Solve | The SKC Approach
The SKC Approach to Childhood Cancer
SKC was created not as a conventional charity but as a nonprofit enterprise that funds and manages a new model in therapeutic development for pediatric cancer.
It all began with one ultimate goal in mind: improving survivorship for all children with the deadliest forms of cancer.
- SKC does not intend to transform the existing clinical development system through advocacy and awareness efforts. Instead, we aim to change the system by facilitating the therapeutic development process through our scientific programs.
- SKC envisions a system that provides appropriate therapeutic intervention to children with cancer immediately, and that simultaneously develops daring research projects that lead to therapies that make survivorship possible.
- SKC’s only goal is to provide children with more effective and less toxic options in the form of therapeutic agents. SKC is not in business to have an agent approved by the FDA or marketed for sales.
- SKC will support any therapy, whether it is an investigational (IND) agent, an already approved drug, or a compound that would not be considered commercially viable. If a trial is successful, it may then be progressed to a later phase trial by a large multicenter consortium, industry, or by SKC.
- SKC aims to create 10 new and effective therapeutic options per year.
SKC solves the problem of pediatric cancer from many angles
SKC believes the deadliest childhood cancers will not be stopped by one agent or one targeted approach. There are multiple and varying processes that contribute to cancer, therefore we believe it is necessary to investigate multiple paths to successfully stop it.
SKC supports therapeutic development projects that target these key paths.
This is accomplished using both existing and novel therapies that are the most scientifically promising.
SKC continuously investigates therapeutic options that are aligned with the identified Therapeutic Paths. We urgently seek ideas from the community of cancer scientists, filter them, and match them against these identified paths.
SKC sponsors pilot, proof-of-principle, and Phase I clinical trials that drive a gained understanding of both safety and efficacy of promising therapeutic agents.
SKC attempts to avoid studying single-agent therapies if evidence shows that using a multi-agent approach would be more therapeutically beneficial. Focusing solely on single-agent therapies could potentially hinder the development of life-extending therapies.
Multiple disciplines for continuous innovation
SKC brings a novel “think-tank” approach to therapeutic development in pediatric cancer. SKC’s Therapeutic Development Initiative (TDI) brings together the diverse knowledge and experience of scientists who represent multiple disciplines in cancer. To tackle this challenging problem, SKC believes we must reach out to experts beyond the immediate field of pediatric oncology to tackle this challenging problem. As such, our TDI board includes leading pediatric oncologists and researchers, as well as experts from other key disciplines, including immunology, systems biology, adult oncology, and clinical trial design. This ensures innovation and creative thinking, and optimizes review of project ideas.
Multiple sources for greater output of ideas
SKC and our Scientific Advisors investigate new scientific ideas to identify promising areas for therapeutic development that already exist in basic research. We also seek ideas from the worldwide scientific community through our TDI. SKC’s Scientific Advisory Board organizes, validates, and prioritizes the most promising of these ideas.
Grant submissions are reviewed on a rolling basis by the TDI Scientific Advisory Board. Additionally, the TDI will solicit specific therapeutic development projects in board-identified areas of importance through the scientific community. Once submitted, an idea is prescreened by the TDI Scientific Advisory Board. If accepted, final approval is contingent on a more thorough review and approval of milestones, budget, protocol, and processes.
Multiple roles to speed the process
- SKC works to remove obstacles that can hinder principal investigators from expediting therapeutic development by:
- Acting as ambassadors to the Life Science’s Industry on behalf of investigators to gain access to promising therapeutics in the pipeline
- Coordinating all stakeholders involved in progressing a therapeutic option — the investigator, Industry, academic research institutions — to make the process as effective as possible
- Participating in the design and roll-out of programs to ensure speed and effectiveness
- Creating standardized and reproducible negotiating contracts between SKC, pharmaceutical or biotech companies, and clinical institutions to save valuable time and resources
- Issuing funding in an accelerated manner
- Maintaining an accessible, user-friendly, and electronic grant submission portal accessible to anyone
Upon final approval of a grant submission, SKC works to develop the project and implement it as quickly as possible. This often includes:
- Negotiating a budget, timeline, protocol, goals, and milestones
- Ensuring as many children have access to the project as possible
- Expediting the project launch actively managing numerous logistical aspects, including:
- Streamlining the contract process
- Getting access to the agent
- Helping with the regulatory process
- Acting as a project manager
- Providing support through a contract resource organization (CRO)
The following articles represent the essence of the SKC Approach. SKC is applying the ideas expressed in these articles to pediatric cancer.
- Daniels C. Milken - The man who changed medicine. Fortune. November 15, 2004. [pdf]
- Specter A. A bridge across the valley of death: The Cures Acceleration Network Act. Cures Acceleration Network Act. April 25, 2009. [pdf]