The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

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. 

Comments

OVERVIEW FOR CTSI RETREAT DISCUSSION

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.

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