This year's TEDMED was held Nov. 18-20 in Palm Springs, Calif. Stanford Medicine is a medical research institution partner of TEDMED, and a group of MD and PhD students who represented Stanford at the conference will be sharing their experiences here.
That’s what I wore on my nametag last week at TEDMED. The theme of this year’s conference was “Breaking Through,” and every delegate was asked to write a brief statement that illustrates an area of health care that they're most passionate about.
The “valley of death” refers to the vast gap in the landscape of biomedical therapeutic development between academia and industry. Traditionally, an academic institution and industry have played two separate but equally important roles in the lengthy and expensive process of bringing new medical innovations to the patient. Academic researchers investigate new mechanisms, pathways and methods, making discoveries that yield promise. Industry then takes these experimental innovations and conducts product development, safety profiling, clinical trials, and manufacturing and distribution, ensuring that extensively tested, safe and efficacious products are widely made available.
However, this transition between academia and industry is not always a smooth one. The pharmaceutical industry is notorious for its extreme risk aversion with new products - and with an average cost of $1B, a 10-year path to FDA approval, and a failure rate north of 95 percent, who can blame them? Meanwhile, most academic labs are neither equipped to nor interested in spending the resources to conduct important yet labor-intensive preclinical work (which, quite frankly, won't help a scientist graduate, secure tenure, or win a Nobel Prize). And so, because of this, potentially beneficial therapeutics are liable to languish in the valley of death between discovery and human trials.
On Thursday, Stanford professor Daria Mochly-Rosen, PhD, took the TEDMED stage to describe her own experience crossing that valley on the TED stage. In the early 2000s her lab had discovered a novel class of compounds for reducing cardiac injury after heart attack. After receiving universal rejections from pharma companies that they hoped would license the compounds, Mochly-Rosen and one of her graduate students reluctantly took matters into their own hands, left the university, and started KAI Therapeutics to bring their compounds into clinical trials. Long story short, they were eventually wildly successful and acquired by Amgen after demonstrating efficacy in Phase II clinical trials. The experience drove Mochly-Rosen to start the Stanford's SPARK program, which offers a variety of resources – including classes, industry mentors and grants - to help scientists here survive their own journeys through the valley of death.
As a scientist developing new potential tools for diagnosis and therapy, and as someone who works frequently with early-stage life science companies, I spend a disturbing amount of time thinking about the valley of death. But to me, the valley is much deeper and wider than what it means for pharmaceutical development. It spans similar challenges in medical devices, diagnostics, and even digital health solutions.
There’s also another valley of death, and that’s the gap in the landscape between revolutionary technology where the potential rewards justify the risk, and me-too products that are risk-free investments but only marginally improve care. What about the not-as-high-tech, or even low-tech, products that make a meaningful difference in health-care delivery, but aren’t technologically or financially interesting enough to attract industry interest? A new shower design for burn patients can save hours of nurse-time and patient discomfort each day, but likely isn’t going to garner much attention from companies.
The most frustrating part about working with early-stage medical technology companies is having to say that a product will struggle to succeed, not because of la lack of clinical need or technical feasibility, but because of economics. In the vast majority of cases, even if a product can be economically viable, investors won't be able to justify putting capital into a venture when that same capital could be used to fund an equally impactful medical product with a higher return. There simply isn’t enough money in our industry to fund all the good ideas, so the money goes to the ideas that are both impactful and profitable - and the ones that are simply impactful are left in no man’s land.
If you’re such a venture, can you make it on your own? Of course, and some do. Mechanisms exist to help you along, such as small-business SBIR grants from the NIH. But with the timelines of such grants on the order of 6-18 months, and NIH funding rates at historic lows, it can take years of hardship and living on a shoestring budget before such technologies can make enough progress to hit the meaningful milestones that institutional investors and industry partners want to see.
So the valley of death exists, and we’re beginning to map out its geography. How can we actually cross it? At Stanford, we're privileged to have resources like SPARK, or its sister programs BioDesign, Spectrum, Ignite, StartX – the list goes on. But what if you don’t have the resources of one of the top universities in the world, or hundreds of millions of dollars to launch new projects out of existing companies (see here, here, here and here)?
It’s an open question, but I was thrilled to learn of one group that’s “Breaking Through” this barrier with a new lens. MIT's Anna Young spoke at TEDMED about her initiative, MakerNurse, which provides hospitals with a rapid prototyping space and resources for nurses and other providers to make their own custom devices. With a complete armament of DIY tools located less than 50 feet from a patient bed, MakerNurse - which is in hospitals today - enables nurses who are on the front lines of patient care to imagine and immediately create the solutions they need, right when they need it.
My TEDMED experience reminded me of how imperative it is that we medical students learn not just about the biological nuts and bolts of the human body but are also provided with at least a rudimentary understanding of industry and the process of biomedical innovation.
Where do new medical innovations come from? Why does their development take so long? Why are drugs so expensive? For our patients and for ourselves, and for our patients 500 years in the future, physicians should know the answers to these questions. Only then can we start chipping away at the complex structures that render such questions necessary, and work to get rid of the “valley of death” for good.
Brian Hsueh is an MD/PhD student in neuroscience and bioengineering. He spends his days working on new technologies to understand and treat diseases of the brain, and his nights trying to find economically feasible ways to bring those technologies to patients.
Previously: SPARK program helps researchers cross the “valley of death” between drug discovery and development
Photo by Eric Trac