By Rene Russo, CEO of Xilio Therapeutics, as part of the From The Trenches feature of LifeSciVC
Prioritization is a concept that we have become intimately aware of, given the continually blurred lines of personal and professional obligations in a 24/7 world. The good news is we all know we need to prioritize; the bad news is we need to find time and courage to do it. In the fast-paced reality of drug development, that time needs to be sooner rather than later. Time can mean life and death for the patients we serve. Many biopharmaceutical companies face an abundance of riches in the scientific opportunities to explore but must contend with constraints in resources, both people and dollars. Given these constraints, a critical part of the development planning process needs to include prioritization of opportunities, whether they be diseases, targets, indications, or trials. But the real question is how do we manage this prioritization in a practical, collaborative, yet disciplined manner?
As I mention in my previous From the Trenches blogs [link and link], I am a big believer in an inclusive Long-Range Planning (LRP) process. When we started our company-wide approach to LRP, we saw it as a way to help functional leaders think about how they were going to build their teams in a way that would enable us to succeed in the more complex and demanding reality of a development-stage company. Now that Xilio has arrived at that very place, we need to further formalize and quantify how we make prioritization decisions.
Since the leadership team at Xilio believes that building capabilities is a key part of our roles as leaders in an early-stage company, and transparency is one of our core values, we knew that company-wide “participation” in the prioritization process would be a determining factor in the success of our efforts. So we chose to include the broader team in learning “how” these prioritization decisions would be made even if they themselves might not be “in the room” when such decisions were being made. We used part of our most recent socially distant, masked, outdoor offsite to engage our teams in a prioritization simulation. We wanted them to understand how, and why, tradeoffs need to be made so that they would model the behavior in their day-to-day decision making on a smaller scale.
Indication Prioritization Exercise
The objectives of an indication prioritization exercise include:
- Identifying the breadth of potential opportunities for investment (indications or applications for a selected target/ compound)
- Prioritizing opportunities based on integrated cross-functional assessment of:
- The strategic fit of the investment (target, molecule, clinical trial, etc.)
- The value (to patients, payers, providers and shareholders)
- The probability of technical and regulatory success
- The cost and time it will take to reach the value inflection (or approval), depending on the situation
Prior to an indication prioritization exercise in real life (vs. simulation), the company must have clearly defined objectives and an understanding of its financing strategy and constraints. For example, is the company looking to be fast-to-market, fast-to-POC (proof of concept) data, specialty-focused, therapeutic area-focused, a commercial enterprise, or a partner with a third party? Next, it’s important to gain management and team buy-in to the scope and criteria that will be applied. This also ensures cross-functional leadership is involved in defining the scientific evidence and clinical complexity, laying the foundation for an integrated and thorough analysis. Lastly, we need to be sure to advise the team to keep an eye out for internal bias that may influence analysis and thinking along the way.
Once the leadership team is on board and the foundation is laid, a gap analysis can be conducted to ensure that all relevant information is available to make informed decisions. If gaps are identified, the team needs to decide how essential it is to fill those gaps and whether to conduct secondary research (desk work) or primary market research (asking the market). This additional information will ensure the asset-specific information is available for consideration.
Developing clearly-defined parameters and ranking methods for the analysis avoids subjective interpretation and bias. The process will involve significant discussion and debate, so being clear on the criteria will keep the exercise focused and efficient. There are many ways to categorize the criteria and many distinct criteria under each category, so taking the time upfront to define those and clearly articulate them to the group will save time in the end.
In the recent workshop that I noted above, we considered the following major criteria with additional granularity that made sense for our fictitious pipeline:
- Strategic Fit
- Patient Impact and Corporate Value
- Development Feasibility
We asked the group to force rank the relative importance of these three categories to the corporate strategy against a 100 point scale. We then asked them to apply the same methodology to each category’s underlying criteria (see graphic for chosen criteria). With this two-step approach, we identified each category’s relative importance in making development investment decisions for the fictitious lead asset.
Observations
Watching and listening to the groups as they moved through the workshop was fascinating. We intentionally mixed the groups to be diverse in tenure, experience, and function. The decision paid off in that we had diversity of thought that we sought, and we were able to provide invaluable on the job mentoring/training across the company – independent of one’s level at Xilio. For example, one of our senior leaders in Finance noted that he “learned quite a bit from the broad range of perspectives” in his group.
Those new to the process began to better understand the need for a clearly defined strategy and cross-functional collaboration in the decision-making process. They saw first-hand how each person/function brings a unique perspective to the exercise. In addition, exposure to the reality of the limited funding and commercialization pressures provided the “big picture” we so often want our teams to have, but they don’t often get to see.
Depending on your company’s stage and staffing, you may find that you have some resource gaps that inhibit your ability to identify a comprehensive set of criteria, facilitate the exercise itself or, in our case, advance the LRP process into a more developmentally focused one. We are fortunate in our industry, particularly in our market, to be surrounded by talented consultants who understand our needs and offer a wide range of support. We leaned on consultants to develop and facilitate this workshop and introduce the concept of prioritization in a way that was right for where we are as an organization. We knew that our strategic planning process (LRP) would expand in 2022, so we wanted to develop these skills now in our team. Therefore, we linked the prioritization exercise to the budgeting component of the LRP, demonstrating that every decision we make needs to be carefully considered in lieu of other options. By participating in the workshop, we are confident that the entire organization will be better prepared for the budgeting process and the choices we will have to make as the assets continue on their commercialization journey.
As Steve Jobs said, “People think focus means saying yes to the thing you’ve got to focus on…It means saying no to the hundred other good ideas there are. You have to pick carefully.” That’s the mentality we want in our team as we advance along the development pathway. We want them to see all of the options and choose the one that deserves their focus.