February 15, 2016 / All Stories

Moving drug discoveries beyond ‘the valley of death’

Universities, governments and private industry are working together to more rapidly translate scientific breakthroughs into medicines that reach patients instead of disappearing in the “Valley of Death.” Here’s some insight into how.

Every year, hundreds of thousands of potential drugs die in the valley of death. That’s what academic scientists call the time between a basic science discovery (usually in academic labs) and the decision to commit resources to develop the idea into a drug (almost always by industry).

Many discoveries, for a variety of reasons, never clear that hurdle. In 2015, for example, scientific journals published 1.2 million medical research papers, but only 396 potential drugs were submitted to U.S. regulators for permission to begin human testing. Not every paper represents a potential breakthrough medicine, of course, but there is growing recognition that something needs to change to narrow the gap.

“Medical science has amazing power to improve people’s lives, but to do that, we need to quickly translate the best ideas into breakthrough medicines and put them in the hands of patients,” says Michael Severino, executive vice president of research and development for AbbVie.

Academia and biopharma: an essential partnership

Even in the best circumstances, drug development takes years. The first steps involve evaluating the discoveries, identifying the most promising ideas and performing the necessary experiments to learn which ones will ultimately result in a drug. “It’s difficult to decide which of those 1.2 million ideas is going to become a drug, and that’s the reason for that gap,” Severino said.

Universities, governments and private industry all have roles to play, and are using a variety of programs and partnerships to move promising discoveries beyond the valley of death.

Academia is especially important, because most basic science insights that lead to the identification of proteins or genes implicated in a specific disease – come from academic scientists, says Jim Sullivan, vice president for discovery at AbbVie. “But when you think about what’s involved in translating those initial breakthroughs into effective drugs that reach patients, the vast majority of those innovations and discoveries take place within the biopharmaceutical industry.”

That includes creating a compound – usually a small molecule or biologic – that acts on the protein or gene identified in the basic research stage, can be manufactured and delivered as a pill or injection, is easy for patients to take, reaches the disease-causing protein, has the desired effect and is well tolerated. "It is a complex, challenging process that can take four to seven years and requires expertise in several very different scientific disciplines," Sullivan says.

Unfortunately, the traditional academic world isn’t well suited for that kind of work, says Daria Mochly-Rosen, founder of Stanford University’s SPARK program. SPARK is a partnership between the school and industry that helps the school’s scientists develop and commercialize their ideas. Dozens of similar programs exist at other universities around the world.

“Academics often don’t understand what’s required for that kind of applied research, because they’re focused on basic biological research,” she says. The culture of most research universities also rewards basic research discoveries, not developmental discoveries. As a result, academic scientists often miss opportunities to help industry understand their innovation and see its potential.

Daria Mochly-Rosen, founder of Stanford University’s SPARK program, shares how she liberates potential drug discoveries from academia to industry and why it matters. Read More

Breaking down silos

The Stanford scientists meet weekly with outside advisors from industry, who provide advice about how to turn the initial ideas into drug candidates that industry can develop. That might involve early work in medicinal chemistry or toxicology or just information about the eventual drug’s potential market.

More formal partnerships between industry and academia also are important sources of new ideas, but they need to be focused to be successful, Severino says. “The sort of broad programs where you just say 'we're going to write a big check to an academic institution and they're going to supply us with a lot of ideas for great drugs,' those rarely work.”

"Shared interest and shared expertise are what make these collaborations work,” Severino said.

“For example, in our collaboration with Washington University, we work with some of the world's leading Alzheimer’s researchers, and combine our technology with their expertise so we can create a real chance of delivering something special.”

AbbVie has partnerships with many other academic institutions, including with Yale University on immunology, another with Massachusetts General Hospital around Alzheimer’s, and one with MD Anderson in oncology.

Licensing is another important source of potential new drugs, but it has its limits, Severino says. “You have to be agnostic about where the best innovation comes from, but none of these programs can ever replace your internal R&D engine,” Severino says. Also, you have to stick to areas you’re familiar with, he says. “It’s hard to make good licensing decisions if you’re not actively innovating in that area, because you don’t know what good looks like.

“But when it comes to our core R&D areas – immunology, oncology, virology and neuroscience – our expertise gives us a real chance at a breakthrough, because we know how to evaluate opportunities and move the best drug candidates beyond the valley of death to benefit patients.”

Learn more with a Q&A with Daria Mochly-Rosen, founder of Stanford University’s SPARK program.

What is the SPARK program, and what led you to create it?

SPARK is a partnership between academia and industry that helps faculty and students within the Stanford University School of Medicine develop and commercialize their inventions.

It’s based on my experience trying to develop some tools I created that I thought might be drugs or drug leads. No companies wanted to license the technology, and colleagues warned me not to start a company to do it myself. They said, “Industry is out to get you; all they do is take your ideas and shove you away.”

I decided to move forward anyway, so I founded the company and planned to work at it for one year. I came back to Stanford after that year, but I stayed involved with the company for 11 years until it was acquired by Amgen.

I was really struck by how wrong my notions – and those of my colleagues – were about industry. I also realized that most of our students were going to work in industry, and that as a university, we were doing a very bad job of teaching and preparing them for those careers. I also feel we have a responsibility to do something to develop our inventions if we think they might help patients.

So I decided to start a program to help others develop inventions that were sitting on the shelf for lack of interest. I recruited advisors I had worked with during my time in industry, and many of them have been coming to Stanford every Wednesday night for eight or nine years as volunteers.

How does it work?

The inventors are faculty or students at Stanford who have come up with novel drug targets, new chemical entities or potential new uses for existing drugs. They meet weekly with outside advisors from industry.

We provide very little funding but we provide a lot of advice and real experience. We guide the scientists in developing their idea, starting from an initial scientific discovery, into a program that is more likely to be picked up by industry. That includes developing a target product profile and experiments that actually increase the value of the invention.

Is it successful?

The program is finishing its ninth year, and 64 teams have completed their training. Of the 64, 30 have entered clinical studies, 22 new companies were founded and seven technologies have been licensed to existing companies. Overall, we have a 57 percent success rate.

SPARK provides much needed guidance to help inventors develop projects that meet industry’s interest in addressing unmet clinical needs, and it helps educate the future workforce in what drug development is, and how intellectual and exciting and really challenging it is. And it also helps make all my colleagues ready for the next time they have a discovery that may have value for patients. After all, it’s our social responsibility. We get the money from the public, so it’s a way to pay back.

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Jaquelin Finley
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Tags: Partnerships, R&D