The Cancer Challenge
Winning the war on cancer is predominantly limited by finance. Driving breakthroughs in cancer therapeutics for patients depends on funding. Our current system of translational clinical research and FDA drug approvals often falls short. Why?
High risks with the current one-shot-on-goal approach mean the traditional success rate in bringing new therapeutic to market is only 4% to 6%.
Regulatory Time Frames
Regulatory time frames can take a single clinical trial an average of 6-to-8 years to successfully complete, and the near-term market does not justify commercial investment because current funding methods do not match the speed of science.
Soaring costs demand between $300 million to $1.5 billion per clinical trial in addition to three years of attorney fees to obtain FDA approval.
Lack of Collaboration
Lack of collaboration among multiple stakeholders can delay or derail a promising project.
A Three-Stage Obligation
To drive a cancer drug from bench to bedside all three independent stages must be fully financed separately.
Basic research is adequately funded through philanthropy, federal, and academic funding. It develops the compound or mechanism for the drug, therapeutic or diagnostic through the animal modeling phase and if successful, results in a patent for a potentially life-saving cancer treatment.
Clinical research is often referred to in the industry as the “Valley of Death”. This stage consists of phase I, II, III human clinical trials to test for the efficacy and safety of drugs, therapeutics and diagnostics. Its funding is woefully inadequate due to the absence of federal, philanthropic and academic funding. Clinical research is often funded through short-run private equity with a traditional success rate of ~4-6% at a cost of $250m-1.5b per compound, therapeutic or diagnostic. CanceRx fills this gap to bridge the “Valley of Death.’’
FDA approval phase receives no federal, philanthropic, or academic institutional support to drive completed clinical research through this critical approval stage. CanceRx will streamline the clinical research organization (CRO) data to the FDA.