Cook MyoSite

At Cook MyoSite, a biotechnology firm in O’Hara Township, information systems director Thomas Joos is leading the charge to consolidate the company’s information technologies and prepare for what is likely to be a rapidly shifting future. Joos, who joined the company three years ago and has over two decades of experience in his field, certainly has his work cut out for him.

Cook Myosite“We have all types of equipment, we have people doing data analytics, we have people doing product research in biologics, we have calibration management systems, and on and on,” he said. “So, we have this massive grouping of software applications and processes. Now, we’re coordinating all of those pieces as we move towards commercialization, because that requires a very coherent, concentrated effort.”

Cook MyoSite was founded in 2002 with the primary focus of researching and developing cell therapies. The company currently is developing a cell therapy called AMDC that is intended to use a patient’s own healthy muscle cells to restore proper function to damaged muscles.

Cook MyoSite is investigating their therapy, which has yet to receive FDA approval, for the potential treatment of a variety of conditions, from bladder leakage to a disorder called tongue dysphagia in which a patient can lose control of their tongue. Running these clinical trials requires a dizzying number of systems and technologies, and it’s up to Joos and his team to develop and maintain them.

“We created the role of enterprise architect for information services to give us a good focal point for all of the areas of our business,” Joos said. “It’s someone who is out in the company communicating with different parties and looking at the interactions between our business, our technology, and our people.”

“When you look at Cook MyoSite, there are approximately 60 different types of applications, infrastructure, or software-based processes that are supported by our team,” Joos said. “And the reason for that high number is that we have clean rooms and laboratories supporting our AMDC product manufacturing.”

The clean rooms that Joos is referencing are where the investigational AMDC product is made – a fully operational 4,000 square foot space and a larger space that is currently under construction. There, Cook MyoSite receives muscle samples from participants enrolled in the company’s clinical trials, processes them to make a personalized AMDC product, and ships that product back to the participant’s physician for injection. Throughout the whole process, Cook MyoSite must ensure that the cells are kept healthy and uncontaminated, which demands complex information systems to support environmental monitoring and rigorous quality testing.

Large information systems of this type are more commonly found in large companies, but Cook MyoSite is closer to medium-sized with just under 200 employees. This presents a human resources challenge: most systems are maintained by one person, with single employees often being responsible for multiple systems. Accordingly, Joos is very particular about who he hires.

“The number one thing we look for is people that like to work in gray space,” Joos said. “If you want black and white, we don’t have that. You have to be excited about walking in the door and having to make decisions and having to move forward when it’s not clear what the path is.”

According to Joos, this can make hiring somewhat complicated in a field that rewards intense technical specialization. But to harness technology for real-world applications, Joos is insistent that he and his team have strong decision-making skills and a balance of technical and business understanding.

As the company moves toward the day when they will submit a commercial application to the FDA, Joos is using his integrated approach to organize Cook MyoSite’s information technologies into a system that ensures alignment between clinical science, regulatory requirements, quality control, manufacturing, and business goals. To aid this strategic transformation, Joos created a new role within his directorate devoted specifically to that end: the enterprise architect.

“The number one thing we look for is people that like to work in gray space,” Joos said. “If you want black and white, we don’t have that. You have to be excited about walking in the door and having to make decisions and having to move forward when it’s not clear what the path is.”

“We created the role of enterprise architect for information services to give us a good focal point for all of the areas of our business,” Joos said. “It’s someone who is out in the company communicating with different parties and looking at the interactions between our business, our technology, and our people.”

Enterprise architecture is a discipline that emerged at the beginning of the information age, in the 1970s, and is primarily concerned with standardizing and organizing IT functions to align with business objectives. While the decision to create the role was important, Joos said, equally important was the person who would fill that role. Because the enterprise architect must have strong knowledge of all areas of the company, Joos internally hired Katrinka Ellena, a biochemist and software system analyst who has worked at Cook MyoSite for seven years in the quality control department and on Joos’ information services team.

“The enterprise architecture role is one of those roles where it absolutely requires a combination of technology and business understanding, and I don’t mean just at a high level,” Joos said. “You really need to know the technologies that the company needs, but you also must know how the company is operating from a business perspective. Having Katrinka with both the biology background and the software applications background made her a very good candidate for that role.”

Day to day, Ellena jumps from meeting to meeting across almost all departments at Cook MyoSite, gathering real-time information on how different departments are using technology systems, what their pain-points are, and what can be done to improve efficiency, quality, and compliance. Over the past six months, she’s been developing a system that the company can use to determine the comparative return-on-investment of their many computer system applications.

“At any given moment, information services has queued a whole bunch of requests,” Ellena said. “But trying to pick what to do next is difficult, especially when these technologies and applications have different levels of impact to every business unit. One person might think that that their group is very heavily impacted, so they might think that this is the next thing we absolutely need to be working on. I’m sort of digesting all that information, trying to make it so that we can rate things objectively.”

The step of creating an entire role dedicated to coordination and resource planning is crucial, Joos thinks, to completing a long-term digital transformation that will affect the business for the better. As enterprise architect, Ellena will be able to provide data-driven insights, rooted in understanding of the company, to prepare Cook MyoSite for commercialization. There will still be lots of gray space, but that’s fine – Joos and his team are built for that.