The Leukemia & Lymphoma Society has announced its first research partnership with a large biopharma company-a four-year, multimillion-dollar deal with Celgene Corp. to solicit and fund proposals from academics and smaller biotechs. The not-for-profit organization expects the deal's framework to serve as a template for future collaborations and is in talks with additional big biotech and pharma companies.

In its first year, the partnership will support up to 10 projects that explore basic disease mechanisms underlying hematological malignancies and up to 2 product development programs for advanced preclinical or early stage clinical candidates. Celgene will provide all research funding and will have right of first negotiation on any IP resulting from the projects.

"Over the last five years we've been partnering with biotech companies in earnest through the Therapy Acceleration Program, where we look for small companies that have assets that might be useful in treating blood cancers. What we hadn't had were partnerships with big pharma or big biotech," said Louis DeGennaro, EVP and chief mission officer of the Leukemia & Lymphoma Society (LLS).

Through the Therapy Acceleration Program (TAP), LLS funds the development of preclinical or early clinical assets discovered by academics or small biotechs. In return, recipients agree to pursue the funded project for a prescribed period of time and LLS is eligible to receive a fixed-multiple ROI that is fulfilled through a small royalty on net sales if a product makes it to market.

TAP currently supports 14 programs (see "Programs on TAP").

DeGennaro said a new program was needed to complement TAP and enable LLS to coordinate with biopharma companies to cofund external research projects. "We needed a new framework onto which we could build a partnership that would ensure that our mission was being fulfilled while at the same time ensuring that the pharma would get something out of the collaboration," he said.

Thus, the organization created the Targets, Leads and Candidates Program (TLCP) to support research via two distinct funding mechanisms: one tailored to early stage research into mechanisms of disease and one tailored to advancing preclinical or Phase I drug candidates.

Early and late

Celgene is the first participant in TLCP. The majority of the projects funded by the partners will explore basic science questions, such as identifying pathways and mechanisms that underlie the development of hematological malignancies. To narrow down research topics, Celgene and LLS will first form a joint steering committee tasked with identifying specific focus areas.

LLS then will issue a call for proposals from academic investigators, which will be peer reviewed in a process handled solely by the foundation. Applications that pass muster will be reviewed by the steering committee for final approval. DeGennaro said this selection and peer-review process is the key contribution LLS makes to the partnership.

"We have a well-established, proven infrastructure to identify high-quality research and have been doing this for 50 years. Our research grant funding has touched the discovery and development of every therapy used to treat blood cancers. What Celgene and other big companies can expect to get is access to that infrastructure and peer-review process and industry-quality project management by the LLS research team," he said.

Celgene spokesperson Greg Geissman said infrastructure indeed was a driver of the company's partnering decision. "We believe that LLS has a particular strength in its network and ability to identify promising early stage, foundational research at academic centers," he said.

DeGennaro said retaining internal control over the review process was essential to the structure of the partnership. "While the joint steering committee has the final go/no-go decision, the LLS vetting and peer-review process is intact. These are the rules that we felt we had to play by. At the end of the day it must be our internal review processes that judge what is worthy of funding," he said.

Unlike other academic project grants funded by LLS, the TLCP projects will have specific timelines, milestones and deliverables, with progress overseen by the foundation's staff.

TLCP will not operate in a vacuum, and to fund preclinical or early clinical-stage research the program will leverage the existing infrastructure used to identify projects eligible for the TAP program. LLS staff members will vet candidate projects as is currently done for TAP, and projects then will be presented to the joint steering committee, which will decide whether to adopt them as Celgene-funded projects.

Although the amount of research funding being provided by Celgene is undisclosed, DeGennaro said that projects will be funded over multiple years with annual budgets of between $200,000 and
$1 million, depending on the type of research and stage of development.

The partners hope to identify research areas of joint interest and issue the first call for proposals before year end.

DeGennaro said LLS is in discussions with potential biopharma partners to set up additional independent collaborations using the TLCP framework.


With additional reporting from Sydney Blankers, Research Analyst.

Cain, C. SciBX 5(40); doi:10.1038/scibx.2012.1046
Published online Oct. 11, 2012


      Celgene Corp. (NASDAQ:CELG), Summit, N.J.

      Leukemia & Lymphoma Society, White Plains, N.Y.