Center for Cancer Drug Development - USC Norris 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.

How to Submit Targets to CCDD

CCDD Partnering Zone

CCDD Team

CCDD Scope

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.

Intake Submission, Triage Review

Faculty complete Intake Form. This signals the first step in the review process.

Faculty will be paired with a MESH representative to:

- - Understand Scientific and Technical Rationale
  - Discuss unmet needs and business considerations
  - Create a path to clinic showing critical inflection points
  - Incorporate information into presentation for EAC review

No cookie cutter approach – each innovation is unique and requires iterative dialogue with faculty to engage and co-create a successful path to the clinic

How to Submit a Target to CCDD:

Please complete the USC Norris CCDD Intake Form and return to the MESH BDIR team at mesh.academy@usc.edu, or submit via the online submission form.

If you have any questions or would like to discuss your target/therapeutic before submitting the intake form, please contact the MESH BDIR team at mesh.academy@usc.edu.

External Advisory Committee (EAC) Review

Faculty give short presentation, followed by Q&A.

EAC will rank each project based on 7 criteria:

- - Scientific Rational
  - Technical Probability of Success
  - Innovation (differentiated solution/unmet need)
  - Fundability – Government, Foundations
  - Fundability – Industry, Venture Capital
  - Current IP Position
  - Potential to create new IP

EAC will provide list of prioritized targets with feedback to the CCDD Leadership team.

Decision to Advance, Project Plan and Partnering

EAC will provide list of prioritized targets to advance

For targets that are advanced, faculty will work collaboratively with:

- - CCDD team to develop a project plan, including development of milestones, budget, timeline, additional resources needed to get to the next inflections points.
  - Domain experts (i.e. clinicians, population science, regulatory)
  - MESH BDIR to formulate industry collaboration/partnering strategies

NCCC Director provides final decision on budget requests

Approved projects typically fall into one of these categories:

- - Managed by CCDD, including an investment of funds
  - Managed by CCDD, including an investment of funds with in-kind and/or cost-share by internal or external strategic partner
  - 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 Minhaal M. Nathani, Senior Director of Development, at Minhaal.Nathani@med.usc.edu