Supporting cancer research is good. It’s important. It funds scientists and labs and countless “EUREKA!” moments in the lab that might help cancer patients. But research isn’t the wole story. In fact, it’s a very small part of the story.
What happens after the money you’ve donated, the money awarded by the National Cancer Institute and provided by other organizations, has funded a breakthrough discovery? How does that innovation get to market so it can start helping real patients? What happens BEYOND RESEARCH, as we like to call it?
Have you ever played the Game of Life? In that classic boardgame, you move down a path, sometimes being thrown curveballs that change your direction or goals.
The path of a medical breakthrough is similarly fraught. And it takes a LOT of money. Its a bit like the game of life – the “Game of Medical Breakthroughs”, if you will. So we made one so we could show you the long path that it take BEYOND RESEARCH for cancer innovations to finally reach patients.
Take a look.
That’s a lot. Let’s break it down a bit. For an example, we’ll look at how a new cancer drug gets to patients.
Research Phase (this is the phase that is paid for by government and private support for cancer research)
Hundreds of thousands – sometimes millions – of dollars go into research projects at labs and universities across the country. This research is funded by the National Cancer Institute, foundations, non-profit organizations and others. When you give money to support cancer research, this is where it goes. And it’s a lot! In the US alone, we’ve spent over $100 billion on cancer research since the start of the “war against cancer” in the 1970s.
And this support can result in some amazing “EUREKA!” moments. But while the the federal funding and non-profit “cancer research” stops there, that’s not the end of the journey.
After the research EUREKA moment, the basic science from the lab has be turned into a product or application that can be used in treatment. This is a crucial stage where scientists begin networking to form a company. They’ll need to recruit a team; scientists to carry out the many stages of testing and refinement, entrepreneurs to build the business, and advisors. And they need to find money to finance the efforts. Finding money is one of the recurring themes in this game.
Discovery and screening are part of this phase. That’s where the new company tests to see what the innovation (from that well-funded lab or university) can truly accomplish. For our example cancer drug, they work to answer questions like: How does the drug work in the development lab on cancer cells? How do we administer the treatment? Is it safe?
This process involves many iterations of test, develop, retest, redevelop. Often, they need to test the concept in animals to evaluate different ideas to find the one that is most effective and poses the least risk. They’ll work to find the very best solution (or “candidate”), then move into pre-clinical development.
Next come those pre-clinical tests (animal or cellular testing) and finally, the Investigational New Drug (IND) Application to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Wait . . . did we say “finally”? That was just the “finally” for this phase of the game – the first “finally.” To get to this point typically costs $6 to $15 million dollars in private funding that’s BEYOND RESEARCH.
This stage is crucial because this is the time to prove the innovation works and is safe. That means that it needs to be rigorously tested in controlled trials.
We won’t hold out on you for this phase. You want the sticker price? The Clinical Phase for our new cancer drug example can cost $40 to $70 million dollars.
The Phase 1 clinical trials involve 20 to 80 patients. Once Phase 1 has shown that the innovation is safe, it can move on to Phase 2, with a larger group – hundreds of patients. Phase 2 tests efficacy – does it work like we expect it to? Once that hurdle is cleared, we got to Phase 3, where it expands to thousands of patients.
Different types of innovation require different levels of testing. A simple, non-intrusive device takes less. Drugs require more rigorous testing.
By the time we’ve completed the clinical phase, we’re into money on a large scale. For new drugs, we’ve racked up anywhere from $48 to $85 million dollars – of “BEYOND RESEARCH funding.
And the journey isn’t over yet.
The final phase, at least for the sake of our board game. For our example cancer drug, this is the New Drug Approval (NDA) process. After the research, after the innovation, after the clinical trials – assuming they all went well – the company has to prove two things:
1. That the drug is safe and efficacious (it does what it’s supposed to do and is safe for patients)
2. That it can it be produced reliably and consistently
This stage can also carry a price tag of $4 to $5 million as the company jumps through the approval hoops. The FDA review meeting of clinical trial results. Jump! The New Drug Application. Jump! Application Review. Labelling Review and Approval. JUMP JUMP! Lastly, the Facility Inspection. And then. ONLY then, does a company prepare the drug for launch.
How Do We Get Innovation BEYOND RESEARCH to help patients??
The journey from the “start square” to winning the game (or launching the life-saving drug) is long and takes a lot of money. Money that isn’t covered by cancer research funding. Money that’s needed BEYOND RESEARCH.
That’s why CANCER FUND exists. Because our founders did some digging and were shocked to learn that so much more needed to be done beyond those research donations. And we first thought that was someone else’s problem. But we realized it isn’t. Traditional investment money is available, but it’s rare in the early stages where the risk is high.
“Someone else” isn’t doing that. WE need to raise funds to move these companies and their innovations across that game board and to the finish line. Because lives depend on it. And together, we can do it.