Life Science Leader Magazine Supplements

CRO Leadership Awards 2017

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they would take Takeda's vision of an outsourcing rela- tionship 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 relation- ship 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 import- ant 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 stra- tegic 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." Azmi Nabulsi will tell you that one of Takeda's princi- pal 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 oper- ations 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 expe- rience 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 outsourc- ing 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 accom- plish. That list was quickly whittled down to the top three that seemed to be most comfortable with the dis- cussion. The dialogue with potential partners involved how they would approach the relationship and how DR. LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 13

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