The Stanford Innovative Medicines Accelerator (IMA) is accepting proposals for projects that address two major challenges in drug development: identification of drug candidates and optimization towards clinical leads. Through this request for proposals, the IMA is soliciting Letters of Intent (LOI) for projects that fall under the protein therapeutics discovery module.
Aim and Scope: The IMA will support the discovery and/or engineering of monoclonal antibodies or proteins with therapeutic potential and sufficiently promising properties to advance as a drug prototype. Competitive projects will have 1) a strong therapeutic hypothesis, 2) a novel biological target or mode-of-action that is well-differentiated from other ongoing translational programs in academia or the biopharma industry, and 3) available in vitro assays, and/ or in vivo models to support protein drug prototyping.
The IMA aims to accelerate the translation of therapeutically relevant scientific discoveries at Stanford University through the prototyping of innovative therapeutics and vaccines while enabling hypothesis-driven studies that impact human health. Basic research, including identification of targets and/or exploration of novel biological mechanisms, is outside the scope of the LOI solicitation. The goal of each project is to validate the therapeutic hypothesis underpinning each project while generating strong intellectual property around the eventual medicine that emerges from this work.
- Prototyping of protein therapeutics: Support through the Protein Engineering Knowledge Center (PEKC) at Sarafan ChEM-H will include discovery of monoclonal antibodies to serve as a therapeutic candidate, structure-based, evolutionary-guided optimization of antibody or non-antibody protein therapeutic candidates biochemical and biophysical characterization of target protein; and recombinant protein production for in vitro validation and in vivo proof of concept studies.
- In vitro and in vivo pharmacology: Support through the IMA’s Preclinical Pharmacology module will include the establishment and/or scale-up of in vitro assays and/or in vivo studies, including the use of appropriate disease models.
- External resources: Depending on the nature and requirements of each project, the IMA will provide access to strategic alliances and vetted contract research organizations (CROs).
- Project management: The protein therapeutics module is led by a senior research staff member, who will collaboratively help the PI formulate a goal- and milestone-driven project plan. In addition, the IMA Project Management team will support the project in planning, budgeting, and identifying outsourcing opportunities.
Awarded projects will be supported for 12–24 months, according to a predefined project plan with critical milestones and go/no-go decision points. Details regarding specific roles, responsibilities, and financial allocations will be elaborated in individual award letters issued to selected projects. The specific level of support will vary by project needs.
Collaboration: It is generally expected that the projects are run in a collaborative and fully transparent manner including decision-making processes, data generation and handling, experimental design, and external collaborations or resources. The IMA will act in a fully confidential manner and guarantee long-term data storage and accessibility.
Deadline: All LOIs must be received by 5 PM PDT on Friday, October 20, 2023. The most promising proposals will be selected for full proposal development.
Eligibility: All Stanford faculty with PI status are eligible to apply. The support of the IMA is limited to one active project per PI at a time. However, PIs with an active IMA collaboration can be listed as co-authors.
Application Instructions: LOIs should be submitted as a single PDF file containing the following materials in the order indicated below. All documents must be single-spaced, Arial 11-point font with 1-inch margins.
- Title page (1 page):
- Project title
- PIs name, co-authors names, department, address, phone number, email address
- Project summary for a lay audience (150 words max).
- Letter of Intent (3 pages maximum):
- Brief description of the medical need the project seeks to address.
- The case for the biological target of the anticipated drug prototyping effort.
- Information relevant to the structure and/or properties of the bioactive protein that serves as the starting point for drug development (if available)
- Description of the intention of your project and the final goal.
- Brief description of the biological assays that will be required to optimize and validate the therapeutic prototype.
- Elaborate the novelty of the proposed approach, highlight potential competitors in academia and industry, and point out the patent landscape (if possible).
3. NIH-format biosketch: Each investigator should submit the LOI directly through the SlideRoom portal using the link provided. https://chemh.slideroom.com/#/permalink/program/75133
You do not need to submit your applications to your Research Process Manager (RPM) in RMG or through your Office of Sponsored Research (OSR) Contract and Grant Officer (CGO) for their approval at this time.
Selection Process: Each LOI will undergo a three-step due diligence process:
- The most meritorious LOIs will be identified based on:
- Novelty of the therapeutic hypothesis and biochemical approach
- Significance of the unmet medical need
- Feasibility of support with the available technologies and resources at the IMA
- PIs whose project ideas are selected will be invited to submit full proposals in collaboration with senior staff members of the IMA The full proposal will cover the following points:
- Description of envisioned mechanism of action
- Strategy and steps towards the generation and/or development of the therapeutic prototype including milestones, timelines, and go/no-go decision points.
- Biological context and description of previous work performed on the therapeutic target.
- Detailed description of in vitro assays and in vivo models needed for optimization and proof of concept studies.
- Profile of the optimal therapeutic prototype (target product profile)
- List of available and/or to-be-generated tool molecules and cell lines.
- Publication, intellectual property, and exit strategy.
- Mutual due diligence call between the IMA and PI to address any outstanding questions or concerns.
The IMA leadership team will make final decisions on full proposals, leading to the project’s kick-off.