Harris Koffer
Harris Koffer
President of Strategic Solutions Division

Achieving excellence is rarely a solitary endeavor. It almost always requires collaboration and trusted partnerships. This is certainly true in the drug development space. Bringing new drugs to market takes time, money, and significant collaboration. In order to streamline the process many pharmaceutical companies and their clinical research partners are trying to find ways to increase operational efficiencies. This was the driving force behind the strategic partnership Takeda formed with PRA, and our mutual desire to drive toward excellence in clinical trials. Harris Koffer, President of Strategic Solutions Division here at PRA, shares his insights on how our two companies are pushing each other to improve the drug development process to benefit patients.

PRA’s Strategic Solutions Division has 40 Sponsors working with PRA, our top clients having worked with us 8-10+ years and most of our clients having worked with us 5+ years. How is the partnership with Takeda different?

Our partnership with Takeda is unique because of its breadth and depth. Unlike many of our existing partnerships, our relationship with Takeda is built upon a comprehensive suite of development services that extend beyond clinical operations into regulatory affairs, pharmacovigilance, medical writing and biometrics services. While many of our current partnerships include some of these functions, our relationship with Takeda stands apart because these services have been bundled into one seamless development operations model. In addition, this partnership brings us significant development capability and expertise through the Japan joint venture, allowing us to grow this important market.

This partnership has also brought a highly experienced team of professionals to PRA. Through the enhanced expertise and experience gained, PRA will strengthen its capabilities in a number of areas, most notably in regulatory affairs. Takeda has gained a committed, expert drug development partner that will enhance its flexibility and free up assets to fund future R&D needs.

How does this new model optimize clinical trials? Make them more efficient? Cost effective?

Patients are at the center of everything we do at PRA and Takeda. Both our organizations are committed to finding the most efficient and cost effective way to bring much needed therapies to market.

Takeda’s core business is based on its extensive knowledge of both research and development. By working in partnership with PRA, Takeda can focus its precious assets on its core strengths and leverage PRA’s expertise in executing key areas of development operations. This frees up funding for future research projects and creates greater flexibility as Takeda manages the ebbs and flows of its development portfolio. Takeda can also leverage PRA’s extensive experience across therapeutic areas and access information to better inform trial design and optimize the selection of sites to enhance patient enrollment and accelerate development timelines.

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Why did Takeda choose PRA as a partner? What were the differentiating factors that set PRA apart from other CROs competing for this partnership?

PRA was chosen as a partner for Takeda because of our unique set of capabilities. Unlike our competition, PRA’s Strategic Solutions Division, together with our Product Registration and EDS divisions, address the fundamental needs of the biopharmaceutical industry providing both outsourced and insourced solutions. PRA’s Strategic Solutions Division has extensive and market leading experience in working in partnership with our clients to seamlessly transition people and services.

Our people oriented approach to Takeda’s development needs ensured that we were able to transition 227 highly skilled Takeda employees to roles supporting Takeda and provide future opportunities for growth and development at PRA. This set of experiences and expertise, along with our company’s values and focus on people, stood in contrast to the models offered by competing CROs.

What are some of the initial challenges of the partnership?

I think that one of the key challenges for PRA is the assimilation of talent into the PRA organization and culture. While the cultures of PRA and Takeda are built on a similar set of values and mission, our new employees will need to adapt to PRA and our mode of operation. A second key challenge will be to successfully migrate from the current operating model into a model that fully leverages PRA’s extensive systems and processes. Achieving our “steady state” goal will enable PRA to optimize its delivery model, further enhance flexibility and drive greater economic benefits for Takeda.

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What are we doing well and why?

We managed to transition 227 Takeda employees reasonably seamlessly into PRA while maintaining the continuity of ongoing work. That’s quite an achievement in and of itself and a tribute to the commitment of the team of Takeda employees who became PRA employees, Takeda and PRA leadership. My “hats off” to the entire team for a job very well done!

We’ve also transitioned Ariad work and team members into the new operating model, successfully meeting key milestones, and maintaining the continuity of ongoing trial work. In addition, we’ve taken on a team of expert professionals in Japan and successfully created a joint venture with Takeda for our Japan operations. Finally, together we’ve met many development milestones while adapting to a new way of working, new colleagues, new systems and a different company culture.

How will this partnership continue to grow?

Our focus on people, customers, quality and delivering results will not change. We will never be satisfied with our performance or the status quo and will continually look for ways to enhance our services, develop new capabilities and work to optimize and transform processes to create greater speed and efficiency in the execution of our clients’ portfolio of products. For Takeda, this will allow us to be a trusted and integral partner to their drug development process, with our expertise relied upon to assist in bringing new products to patients with unmet medical needs.

In considering our long-term vision for the partnership, what are some of the milestones on the horizon?

A key milestone on our horizon is shifting from the current “Embedded” operating model to the steady state model. The adoption of the steady state model will allow us to optimize our development services supporting Takeda by leveraging the full suite of PRA’s systems and processes as well as PRA’s extensive experience, expertise and access to data. Again, our goal is to provide Takeda with a more flexible operating model, freeing up assets for future product development and clinical trial work and ultimately improving the lives of patients globally.

Japan Group Photo