Venture philanthropy models: The Leukemia & Lymphoma Society's Therapy Acceleration Program
FasterCures has long believed that philanthropy can be a significant force for progress in medical research, when applied strategically. In an extremely informative Webinar on June 19, participants heard about a terrific example of the strategic application of philanthropy at the Leukemia & Lymphoma Society (LLS) in its Therapy Acceleration Program (TAP).
Lou DeGennaro, Ph.D., chief mission officer of LLS, began by describing the unique role LLS is playing in forging partnerships and “aligning all the players in the treatment ecosystem” – academic researchers, the pharmaceutical industry, the FDA, payers, and patients.
Every year LLS funds about $60 million in academic research grants, and it currently manages a portfolio of about 300 projects. In order to move the promising results of some of those projects toward new therapies for patients, however, LLS realized it needed to fund more than basic discovery, and it has built a suite of programs over the last few years, now called the Therapy Acceleration Program, to do that:
- The Academic Concierge supports translation of projects pulled from the academic grant portfolio
- The Biotechnology Accelerator invests in companies to assist in gaining proof-of-concept findings and leveraging follow-on funding
- The Clinical Trials program plans to introduce a network of Phase I and II clinical trial sites to accelerate studies in blood cancers
DeGennaro discussed some of the details of LLS’s diligence process in choosing which opportunities to invest in. They look at the results of their basic research grants “through not only an academic science lens but through a drug development lens,” looking for projects that are ready to move into translational stages of development. They find companies in which to invest by participating in biotech and pharma investor conferences. They look for investments to which LLS can bring unique value as a partner, beyond the funding. Last year 48 opportunities were evaluated and only four approved, with a similar record so far in 2013.
DeGennaro also described some of the elements of their contract structure (including timeline/milestones/deliverables, interruption clauses, and return on investment) and how they measure the impact of their investments. Many of the academic and industry assets in which they have invested have been partnered, licensed, or acquired by biopharma companies, resulting in leverage of 30 times LLS’s investment – more than 100 times if out-year milestones are included. “We are a catalyst for further investment,” DeGennaro noted.
Lawrence Mayer, Ph.D., founder, president, and head of research at Celator Pharmaceuticals, discussed some of the details and benefits of its partnership with LLS. TAP provided funds that allowed Celator to evaluate a new leukemia drug in two large, randomized Phase II trials for acute myeloid leukemia. Results in both trials were very positive, and additional TAP funding is helping Celator complete the final Phase III trial required to get the product to patients.
Mayer highlighted key elements to the success of the Celator-LLS partnership:
- LLS funding allowed them to conduct two randomized trials instead of one, and to size them appropriately, allowing for more definitive results
- LLS’s review process was very efficient
- Realistic goals, milestones, and costs were negotiated by knowledgeable individuals with past experience in drug development
- LLS’ “good housekeeping seal of approval” helped the company complete financing for Phase III
As Mayer later noted in answer to a participant’s question, it was very important that “our proposal was central to what we were on a path to do as an organization … If a company views the TAP funding as ‘it would be nice to be able to try our drug out in another new cancer type without having to incur a lot of costs,’ I think the ability to develop a compelling and successful application may be hampered.”
Finally, DeGennaro described LLS’ most recent program, Targets, Leads & Candidates, which provides a contractual framework for partnerships between LLS and pharmaceutical companies, the first being Celgene. Industry partners provide funding for academic grants and/or for TAP investments, and LLS provides the process and infrastructure for identifying high-quality research and industry-quality project management.
To date LLS has funded the development of nearly every drug that has been used in the battle against blood cancers, and it is continuing to forge new paths in the quest for better solutions for patients.