Research Management Group (RMG)

Stanford University and Pfizer’s Center for Therapeutic Innovation (CTI)
CTI Request for Programs

Stanford University and Pfizer’s Center for Therapeutic Innovation (CTI) announce the inaugural request for proposals for all Stanford faculty (with UTL, MCL, NTL-Research and CE appointments).

 

Internal Pre-proposal deadline: Sept. 27, 2013 (see internal proposal guidelines below)

Institutional representative: you do not have to submit your internal proposals through your institutional representative. However, if you are ultimately invited to submit a full proposal, then you will have to prepare a PDRF form and submit your full proposal through your institutional representative (RPM/RMG or OSR).

Guidelines-Download these 3 files:   
1. CTI RFP and pre-proposal guidelines download >> pdf file
2. CTI Brochure (how the CTI works)  download >>   pdf
3. CTI Technologies and Resources download >>     pdf file


Eligibility: all Stanford faculty (with UTL, MCL, NTL-Research and CE appointments)


Amount of funding
: not specified

Purpose
Stanford University is excited to announce a Request for Proposals (RFP) for this year’s round of funding from Pfizer’s Center for Therapeutic Innovation (CTI). CTI is an innovative Pfizer program that partners with leading academic medical centers nationwide to accelerate the translation of novel biomedical insights to the clinic. CTI enables translational medicine by accelerating research and development of discoveries from target identification (validated target) to proof of mechanism in a Phase 1 clinical trial.


Core elements of the CTI partnership with Stanford University include:

    • Focus on protein therapeutics (e.g., monoclonal antibodies, antibody variants, recombinant proteins, Fc-fusion, pegylated proteins, antibody and protein conjugates, bi-specific antibodies and peptides)
    • Focus on understanding patient heterogeneity and stratification
    • Equitable IP and publication rights
    • Joint Steering Committee governance with equal representation from Columbia University and Pfizer
    • Co-location of scientists, technology and drug development expertise
    • Collaborative use of Pfizer’s proprietary drug discovery tools and technologies
    • Support for IND- & clinical-enabling functions (toxicology, regulatory, etc.)
    • Success-based funding/financial incentives (milestone & royalty payments)

 

Goal
The goal of a funded CTI program is to establish proof of mechanism in the clinic for a new therapeutic that may be licensed to Pfizer and commercialized to treat patients with unmet medical needs.


Out of scope
As a general rule, CTI is currently unable to accept therapeutics that are small molecule, radiotherapy or vaccines in nature. In addition, there is limited opportunity to pursue HIV targeted therapies within CTI.

 

Internal pre-proposal guidelines

By Sept. 27, 2013, please submit one PDF file containing the following in the order listed below to:
Kanad Das, Program Manager
kanaddas@stanford.edu

Faculty-you do not need to prepare a PDRF form or submit your pre-proposals through your institutional representative (RPM/RMG or OSR).

1) Title page
Name of this RFP: Stanford University and Pfizer's Center for Therapeutic Intervention (CTI)
Request for Proposals
Project title:
PI name, title, department, address, email, phone #

2) 3-4 page non-confidential pre-proposal containing:
(this page limit includes references and illustrations)

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/are the unmet medical need(s) this target/pathway could address? Is this pathway targetable with a biotherapeutic?
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. If available, please describe the characteristic s of said molecule (affinity, humanization, PK etc.) (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 the first potential clinical study to demonstrate prood of mechanism including:
1) Patient stratification/selection for the study (i.e. molecular signature, SNP, genetic deficiency etc.)
2) Clinical study endpoints that would allow for testing mechanism in patients.
3) Will this allow for clinical differentiation from other therapies?

RESEARCH PLAN AND REAGENTS
Provide a brief description of research plan to be carried out (objectives, specific aims) leading to demonstration of PoM. 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.)

3) PI biosketch (attachment of an NIH biosketch is acceptable)

 

Selection process
Stanford University scientists (faculty) whose pre-proposals are selected for further consideration will be invited to submit a full proposal that may be written in collaboration with Pfizer scientists to be evaluated for funding by the CTI-Stanford Steering Committee.

 

Questions? Contact person
Please contact Kanad Das, the Program Manager at kanaddas@stanford.edu regarding any questions about the Pfizer CTI program.

 

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