Stacie Yonkin
A Q&A with experts from Biogen and Quintiles on their unique development relationship

Outsourcing clinical development through a sole agreement model is a new trend among biopharmaceutical companies. This business model can have many benefits, including greater efficiencies and a common focus on long-term strategic outcomes, though some stakeholders worry about the risks of moving such an important aspect of their operations to single service provider.

In late 2013, Biogen embarked on just such a project with Quintiles. We met with Frances Grote, senior director of clinical vendor management at Biogen, and Stacie Yonkin, senior vice president and managing director of the Biogen customer account team for Quintiles, to talk about how this business model works, the benefits achieved to date, and Biogen’s perspective on the benefits and opportunities that companies can find in this strategic outsourcing model.

Tell us why Biogen was interested in a sole agreement to outsource its clinical development program?
Grote: We were projecting to grow rapidly in terms of the pipeline, and we wanted to continue to be productive and innovative in getting medicine to patients with unmet needs. However, we didn’t want to grow rapidly in terms of infrastructure so we looked for a different approach.

Just two years ago, the standard model in the industry was having at least two service providers.  Companies would say, “Well, that’s how you guarantee that you get enough of the provider’s attention without putting too many eggs in one basket to maximize the benefits of outsourcing.” But from our position, we saw that approach as diffusing the effort.

We wanted to have a truly strategic relationship, which is what we have formed with Quintiles. We have an integrated team that is working to accomplish one set of common goals.

Stacie, what was that value proposition from the Quintiles perspective? Why was Quintiles interested in a sole provider relationship?
Yonkin:
The value proposition for Quintiles was the opportunity to continue to lead the industry in doing something different. We’ve debated amongst the Quintiles-Biogen team that the idea and terminology of a ‘partnership’ doesn’t encapsulate what we’re doing here, because partnership is used in a lot of different scenarios.

From a people perspective, it is about being a collaborative thought partner for Biogen, improving their probability of success, and helping with key decisions on critical compounds.

We’re able to focus our time on getting the right study strategy and the best possible approach to conducting the clinical trials. We are starting at a different point in Biogen’s development, which is of high interest to Quintiles. In addition, their focused pipeline is aligned quite nicely with some of our therapeutic expertise.

What is an example of an efficiency that has been achieved to date thanks to this collaboration model?
Grote:
The most significant one Biogen can point to is that prior to this model, we had an average of three internal clinical operations people assigned to each protocol — even though those protocols were outsourced. A year after implementing this collaboration model, we now have three protocols per clinical operations lead. That’s a huge efficiency gain.

Another efficiency example that really shines is that for a recent registry, we enrolled more than 14,000 patients in just three months. That is because Quintiles had people ready to work on it right away because of their early engagement and strategic input.

If this had been a competitive bid with an RFP, no provider would’ve have had people available so quickly.

April was the one-year anniversary of the team working under the new model, and it was only a six-month start-up to get to that point. Looking back, what would you do differently?
Grote:
From my experience, that was a groundbreaking timeline to achieve the actual run rate. We also had an internal goal of hitting 85 percent of our development science scorecard goals in the first year, and because of working within the collaboration model we hit 94 percent. So not only do we start up faster than anybody I’ve ever heard of, but we exceeded our goals in our first year by a good amount.

That being said, there is one main thing I would do differently — I would be more cognizant of the fact that my stakeholders go well beyond the people involved in the collaboration model. We did a tremendous amount of work engaging everybody who we thought might have a stake in the game. Whether they were going to use the model or not, we invited every function in our development science organization to participate in this election process so they could feel the ownership of that selection. But we never stopped to think that our commercial colleagues, who aren’t going to use the collaboration model, are also stakeholders. That’s one thing I would have done differently.

Yonkin: I would put more emphasis on our change management approach and getting the right people and the right processes in place even earlier. This is a longer engagement than anyone is ever going to contemplate, so it is really important to reinforce the change management evolution, and to acknowledge that this effort is a marathon and not a sprint.

Fran, what advice would you give a company that is considering a sole outsourcing partner?
Grote:
The first piece of advice that I give is to understand what your internal model needs to look like for success. Historically, our industry has been guilty of understanding that they need to outsource and thinking about what they want the outsourcing engagement to look like, but failing to take into account what they have to do themselves to make that outsourcing successful. That has to be fundamental to the process.

The second question I get asked frequently is how does a small pharma company get appropriate attention from a bigger CRO? The answer is that for every company that has that person-dollar spend, there are one or more CROs who are hugely interested and would be enthusiastic to partner with you strategically. Your job as the sponsor is to figure out what it is that makes your company interesting to those providers, and to position whatever you have to offer as a sponsor to the right group of people in a way that appeals to their skill set.

Do you think more companies will go to this sole agreement model?
Grote:
It’s interesting because yesterday I was invited to a local clinical research forum where I was asked specifically to talk about the Quintiles relationship as so many of these companies are interested in at least thinking about doing something like this. A lot of their questions were around does it really work, how do you make it work, and how do we avoid the pitfalls. Once people began to realize that if you think through what your challenges are going to be and you’re prepared to address them, they don’t blindside you. They were very excited about thinking this way. So I do think that we’re starting a groundswell here.