Read Part One: The Making of a True Collaboration
Read Part Two: How the AbbVie-BioArctic Partnership Executes Collaboratively
For two years the partners had been following the workplan, advancing the science that they hoped would produce a game-changing treatment for Parkinson’s Disease. For that to happen, AbbVie had to “opt-in” to license the antibodies for clinical development. If it decided not to, for any number of valid business or scientific reasons, BioArctic would need to go find another partner. If that rejection were to occur, it would cost them valuable time in both the exclusivity to the underlying intellectual property and in the competitive arena. It would result in devaluing the asset in the eyes of a new development partner. In October 2018 BioArctic delivered the “Golden Package” containing the fruits—all the data and deliverables—of the two years of work to AbbVie, which had 90 days to make a decision. Thanks to a proactive approach with much of the ground already laid, the review was quick and internal alignment secured. Within two weeks it informed BioArctic that it would exercise its license option bringing the alliance to a successful outcome.
Marshalling the Stakeholders
Decision making in a company the size of AbbVie can be complex. There are many stakeholders who need to align to make a licensing decision. In doing so, AbbVie would make a $50 million milestone payment to BioArctic and be committing to devoting additional people and money to the development of the asset. Having been at the forefront of many such opt-in decisions in a prior company, the head of AbbVie’s alliance management started preparing stakeholders for the decision about a year before the actual decision point. “I knew that the option decision was not going to be straightforward. It is complex, with both legal and financial implications. I wanted to be sure we were doing this well. I started asking my key internal stakeholders what were the most important things they needed to see to enable a positive decision.”
Equally, it was important that BioArctic understood what those stakeholders needed. “When I asked myself does our partner know what our highest priority is, I didn’t think it was clear. I started having biweekly meetings with the [BioArctic] CEO sometime in January, in advance of the October decision. She heard us very clearly and quickly reorganized resources and started addressing our concerns. It eased the licensing decision.”
By being proactive in identifying and communicating the requirements, the alliance leader engaged in perhaps the most important practice related to orchestrating opt-in decisions: mitigating the risk of an unfavorable decision. Afterall, despite the great collaboration and tremendous learning that occurred during the course of the research, the alliance would not be a success if the deliverables didn’t include the critical elements that would convince her organization the asset was de-risked enough to invest further and take it to the next stage of development.
An Agile Decision Process
It was important that BioArctic understood the decision process that AbbVie would follow. Large companies have fairly rigid governance meeting timelines. As important as this alliance and the asset was to AbbVie, decisions about it would flow through normal channels and calendars. According to the AbbVie project lead, “We clearly set out the internal decision path and the different committees it would need to get support from. We were very transparent about it.” It helped that many of the team at BioArctic had extensive experience working at big pharma and thus knew not only what to expect, but also how they could help facilitate the decision-making. “BioArctic did everything they could to prepare us. I would ask them to help me with the slides or ask a question, and within less than 24 hours I would have all the answers.”
One of the deliverables included in the Golden Package was the documentation for the Investigative New Drug application or IND that would be filed with the US Food and Drug Administration (FDA). This would assemble all the data generated by the work package teams into one cohesive story demonstrating why AbbVie should be allowed to initiate clinical trials. A transition team was established to conduct the work. The first task was to align on a process. As with everything about the alliance to date, the focus was to be agile and to produce a high-quality document. In keeping with its emphasis on regular and robust communication, the project manager prepared a weekly email laying out who was on point for what for that week. This kept everyone aligned and continued the culture of accountability that developed over the course of the alliance. There were no proverbial balls dropped.
Of course, there were other components to the opt-in package. According to a member of that team, “We had to lay out all the deliverables and when AbbVie would receive them. Then we had to find a mechanism to transfer, track, and review them.” A data room was established, so as soon as reports would come in, AbbVie had access to them. “We set up a process to review them right away. Everything was done in an agile way. There was no wasting time on bureaucratic process.”
Educating the Decision Makers
In parallel to producing the opt-in package, the AbbVie members of the team developed a very clear plan for stakeholder management. Each key stakeholder was identified, along with what the ask would be of them and the documents they would be tasked with reviewing. Then the timing of setting up those reviews was carefully coordinated with when BioArctic would deliver the documents. It takes a lot of work to get leadership aligned—and it began well in advance of the decision with the regular consultation the head of alliance management did with the key leaders. This was critical to bring them along and of course, hear and address their concerns.
According to the senior AbbVie executive overseeing the project, “Throughout the alliance, every time we gave a report to senior leaders, a key element of the report would be how well the alliance was going. It gave them great confidence. With all the proactive listening, risk mitigation, and tremendous transparency about not just process, but what could and couldn’t be known, or done, it is no wonder that, “By the time we got to the governance meeting, the decision had already been made.” As one of the team members shared, “The team’s recommendation was sufficient for the decision. That made us all feel good.”
The Essential Element of Collaborative Leadership
For all the good alliance practices the collaboration benefited from, an essential element is the empowering collaborative leadership demonstrated by the BioArctic CEO, the project leads from both partners, AbbVie’s head of alliance management, and the senior executive on the project. They worked together as one team with a singular objective—to present AbbVie with a good asset that it would opt-into licensing for development, creating the most direct pathway for the exciting science to one day reach patients in need. They were always willing to be straightforward, to ask the right questions, to listen to understand, to be accountable, and to demonstrate trustworthiness. Challenges were addressed proactively, always letting the science guide their decisions. Observing their leadership allowed the teams to perform at their best, setting an example for all to follow. Indeed, bad behavior on this alliance would have been so obvious as to be untenable. As one of the work package leaders said, “We brought out the best in each other.”
In many opt-in situations, the potential licensor controls the situation, providing only periodic reports to the option holder, who doesn’t assign resources to work on something that is not yet part of their portfolio. That approach does not result in an asset that has been de-risked in the most impactful manner. It doesn’t result in each partner learning from the other. All of the resources committed and work done by AbbVie—its willingness to be a true partner to BioArctic—and BioArctic’s commitment to do what was necessary to produce what AbbVie needed is a testament to a deep appreciation by leadership that collaboration produces better outcomes.
For the team members, it was hard to let go. Once the opt-in decision was made, it became an AbbVie development program and BioArctic was no longer involved in the work. Letting go was described as “painful.” Another team member summed it up, “I wish this collaboration could continue forever.”
The partners embarked on this project with The Rhythm of Business to share their experience and their learning about how partnerships to develop innovative medicines should work, but too often don’t. In our experience advising biopharmaceutical alliances for more than 20 years, less than optimal results occur because of leaders that don’t know how—or won’t—collaborate to lead by example. They consider transparency weakness, fear a loss of control, and never build sufficient trust to be confident that everyone is pulling in the same direction, confident that the biggest win comes from everyone winning—and that starts and ends with the patient.
The asset AbbVie licensed is currently 18 months into Phase One clinical trials. Whether or not a beneficial therapy results from this exemplary research collaboration will not be known for many years. What we can know at this point are five key practices (See Figure 1) that got the alliance to a successful outcome that others can follow:
- Align on a Strategic Value Assumption – Align strategically and scientifically around a robust value assumption and define the alliance’s North Star.
- Plan to Execute – Have an agreed development plan with milestones, actions, and owners prior to financial negotiations.
- Start it Right – Take the time to have a comprehensive startup process. There is a saying among alliance professionals: “Start it right or start it again, after conflict and lack of trust.”
- Meet Regularly and Often - Create a one team mentality, sustained through frequent, regular meetings, together with leadership who communicates openly.
- Provide Transparency into Decision Making – Understand and be transparent about the pathway to reach important decisions.
The practices AbbVie and BioArctic followed to get to a successful outcome are core practices of the discipline of alliance management, but are not always followed. The trust the partners built and the collaborative behaviors they executed allowed the science to benefit from all the resources—human, financial, and otherwise—the partners brought to the table. That results in producing a win for the partners and the patients and a blueprint for others to follow.