One of the aspects of drug discovery project management that generates a certain amount of consternation is the underlying difference in the nature of a drug discovery project versus a drug development program – the Great Divide that I wrote about previously.
In the beginning, virtually everything that can impact the timeline of a drug discovery project is an unknown, which makes establishing a timeline a bit challenging. To mitigate this, the Research PMs, and for that matter scientists who play a PM-like role, will often organise the work into milestones.
The milestones can either be date-driven where a certain amount of work must be performed within a given timebox. Or goal-driven where meeting the goals determines if the program can proceed to the next milestone. The goals are usually a set of scientific questions that must be answered in order for the project to progress. For example, the goal of the first milestone of a project might be to identify a set of targets for a given indication, and determine their tractability and priority.
At the end of the sprint (a two-week timebox within the span of a milestone), the team reviews the data with a view to answering several key questions:
- Did the assays/experiments give us a clear enough answer to the question that we can now proceed with confidence? If not, what are we still missing?
- If, for example, the team has created a library of compounds, and screened those compounds, then they might ask “which of those compounds should be considered hits, that we might iterate upon”.
- Are these compounds getting closer to the ideal compound defined in the Target Candidate Profile (TCP)? What aspects of these compounds need to be optimised? Safety? Bioavailability?
When reviewing the milestone, the team’s primary question is “did we meet the criteria necessary to advance the project”?
The Pipeline Planning Module
In Pipeline’s Planning module, we’ve borrowed a framework from the world of Development Project Management called GRIDALL, which stands for Goals, Risks, Issues, Decisions, Actions and Lessons Learned. This framework is described in detail in Joe Stalder’s book Project Management for Drug Developers. One of the key features of the framework is the ability to tie an action or a decision to a goal that you were trying to achieve. More importantly, since drug discovery companies are by nature learning organisations, the ability to collect lessons learned at each milestone in the project makes it possible to then “push” relevant lessons learned, to the right people, at the right time in a project.
Because discovery project management is at best a part-time undertaking, it’s important to understand that the focus is very much on providing “just enough project management”. As we were building Pipeline, we realised that any tool designed to support discovery, would need to fit the way people worked, and would need to minimise the amount of work to maintain it. No drug discovery leader would advocate for a system that created more work for teams that were already stretched thin. So keeping data entry to a minimum was paramount.
To meet this design goal, we implemented a number of unique design features including:
Plan Templates: these templates allow users to define the fields of data to be used for any type of plan. Want to create a CMC version of a TPP? Need a task plan for a typical small molecule oncology project? You can use the plan templates to get the process started.
Milestone Templates: in addition to being able to create templates for individual types of plans (like Assay Plans or TPPs), you can create a template for an entire milestone of plans. You can then import these plans into your project to further accelerate the process.
Notifications: Status updates would need to result in updates to the project plan, and in notifications being sent out to team members to ensure that everyone was kept on the same page.
But a plan must serve more than one purpose.
First and foremost a plan is a vehicle for setting expectations and aligning team members. Whether that’s determining how busy your team will be, or how long it will take, or how much it will cost to achieve your goals, the plan will set those expectations.
- It’s a means of keeping everyone on the same page and helping to coordinate activities across the enterprise, and its network of CRO partners.
- Because the Assay Plan is integrated with the Inventory system, it means that your plans can help you determine if you have enough of the right materials (i.e. protein and compound) needed to perform the assays in the Assay Plan.
- It’s been said that “a plan without action is a fantasy”, and therefore the plan serves as a launching point for a given milestone. The Project Lead can, with a single button click, turn an Assay Plan and a list of compounds into a series of requests, and can monitor the progression of those requests in real time.
If you’d like to learn more about the Pipeline: Planning module and how it can improve the effectiveness of your drug discovery organisation, reach out to us at info@aspenbiosciences.com