Q. What is the Stanford Alliance for Innovative Medicines (Stanford AIM)?
A. Stanford AIM was launched in summer 2017 as a new collaboration with Takeda Pharmaceutical Company to accelerate the translation of research discoveries at Stanford into next-generation therapies of all modalities. Stanford AIM brings Stanford and Takeda scientists into close collaboration to share ideas, knowhow, and technical acumen. Stanford faculty projects selected to participate in the program will benefit from access to industry drug development know-how and in-kind use of industry research functionalities such as medicinal chemistry, high-throughput screening, scaled up protein production, monoclonal antibody discovery or engineering, pharmacokinetics, and safety/toxicity profiling. Stanford will retain all intellectual property from Stanford AIM-supported research and Takeda scientists will get the chance to participate in cutting edge research at one of the nation's top research universities.
READ THE STANFORD AIM PRESS RELEASE
Q. How are AIM projects selected?
A. Stanford AIM accepts letters of intent from Stanford faculty every 6-12 months. Ideal projects for entrance into Stanford AIM will have a compelling therapeutic rationale, an identified target that is amenable to therapeutic intervention, and sufficient evidence to support the rationale for a drug discovery effort (please see ‘Definition of AIM Ready Projects’ page). It is essential that the short letters of intent submitted to the program identify a novel target or a novel approach to a known target with a distinct advantage over existing approaches to that target. Stanford AIM is open to all therapeutic areas and modalities. The goal of Stanford AIM is to advance selected faculty projects through proof-of-concept in animals by leveraging in-kind access to discovery and preclinical development capabilities through Takeda. Submitted LOIs will be reviewed internally within Stanford to ensure that the proposal demonstrates a direct path to therapeutic development and for novelty. A Takeda representative will then review only the title of submitted LOIs to eliminate proposals with potential internal Takeda program conflicts. A Review Committee, consisting of an equal number of Stanford faculty and Takeda Senior Executives, will review the remaining LOIs. The Review Committee will select a short list of LOIs for invitation to submit a full proposal. The full proposal will include full rationale, work plans, budgets, resourcing, and success criteria. Full proposals will be developed by the Stanford investigator with Takeda participation. The Review Committee will rank and recommend full proposals for support to the Stanford AIM Board. The number of projects selected for entry in to AIM will depend on available resources from Takeda and Stanford. Stanford AIM hopes to support 6–8 projects at steady state.
Q. How do I know if my project is a good fit for AIM?
A. Stanford AIM seeks to support the translation of Stanford research discoveries into next generation therapeutics. Ideal projects for entrance into Stanford AIM will have a compelling therapeutic rationale, an identified target that is amenable to small molecule or macromolecular therapeutic intervention, and sufficient evidence to support the rationale for a drug discovery effort. It is essential that proposals identify a novel target or a novel approach to a known target with a distinct advantage over existing approaches to that target. Stanford AIM is open to all therapeutic areas. Projects aimed at the discovery of small molecule or macromolecule drugs are encouraged, but the therapeutic modality must be identified upfront in order to engage appropriate Takeda expertise. Basic science projects or research projects that could be supported by traditional government research grants would not be appropriate for this program. Examples of projects that are a good fit for the program include:
- Novel target/mechanism/phenotype linked to a disease with high unmet medical need and a confirmed hit (any modality utilizing Takeda capability areas)
- Novel target/mechanism/phenotype linked to a disease with high unmet medical need with no confirmed hits, but with either a robust primary assay ready for HTS optimization, unique expertise from the PI lab for the development of assays or an alternative approach to identifying progress-able hits such as structural modelling and virtual screening approaches
- Novel chemical biology or biological (therapeutic proteins, gene therapy, antisense and editing, oligonucleotides, cell therapy, oncolytic viruses) approach to an existing target where unmet medical need remains
- Examples include, but are not limited to (a) allosteric modulators where previous unsuccessful work described orthosteric modulators; (b) irreversible covalent modulators with increased affinity where previous unsuccessful work described reversible non-covalent weak binders; (c) PROTAC degraders for difficult to drug protein-protein interactions (d) Protein, antibody, cellular and genetic approaches to disease modulation
- Novel combinations, e.g. optimization of the PK of one drug via new chemistry to make it more compatible with its partner drug
Please also see ‘Definition of AIM Ready Projects’ page.
Q. Who decides which projects are selected for AIM?
A. Submitted LOIs will be reviewed by the AIM Review Committee, which consists of four voting members from Stanford and four voting members from Takeda, and also includes the Stanford Alliance Director (non-voting) and Takeda Alliance Director (non-voting). The Review Committee will select a list of up to ten LOIs for invitation to submit a full proposal. Full proposals will be developed by the Stanford investigator with Takeda participation. The Review Committee will rank and recommend full proposals for support to the Stanford AIM Board. The AIM Board consists of two members from Stanford and two members from Takeda plus one independent Board member, who is not an employee of Stanford or Takeda.
Q. How are projects managed once they are selected for AIM?
A. Each project is co-led by the Stanford PI and a Takeda Project Leader. The Stanford Alliance Director, Dr. Paul Humphries, and the Takeda Alliance Director, Dr Cathy Tralau-Stewart will provide direct support to the project teams in defining the goals and tasks of their target-driven drug discovery efforts, assessment of progress toward these goals, identifying obstacles and developing solutions, and evaluating resource needs. The Stanford Alliance Director will be responsible for direct support of the Stanford PIs and The Takeda Alliance Director, will support the Takeda Project Leader in managing Takeda project resourcing and strategy. The Alliance Directors will jointly recommend adjustments of goals and/or resources to the AIM Board, as needed.
Q. What kind of support does Takeda provide to selected projects?
A. Takeda will provide drug discovery and preclinical development capabilities, resources and expertise. Support provided by Takeda is provided to Stanford at no cost, resources are a world class industrial capability. In addition, Takeda will provide strategic advice, initial competitive, safety, DMPK and translational assessments as appropriate.
Takeda will not provide any direct research funding to the Stanford faculty member. The specific in-kind resource commitments for each project will be identified as part of the full proposal development process and ultimately approved by the Stanford AIM Board. It is anticipated that most selected projects will receive in-kind support for ~18 months.
Q. What funding can I use to support my AIM project, since Takeda isn’t providing funding?
A. Stanford AIM PIs will be responsible for supporting any Stanford faculty effort, relevant laboratory personnel effort, as well as any research costs for collaboration activities carried out at Stanford. To help defray collaboration costs incurred at Stanford, Stanford projects selected for entry into AIM can request up to $75K (per year in AIM) in research support in the form of a University Research award from Stanford ChEM-H as part of the full proposal budget. However,
- investigators may not use funding from other for-profit entities for AIM projects;
- investigators may not use research materials received from other companies in AIM projects; and
- investigators may only use funding from non-profit sources if pre-approved by the Stanford Alliance Director.
Q. Can I use NIH or other government funding sources to support AIM research?
A. Faculty may only use funding from federal agencies such as the NIH to support research that is complementary to the AIM project. For example, you could use federal funding to support the development of a relevant animal model, or for doing structure-function analyses that are not contemplated under your AIM Project Plan, or for doing pharmacological studies for a disease indication that is not within the scope of the AIM Project Plan. If you choose to use federal funding for such purposes, please discuss this with the Stanford Alliance Director in advance.
Q. Can I use other non-profit sources of funding to support my AIM research?
A. Only if the terms and conditions of such funding have no strings attached, with such terms to be reviewed by the appropriate Stanford research administration office. As mentioned above, a good use of other non-profit funding would be for research that is complementary to your AIM project. If you elect to use non-profit funding for such purposes, please discuss this with the Stanford Alliance Director in advance.
Q. What can I tell other funding agencies if I want to apply for such complementary funding?
A. You should not disclose details about your AIM project work plan to any third parties, but you could, for example, disclose that you are working on finding lead compounds against Target X with a company and would like to complement those findings by (e.g. creating a relevant animal disease model; exploring structure-function relationships of the target protein; etc.). If you apply for supplementary funding from a third party, please discuss this with the Stanford Alliance Director in advance.
Q. Who will be named as inventors on patents resulting from AIM research?
A. US patent law clearly sets forth the rules on determining who is an inventor. These laws will determine who is an inventor on AIM inventions. An inventor is the person who contributes to the claims of a patentable invention. Under US case law, an inventor is the one with "intellectual domination" over the inventive process, and not merely one who assists in its reduction to practice. Clearly this means that both Stanford and Takeda scientists may be co-inventors on patent applications at the completion of the AIM project.
Q. Who will own inventions from AIM work?
A. The Takeda relationship is unusual in that Stanford owns all inventions resulting under the AIM project, whether invented by Takeda employees, Stanford investigators or jointly between them.
Q. Who will file and prosecute patent applications and manage inventions resulting from AIM research?
A. Stanford’s Office of Technology Licensing (OTL) will manage the inventions and will work with outside law firms on patenting. Investigators will disclose inventions directly to OTL, as per usual Stanford practice.
Q. Who will handle the licensing of AIM inventions? Will inventors have input into the choice of licensee?
A. OTL will handle the licensing of inventions. Takeda has the first right to review inventions resulting from AIM projects for 120 days. If Takeda is interested in licensing, both parties must negotiate in good faith toward a license during this period. If no license is executed, Stanford may offer a license to other companies, with some time-limited restrictions on terms. However, notwithstanding the above, Stanford may instead choose to exclusively license AIM project IP to a Stanford startup formed to commercialize such IP, irrespective of Takeda’s review and negotiation period.For Stanford start-ups, please discuss with Takeda as Takeda Ventures may have an interest. Per its usual practice, OTL will consult with Stanford inventors on licensing opportunities.
Q. How are royalties from AIM inventions shared?
A. As per Stanford policy, OTL will deduct a 15% charge from royalties for licensing and also deduct the unreimbursed costs of patenting. All inventors on an AIM project patent, including Stanford inventors and Takeda inventors, as applicable, will share in one-third of the balance. The remaining two thirds is distributed in equal shares to the inventors’ Schools, and to the departments and/or affiliated units (including ChEM-H, if applicable).
Q. How many Takeda researchers are likely to be co-inventors in my project?
A. This of course depends on the scope of the project, and will vary from project to project. In general, for a project that is supported by AIM over the anticipated duration of 18 months, one might expect one or two Takeda researchers to make contributions to the project that rise to the legal threshold of warranting inventor status.
Note: Each project is likely to involve an average of 1 to 2 Takeda scientists (FTEs) in total. However, this will vary. This is likely to be an aggregate of many scientists with a variety of necessary skill sets to fulfill the 1-2 scientist resource and optimally support the project.
Q. What are the confidentiality requirements once successfully entering AIM?
A. Both Stanford and Takeda must keep one another’s confidential information as confidential. Stanford cannot provide Takeda’s confidential information to any third parties, nor use it for any purpose outside of the AIM project.
Q. What are the rules on publications and public presentations?
A. In case any AIM researcher wants to publish their work or present it publicly in a lecture or poster, they must share the publication with the non-publishing party - Takeda or Stanford – at least 30 days in advance of submission or presentation. The other party may review for disclosure of its confidential information or for disclosure of a patentable invention, in which case the proposed publication may be delayed for up to 45 days for Stanford to file a patent application.
Q. Can Takeda look at my LOI and decide to start their own internal project?
A. No, Takeda cannot use any information gained during the review process to launch their own internal program on that target.
Q. Can I work with another company other than Takeda on the same target or research that is described in my AIM Project Plan?
A. No, investigators who would like to work with a company other than Takeda on a particular target should notapply to the AIM project for this same work.
Q. Can Stanford investigators or members of OTL actively engage in licensing/partnership discussions whilst my project is actively in AIM?
A. No, except with Takeda. Otherwise projects must have exited AIM with the necessary waiting period (if applicable) before any licensing/partnership discussions can begin.
Q. If Stanford has already optioned or licensed out my target or other IP that would be further developed under the AIM program, can I still apply to AIM with that target?
A. No, if your target has already been licensed to a company, including a Stanford startup, then your proposal will be removed from consideration.
Q. Who do I contact if I need help determining if my project is appropriate for AIM?
A. Please contact Dr. Paul Humphries, Alliance Director, if you wish to discuss your project idea before preparing an application.
