The pharmaceutical industry typically develops new drugs to help manage diseases. But a new project inside Johnson & Johnson posits a different model: what if you could identify people at risk of developing a disease, and create products to stave it off?
The question is the driving force behind the Disease Interception Accelerator at J&J’s Janssen Research & Development division in Raritan, New Jersey. It originated with Bill Hait, the Global Head of Janssen R&D, who wanted to test out a new paradigm for the pharma industry. Instead of “disease care,” this would be true “health care.”
Already, notes Ben Wiegand, head of the Disease Interception Accelerator, there are a few examples of treating someone before they’ve been officially diagnosed. In one example, if a person has diabetes and high cholesterol, “we know that they’re headed toward heart disease, and so we provide them a statin,” Wiegand says. “We’ve made a tremendous difference in intercepting that disease before it happens. Same with aging and people having bone density issues—we give them Fosamax [to build bone] before they suffer a break.”
Going “Off the Grid” to Examine 80 Diseases
Hait gave Wiegand, a former head of open innovation at J&J, free reign to “be off the grid, and be a separate group” in order to approach things differently.
Governance of the new accelerator consisted of Hait and his Chief Financial Officer, Chris Picariello. “We make decisions faster than I ever have within J&J, and we have access to Bill 24/7,” Wiegand says. “When we need to spend or make decisions, we have quick access to them. When we can show value creation, we can access more resources.” They also keep the Chief Scientific Officer of J&J, Paul Stoffels, apprised of their progress.
“We wanted to explore what would the future of intercepting disease look like—the types of competencies and capabilities you’re going to need,” Wiegand says. Working with the consulting firm Innosight, Wiegand says he began to “think through a ‘future back’ approach. Even though our first product might not hit the market until the 2020s, what are the success stories in 2016 and 2017 that will show that we’re on the right path?”
A first step was examining more than 80 diseases to find those where there was a useful signal that could help identify people who were susceptible to developing a disease, and potential targets that a drug might hit to delay its onset. “We didn’t want this to be a research exercise, and we wanted to avoid solutions that we would have to invent de novo, if we could,” Wiegand says. That led to identifying six diseases “where we felt like we could identify people who were at risk, and we had at least a hypothesis about progression markers” that would indicate how quickly or slowly the disease was proceeding.
Small team, low expenditures
The team, initially, was just Wiegand, who has a PhD in chemistry, and David Yazujian, who focused on strategy and operations. “We wanted to maintain a very small footprint because we’re early in our process,” Wiegand says. “We want to manage our capital outlay.” In 2017, the DIA is just 11 of J&J’s 127,000 employees. “We have lots of people at J&J with deep expertise, and very innovative people,” he says. “At least 70 people are helping us on an on-going basis because they have ideas—they see this as the future. Our vision of transforming medicine resonates with people. They may send us people to talk to, or diseases to think about.”
An early focus for the accelerator is Type 1 diabetes, sometimes called juvenile diabetes, which affects roughly 20 million people globally. It can be spotted early by examining a gene family called HLA, and Janssen is already conducting a clinical trial of a drug that is currently on the market for immune- related diseases, Simponi, to see whether the injectable drug can slow down the loss of pancreatic cells that secrete insulin; their death leads to problems processing sugar. “We’re hoping to delay the onset while we work toward the ultimate goal: stopping progression toward the disease,” Wiegand says, even if “the first thing out of the gate won’t be the final solution.” A phase two trial got underway in mid-2016.
The Disease Interception Accelerator seeks out collaborations with academic researchers and startups outside of Janssen’s walls. “Today, we have 30-some collaborations in Asia, Europe, and throughout the U.S.,” Wiegand says. “We want to work with the best people, whoever they are.” The DIA’s current model is “one person per disease state,” meaning one internal person searching out and coordinating with external entities; in the case of diabetes, the lead is Joe Hedrick, a former research leader at the JDRF, a nonprofit focused on Type 1 diabetes.
Getting Varied Groups to Work Together
To craft contracts for most of those outside collaborations, Wiegand’s team got legal and finance help from the staffers at J&J’s network of innovation centers, as well as other groups around the company. “We don’t have our own contract, regulatory, or health policy groups,” Wiegand says. “So we’ll leverage J&Js infrastructure, until we hit critical milestones.”
“When we talk to people outside the company, whether patients or consumers or doctors, they look at us as J&J,” Wiegand says. “So they expect us to be working together. They assume there are no silos or divisions between the different organizations or companies here. That’s what they expect, and that’s what we’re trying to work toward.”
Connecting with Patients
A big part of the DIA’s approach has involved working with patients, patient advocates, and even people who blog about diabetes. Wiegand says he wants to build a community that will not only understand his approach, but provide input as the team tries to bring new treatments to market. The team has organized webinars and conference calls to explain what they’re doing, answer questions—and ask questions of the participants.
“Most of these bloggers have kids with Type 1, or they’re suffering from it,” Wiegand says. “So we were trying to understand things like, what was your experience? When did you know you had the disease? If you would’ve known earlier, what would you have done? Would you have been willing to go through surgery? Take a medication? Would you help us get the word out? Now, even the Food & Drug Administration is looking for the perspective of the patient, and not just clinical data, when you submit something for approval. They want to understand what the trade-offs are. And we wanted to be sure the marketplace would be willing to accept what we were thinking about.” Participants asked tough questions, and there was definitely some skepticism about whether the effort could succeed, Wiegand admits. But “we’re trying to create a business not all by ourselves, but trying to get the community to come alongside,” he says. That will take work, and the team is planning to organize another webinar for the patient community in 2017.
The DIA team is also working with national governments in countries like Singapore and Finland—countries that have a high prevalence of diabetes, and have made high-profile commitments to develop treatments. “We’re trying to get footholds in a few countries to prove that this model works, and then cascade it around the globe,” Wiegand says. “Once you have those early proof points, it’s easier to scale afterward.”
Diabetes isn’t the only disease that the DIA is working to intercept; there are activities looking at cervical cancer, perinatal depression, cataracts, and others. And the expectation is that delaying—or preventing—the onset of disease won’t just rely on pharmaceuticals, but may involve behavioral solutions, nutrition, exercise, or other approaches.
Bill Hait, the original catalyst behind the DIA, says that the project is delivering on his original vision. “The groundwork Ben and his DIA team have been laying during the last two years has the potential to change the way we look at health care forever,” Hait says, “away from today’s ‘disease care’ towards true health care in the future.”