By Jessica Goodman and Neha Garg
Most biopharma alliances start with an alliance agreement: a legal contract outlining the terms under which the partners have agreed to jointly work toward an objective. The contract usually sets forth the alliance governance, including the joint steering committee (“JSC”) and other decision-making bodies. Most JSCs will also draft an alliance charter, workplan, etc., to lay out basic principles of how the parties will work together: what work will be done, by which partner, and by when.
For many alliances, having these elements in place is sufficient. But some particularly challenging alliances require more; they may benefit from developing a more detailed and specific “Ways of Working” document.
Partners Large and Small: A Disconnect
The two of us lived through one such situation in a previous alliance. Jessica was an alliance manager for a small biotech that was working with Neha’s mid-sized biotech on filing an investigational new drug (IND) application for a molecule that was being developed under a collaboration and license agreement between our two companies. The smaller biotech was responsible for all work up through the preclinical stage, while the larger biotech was responsible for Phase 1 studies and beyond. The work plan from the agreement defined the overarching responsibilities: the smaller biotech conducted the experiments and collected the data necessary to file the IND, while the larger partner was tasked with the actual IND filing. But the ambiguous language in the work plan left certain activities open to interpretation. For example: Which company would actually author the IND application?
The two partners’ cultures were very different. The smaller biotech was nimble, capable of turning on a dime when needed. The larger partner, on the other hand, had its own processes, committees, and timelines, which tended to take longer. There were strong personalities on both sides, and differences in leadership composition andstructure.
It became a challenging relationship: from the small biotech’s perspective, the larger partner was rigidly insistent on its own ways and wasn’t willing to compromise. But the larger company was the IND sponsor and responsible for the IND filing, which meant being answerable to the FDA and addressing any concerns associated with the preclinical work. The small biotech was worried about completing the work on time with limited resources. If it missed the deadline for filing, the small biotech might miss the milestones set forth in the contract and might not get paid, so achieving the milestone was important.
So Now What? Fix It!
This disconnect and the lack of clarity on roles and responsibilities to meet deliverables led to confusion and disagreements. People were upset, work wasn’t getting done, and there was a real danger that important, “critical path” activities might not be completed on time, which could result in missed deadlines, a delayed IND filing, and ultimately loss of value. Trust had not yet been built sufficiently to allow us to have the kind of discussion we so desperately needed.
Adding to the challenges, we were trying to navigate these issues during the worst of the Covid-19 pandemic, which meant we couldn’t meet in person to resolve issues, socialize, and connect over meals and informal conversations.
Multiple discussions and escalations to senior leadership created pressure to fix this alliance, and fast. But how?
Turn of Events
Turnover in alliance managers at the larger partner company was another factor in the stalemate, but led to a lucky break when Neha was assigned to be the alliance manager for this collaboration and was partnered with Jessica to work toward a resolution. The two of us found that we were able to work together collaboratively and focus on solutions. We could each represent our own company’s interests while being able to listen and try to understand the partner’s (very different) perspective.
Jessica remembers that it was her leader at the time who suggested developing a “Ways of Working” document as a way through the impasse. The purpose of such a document is to outline the activities, procedures, and processes that the alliance partners have agreed to in order to help the partners collaborate more effectively. In our case, the Ways of Working document expanded on a subset of activities included in the original work plan from the agreement. The document outlined the specific activities and information missing from the original work plan, detailing roles, responsibilities, timelines, and processes for data sharing and communication. It also defined decision-making authority for each activity. The process was driven by program management, with input from the functions and from us as the alliance managers.
It was tough. It took two months to negotiate and align on a final document that both companies could agree on. Fortunately, the relationship between the two of us kept getting better, and over time we were able to build more trust. (All these years later, we’re now colleagues!) Building trust helped us to get through many arduous and difficult conversations, to sort through the details, and to see each other’s point of view.
Feeling a Shift
Once we had alignment over the Ways of Working document, things got easier. Not overnight, but gradually we could feel a shift. People became less hung up on tensions and conflicts and more focused on the work itself. The joint teams started to work more cooperatively once there was clarity on roles, responsibilities, and timelines. The arguments became fewer; the barriers to collaboration were removed. The spirit of the alliance was more productive, and overall morale increased.
While developing a Ways of Working documentis not a panacea, it can be extremely beneficial. It’s an operational document, somewhere between a RACI chart and a project management plan, spelling out decision-making, roles, responsibilities, timelines, processes, behaviors, communication management, and other key details. In our case, it took time and negotiation to craft, but in the end it was well worth it.
Ways of Working Pointers
Through this process, there were a few lessons learned. While not all alliances absolutely require a Ways of Working document, it can be a valuable best practice for those that need help. If that rings a bell for you, here’s a few tips:
· Set it up right from thestart. The contract is your template and starting point, but it’s up to alliance management to take its broad strokes and add color. Look at what the contract says, and what it doesn’t say. Where are the gaps and gray areas? Where do you foresee potential challenges? As much as possible, get ahead of those issues.
· Dig into the details. What are the critical-path activities, who’s responsible for doing what, and what are the timelines? What’s the escalation process? What are the shared resources and systems? Details matter.
· Leverage your relationship with your alliance management counterpart. This was huge for us, and it cannot be emphasized enough. Having a collaborative partner and strengthening that relationship is a must, not only for creating a document of this kind, but for building trust, improving team morale, and ensuring that the necessary work gets done.
· Consider doing an after-action review or “lessons learned” exercise. This can be invaluable if you have multiple collaborations with the same partner, but it’s also useful in shaping the operational contours of future deals.
Fun fact: After we aligned on the Ways of Working document, the actual document was never referenced again! It turns out that generating the document was what we needed to do in order to get alignment and move forward. It wasn’t the existence of the document that mattered; it was the process of creating it.
Once we did that, we didn’t just have a document to file away, we had trust and a shared understanding. It took time, a lot of escalations in the beginning, and many back-and-forth conversations, but keeping that open line of communication, and continuing to listen to and acknowledge each other’s perspectives, was critical. Working together to get to that point was where the value actually resided. It saved this relationship and made for a far more productive alliance.
Jessica Goodman, PhD, CSAP, CA-AM, works in R&D Global Alliance Management, OncologyTherapy Area Unit, at Takeda. Neha Garg, PhD, works in the R&D AssetTransition and Integration Office at Takeda.
Note: The opinions expressed above, and the example, are those of the authors, not those of Takeda.
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