SAN DIEGO CTI PRE-PROPOSAL: 2011 RFA
Pre-Proposal
Please see the information below on the information required and the format for pre-proposals. Only
the Joint Science Committee (JSC) and selected reviewers will have access to the pre-proposal. However,
information in the pre-proposal is not considered confidential and so unpublished or proprietary
information should not be disclosed in the pre-proposal. Please discuss any questions with Jennifer J.
Ford (jjford@ucsd.edu), Principal Contract and Grant Manager, OCGA, Phone 858-534-3335, or with
your licensing officer if you have any questions regarding information that is appropriate to disclose.
Pre-proposal deadline is 5 pm, November 10, 2011. Email your proposal to Jennifer J. Ford, OCGA at
jjford@ucsd.edu. Once your proposal has been reviewed by OCGA, you will receive an e-mail
notification and the pre-proposal will be uploaded to the Pfizer CTI portal for you.
It is strongly recommended that a clinical PI participate in the project to bring insight and expertise on
clinical proof of mechanism studies that will ultimately be required. If you do not have this expertise
available and would like help identifying an appropriate collaborating UCSD clinician, please contact
Doris Dworschak (ddworschak@ucsd.edu) who can work with the CTRI to help find a potential clinical
collaborator.
For help with scientific questions please contact Andrew Wiseman, PhD, Corporate Business
Development Officer, UCSD Health Sciences: anwiseman@ucsd.edu or at 858-822-1706
Decision Guidelines that will be used to help prioritize and select Pre-Proposals that should be considered
for a Full Proposal:
1)
2)
3)
4)
5)
Proposal is focused on development of a protein therapeutic
Strength of scientific rationale
Novelty/differentiation
Link to human disease
Path to clinical proof of mechanism (biological readouts that can be used in the clinic to
determine action on target/pathway)
6) Available reagents from PI laboratory (Pfizer resources listed on CTI website)
7) Proposals that impact orphan or rare diseases are encouraged
Next steps after Pre-Proposal
If a pre-proposal is selected for full proposal development, all investigators will be required to attend a
meeting with the UCSD contracts and licensing team to understand key terms of the agreement. Dates
for these meetings are January 10, 2012 at 4:00 PM and January 13, 2012 at 9:00AM and PIs need to
commit to one of these dates as attendance is mandatory.
Investigators will be partnered with a Pfizer senior scientist for development of the full proposal.
Authors will have the opportunity to briefly present and discuss their proposal with JSC prior to selection
of funded full proposals.
Key Elements the Pre-Proposal
Please use the following form to submit your pre-proposal and limit the content to the recommended
word count. Please also include data (tables, graphs) or cartoons as appropriate.
PRINCIPAL INVESTIGATOR, COLLABORATORS/CO-INVESTIGATORS
INSTITUTIONAL AFFILIATION(S)
All institutional affiliations for Investigators and collaborators on the project.
Examples include: UCSD, or Sanford-Burnham.
PROJECT TITLE
Subject of CTI Research Project
ABSTRACT
Short summary of proposal
SCIENTIFIC RATIONALE AND BACKGROUND
This section should contain:
1)
A brief description of the target/pathway and link to human disease and disease
mechanism(s). What is the unmet medical need that this target/pathway could
address?
2)
Please indicate the novelty/differentiation of this target or approach relevant to
disease mechanism (if there are other treatments available, please describe why this
is different – greater efficacy/safety etc.)
3)
Key evidence available to support the hypothesis above (i.e. human genetic, human
tissue, preclinical proof of mechanism/concept models)
PROPOSED BIOTHERAPEUTIC DRUG CANDIDATE
Please describe any available potential biotherapeutic molecule(s) the PI has generated against the
target and its mechanism of action. (Please be sure to communicate within limits of any Intellectual
Property constraints). If unavailable, please indicate the characteristics of the preferred biotherapeutic
agent.
PROPOSED (or concept) FOR FIRST BIOLOGICAL READOUT IN CLINIC (PROOF OF MECHANISM)
Brief description of potential therapeutic indications expected to be impacted by this mechanism.
Describe potential clinical study(ies) to demonstrate proof of mechanism (a biological readout relevant
to mechanism being tested).
RESEARCH PLAN and REAGENTS
Provide a brief description of research plan to be carried out (objectives, specific aims). Please list the
available reagents and assays to support research plan. Alternatively, please describe reagents and
assays that may need to be developed, and any gaps in the plan (and how Pfizer scientists may
contribute, i.e. complete mechanistic studies in vitro, develop cellular assays, discover biomarkers, etc.)
BIOGRAPHICAL SKETCH OF PRINCIPAL INVESTIGATOR
Please provide a copy of an NIH brief biosketch format for all PIs, collaborators/co-PIs. (Or similar
biosketch to NIH short form).
UCSD PRE-PROPOSAL SUBMISSION FORM
Send completed this form and the IP pre-proposal questionnaire to Jennifer J. Ford at jjford@ucsd.edu .
For scientific assistance you may also contact Andrew Wiseman, PhD at anwiseman@ucsd.edu .
PRINCIPAL INVESTIGATOR:
PRINCIPAL INVESTIGATOR INSTITUTIONAL AFFILIATIONS (ie. UCSD, Sandford):
COLLABORATORS/co-PIs and their INSTITUTIONAL AFFILIATIONS:
PROJECT TITLE
ABSTRACT (max 200 words):
SCIENTIFIC RATIONALE AND BACKGROUND (max. 500 words or 1 page with graphics)
This section should contain:
1)
a brief description of the target/pathway and link to human disease and disease
mechanism(s). What is/are the unmet medical need(s) this target/pathway could
address?
2)
please indicate the novelty/differentiation of this target or approach relevant to
disease mechanism (if there are other treatments available, please describe why this
is different – greater efficacy/safety etc.)
3)
key evidence available to support the hypothesis above (i.e. human genetic, human
tissue, preclinical proof of mechanism/concept models)
PROPOSED BIOTHERAPEUTIC DRUG CANDIDATE (max. 200 words)
Please describe any available potential biotherapeutic molecule(s) the PI has generated against the
target and its mechanism of action. (Please be sure to communicate within limits of any Intellectual
Property constraints). If unavailable, please indicate the characteristics of the preferred
biotherapeutic agent.
PROPOSED (or concept) FOR FIRST BIOLOGICAL READOUT IN CLINIC (PROOF OF MECHANISM)
(max. 200 words)
Brief description of potential therapeutic indications expected to be impacted by this mechanism.
Describe potential clinical study(ies) to demonstrate proof of mechanism (a biological readout
relevant to mechanism being tested).
RESEARCH PLAN and REAGENTS (max. 500 words)
Provide a brief description of research plan to be carried out (objectives, specific aims). Please list the
available reagents and assays to support research plan. Alternatively, please describe reagents and
assays that may need to be developed, and any gaps in the plan (and how Pfizer scientists may
contribute, i.e. complete mechanistic studies in vitro, develop cellular assays, discover biomarkers,
etc.)
BIOGRAPHICAL SKETCH OF PRINCIPAL INVESTIGATORs and COLLABORATORS/co-PIs
Please attach a copy of NIH brief biosketch (2 page) for all investigators associated with the project.