Regulatory Focus™ > News Articles > Cancer Center Announces $3 Billion Anti-Cancer Initiative, With Focus on Regulatory Challenges

Cancer Center Announces $3 Billion Anti-Cancer Initiative, With Focus on Regulatory Challenges

Posted 21 September 2012 | By

"We choose to go to the moon. We choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win, and the others, too." - John F. Kennedy, 25 May 1961

On 25 May 1961, US President John F. Kennedy's now-famous "moonshot" speech kicked off the launch of a new era of exploration, transforming the US from a nation that had never sent a man into space into a nation that was the first to send a man to another terrestrial body. Now, a new $3 billion initiative by the University of Texas' MD Anderson Cancer Center is trying to replicate that spirit, calling for a giant leap to fight cancer.

Calling the initiative, dubbed the Moon Shots Program, a "disruptive paradigm," MD Anderson officials said the program would work to bring numerous parties together in the hopes of generating new drugs, devices, tests and policies in the hopes of bringing new cures to patients.

"The Moon Shots Program signals our confidence that the path to curing cancer is in clearer sight than at any other time in history," said Ronald DePinho, president of MD Anderson. "I believe that we have many of the tools we need to pick the fight of the 21st century."

Regulatory Challenges at Center of Initiatives

The program will first focus on eight cancer types responsible not only for a disproportionate number of fatalities, but also for their potential for mitigation in the short term. Each of the trials will be given a number of resources to assist development, including some tools that may assist in the eventual regulatory decision making of the US Food and Drug Administration (FDA). For instance, MD Anderson said it will provide the tools to develop biomarker-driven clinical trials, genome sequencing for patients, new tools for detecting early-stage cancers, new diagnostic tests, data analytics and translational research to reduce clinical trial times and costs.

Advancements in these sciences could ultimately lead to faster, cheaper and more definitive clinical trials capable of generating high-quality evidence that leads to shorter review times by federal product regulators.

The initiative will also develop what it's calling the Center for Co-Clinical Trials, a program aimed at using animal and human cell models of human cancers to research the use of new drugs and combinations of existing drugs to try to find subsets of patients who might respond particularly well to a therapy. Another center, the Institute for Personalized Cancer Therapy, is set to analyze the genomes of patient tumors to direct them to the best clinical trials, while an Institute for Applied Cancer Science is set to develop targeted cancer therapies for patients.

The program, being billed as the, "most ambitious program MD Anderson had ever mounted," will take place over the coming decade, with total costs estimated at $3 billion. The program will begin in February 2013, with the program operating at capacity by mid-2013. 


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