Dan Hilby, Principal Technical Services Manager, PRA Health Sciences

This post is the fourth in our larger series, Industry Insider Interviews. Read our previous posts, featuring Ed Potero of Biogen, Dagmara Kulis of EORTC and Alexandra Crane and Jessica Millman of TransPerfect


Oversight of Takeda Pharmaceuticals IRT

YPrime: Tell us about your background in IRT

DH: It started in 2007. I worked in IRT project management for 4-5 years, then moved to the sponsor side. On the sponsor side, I worked as an IRT specialist, then moved into a management role where I oversee the team. It’s also a leadership role where I provide strategy and direction for IRT.

YPrime: Since you’ve entered the industry, IRT has significantly evolved. What has been the biggest improvement?

DH: The move to the web, and now mobile are some of the biggest changes. On the sponsor side, being able to work with vendors to build standards and libraries to speed up delivery are definite improvements. Most important is improved quality, so we’re no longer coding everything from scratch.

In terms of functionality, the biggest improvements have been bringing in some of the drug accountability and returns features to the web that would not be user-friendly to do over the phone. On the web, it makes tasks much easier. The trend of taking things off paper and putting into the system to have instant information and be able to instantly see where things are in the process.

YPrime: What’s important for Takeda?

DH: At Takeda, we like to keep the IRT system clean, so we focus on the randomization and drug supply management pieces.. For randomization, being able to support complex study design and adaptive trial design is important. We have a lot of oncology work, and studies that involve dose escalation and adaptive arms. Being able to have these functions and implement them quickly is important.

Quality and speed is important, but we also need that flexibility. So, we’ve seen some out-of-the-box systems that may provide quality and speed but no flexibility. You lose a lot of time when you try to go out of that box. There are other options that can do anything you want, but there’s not of speed to it. So, we’re really looking at solutions in the middle. We don’t want to handcuff or limit teams in terms of study design, and at the same time we have to deliver quality systems in a timely manner, as there’s also expectations for getting studies started and completed sooner.

On the supply side, there’s a little more focus on being able to pool drug, so there’s savings for us if we can pool drug within in a program or potentially across programs.  And there’s also time, resources and money, when you can put more of the lifecycle of the drug supply within the IRT. How early can we do more of the drug supply stuff,but what’s really important at the end of the study is being able to track the full cradle to grave. The ability to speed up the closing down of a study has saved us significant amounts of effort and resources.

YPrime: How have your past experiences informed how you select and manage IRT vendors now?

DH: There’s a combination of things. We’ve looked at AQSCIR and assurance of supply. We’re looking for how we have enough assurance of quality in terms of the level of service, the people and the infrastructure to be able to support our studies long-term. We want to make sure we build partnerships that will give us a high-level of quality. We know there will be issues, and we don’t expect things to be perfect out of the gate or all the time, but we are looking for people who are vested in a culture of quality, to be able to respond quickly to issues and challenge themselves to improve what they’re doing and be able to support us. It goes a long way with the culture of the people and the organization in terms of their focus on quality. We look to outsource a lot of our work, so service is another key component. We want strong project managers and partnership from the account team. When we contract with suppliers, we expect the project manager to own that project, so they are responsible for all the deliverables, quality -- and for making sure we’re staying within cost.

Also, sometimes we feel a bit removed, but we all need to remember that our key users are the sites and CRAs. It’s very important for them to have a good customer service experience. So, when they contact support, they get resolution. The support team must be very knowledgeable, follow up on any issues, and proactive in managing the calls or change orders. It’s important during study set up and even more important during maintenance. If the users can’t serve their patients, it’s a big problem.

YPrime: You mentioned the importance of project management. What key skills and qualities are important to you?

DH: There are two that stand out to me. One is proactivity. The project manager is in a lead role, and needs to take ownership, being there to help us succeed, and being part of that team culture. The second is having the technical expertise, so the project manager really understands what he/she is delivering, what the service is, and having the ability to guide the team on what is the right solution. It’s really those two things combined.

YPrime: When evaluating new providers, what qualities are important?

DH: First, we want to see if they are good fit in terms of Takeda standards and how we ideally like to have our IRT system set up and operate, so we want to see functionality-wide, is it a good fit? We want to understand the philosophy and how these organizations are set up. Is this their main business? Is this what they are focused on? Are they innovating? Are they trying to drive forward? If they are part of a large organization; maybe this isn’t their bread and butter? We’re looking more at the organizations that have IRT as their focus, and they continue to innovate. If there are things we want to push forward, we want to make sure we have the focus of their organization.

YPrime: Across the industry, what are the biggest areas for improvement?

DH: I think there’s always opportunities to improve in terms of the level of service, project management, customer support. We can also look at trends in mobile technology and see what new capabilities are out there to support our users better and make their lives easier. Also, the tools for self-empowerment are beginning to develop, so users can get things done directly through the system and not have to go through customer service to get their work done.

A lot of the self-service tools are on the clinical supply side, for inventory management. This includes the ability to control the different parameters that affect the drug, from release and shipping to dispensing and returns. On the site side, the system should be simple and intuitive enough to make data changes right in the system, without having to contact customer service.

YPrime: What do Takeda’s future IRT needs look like?

DH: Capabilities that focus on the users and all the different systems they have to use. The more streamlined we can make it for the users, with fewer systems to log into, or single sign-on functionality will be better for them. We’re not there now, but we need to integrate better so sites can do their jobs easier.

Another area that will be helpful is data mining and predictive analytics, and the ability to use these tools within the IRT system to improve clinical supply manage