Pharma

When worlds collide: What can companies learn from Otsuka and Proteus Digital Health collaboration?

Andrew Wright, Otsuka America Pharmaceutical Vice President, digital medicine and medical device division, and David O'Reilly Proteus Digital Health Chief Platform Officer, shared some insights on what it takes for a collaboration to succeed, especially when you are doing something that's never been done before.

When Silicon Valley health tech company Proteus Digital Health and Japanese drug developer Otsuka Pharmaceutical succeeded in getting FDA clearance for the first digital medicine, it was celebrated as a unique achievement and a reflection of the convergence between health IT and pharma. And yet, behind the scenes, one of the most interesting aspects to this story was that the two companies were able to succeed in this collaboration.

In a panel discussion at the Eye for Pharma conference in Philadelphia earlier this year and in an interview afterwards,  Andrew Wright, Otsuka America Pharmaceutical Vice President, digital medicine and medical device division, and David O’Reilly, Proteus Digital Health Chief Platform Officer, highlighted some of the inherent challenges of pairing their respective drug, Abilify, and sensor technology. But they also called attention to the complexities of two completely different companies and corporate cultures working and solving problems together and with the FDA.

Here are a few examples in their own words.

Getting user-centered design right

Andrew Wright, Otsuka America Pharmaceutical

Wright: When we first designed the packaging we thought we would just use healthy volunteers, employees, and it went swimmingly well. And then we put it into the first human factors test and it completely bombed.  Because they just pulled the packaging apart, they picked up that lovely patient information leaflet, got completely lost between the pills and the patches so we went back and redesigned it to make sure people followed the right steps.

Wright: [The process of ] developing a user-centered design is fascinating to watch and challenging to get just right. So that took some time as well as negotiations with the FDA: How will this be regulated moving forward so we can keep up with the speed of and velocity of how tech works [while] also making sure the components that need to be regulated items are following the…process regarding hazard analysis, risk identification, and subsequent human factor studies that need to be regulated.

Regulatory innovation

David O’Reilly, Proteus Digital Health

O’Reilly: What Andrew is describing is an often unrecognized, unappreciated and an underreported aspect of fundamental innovation in the medical space. Here’s a Silicon Valley reference: If you go as an entrepreneur to any venture capitalist and say you want to do regulatory innovation, you will never get another meeting. That is the worst thing you can present to an investor that you are going to do regulatory innovation. But it is an absolutely essential thing that you need to do if you are going to a new category and trying to solve an unmet need. So we often talk about tech innovation or new apps but this is an essential aspect of it in the medical space.

Wright: This is where the regulators are actually ahead of the pharma industry. A lot of questions I get from other companies is: ‘If it is not in the label, I can’t do anything with it.’ And what they are missing here is actually if you want a viable, successful, high-velocity, customer-centered product in the marketplace you don’t want it in the label and again this is where regulators are ahead of the industry. And I want to give hem a big shout out for that. We are trying to educate pharmaceutical colleagues to understand where they need to be to in the next few years to have successful products.

How to disagree productively 

In an interview that followed that followed the discussion, Wright and O’Reilly talked in more depth of what it takes for alliances between a tech and pharma company to work. They also claimed that most collaborations, even between two pharma companies, usually fail.

O’Reilly: A good alliance has a respectful interaction where you can disagree.

Wright: The worst sign, in my experience, [that the collaboration isn’t working] is when you freeze each other out and you aren’t disagreeing.

Minimizing  company politics in the collaboration process 

In the interview, O’Reilly noted that both he and Wright have sought to instill a one-team approach, to prioritize the alliance team ahead of the company that is responsible for one’s paycheck. He also noted that the complete response letter the group received from the FDA was “probably the best thing that happened to us” because it sent the companies back to the drawing board and gave them a renewed sense of urgency to resolve outstanding issues.

O’Reilly: When it comes to discussing an issue or solving a problem, what I have seen in a lot of alliances is people are trying to solve problems in their own companies and then coming to the alliance table saying, ‘this is the problem. This is what we have to do.’ We tried to flip that to get people to speak for their collaborations, not their companies. That required a lot of transparency. We shared a lot of things — all of the warts, the problems, what is happening in the supply chain with our vendors and bringing that all to the table…so we could solve these problems together.

O’Reilly: Some alliances I have been in…in my career, things blow up because they can’t solve difficult problems together, they have no [milestones] and then things just fizzle away.

Wright: I have worked now in seven different alliances and sometimes I have been the David and at other times the Goliath and you need … what we tend to do is have a meeting before the meeting before the meeting within our own company so that we are all aligned, so there is no inflexibility in the discussion because you have already become entrenched.

It’s fine to air dirty laundry on either side with the understanding that it is no judgment — people make mistakes. And I think because of that we have had a closer collaboration and that to me is what a collaboration should be to take it to the next level.

Photo: Getty Images

Correction: The surname of David O’Reilly was misspelled in a few instances in this article. We regret the error.

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