Catalyst Awards for the Development of Therapeutics, Diagnostics, Devices, and Digital Health

Description

The Catalyst Award combines customized product development advice and funding to help drive promising early-stage research with high commercial potential through the lengthy and complex process of translating ideas into patient benefit. Previous Catalyst awardees include UCSF investigators whose works span a broad range of innovative concepts in therapeutics, diagnostics, devices and digital health products. The expert consultation and funding they received enabled them to reach key milestones along the most effective development path towards safe and effective solutions for patients. It is strongly recommended that interested applicants reach out to the Catalyst Program team to inquire about the goodness of fit of their projects with the program's goals.

Therapeutics Collaboration

ShangPharma Awards for the Development of Therapeutics

UCSF now has a collaboration with ShangPharma Innovation to progress therapeutics projects (small molecule and biological) towards the clinic. This collaboration, managed by the Catalyst Program, includes both in-kind services to be provided by ChemPartner including full discovery services (chemistry, biology & preclinical development, pharmaceutical development and biologics development) as well as direct project funding.

Award Amounts
Therapeutics

  • if chosen for a collaboration with ShangPharma Innovation, a project can qualify for funding of up to ~$400,000/year together with up to ~$600,000/year in additional support provided as paid-up CRO services - a total of up to ~$1 mission/year. Some or all of these services will be provided by ShangPharma's preferred partner and affiliate, ChemPartner. Funding award size will be based on 12-month workplans developed by the PI in close collaboration with the ShangPharma Innovation Team
  • if chosen for UCSF Catalyst funding only the maximum award is $100K

Devices and Diagnostics - Up to $100,000 
Digital Health - Up to $50,000 

The Spring 2018 Cycle, is a modified version of the successful original Catalyst Program, which reduces the time to award decisions and focuses the advisory consultations onto successful projects.Note that submissions to Catalyst in addition to another RAP grant mechanism are allowed. Catalyst applications are only funded by the Catalyst program and will not be considered by other funding agencies.

Award Process
The Catalyst Program, involves advisors from industry in proposal review and subsequent consultations. Successful applicants negotiate through three distinct stages to receive critical feedback, expert consulting and funding for their projects:

Stage 1
Review

The first stage involves a thorough review of the applications by panel members with expertise in specific technology area. All applicants receive thoughtful feedback that highlights the promising aspects of their research as well as key gaps that need to be addressed to strengthen their likelihood for progress to commercial implementation and clinical practice.
Stage 2
Presentation
A select number of applicants will advance into the second stage. This will involve a pre-presentation consultation and a presentation to a group of selected reviewers from the Catalyst expert advisor panel. The expert panel will then score the applicants and those evaluations are used to decide who receives a Catalyst funding award.
Stage 3
Consultation
The successful applicants will be matched with expert advisors in their field, who will help them to address the gaps that were identified by the review panels and to identify the optimal development pathway for their technology. A final budget for the award will be agreed at this point.

NOTE: Eligibility requirements need to be met as of date of submission, no waivers allowed.

Applicants: To qualify, you must be a UCSF Faculty member in any series (Ladder Rank, In Residence, Clinical Health Science Clinical, Adjunct) or any rank (Instructor, Assistant Professor, Associate Professor and Full Professor). Residents and Postdoctoral scholars are eligible to submit applications as a PI only if they have a faculty member as a Co-PI.

Projects: Research projects with a clear clinical indication (or use case) early target validation or early proof-of-concept data and viable commercialization potential will be eligible for consideration. The therapeutic area can cover any disease where there is an unmet medical need or the potential for significant improvement over current treatments, diagnostics or services. For the digital health track, projects must be able to demonstrate that they are fulfilling a pressing clinical need in addition to having commercial viability and impact.

Intellectual Property: Projects should have a strong potential for obtaining defensible intellectual property. Existing IP has to be assigned to or jointly owned by the Regents of the University of California. If IP has not been filed, applicants must have an obligation to assign inventions and patents to the Regents of the University of California in accordance with University of California Patent Policy. Having IP filed before submission to Catalyst is not a requirement, but invention disclosure to the Office of Technology Management is recommended.

Proposals will be evaluated on the following:

1.       Unmet need

2.       Scientific rationale

3.       Development feasibility

4.       Commercial attractiveness

5.       Intellectual property status, potential position and issues

Estimated Program Review and Award Timeline:

Feb 26 RAP Application Deadline
March 30 Announcement of proposals advancing to Stage 2
April 16-26 Report-Out Presentation (Stage 2)
April 27
Announcement of awards and consultations to follow

TO APPLY:

STEP 1) Complete the electronic application form 
STEP 2) Upload your proposal as a SINGLE PDF that includes all the things listed in numeric order in the instructions below. Do not include form fields in your PDF document.


 INSTRUCTIONS FOR PROPOSAL PDF

Please write your proposal following the instructions listed below and create one single PDF file. Do not include form fields in your PDF document.

Proposal Length: Maximum 6 pages, including figures and tables, excluding table of contents and literature cited.

Format Requirements:  Arial font; 11 pt; minimum 0.5 inch for all margins; no appendices; include page numbers and table of contents.

Resubmissions
Definition: same research topic with an amended application or research plan rather than a new research topic and new research plan.

Requirements:

Please use up to one extra page to introduce your revised proposal, addressing the issues raised in the review, and any additional changes to your proposal. A new letter from the Chair is not required if the resubmission is within 2 cycles (one skipped cycle max). You will include the old letter and state your resubmission is within 2 cycles and new letter is not required. Make sure the new changes are highlighted in bold or italic font so the reviewers can easily see where and how the proposal has changed. Do not use track changes.

1.  P.I. Name(s) - Optionally, you may apply with two PIs. If funded, PI1 will be the primary contact for the award set up and management. If the proposal has multiple PIs, both PI1 and PI2 need to meet the eligibility criteria listed for this grant mechanism.

2.  Project Title

3.  Proposal (maximum of 6 pages, including Executive Summary, Figures and Tables, excluding References)

a.     Executive Summary (maximum of 1 page)

                                     Briefly describe the unmet need being addressed, the significance and potential clinical impact of the proposed research project, and the project objectives with measurable criteria for success.

b.     Background and Significance

                                     Describe the significance of the unmet need being addressed and the current standard of care. Describe how the product, which may result from the proposed research, will be used to inform clinical decisions and/or improve care. Provide supporting evidence for the project hypotheses and objectives.

c.     Research Strategy

                                     Describe the proposed research objectives, approach, expected outcome and specific, measurable criteria for success.

d.     Research Timeline

Provide a timeline for key project tasks and milestones.

e.     Collaborations and Other Sources of Support

                                    List any research collaborations and/or other sources of funding related to the proposed research program.

f.      Product Development and Commercialization

                                   Describe the expected next steps after the successful completion of the proposed project milestones (including research/development activities, patent filings, clinical trials, regulatory activity).

h.     Competition

                                    List any existing competing products or other research or development programs that may result in competing innovations.

i.       Intellectual Property

                                    List existing intellectual property (e.g. disclosure, patent applications, or issued patents) related to the project.  Note the case number if a disclosure or an application has been filed with the Office of Technology Management.

                                    Note if there are pending obligations or out-licenses for this or related IP.

                                    Describe the potential of generating intellectual property after the successful completion of the project milestones.

 j.       Strategic Partnerships

                                    Provide a brief description of existing partnerships with organizations related to the research. Describe potential strategic partnerships that may be beneficial in the development of a resulting product.

k.     References (not included in page limit) 

4. Detailed Budget 

Construct your budgets witht he following caps for a 1-year project:

Therapeutics - Up to $200,000

  • if chosen for a collaboration with ShangPharma Innovation, a project can qualify for initial in-kind services with ChemPartner (up to $500K) and funding up to $200K. (An initial outline budget is required in the proposal and if selected for a collaboration with ShangPharma Innovation, a new detailed budget will be requested at a later stage) and up to $100K for UCSF funding only. Those to be considered for both should prepare budgets for both $100K and $200K.
  • if chosen for UCSF Catalyst funding only the maximum award is $100K.

Devices and Diagnostics - Up to $100,000

Digital Health - Up to $50,000

Use the following budget template form:https://accelerate.ucsf.edu/uploads/catalyst-award-budget-template.xlsx

 

  Allowable Not
Allowable
PI Salary * X  
Co-Investigator(s) Salary* X  
Post Doc Salary X  
K career development awardees – salary support   X
Consultants X  
Administrative Support   X
Supplies X  
Equipment X  
Software X  
Personal Computers   X
Mailing   X
Tuition   X
Travel** X  
Research Staff Support (e.g. RSA; Lab. Technician) X  
Patient Care   X
Indirect costs on subcontracts   X

*NIH base salary cap. Multiple PIs can decide how to distribute the salary support among them.

Total Salary Component cannot be more than 25% of the total budget.

**Travel is restricted to reaching project sites.

5. Budget Justification: Clearly and fully justify all costs. Use the following budget justification template form: https://accelerate.ucsf.edu/uploads/catalyst-award-budget-template.xlsx

6. NIH Bio-sketch of Principal Investigator(s) and Co-Investigator(s) and UCSF Faculty Mentor(s) (5 page maximum): Use Form (http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx) with other support pages. Include active, pending, and planned proposals. Include percent effort, total direct costs (current year) and potential overlap with the current proposal. Include bio-sketch for both PIs of a multi-PI application.

7. Letter(s) of support: Provide a letter of support from the department chair or other unit head. In addition, for junior investigators, department chairs/unit heads should comment on the independence of the applicant and availability of research space and other resources for the proposed research. Include the letter of support at the end of your PDF proposal and address it to the RAP Committee. If there are multiple (two) PIs, a letter of support is required for both PIs. If PIs are in the same department, the chair can vouch for both PIs in a single letter.