Memorial Sloan-Kettering, The Rockefeller University, and Weill Cornell Medical College have announced that they have formed the pioneering Tri-Institutional Therapeutics Discovery Institute, Inc. and have partnered with Takeda Pharmaceutical Company, Ltd.
The Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI) is a unique partnership among Weill Cornell Medical College, Memorial Sloan-Kettering and Rockefeller University. Tri-I TDI has entered into an initial partnership with Takeda Pharmaceuticals to assist academic investigators at the three institutions to develop small molecule therapeutic agents and molecular probes. While Tri-I TDI will initially focus on the development of small molecules, Tri-I TDI plans to expand over time to include biologic agents, especially monoclonal antibodies, and molecular imaging agents.
The concept, goals, and structure of Tri-I TDI have been under study and discussion for more than 30 months, including site visits to other programs and analysis of other academic-industry partnerships. Ultimately, there was a consensus that Tri-I TDI could best achieve its goals by being organized as a non-profit corporation that integrates the resources of the three academic partners and forms collaborations as needed with pharmaceutical companies and biotech companies. The first of these is with Takeda, which has extraordinary strengths in medicinal chemistry.
Faculty members will likely have many questions about Tri-I TDI and how to access its resources, and this communication is designed to begin to answer those questions.
Tri-I TDI is a non-profit corporation overseen by a Board of Directors (BOD) that is presently made up of the leaders of the institutions—Dean Laurie Glimcher of Weill Cornell, President Craig Thompson of MSKCC and President Marc Tessier-Lavigne of Rockefeller University. The BOD will appoint the Director of Tri-I TDI and the search for an outstanding leader is nearing its conclusion. The BOD will also appoint a Scientific Advisory Board, currently under formation, composed of internal and external academic and industry scientists leaders and a Takeda representative. Proportionately speaking, each institution’s SAB members and Takeda will each have one vote and the external SAB members as one group will have two. The SAB will advise the Director on the selection of projects to be undertaken by Tri-I TDI. The Director will advise the BOD and the BOD will make the final decisions.
In addition to the Director, Tri-I TDI will have a small support staff to assist in project management and a team of ~15 chemists on leave from Takeda to perform the required medicinal chemistry. TDI will initially occupy office space and chemistry labs in the new Belfer Research Building at Weill Cornell. The building is scheduled for occupancy in early 2014. We expect up to 6 chemistry projects per year can be accommodated. The number of biologic agents will be decided in the future.
Faculty members from the three institutions are eligible to propose a project to Tri-I TDI. An application form is being developed. We anticipate a first call for applications near the end of 2013. As noted above, the applications will be reviewed by the Director and Scientific Advisory Board and their recommendations will be considered by the BOD, which will make the final decisions. The criteria for selection of projects designed to develop therapeutics will include the potential for scientific and medical impact, the biologic and medicinal chemistry plausibility of the approach proposed based on preliminary data, and the likelihood of success. Another criterion will be the project budget and the willingness of the host institution to ensure that its own contribution plus the originating investigators’ contribution for consumables and services will be sufficient to complement the Tri-I TDI’s chemistry contributions and to reach the conclusion of the research plan and the pre-defined milestones prepared by the PI and TDI. In contrast, prospects for commercial success or patient market size will not be a selection criterion. However, the importance of creating a high quality tool compound or the potential for ultimately identifying an industry partner or creating a new company to support late stage development will be considered. If a project is accepted for TDI development, there are certain advantages or restrictions that you should be aware of, that are detailed below.
Tri-I TDI’s initial funding is coming from philanthropic gifts, in-kind and monetary contributions from the three institutions and major contributions from Takeda, including the fully loaded costs for up to 15 chemists on site. The institutional in-kind contributions will include access to core resources from the three institutions. The institutional monetary contributions will include those for equipment and operating expenses, and when necessary, for their own faculty’s projects in terms of consumables for the medicinal chemistry, biologic and animal experiments, core expenses, and related assays. Takeda’s in-kind contribution will also include the salaries, benefits, housing, travel and other support of the medicinal chemists. We anticipate that Tri-I TDI will continue to attract philanthropic support as it demonstrates its potential for speeding the development of new therapeutic agents. Tri-I TDI may apply for grants with PI’s and one of its major goals will be to help the faculty do so. In addition, the institutions will share with Tri-I TDI a portion of the royalties and licensing revenues that they are expected to realize from the compounds made in Tri-I TDI, and this will be another source of long-term support.
The faculty Principal Investigator will be an integral and necessary part of the project team. This is not considered a hand-off to TDI but rather, Tri-I TDI is designed to encourage academic investigators to work closely with Tri-I TDI personnel to speed project completion and learn about the process of drug discovery. Academic investigators will be expected to provide support in conducting biologic assays in a timely fashion to complement the medicinal chemistry efforts undertaken by Tri-I TDI. Each project will have a timeline with milestones and “go”/“no go” decision points.
Inventorship of intellectual property (IP) developed by Tri-I TDI in pursuit of projects submitted by investigators from the institutions will be determined by the relative contributions of those working on the project, as determined by patent law. Such IP will not be owned by Tri-I TDI or by Takeda; it will be assigned to the institution or institutions whose faculty submitted the project. When compounds are licensed, the distribution of royalties will reflect both inventorship on any patentable compound and other contributions to the development of the IP. Individual Takeda personnel (not corporate Takeda) may share in the institutional distribution of IP revenue as appropriate with respect to their individual contribution. Each institution will control the licensing of its own faculty’s IP.
The PI, TDI Director and SAB will periodically review each project for progress toward the predefined goals. New goals may be set upon generation of data or a project may be terminated as not feasible. If so, the project and data will be returned to the investigator for their own use.
Yes. However, each investigator should follow the policies of their institutions for protecting potentially valuable intellectual property and know-how before publication.
Contractually, robust efforts will be made to keep all of the data on a project confidential until publication by the investigators and data and know-how will not be used by our corporate partners for patents and commercial uses.
No. Takeda does not have an exclusive right to license technology coming from Tri-I TDI. If Takeda is potentially interested in licensing an institution’s intellectual property that is under development in Tri-I TDI, Takeda may provide resources beyond those currently available through Tri-I TDI, such as high throughput screening for additional lead compounds, IND toxicology and formulation. Takeda has the privilege of making a first offer for licensing of TDI projects, but the investigator is under no obligation to accept the offer.
Tri-I TDI will marshal the resources of the participating institutions’ core facilities and add the major additional resource of pharmaceutical-quality medicinal chemistry. Takeda personnel will carry out synthetic and analytic chemistry for TDI projects. When appropriate, existing core facilities will carry out such tests as permeability, stability and pharmacokinetics, and therapeutic activity in models. In some circumstances, Tri-I TDI may retain the services of contract research organizations. It is hoped that if a drug is successful in reaching the IND stage either within TDI, or more likely, after licensing out, that the three institutions will continue to participate in the drug’s development either clinically or with correlative lab studies by the PI.
No. The existing cores will continue and in some cases grow. They will serve the faculty in their respective institutions, whether or not the projects have been submitted to or accepted by Tri-I TDI. They will perform many functions that precede full-scale medicinal chemistry campaigns, such as testing “hit” compound identity, integrity and purity, resynthesizing compounds or synthesizing small numbers of analogs of “hit” compounds in support of a preliminary analysis of structure-activity relationship. In many cases, the institutional chemistry cores will help investigators generate preliminary data for applications to Tri-I TDI.
Yes, this is a major goal of Tri-I TDI. Tri-I TDI will develop a range of educational activities on drug development for both trainees and faculty. These will include written materials, lectures, and hands-on learning opportunities related to key activities, such as assay design and refinement.
Tri-I TDI will have its own website soon after the Director is selected that will contain additional information about Tri-I TDI and links to application forms.