UC San Diego CTRI and Pfizer’s Centers for Therapeutic Innovation (CTI) Announce the Call for Proposals: Biotherapeutic and Small-Molecule Targets; Small-Molecule Targets (Accelerator)

September 16, 2015

Proposal Deadline: October 16, 2015
Below are templates for submitting proposals (biotherapeutic and small molecule targets).

CTI SMALL MOLECULE (Accelerator) PRE-PROPOSAL
Required Contents of the Pre-Proposal

Please use the following form to submit your NON-CONFIDENTIAL Small Molecule Accelerator project proposal. Please limit the total length of your pre-proposal to 2 pages.

INVESTIGATOR NAME:

INVESTIGATOR HOSPITAL/ACADEMIC AFFILIATION:

PROJECT TITLE:

PFIZER COMPOUNDS REQUESTED (and amount):

SCIENTIFIC HYPOTHESIS and RATIONALE:
This section should contain:

  • A brief description of the target/pathway and link to human disease and disease mechanism(s). Please indicate the novelty of this target or approach relevant to disease mechanism.
  • What is/are the unmet medical need(s) this target/pathway could address?
  • Key evidence available to support the hypothesis above and demonstration of target validation (i.e. human genetic, human tissue, preclinical animal models)

RESEARCH PLAN:
This section should contain:

  • A description of the research plan, including objectives and specific aims, to be carried out with the Pfizer compound.
  • Specify the readouts of your studies and potential outcomes. What is the time frame for completing this work? Describe your Go/No Go decision based on results with testing the Pfizer compound.

BIOGRAPHICAL SKETCH OF PRINCIPAL INVESTIGATOR:
Please provide a brief bio-sketch of the PI and key publications. Attachment of NIH biosketch is acceptable.

SCOPE/ADDITONAL INFORMATION
What CTI is looking for: A well supported hypothesis and strong rationale for the target/pathway in human health and disease, in a therapeutic indication of interest to Pfizer, which include: Oncology: Immuno-oncology, epigenetics, novel tumor specific cell surface antigens, and targets identified by unique insights in tumor biology, Inflammation and Immune disorders: Fibrosis, NASH, Crohn's and Colitis, microbiome-epithelial interactions, and epithelial barrier protection, Cardiovascular and metabolic diseases: dysfunctional cardiac metabolism, vascular inflammatory processes, and cardiac fibrosis, Neuroscience: neuroinflammation, neurodegenerative disorders, remyelination, misfolded proteins, Alzheimer's Disease, Parkinson's Disease, and Multiple Sclerosis, Rare monogenic genetic diseases. Click here for further information about Pfizer's therapeutic areas of interest.

What CTI is NOT looking for: As the Small Molecule Accelerator program is aimed at assessing the role of a specific target in defined indications, this is not a broad screening collaboration and therefore screening the entire available compound set is out of scope.


CTI BIOTHERAPEUTICS AND SMALL MOLECULE PRE-PROPOSAL
Required Contents of 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. Please limit the total length of your pre-proposal to 2-3 pages.

INVESTIGATOR NAME:

INVESTIGATOR HOSPITAL/ACADEMIC AFFILIATION:

PROJECT TITLE
Subject of CTI Research Project

EXECUTIVE SUMMARY
In four sentences or less, please provide a BRIEF statement summarizing the following:

  • Overall goal & impact of the mechanism
  • Desired characteristics
  • Patient stratification & evidence of PoM

SCIENTIFIC RATIONALE AND BACKGROUND
This section should contain:

  • 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/small molecule?
  • 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.)
  • key evidence available to support the hypothesis above (i.e. human genetic, human tissue, preclinical proof of mechanism/concept models)

PROPOSED BIOTHERAPEUTIC/SMALL MOLECULE 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 characteristics 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.

For Small molecule, list any tool compounds if available.

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 proof of mechanism including:

  • Patient stratification/selection for the study (i.e. molecular signature, SNP, genetic deficiency etc.)
  • Clinical study endpoints that would allow for testing mechanism in patients.
  • 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.)

BIOGRAPHICAL SKETCH OF PRINCIPAL INVESTIGATOR
Please provide a brief bio-sketch of the PI and key publications. Attachment of NIH biosketch is acceptable.

OUT OF SCOPE
As a general rule, CTI is currently unable to accept therapeutics that are radiotherapy, nanoparticles, RNAi or vaccines in nature. In addition, there is limited opportunity to pursue HIV targeted therapies within CTI.


For more information about submitting a proposal, please contact Sylvia Plummer, CTRI, at stplummer@ucsd.edu.

Please click images below to download relevant documents

Biotherapeutic Flyer

Small Molecule Flyer

Biological Targets

Cover Page