projects currently underway at UCSF and other UC campuses along with their government and community partners to explore fruitful routes and best practices for maximizing the applicability and interoperability of publicly available (and potentially available) datasets, including clinical and population health data; economic and demographic data; transportation and planning data; and research datasets that could influence and improve the health care and health status of individuals and populations. 

Activities at UCSF that fall under the rubric of this initiative include SFHIP (including HUMS), CELDAC, and DataShare. Partners in San Francisco include the Hospital Council of Northern and Central California, SF Department of Public Health, DataSF/Mayor’s Office of Civic Innovation, SF Police Department, SF MTA, SF Rec and Park Department, District Attorney’s Office, and other city offices and agencies. Community partners include the San Francisco health disparities and health parity coalitions, healthy retail coalitions, alcohol prevention coalition, and nonprofits such as the YMCA. Resources would support the application and use of open data to meet the aims and activities of those health improvement and disparities-focused partnerships. Resources would also support the development of evidence-based health and healthcare apps and other technology tools (registries, health information exchanges, new and improved mobile devices). Activities would include Translational Science Hackathons and intensive workshops to identify mutually-held incentives, establish cost-savings goals, and activate assets and resources to maximize the impact of collaborative efforts.



Summarize the problem being addressed.  Please make sure this is NOT disease-specific

There is a need for clear, coordinated efforts to organize and use abundant and varied publicly available health-related data to advance and accelerate clinical and translational research to improve health outcomes and eliminate health inequities.


Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases

An initiative to explore fruitful routes and best practices for maximizing the applicability and interoperability of publicly available (and potentially available) datasets to improve the health of individuals and populations. SFHIP (including HUMS), CELDAC, the CRN, and DataShare are existing efforts that could serve as frameworks. Activities could include hackathons, workshops, policy forums, etc.


What partners are involved in the solution?

Such an effort requires intensive partnership to make the use of open data relevant and acceptable, and the application of data feasible. Partners range from biobanks to the World Health Organization and include local, regional, state and federal departments and agencies; NGOs and nonprofit organizations; academic institutions; and commercial entities.


What is the potential impact?

  • Coordinated, streamlined process for collection and effective use of publicly available data.
  • New policies and regulations for data collection and use.
  • Improved health outcomes and reduced health inequities.
  • New and enhanced partnerships.

CTSI has the potential to substantially improve the ability of the UCSF research community to answer important research questions by accessing a variety of open and unconventional data sources.
We envision CTSI organizing an an ongoing open proposal process to solicit research questions that might benefit from access to these data sources. Winning research questions will be featured at public data meetups, either online or offline (hackathon style).
In addition to UCSF's existing communities of researchers and data experts, we will also leverage our wide networks to invite a variety of data "matchmakers," such as civic groups like Code For America, search and social media companies like Google and Twitter, public interest technologists like the EFF and hacker spaces, unconventional civic data sources like Uber and Lyft, major retailers like Target and Wal-Mart, drugstores like CVS, and health data experts internal to UCSF. (If we're incredibly lucky, perhaps the NSA will join up as well.)
These data matchmakers will brainstorm, make connections, and help introduce researchers to a variety of possible sources. CTSI will help facilitate infrastructure, expertise, and relationship management to create an ever expanding capacity for research using open and unconventional data.

v. cool... ties into ideas we're building with Reg4All/Genetic Alliance

(Group: Fabrice Baretta, Paula Fleisher, Lattice Armstead, Talmadge King, Jaime Sepulveda, Erin Bank, Sharon Terry, Julie Harris-Wai, Nooshin Latour)

  1. How do we maximize impact and broad applicability of the proposal?

    New title for proposal -> Discovering the value of Open Data & Building the Infrastructure to Understand / Use it

-1st need structure or mechanism to make sense of it, educate about it, advocate about it to improve health -> acknowledging that people are needed to create the data
- To maximize impact we need to link one patient’s data to all the various databases mentioned (linkages and interoperability of data sets), which also requires educating patient.

-Only common element is the patient. So if the individual has control (most likely will share if you ask them) – find a way to unify that. Consider it as a snapshot.

-Start with the Bay Area – do it well and make scalable to CTSAs, national network (ex., Choose pilot )

-Build platform for capturing the data: Start unifying how data is collected and organized (ex., asthma patient form filled out by doctor), make consistent

-Skeptical patients cannot just use and interpret their data -> provide a better way for analysis/immediate dissemination of data (ex., dashboard)
-Ideal is Health Information exchange – build a cloud based registry and payers could plug in

**Measurable outcome: With dataset -> Enabling groups that couldn’t have done this research before

-Aggregated population level data

 2.     What foundation exists on campus already that will ensure success of the initiative?

-Campus data service programs (gurus) / BioMedical Informatics core / Community Engagement & Health Policy

-Facilitate a conversation with one disease area (ex., Hepatitis B with SF Health Improvement Partnership)

-UCSF Decision Services

 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

-Disease advocacy organizations need publicly available datasets. (Ex., Hep B/C, Obesity advocates to pilot w/)
-Kaiser Permanente, Division of Research, Bioinformatics core
-Community Stakeholders
-Health Disparities experts

this could also be a scalable solution for secure data warehousing to comply with NIH requirements for post-award data sharing of grants of more than $500,000 annual funding.

Commenting is closed.


Proposal Status: 

Osteoporosis is a highly prevalent disorder in older postmenopausal women both nationally and internationally, and a potent major risk factor for subsequent fracture.  Among older women of white race, it is estimated that approximately 1 in 2 women will experience an osteoporotic fracture in her lifetime. Nationwide efforts during the past two decades have led to evidence-based consensus guidelines for osteoporosis screening and treatment, with the goal of both primary and secondary fracture risk reduction. Models to assess fracture risk integrating a number of independent clinical risk factors have also been developed to support clinical therapeutic decisions, including web-based applications.  Beyond pharmacologic therapy, the importance of falls prevention, patient and family education, and modification of lifestyle factors and/or the home environment have been increasingly recognized. Given the projected increase in the U.S. population aged 65 years and older during the next two decades, there is a critical need to develop interdisciplinary programs and research methodology that focus on comprehensive risk assessment, including markers of bone fragility, nutritional status and novel methods for assessing functional status and risk of falls, in the context of osteoporosis care. 

This proposal will bring together expertise in endocrinology, geriatric medicine, nutrition, physical therapy and epidemiology/biostatistics and focus on the development of a large prospective cohort of older community-dwelling individuals across diverse health settings and communities (e.g. UCSF, Kaiser, SFGH, VAMC and other new Bay Area partners in geriatric care) and integrate existing data available in the electronic health record, newly collected data elements and novel interventions with the overall goal of maximizing the net clinical benefit of fracture prevention strategies in both white and non-white populations.  The proposed initiative would facilitate innovative approaches to improving individual-level risk assessment, enhance our understanding of the factors driving disparities across various patient subgroups, and create a population-level resource to support new efforts in fracture risk reduction and quality improvement strategies. 

Commenting is closed.