USC Norris Comprehensive Cancer Center
An NCI-designated Comprehensive Cancer Center
ACCELERATING PROMISING ONCOLOGY THERAPEUTICS INTO THE CLINIC THROUGH COLLABORATIVE DRUG DEVELOPMENT
About the CCDD at USC Norris
USC Norris Comprehensive Cancer Center (USC Norris) is pleased to launch the Rosalie and Harold Rae Brown Center for Cancer Drug Development (CCDD) with a generous gift from the Rosalie and Harold Rae Brown Foundation. The CCDD employs an integrated academic-industry focused management model to engage investigators from different disciplines, collapse gaps in expertise, resources, and funding, and ensure that programs have a high likelihood of progressing to late Pre-Clinical stage development and submission of an Investigational New Drug (IND) application. Initial projects will be sharply focused on cancers that disproportionately affect members of the community for whom there are dramatic ethnic and racial disparities, such as breast cancer, prostate cancer and colorectal cancer, and blood cancers.
Advantage for USC Researchers
- Help researchers navigate the challenges of drug development.
- Provide a rigorous but collaborative approach to managing the drug development process that is driven by timelines and milestones.
- Provide financial resources and advisory capabilities.
- Leverage expertise across USC and enable access to existing core facilities to support drug discovery activities.
- De-risk projects and enhance the likelihood of partnership and progression to clinical development.
Advantage for Industry Partners
- Connect to a highly collaborative, NCI-designated comprehensive cancer center, clinical trial expertise, and one of the most diverse patient populations in the country.
- Earlier access to innovative preclinical drug candidates that can be expedited to IND readiness.
- Formulate partnering strategies that will de-risk projects and accelerate path to patients.
- Flexible agreement models that are mutually beneficial.
Caryn Lerman, PhD
Director, USC Norris Comprehensive Cancer Center
Associate Dean for Cancer Programs
H. Leslie and Elaine S. Hoffman Chair in Cancer Research
“This gift will have an immediate impact by transforming USC Norris discoveries of the underlying causes of cancer and disease progression into new treatments and clinical trials for our patients.”
CCDD Scope
- Drug Development Stage focus: Target identification up to Phase 1.
- Therapeutic Areas: Oncology needs and USC Norris catchment area priorities.
- Therapeutic Scope: small molecules, large molecules, antibodies, cell therapies, and vaccines. Repurposing of existing drugs with known safety profiles and mechanism-based therapies with strong associated biomarkers of response. Finding effective combinations for drugs that were abandoned for lack of single agent activity.
- Process: The level of funding for target ID to pre-clinical will be evaluated by a new systematic and transparent process which includes internal experts and external advisors.
- Business Model: Secure strategic external partnerships for high-impact projects; leverage internal cores as appropriate.
- Eligibility: Individuals with a track record of conducting cancer research. Concepts from USC Norris members may be prioritized.
CCDD Goals
- Identify high potential projects and support the development of Oncology therapeutics through strategic alliances with expert drug development partners.
- Provide specialized concierge service through the MESH Academy to USC researchers and External Partners that will:
- Grow a community of innovative drug developers.
- Build and manage relationships and strategic alliances with industry and venture capital.
- Formulate partnering strategies that will de-risk projects and accelerate path to patients.
- Provide one-on-one project consultation and training materials pertaining to science and business considerations unique to drug development.
- Leverage expertise across USC and enable access to existing core facilities to support drug discovery activities.
CCDD Process
The USC Norris CCDD drug development process is uniquely structured in partnership with faculty to accelerate a rigorous review of projects. This process will be managed by the MESH Academy Business Development and Industry Relations team to ensure transparency, establish a central point of contact, and reduce redundancies and missed opportunities.
How to Submit Targets to
CCDD
Faculty are invited to complete the USC Norris CCDD in-take form and return this form to the MESH Business Development and Industry Relations (BDIR) team. The in-take form will also be made available on the KSOM intranet, MESH website, or can be requested directly from the MESH team.
This form is the first step in the CCDD review process that is focused on scientific rationale and unmet need. The MESH BDIR team will review the in-take forms and triage according to the specific criteria and responses provided by the faculty. This is a collaborative approach and faculty who have submitted projects can expect frequent interactions with MESH BDIR throughout the review process.
Deep Dive Review to External Advisory Committee
Upon review, faculty will be notified whether their submission enters the second step: Deep Dive review (commercial viability and IP analysis). MESH BDIR will research information on the competitive landscape for a submitted project and connect with the USC Stevens Center for Innovation to obtain information on intellectual property matters as needed. This information is incorporated with the intake form and each project is presented to the CCDD Directors and the USC Norris Executive Committee for review. CCDD Directors will then present this information to an External Advisory Committee (EAC) for feedback, which will enable the prioritization of targets.
Decision to Advance to Project Plan Initiation and Partnering
The list of prioritized targets and the feedback from the EAC will be presented to the USC Norris Director who will decide whether to advance the project to the next stage, with input from the USC Norris Executive Committee.
For targets that are advanced, faculty will work collaboratively with CCDD Directors to develop a plan, including development of milestones, budget, timeline, additional resources needed, and partnering strategy. For targets that do not advance, faculty will receive feedback and have an opportunity to resubmit.
Approved projects typically fall into one of these categories:
- Managed by CCDD, including an investment of funds and/or cost-share by strategic partner.
- Managed by CCDD, without investment of funds but include in-kind contribution from external partners or collaborators.
- Moved directly into discussions with prospective industry partners.
CCDD Partnering Zone
The MESH BDIR team will collaborate with the faculty/project team and with potential prospective external collaborators to formulate a partnering strategy that is mutually beneficial. The focus of the partnering zone is to:
- Build relationships to create long-term value.
- Bridge gaps in expertise, resources, and funding.
- Encourage partnering discussions at any stage of development.
- Provide optionality for USC to accelerate their targets to therapy.
Contact Information
For more information on the CCDD review process, please contact Melissa Rodgers or Camilo Ansarah-Sobrinho from the USC MESH Academy Business Development and Industry Relations team.
For general questions or interests in partnering with the CCDD, please contact Vasiliki Anest, Business Director.
To learn more about giving to USC Norris, please contact Robert Weiner, Assistant Vice President of Development, at Robert.Weiner@med.usc.edu.
CCDD Team
Caryn Lerman, PhD
Director, USC Norris Comprehensive Cancer Center
Associate Dean for Cancer Programs
H. Leslie and Elaine S. Hoffman Chair in Cancer Research
clerman@usc.edu
Heinz-Josef Lenz, MD
CCDD: Co-Director
lenz@usc.edu
Steve Kay, PhD
CCDD: Co-Director
stevekay@usc.edu
Vasiliki Anest, PhD
CCDD: Business Director
Vasiliki.Anest@med.usc.edu
Camilo Ansarah-Sobrinho, PhD
Business Development and Industry Relations
Camilo.ansarah@med.usc.edu
Melissa Rodgers, PhD
Busines Development and Industry Relations
rodgersm@usc.edu