The Lilly TB Drug Discovery Initiative (LTI) is a non-profit public-private partnership with a mission to accelerate early-stage drug discovery and to develop clinical candidates by bringing together specialists from around the world for the systematic exploration of vast, private molecular libraries in search of new TB treatments. Headquartered in Seattle, Washington, the Initiative’s goal is to fill the pipeline with new TB drugs.
The Initiative conducts a variety of projects ranging from early discovery to preclinical candidate evaluation, using the core capabilities of the member institutions. The Initiative’s capabilities include:
Access to the Lilly corporate compound collection of over 1 million molecular entities
High throughput screening facilities for biochemical targets
High throughput screening facilities for whole cell phenotypic screening under Biosafety Level 3
Target validation through molecular genetics
Testing of compounds against virulent M. tuberculosis using various microbiological assays
Access to proprietary computational analysis in hits to lead analysis
In vivo testing of lead compounds in validated animal models of disease
Advanced preclinical development advice from pharmaceutical industry experts
Advanced product development
We have conducted numerous projects in collaboration with other organizations. Learn more about successful collaborations here.
If you have biological assays or compounds with potential for discovery of new anti-tuberculosis drugs, we invite you to submit details for confidential consideration by the Initiative’s Executive Team. To do so, please contact us. You will be asked to complete a brief form for each project and given instructions for submission. Please note that the Lilly Initiative offers assistance through medicinal chemistry expertise, screening campaigns, access to the Lilly compound library, and advanced preclinical optimization, as a collaborative effort, but does not provide funding assistance.
The Lilly TB Drug Discovery Initiative (LTI) takes a carefully thought out approach to the protection of its members and collaborators’ intellectual property (IP). All agreements will be consistent with the following guiding principles:
While the LTI will develop compounds for TB, except in rare circumstances, the owners will retain all rights for indications other than TB.
The LTI seeks to protect IP for certain inventions discovered during the research and development of molecules for the treatment of tuberculosis with a focus on major market countries. LTI may file narrowly tailored patent applications to protect candidate compounds and/or a narrow genus of compounds closely related to the candidate compounds. LTI will not seek patent protection over mechanisms of action for broad classes of compounds or claim research tools arising from the research results.
Collaborators with the LTI will continue to own all right, title, and interest in any of their existing IP. To the extent a collaborator has received funding from the U.S. federal government, collaborators recognize they are bound by the requirements of the Bayh-Dole Act of 1980 to report any invention made with the LTI to the U.S. government. If LTI finds a hit in the Lilly library using the collaborator’s assay, Lilly will negotiate ownership interest with the participant and, regardless of ownership, such participant agrees to grant LTI an exclusive, royalty-free, sublicenseable, worldwide license in the field of TB.
Ownership of IP with collaborators who bring compounds to the LTI will be determined on a case-by-case basis.
1. Why was the Lilly TB Drug Discovery Initiative started?
TB remains a global problem and is developing into an even bigger problem than before, including TB caused by strains resistant to all existing antibiotics. To fight TB we urgently need new classes of antibiotics to shorten the current lengthy therapy and to treat drug resistance. The pharmaceutical industry estimates that a million compounds need to be screened to get 10 candidates into clinical trial, and from these 10, only one is likely to become a new medicine. With the odds so low, it is important to evaluate many more compounds to find new TB drug candidates. LTI was created with a mission to accelerate early-stage drug discovery by bringing together specialists from around the world for the systematic exploration of vast, private chemical libraries.
2. Why did Lilly get involved in the Initiative?
Eli Lilly and Company launched the Initiative in 2007 as part of its philanthropic Multidrug Resistant TB Partnership. The Company has committed more than $20 million to establish and support the Initiative, including $9 million in-kind donation of high throughput screening and chemistry equipment as well as access to research tools and technical expertise.
3. Does the Initiative offer funding assistance?
No, the Initiative does not provide funding to collaborators, but it does offer assistance through medicinal chemistry expertise, screening campaigns, access to the Lilly compound library, and advanced preclinical optimization as a collaborative effort.
4. What kind of success has the Initiative had?
The Initiative has established a series of productive collaborations with outstanding scientists and organizations, resulting in a portfolio of projects spanning early discovery to preclinical.
5. How do I collaborate with the Initiative?
If you have biological assays or compounds with potential for TB drug discovery, you may confidentially submit details for confidential consideration by the Scientific Advisory Committee.
6. How can I find out if my compounds have activity against TB?
Instead of a proposal to the Scientific Advisory Committee, you may want to consider submitting compounds to Open Innovation Drug Discovery (OIDD) to be tested for anti-tubercular activity. OIDD was established by Eli Lilly and Company, and the Initiative participates in the program with IDRI providing a panel of TB assays. In addition to information about compound activity, investigators may gain access to relevant computational methods and participate in structure design cycles.
7. What happens if one of these compounds is a success; what are the next steps?
Candidates that emerge from this process ready for clinical trial could be further developed by the Initiative, the private sector, the donor or some combination of organizations. Once approved for TB therapy, we envisage partnerships with other companies, government agencies and world health organizations.
8. Why should people in developed countries care about TB – a disease that is mostly prevalent in developing countries?
People think of TB as a disease of the past, but without the right treatment, TB will be a disease of the future. In 2013, the World Health Organization (WHO) estimated that there were 9 million new cases of tuberculosis worldwide. Of those, over 480,000 were resistant to the two most potent anti-tuberculosis agents, isoniazid and rifampin, and were consequently classified as multidrug resistant TB (MDR-TB). Cases of extensively drug resistant TB (XDR-TB) have recently been reported, and some countries have found cases of strains completely resistant to all known anti-tuberculosis drugs. 100 countries worldwide reported XDR-TB cases in 2013. On average, an estimated 9% of patients with MDR-TB have XDR-TB. Every person in every country is at risk.