WHAT’S smaller than a breadbox, can cost $800 million or more, and takes more than eight years to research and develop?
A new medicine, according to data from the Tufts Center for the Study of Drug Development in Boston.
And that’s just for traditional drugs made by using old-fashioned chemical molecules. Developing new biopharmaceuticals — those high-tech wonder drugs fashioned from living cells — can cost $1.2 billion, according to the center.
Such amounts, of course, are staggering. Mind you, those costs aren’t only for the drug that has successfully made it through the testing gamut to your medicine cabinet, but also for all earlier iterations that failed. In fact, most of the cost in drug development is the price of failure, said Mervyn Turner, the chief strategy officer at the drug giant Merck.
This linear, trial-and-error method is no longer a sustainable model for big pharmaceutical companies.
“We invest far too long in bad ideas,” Dr. Turner said in a phone interview. “It is really important to stop that at an earlier stage in the cycle.”
Now big-picture thinkers, within the industry and outside it, are re-examining every stage of drug development — from molecule to market — in an effort to foster faster innovation. It’s a holistic approach, called “systems thinking,” that originated in methods that engineers used to streamline projects in the aeronautics and automotive industries.
The Massachusetts Institute of Technology, for one, started a pharmaceutical innovation program this year to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.
“Aerospace had to change from ‘higher, faster, further,’ the mentality of performance at all costs, because they could not stay competitive,” said Deborah Nightingale, a professor of the practice of aeronautics and astronautics, and systems engineering, at M.I.T. Aeronautics had to re-examine cost in concert with quality, she said. “They had to become better, faster, cheaper.”
Still, even Dr. Nightingale said that pharmaceutical executives weren’t yet feeling the heat — or “the burning platform” beneath their feet, as she calls it — that would force them to make large-scale, systemic changes.
Perhaps that’s why initiatives at M.I.T. and other places are all the more important if the industry is to be nudged forward.
The M.I.T. project, called New Drug Development Paradigms, has gathered a powerful consortium of interested parties — including major drug makers and federal health authorities. One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.
If that is to happen, some drug companies that have been fierce rivals will have to play nicer. Think of it not so much as swords into plowshares but as silos into platform-sharing.
One idea is for drug makers to share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.
Although many companies have committed to publishing the results of clinical trials, whether or not they succeed, drug makers don’t typically publish information about projects that fail at an earlier stage. A result is that companies waste many millions going down experimental paths that their competitors have already found to be dead ends.
M.I.T. is proposing dead-end drug disclosure, a concept that goes by a euphemistic mouthful: “precompetitive information sharing.”
Drug makers may realize that the financial and medical value of sharing such information outweighs the competitive risk, said Dr. Gigi Hirsch, the executive director of the M.I.T. Center for Biomedical Innovation, the locus of the drug project. “There should be more information available about failed compounds in the interest of the greater good,” Dr. Hirsch said.
(Disclosure alert: This reporter’s father is a math professor at M.I.T. I did not tell him until now that I had spent a day on campus gathering material for this column at a conference on systems thinking. Sorry about that, Dad.)
IN the absence of a public database on failed drug compounds, a small group from the Sloan School of Management at M.I.T. and the Harvard Business School has created Pharmer’s Market, an online prediction market that uses crowd-sourcing to forecast the likelihood of a drug’s success. Introduced last month, the market has invited biomedical researchers and other drug industry experts to place anonymous bets, using virtual money, on the likelihood that certain breast cancer drugs, currently in clinical trials, will succeed or fail.
After the clinical trials conclude, researchers can assess whether this kind of collective intelligence may be a useful predictive tool for drug companies, said Ragu Bharadwaj, who helped devise the project as an M.I.T. graduate student.
Many drug companies, meanwhile, are already incorporating new paradigms for collaborating on drug innovation. Two years ago, for example, Merck established a virtual lab, called External Basic Research, where company scientists can collaborate with outside researchers on identifying novel “targets” — the disease pathways in the body that medicines are intended to treat.
This year, Dr. Stephen H. Friend left Merck, where he had worked as head of oncology, to start a nonprofit open-access information platform called Sage Bionetworks; the idea is to collect huge biomedical data sets to help researchers better understand the molecular basis of disease, ultimately leading to the creation of smarter drugs.
The overarching goal of new approaches industrywide, said Thomas Unger, executive director of research and development at Pfizer, is to bring new medications to patients faster, using a system “that makes the drugs more efficacious, offers greater safety and ultimately reduces the cost of therapies.”