with Joe Stalder
“The Keys to Effective Project Prioritization in Biopharma”
Today, we discuss how to improve project prioritization in biopharma with Joe Stalder, the executive director of program management at Mirati Therapeutics.
Joe is an effective project manager with a broad background in pharmaceutical development, including pre-clinical research, clinical development, and commercialization, and has worked for such companies as AstraZeneca, Calithera Biosciences, and Genentech, to name a few. He is a regular speaker at biopharma project and portfolio management conferences and he’s the author of an upcoming book on managing drug development projects.
Stream or download “Keys to Effective Project Prioritization in Biopharma” below.
Subscribe to Project Management Paradise via one of the links above and you’ll automatically receive new episodes directly to your device.
Highlights from Episode 147: “Keys to Effective Project Prioritization in Biopharma” with Joe Stalder
Can you tell us a bit about yourself and your background?
I’ve been working for biopharmaceutical companies for about 10 years, managing projects, mostly at the development stage. So, that means when a drug candidate passes from the research stage and to clinical development and before it goes commercial, that’s kind of my space, that development stage. In biopharma, there are a bunch of different types of project managers. We have research project managers, we have development project managers, and commercial project managers, all separate. We also have regulatory project managers and CMC project managers.
Now there are even more, specific project managers, there are clinical pharmacology project managers. So, we have PM all over the place and it’s becoming more specialized. When I originally started, 10 years ago, we didn’t have all these specializations. We really just had one project manager that dropped in and did everything. And so through that time, I’ve become more specialized in development. So, that clinical stage of drug development. And that’s been my career path for the past five years or so. And the companies you mentioned are mostly oncology companies. I work in cancer research, in particular late-stage. So stage 2, and stage 3, phase 2, phase 3 drug development. So, that’s been the past 10 years of my career.
How did you get started in project management? Was this an area that just stood out to you and you were looking to start your career? Or was it something that you just naturally fell into as you started to progress?
Yeah, it’s funny how it always works out. I was part of a postdoc fellowship program that I was interested in clinical research so I wanted to run clinical trials. Over time, over the two years of that opportunity, I was exposed to other roles and was given the opportunity to work in project management. So, corporate project management as they called it, and I really liked that role. It’s a generalist role that fits my nature. We get to tap into a lot of fields in the industry and it’s a gregarious role, too. So, it’s something that I really enjoy, I like being around people and pulling people together and keeping work streams going. I’m goal focused. So, that always works well for a project manager. And so the role really fits my personality and I think that’s why I stayed with it and that’s why I still enjoy it to this day.
You’re widely known in the PM circles for your GRIDALL methodology. Can you explain exactly what this is and how exactly it works?
Yeah, thanks for bringing that up. So, GRIDALL, I like to think as an improvement upon some of the tools that we use quite often these days — that’s ADI Logs or RAID Logs. GRIDALL stands for goals, risks, issues, decisions, actions, and lessons learned. And that framework — all of those steps — form what I think is a complete project management life cycle.
You always start with goals. Every project has goals. Every goal has risks. Every risk can become an issue. Every issue requires a decision. Every decision has an action that comes out of it and every action gives you an opportunity to learn a lesson and those lessons can be cycled back. You can then go back into applying those to the next goals, the next risks, and the next issues.
And so it becomes a framework for managing projects and tracking project information from its inception from the development of the goal through to lessons learned and then applying it back.
It is also useful as a PMO framework. So, for organizations that are building their methodology for the first time or identifying gaps in their methodology. It’s a way of seeing “Do we do a good job of planning our goals? Do we do a good job of identifying risks and managing risks?” If not, if there is a challenge there, there are tools within each of those categories that we can apply. There are goal trackers, risk registers, there are issue logs, and decision frameworks. There are all types of tools and if anyone’s interested, there are materials available on my company’s website that’s Groundswell Pharma Consulting and you’ll see a list of a bunch of tools under each of those components. And so through identifying the gaps, you can then pick a tool that works for your company and apply that and that completes your project management methodology.
It’s also a good communication tool. GRIDALL is a good communication tool because the previous step provides the context for the current step. So, let me give an example. The company is working through an issue and needs to make a decision. The context of that decision is the issue and prior to that, it was hopefully a risk that was identified, and then it’s a risk to a goal. So, if you provide that information to the decision maker, it gives them the context that they need to make that decision. So, it’s good for communicating the information to the appropriate stakeholders by looping it back, by tracking back to the previous step in the GRIDALL framework.
I found it to be a really useful tool. It’s again, it’s an improvement of ADI logs because it provides more information and it goes in sequence. It goes from goals to risks to issues. That’s something I’ve been using for the past five years or so. And I’ve been trying to promote it and get other people aware of this tool, this framework has been generally, well received, and I’ve got a lot of good feedback and got a lot of good suggestions on how to make improvements. And the nice thing about it is something that not just the biopharmaceutical industry can use anyone who manages projects can use it. And so I’ve been starting to promote it outside of the pharma industry and getting good feedback.
What are the key elements of good governance in project management in your opinion?
It starts with good information. I think having good intel is the key to making good decisions. Good intel — it’s variable on who you ask and in biopharma. There’s never enough information to make an easy decision. We’re always making decisions with about 3/4 of the information that we actually need. And that’s because, in biopharma, we’re constantly experimenting, we’re putting drugs — we’re putting new molecular entities — into patients and seeing if the drug works.
And we have a basis for that, there’s a mechanistic rationale for why it’s supposed to work. We even have some preclinical models that give us an indication of if it’s going to work. But there’s always a risk; biological systems are really complicated and so we never have enough information or we never have clear information on making a decision.
But we do have things like development costs, we have expected revenues, and you can calculate an NPV with that. And by standardizing those and standardizing other criteria by which you make a decision and housing that in a central repository so there’s no gaming of the information, I think that’s one of the keys to good governance, keys to good decision-making, I would say.
Having a governance framework is also very important. When I say a framework, especially at large companies — as you mentioned, I was at AstraZeneca, Genentech/ Roche — there are multiple governing bodies within the organization, and so that governance framework is all of those governing bodies that come together that are basically there to control how projects are run and made sure that projects are being run according to the plan. For example, there might be a Development Review Forum that reviews your development plan. There might be a Commercial Review Forum that looks at whether the sales forecast is accurate in their view. And those all come together at a Portfolio Committee that then makes the decision whether to move forward with the investment or not. Through all those reviews, you’re getting governance. You’re getting some input on how to manage your project.
The appropriate sequence of those decisions and those endorsements, that’s important. And so having a governance framework that’s clearly defined and having the steps clearly defined before you go through it is really important to reduce swirl, and that’s either indecision because you don’t have the right people in the room to make a decision, or once a decision is made it gets contradicted afterward or it gets circled back on and undone. So, that’s something we try to avoid in the biopharma industry is trying to make sure that decisions stick.
Having the appropriate governance framework, I think is key, having the roles clearly spelled out. And on roles, there are several frameworks that can be used to define decision-making roles. My favorite is called RAPID, it’s from Bain & Company. There are others, Mackenzie has one that’s called DARE. There’s the DACI which was more focused on decision-making rather than task management. DAI is another kind of uncommon one, but it’s available.
So, there are all these frameworks. I think what’s important is that a company picks one of those frameworks and makes the rules clearly understood across the organization. We want people to know what those roles are without even thinking about them. They know if I’m the Recommender, I know exactly what that means. If I’m providing Input, I know exactly what that means. If I’m Performing the task after the decision is made, I know exactly what that means and what’s expected of me. So, having those definitions clearly understood across the organization, I think that’s the important part more than having the right framework or having the perfect framework because none of them are perfect.
So, I think those are the key things: having the right information, having good governance, and having good decision-making roles. Those are the key parts for making good decisions across biopharma.
How would a company choose from these frameworks?
I think it’s important to know someone who has experience with them and has tried them out it in various formats. The company culture plays a huge part in it. At small companies, where there is a single decision-making body and where your leadership might be more focused on science than on the economics or the business side of things, having a bureaucratic, we could be called bureaucratic, but having a clearly defined process like that might scare them.
When I tried to introduce RAPID to say, for example, Calithera, it was a small company, it was very science-driven, and they had a single asset. There was pushback in defining something like this: “we don’t need something that detailed”; “we don’t something that technical”; “we just make decisions at the CEO level and that’s just how it’s done”. So, culture plays a lot in picking the right framework. And so it takes a bit of time for any organization to realize how useful and beneficial some of these tools are, and the culture kind of has to get there.
And as project managers, we shape a lot of the culture, we shape the culture on our project teams, we shape the culture in the leadership and what information comes up and what decisions are being made at leadership. It’s important for us as project managers to know all these frameworks and know which ones work best in certain situations. And so I would encourage any project manager to kind of go out, research, try a couple of frameworks with the team or, if they’re at a small company, try it with their leadership. See how it goes, and attend courses. There’s for example, a change management framework called ADKAR, that’s produced by Prosci, there are courses available for you can be trained in these types of things. Go out and learn these things and then bring them into your organization and apply them.
So, that’s what I’ve done over the past 10 years, I learned about things, I apply it to see where it works well in certain situations and things that don’t, kind of pass them on them. And that goes back to that GRIDALL methodology — learning lessons and applying it in the future.
Can you explain what the key to effective strategic portfolio management might be?
Portfolio management is difficult in the sciences because as I mentioned before, not all the information is available at any time. And so there’s guesswork, there’s a lot of guesswork that takes into account. I think it’s important to start with a menu of the opportunities that are being decided on in the portfolio. And then, identifying the information that’s needed across those investment opportunities.
The information that’s needed is the criteria that are used to make the decisions. And a consistent framework for gathering and tracking that information is required. And when I say consistent, that’s the key thing: consistency. A structured framework, that allows the right information without bias. That’s the hard part: there’s always bias introduced any time there’s guesswork and there are leaders in any organization that have their pet projects. And because not all the information is available, there’s the ability to kind of manipulate and tweak some of the metrics and fit it into decision-making criteria that it doesn’t always fit.
It’s true in any organization, it was true at AstraZeneca. They were pet projects there. It was true at small companies like Calithera. There were just projects that scientifically were very interesting but economically, from a business case, didn’t always make sense. And so I think it’s good to have a framework that captures both [the science and the economics].
When it comes to making decisions, I think it’s important for the organization to understand what is committed and what should be worked on versus what should be killed or put on the back burner. A lot of times these pet projects, they’re called zombie projects, if the organization, if the governing body tries to kill it but there are people on the team who don’t want to let it go, they kind of continue on. So there are zombie projects that are tried to be killed but they keep going. It’s common in big companies – that happens a lot.
So I think having a ruthless interrogation into your portfolio is important. Aligning those projects to the strategy, aligning the opportunities to what the business is trying to achieve. I think that’s important to keep doing that quarter-over-quarter, even month-over-month.
Connect with Joe on LinkedIn here
Learn the keys to effective “project prioritization in biopharma” by accessing a complimentary guidebook by Joe Stalder at corasystems.com/prioritizationguide
Tune in to a bonus webinar by Joe Stalder on “project prioritization in biopharma” by visiting corasystems.com/effectivewebinar