Amazing Discoveries: Takeda Showcases Tips for Partnerships at the Earliest Clinical Stages
Clinical and preclinical development alliances are nothing new to biopharma alliance managers and ASAP members from the pharmaceutical industry. However, drug discovery alliances have been an unexplored area relative to later clinical stages in the drug life cycle, which is why 2022 ASAP BioPharma Conference attendees were privileged to learn the nuances of these partnerships from three executives from Japanese pharmaceutical giant Takeda in the interactive session “Lessons Learned in Creating and Maintaining a Vibrant Drug Discovery Alliance Portfolio.”
What, Why, and How to Make Ideas Worth the Paper They’re Printed On
The drug discovery phase in some ways is about helping company scientists formally explore their aspirational and somewhat abstract ideas for new medicines.
“It’s our jobs as alliance managers to help our scientific teams take those ideas and turn them into a successful collaboration,” said Regina Lemus, PhD, an alliance manager in Takeda’s GI Drug Discovery Unit.
How does an alliance team do that? By getting those ideas on paper, articulating the value proposition, and mapping out a plan to march toward that North Star, a process that starts with strategic conversations about who to partner with—and when—and continues well after the kickoff of an alliance, as the science often dictates a change in direction and the integration of new ideas. Takeda borrowed heavily from The ASAP Handbook of Alliance Management in developing scientific reviews, aligning partners, doing due diligence in partner selection, and composing contracts and amendments in the early stages of discovery collaborations.
Kristin Rosner, CA-AM, PhD, global alliance management lead at Takeda, said the first big challenge in implementing this framework was the science team’s proclivity to think about how they were going to achieve their goals “as opposed to [first] taking a step back and really articulating the ‘what’ of the value proposition and ‘why.’ How does it fit into our portfolio? How is this going to help us?”
The business development team, meanwhile, has to work closely with the science team and the science and business development stakeholders at the partner organization to understand the financials—in-licensing arrangements, the IP that will be generated, etc.—very early in the collaboration.
“It’s not only about partnership alignment with your external partner, but also with your internal partners,” said Jen Rice, PhD, associate director of R&D business development at Takeda.
A Change in Direction: Mapping the Twisty Road to Milestone Decisions
The output of these efforts should include a milestone-driven research plan that ultimately serves as the “roadmap” for the partnership, according to Lemus. And that road takes plenty of twists and turns. If the early returns on the science are positive, alliance managers must be proactive about evaluating whether it makes sense to expand the partnership’s scope of activities—are they making sound decisions or simply chasing a “shiny object”? Conversely, if the initial data isn’t what the two organizations hoped, or if things are running behind, it’s up to the alliance manager to shift gears or narrow down the priority list so that everyone focuses on meeting the collaboration’s major deadlines. Either way, the goal is to have everyone on the same page regarding “go/no-go decisions” when it’s time to make them.
“Because discovery science is so dynamic, you start in one place and sometimes you want to go in a different direction,” said Lemus. “We have a preset period of time where we are going to talk about this and maybe decide together that it doesn’t make a lot of sense to move forward based on the data being generated so far.”
Chartering a Way to Get Alliance Managers and Scientists to the Table
Team charters are critical for aligning stakeholders on what decisions will be made, how, and by whom. When Takeda’s GI discovery alliance teams put together charters, they convene a forum where all stakeholders provide feedback on the who, what, and how. These forums eliminated a problem Rosner discovered upon arriving at Takeda in 2019: champions were talking to stakeholders individually to get their buyoff on alliance initiatives, only to see them get stuck because the group collectively wasn’t on the same page.
“[The forum] has helped align my leadership team with Jen’s team in the BD side,” she said.
“This team charter is really beneficial in creating a seat at the table for the key stakeholders of a drug discovery deal: the scientists and the alliance managers,” said Rice, who added that the alliance manager’s historical perspective and visibility into other alliances is invaluable in deal negotiations.
However, there may be some hand-holding in charter creation.
“Discovery teams aren’t really used to doing team charters,” cautioned Rosner.
Making a Match: Divergences Arise Between Big and Small Organizations, Academia and Big Pharma, and Internal Divisions
The three presenters outlined frequent sources of mismatched expectations in Takeda’s drug discovery alliances. Rosner noted some common challenges with “David-Goliath” partnerships, even admitting at one point that she missed the days when she could pop into her CEO’s office to get an agreement signed at a previous job with a smaller entity. Rice, who is heavily involved in partnerships with institutions of higher learning, reminded the audience of the importance of understanding the sometimes-divergent goals of academia and private sector organizations: the former’s goal is to publish their research, while private-sector companies want to get drug discovery candidates to the clinic quickly.
Competing internal interests are a factor, as well. Lemus mentioned that it’s an ongoing challenge to continually attract the necessary resources from other divisions, which have their own priorities. Alliance managers must use their holistic view of the company’s alliance portfolio to identify areas of competing internal interest early on. Then, they need to illustrate the alliance’s resource needs so that these division heads can allocate the appropriate budget and personnel.
Rosner, Rice, and Lemus had other great insights. ASAP BioPharma Conference registrants can access the recording of their presentation and hear the three questions all stakeholders need to answer about their collaborations and learn how to navigate IP issues with the legal department, among many other useful tidbits of information.