Dr. Azmi Nabulsi will tell you that one of Takeda’s principal beliefs is that it cannot do everything on its own. Therefore, the company strives to achieve excellence in R&D by working with trusted partners. As the deputy CMSO (chief medical and scientific officer) and head of strategic and professional affairs for Takeda, Nabulsi understands that the benefits of those partnerships can manifest themselves in everything the company does, from bringing new compounds into the pipeline to increasing operational efficiencies. The strategic partnership Takeda formed with PRA Health Sciences last year was a major part of that philosophy and the company’s drive toward excellence in clinical trials.
“We looked at our clinical trials and asked ourselves how we could better execute those studies,” says Nabulsi. “We were not only interested in the area of clinical operations but also in optimizing pharmacovigilance and the regulatory operational elements. Like many other companies, we have moved from being internally driven to doing more outsourcing with CROs.”
But that wasn’t enough. To achieve true operational excellence, the company wanted a model that would give it the best of both worlds. In other words, the sourcing flexibility and efficiency of an outsourced model matched with consistency in talent and experience of an insourced model. “We needed a model that embodied all of those elements, with the hallmark being excellence,” adds Nabulsi. “We started designing that model, and in the end, we came away with an exclusive partnering agreement with one company running our trials and other operational activities.”
A DIFFERENT KIND OF RELATIONSHIP
For Takeda, deciding it wanted an exclusive outsourcing partnership was the easy part. Once that decision was made, selecting the right CRO was a process that involved a lot of personnel and a great deal of time and thought. Nabulsi notes that the company spoke to a number of potential CROs and explained its vision. The internal R&D leadership team handled the interactions, and the therapeutic, functional, and operational area leaders were also heavily involved in the process.
Takeda started with a list of five CROs it had worked with in the past. Although the company had worked with almost all of the prominent CROs, these five were the ones that seemed the most open to having serious discussions about what the company hoped to accomplish. That list was quickly whittled down to the top three that seemed to be most comfortable with the discussion. The dialogue with potential partners involved how they would approach the relationship and how they would take Takeda’s vision of an outsourcing relationship and make it operational.
“We did not want a traditional CRO relationship, and we needed our potential partners to understand that,” says Nabulsi. “We were not embarking on this relationship simply to drive cost or speed. This was not about the traditional metrics surrounding a clinical trial. We were looking for a true partner that could embody the key elements of our vision and culture.”
All of the potential candidates performed very well when it came to the capabilities of execution metrics and the ability to source. Since Takeda had worked with all of the CROs in the past, it was also familiar with the capabilities of each company. But Nabulsi notes he was looking for a CRO that would view the relationship as a true partnership.
“We did not want them to think about trial results as simply a deliverable metric,” states Nabulsi. “Drug discovery is about patients. That was important to us, and we wanted a partner who valued it as well. For us, trials are not just about getting a molecule approved. They are about connecting a medicine we discover with a patient in need. That was one of our key elements.”
TAKE CARE OF OUR EMPLOYEES
People were another key element for Takeda. The new partnering agreement would transfer approximately 300 people from Takeda’s offices in the U.S. and Europe and approximately 140 in Japan to the CRO partner. Takeda asked all the candidates to provide details (including examples) of how they would manage that transfer. Takeda would be transferring some of its most talented and passionate individuals, and Nabulsi wanted to know how the selected CRO would create opportunities for them.
“We wanted to be sure they were looked at as important members of the team and not just as resources that would be lumped into some efficiency metric,” he notes. “We wanted them to remain a part of this strategic relationship, and we wanted to ensure that they would remain engaged with our projects as long as we had a sufficient workflow available.”
On its first contact with the selected CROs, Takeda explained, at a very high level, what it was hoping to achieve. The company used specific bullet points to explain what it wanted out of the relationship. “It was literally just a concept — nothing more than that,” says Nabulsi. “We asked them to go away and come back to us with an idea or a vision. We wanted to see something that would help us understand what they would help us get out of the relationship. Then we had meetings in our offices, Deerfield, IL, in particular, where they came in with their initial plans. We asked them to come in with free-flowing ideas that would help us understand their vision.”
“WE DID NOT WANT THEM [POTENTIAL CROs] TO THINK ABOUT TRIAL RESULTS AS SIMPLY A DELIVERABLE METRIC.”
Dr. Azmi Nabulsi
Deputy CMSO, Head, Strategic & Professional Affairs
IF YOU’RE THE BEST, CONVINCE ME
Nabulsi notes that he did not request any specific type of presentation. Companies were asked to send whoever they felt would be relevant to the relationship and explain their plan. The disparity in presentations was actually quite surprising. All of the potential partners showed up with senior executives. Some teams even included the company’s CEO. While some of the presentations were structured and had an engineered feel to them (including detailed slides with parameters, metrics, and promised deliverables), others brought in a team of high-level executives who just sat and talked about what they hoped to accomplish with the partnership. Although more informal, these conversations were still very deep.
Although the feel of the presentations varied, he notes that was expected because of the lack of formal guidance provided. “For the first engagement, we were far more interested in how we connected with each other,” he says. “We wanted to know if they had an appreciation for what we were trying to accomplish. This was not a bid process. It was an attempt to see if we had enough in common to form the basis of a successful trusting partnership.”
After that process was complete, Takeda moved on to the next step, which was asking the CROs to present a couple of key elements of their plan. There were generally two or three of those meetings, and they were more in-depth than the initial meetings. More individuals were involved, and technical details were provided on outsourcing and procurement. Takeda personnel asked a lot of specific questions, and the CROs were also permitted to ask questions in response. This allowed Takeda to gain additional insights into the plan being presented.
TAKEDA IS COMING TO VISIT
The next phase of the selection process involved visiting the CROs in their offices and meeting their people. Each CRO was asked, “If we move forward with this partnership, who are the people on your side who will be involved?” The company then had meetings with those individuals to see if the two sides would click. The discussions at each meeting became more technical and more operational. There were also more questions along the line of, “What would you do in this case?” Or “How would you handle this situation?” Nabulsi notes that each discussion became more in-depth than the previous.
During this entire vetting process, the CRO rankings maintained by Takeda changed dramatically. Nabulsi emphasizes again that these changes were not entirely due to technical elements. Those elements were certainly important and were weighted accordingly. But equally important were the feelings of Takeda personnel about how the two companies could work together as partners, and Nabulsi believes that factor, more than any other, helped make the decision easy.
“Simply looking at measured deliverables might be sufficient when signing a two- or three-year deal,” says Nabulsi. “But we were interested in a long-term relationship. Therefore we needed to see if each partner had the ability to commit to and invest in that type of relationship. This is something we had never done before, so having an experienced partner beside us on the journey was paramount. We also needed them to work with us to create the model we wanted, as opposed to trying to force us into a model they wanted because they had done it before. They had to be open to saying, ‘We have never done this before, but we think it is a great idea and are willing to discuss how we can do it together.’”
THEY ARE NOT A CRO
If you ask Nabulsi about outsourcing to a CRO, he will quickly correct you and describe the relationship as a partnership. In fact, in internal discussions, Takeda does not even refer to PRA as a CRO. He notes it is part of the culture they are trying to build between the two companies.
“I hear people say, ‘My company has contracted with a CRO,’” says Nabulsi. “We do not consider this to be outsourcing, and we do not see them as an external company. They are a partner. With the recently announced creation of a Takeda-PRA joint venture in Japan, we have more than 400 employees moving from one location to another. We are trying to make that message very clear.” Since culture is important to the partnership, determining the culture of the candidates was important, and the site visits were a critical component of the selection process.
Takeda took a close look at the employees: How they worked, how they interacted with each other, how they expressed themselves, how they communicated with Takeda personnel, and how natural they were in those conversations. Employees were also asked about how they dealt with internal transformations and prior mergers and acquisitions.
“Having that communication with employees, whether it was formal or informal, gave us a good sense of their internal culture,” says Nabulsi. “They allowed us to see how they think, what is important to them, and what they value in partners. That helped us to determine what it would be like to work with them as colleagues and partners and how they work and interact. We wanted to know how they motivate their employees and how they develop their internal talent. We wanted to be sure that our people would be working in the right environment and would be motivated to work there.”
STILL MORE WORK TO DO
Although Nabulsi is very pleased with the relationship thus far, he adds there is a lot more work to be done. Much of that centers on execution of the partnership and taking the vision of the two companies and making it a reality. He is looking forward to seeing that execution come to fruition, and is confident it will be done. “We believe this is a model other companies will want to emulate,” he adds.
CROs often complain that a sponsor will spend months deciding on the best partner and then proceed to tell them how to do their job. Nabulsi notes that will not be the case with this relationship and is a part of the execution challenge. Takeda’s goal from the outset was to improve operational excellence, and that entails ensuring the best practices of both companies are used in its clinical trials.
“We are very open to using the processes of our chosen partner,” adds Nabulsi. “That is the best way to achieve operational excellence. Moving forward we will look at the expertise PRA brings to the table and move forward with what we together think is best. We let them know we were not coming into this relationship insisting that they use the processes and procedures we had in place. We believe that will be a very positive outcome of this partnership.”