THE LEUKEMIA & LYMPHOMA SOCIETY ANNOUNCES OUR

Screen to Lead Program (SLP)

INTRODUCTION

The Leukemia & Lymphoma Society (LLS) is sponsoring and issuing this Request for Applications (RFA) from qualified academic laboratories for drug discovery support specifically directed towards medicinal chemistry and/or drug target screening in hematological malignancies. LLS recognizes a significant need for investigators to receive resources for high-throughput screening and optimization of small molecules into drug-like compounds suitable for in vivo testing in a disease-relevant model that can be used for further preclinical proof-of-concept testing of the new drug target. Up to six laboratories/projects will be selected during the first year to participate in this new model of collaboration whereby LLS, grantee, sponsoring institutions, investigators and appropriate service providers such as contract research organizations ("CRO") or core facilities at academic institutions, work together to develop compounds with the potential to change the standard of care for patients with blood cancer. Continued funding/sponsorship will be contingent on available funds and assessments of progress toward the goals outlined in each individual proposals accepted by LLS.

OBJECTIVES

The goal of this RFA is the development of small molecule for in vivo proof of concept studies in disease relevant animal models for hematological malignancies. Proposals should include strong scientific rationale for a new drug target in a hematological malignancy; provide information to assess existing intellectual property or the potential for novel chemical space; demonstrate or explain how a screening assay can be developed to accommodate a high volume of compounds; or indicate how a tractable lead compound can be further developed.

ELIGIBILITY

Investigators at academic laboratories are eligible to apply. Investigators must demonstrate that their research environment is equipped and suitable for aspects of the work plan that would be carried out at their facility or in their lab rather than at a CRO. Collaborations between multiple investigators to strengthen the work proposed will be considered favorably, but are not a requirement. Applicants need not be United States (U.S.) citizens nor associated with a U.S.-based institution. Applicants should hold a Ph.D., M.D., D.V.M. or equivalent degree.

APPLICATION and AWARD INFORMATION

LLS plans to sponsor several awards during the initial year of this program. It is anticipated that each project will be unique and the cost of each work plan variable, depending on the nature of the medicinal chemistry work required. For this reason, applicants will need to submit a proposed work plan (subject to modification by LLS and collaborators upon review) and a proposed budget with justification for its relationship to the work plan. These factors will be evaluated as part of the peer review application process. As collaborators in CROs or core facilities will conduct the greater portion of the work, LLS will coordinate the appropriate contracting for services according to the work plan. LLS will work with applicants to determine where the work should be conducted and help to manage the process. For any budgeted line items that are specifically related to the PI, for work conducted in their laboratory, indirect costs will be capped at 11.1%. Any new intellectual property created through this collaboration shall be owned and managed by the academic institution. LLS and CRO?s subcontractors shall assign all ownership rights to the institution. LLS will put in place, as it does with all its grants, an IP policy that must be agreed upon and executed at the time an award is accepted by a researcher and researcher's academic institution.

Applicants should include the following in their application:

• Scientific rationale for novel target in hematologic malignancies and summary of supportive data
• Characterization of existing compounds, where appropriate;
• A summary of the intellectual property landscape (to the best of knowledge) on the target/chemical space;
• Description of unmet medical need, i.e., what therapeutic deficiency will this new drug target address; and
• Capabilities of support from laboratory (i.e., describing the level of throughput for assays applicants propose to run in their laboratories)

APPLICATION FORMAT and SUBMISSION

Applications should be no more than five pages in length. Application templates may be obtained by e-mailing us at researchprograms@lls.org or by dowloading the Screen to Lead Application here.

Applications must be submitted as a Word document or PDF file by email to researchprograms@lls.org. While applications may be received on a continual basis, a formal review will take place once a year. As such, the cut off for the receipt of applications is on the following date/time:

Call for Proposals: November 2012

Deadline: January 3, 2013, 5:00 p.m., ET

Scientific Peer Review Committee: April/May 2013

Notification of Awards: June 30, 2013

Anticipated Funding Start Date: September 2013

DESCRIPTION of PEER REVIEW PROCESS

Each application will undergo a thorough review that consists of two parts. There will be an internal review by LLS Research staff for compliance with guidelines, eligibility, and responsiveness of the project to the RFA. The internal review may involve additional requests for more detailed information on the project and direct discussions between the PI and LLS Research staff regarding the proposal to assess the appropriateness of the project.

There will be a second review hosted by LLS that is a more extensive external peer review by experts in drug discovery and development, medicinal chemistry, and hematological malignancies. The second review will involve a short PowerPoint presentation of the proposal to the peer review committee that will allow for questions and further discussion.

The application will be assessed upon the following criteria:

• Scientific Rationale and Supportive Data
• Unmet Medical Need/Scientific Impact
• Research Plan & Feasibility
• Resources & Qualifications of the PI