Session Notes: Schedule vs. Time: Who Owns the Critical Path?
Amelie Le Bihan
Director, Program Management, Noema Pharma
Ire Mencía Castaño
Associate Director, Global Medical Excellence Project Management, AstraZeneca
Sabine Pfeffer
Global Program Executive Director, Novartis
Tim Rumbaugh
Vice President Program Management, Edwards Lifesciences
Executive Summary
This panel explored the tension between realistic project schedules and external time pressures in pharmaceutical development, focusing on who ultimately owns the critical path. The discussion revealed a significant evolution in how organizations manage buffers, trust, and communication, with pharma companies moving toward trust-based planning while biotech startups operate in buffer-free environments relying on rapid response to delays.
Full Notes
The Schedule vs Time Tension
The fundamental challenge emerged clearly: project schedules represent internal planning with dependencies and realistic timelines, while time pressures come from external forces like competitors and regulatory requirements. Sabine Pfeffer from the biotech perspective highlighted how companies fall into 'just in time' planning mode, taking significant risks by compressing schedules. The discussion revealed that while some activities have fixed durations (39 weeks for dog studies, 26 weeks for rat studies), others can be accelerated with proper resources and decision-making. This creates ongoing tension between what teams know they need and what business pressures demand.
Trust and Communication Evolution
Tim Rumbaugh shared a compelling transformation story from Edwards, where detailed task-level tracking evolved into trust-based planning over several years. Initially, leadership would compress timelines arbitrarily ('August becomes June'), leading to consistent missed objectives. The breakthrough came when leadership began asking about buffers rather than denying their existence, shifting the conversation to 'How much buffer do you have?' rather than imposing unrealistic compressions. The team also discovered that weekly status emails to leadership eliminated communication breakdowns and blame cycles, establishing clear accountability for project decisions and delays.
Buffer Management Innovation
A significant methodological insight emerged around the Theory of Constraints approach to buffer management. Rather than allowing individuals or functions to build in their own buffers, the system uses two estimates: a low-risk estimate and a focused duration estimate. Workers receive the focused duration timeline, but all buffers are pooled at the project milestone level. This prevents sandbagging at the individual task level while maintaining realistic project timelines. The approach requires strong trust between project managers, functional managers, and work package owners, but has proven effective in creating more accurate overall project timelines.
Biotech Reality and Resource Constraints
The biotech perspective revealed a starkly different reality. As Pfeffer noted, 'We don't have buffer. We are just trying to balance between realistic and optimistic.' Small biotechs operate with extreme resource constraints, focusing on early reaction to problems rather than planned contingencies. When delays occur, the approach is immediate problem-solving and innovative solutions rather than falling back on built-in buffers. This creates additional pressure for clear communication with management about resource needs and potential delays, often requiring difficult conversations about accepting delays or investing additional resources to maintain timelines.
Future Challenges and AI Impact
Looking forward, the panel identified emerging challenges around resource allocation in volatile environments. With AI projects and new initiatives competing for team attention, organizations need explicit discussions about allocation percentages rather than assuming 100% dedication to any single project. Amelie Le Bihan emphasized the need for conscious decisions about team allocation, potentially giving team members 50% allocation to account for new projects rather than optimistic full-time estimates. This requires governance discussions about project priorities and realistic resource planning in an environment where change is constant.
Action Items
- → Not specified — Implement mile marker tracking system for annual objectives open
- → Not specified — Establish scope revision discussions for compressed timelines open
Key Insights (16)
Trust-based timeline management
Sabine Pfeffer Buffer ownership debate
Sabine Pfeffer Communication prevents surprises
Sabine Pfeffer Biotech reality check
Sabine Pfeffer Theory of Constraints application
Sabine Pfeffer Assumption transparency critical
Sabine Pfeffer Leadership buffer evolution
Sabine Pfeffer Resource allocation realism
Sabine Pfeffer Implement milestone markers
Sabine Pfeffer Scope revision discussions
Sabine Pfeffer Buffer elimination strategy
Tim Rumbaugh Leadership communication shift
Tim Rumbaugh Biotech reality
Sabine Pfeffer Accountability establishment
Tim Rumbaugh Theory of Constraints methodology
Sabine Pfeffer Mile marker tracking system
Sabine Pfeffer Full Transcript (click to expand)
Apr 22, 2026 Schedule vs. Time: Who Owns the Critical Path? - Transcript 00:00:00 : We have where from Barcelona. Wonderful. and two. Yes. Now, yeah, perfect. So, we don't have prayer now. We have prayed later. Yes. Wonderful. Good. One, two, three, four. Complete. Perfect. So time interesting maybe start to understand what's the definition schedule with some basics. Yeah, it's really good. So we uh the schedule is yeah what we understand is basically the project plan. and see uh what we put together as a sequence of activities dependencies and we've heard in the previous uh talk wonderfully how many complexity is to put a reasonable schedule together reliable schedule together and then we have the time component which comes often let's say from the external side pressure with uh competitors uh in place um regulatory u uh requirements etc. So we have these two elements schedule uh time and then the big question is who owns then the critical parts do you want say um coming from the experience of the farmer but now the biotech I'm happy that we perhaps bring different perspective and I think that what I experience now is that we are sold to on the critical path because we are getting to this mode of just in time planning. 00:02:19 : say more or less you take a lot of risks and um and I think here um yeah this this planning of these different activities in our clinical development plan that can spread across different function from CDC from clinical operation from nonclinical and for sure there is how we plan them there is kind of not being able to be compressed I mean yes nonclinical long-term talks is 39 weeks in dog or 26 rats mix weeks in rats and that can change. However, there is also things where you can be asked to accelerate and so it's a bit the concept of time versus schedule and um yeah pressure is always high we deliver on time before if that would be an option and I think that that resonates also to one of the question in the morning it was if you are late what can you do to accelerate and if any increase in budget could or any decision making earlier on could help you manage your teams. So I mean that kind of triggers the question how to make sure we really understand the timelines from the functions whether there are any buffers in it any hidden things how is it working with your Europe. 00:03:41 : Yeah thank you. So um in terms of this planning I think um the assumptions that are hidden in the timelines are very important. Um there are some discussions that need to happen and again this was mentioned earlier communication with the teams is very important. So it's not about just your schedule looking realistic. is having made time in with the team to make sure that they have been able to flag anything that may be hidden that may be impacting things and then there can be surprises later. Of course, there can be things that are very difficult to anticipate, but um my take on this is that there is um very strong component of trust and communication with the team. That is key to make sure that your um schedule can be realistic and that your critical path is not over optimistic which sometimes may may happen because we tend to remove um some of the items. So try to make things faster and being over optimistic can have a backlash a little bit. Um so that would be my my recommendation. 00:04:47 : Make sure that the timeline is communicated to the team and it's discussed and there is opportunity to challenge that this optimized timeline that leadership is asking that we want to deliver faster that it's not going to backfire and if it's this is very um kind of gods but um I've been in the situation where we've had to explain that this hadn't been accounted for and it was like really things that could have been avoided because the the person was not available to speak up at the right time. Um so that that would be my recommendation for for anyone in in this um exercise of trying to optimize the timelines. Make sure that you don't overpromise. Anyone more want to talk about trust and confidence? I mean it takes a lot of trust to promise timelines, not building a buffer and suddenly be the one sitting on the red chair. But my question is I think if you want really to have reliable timelines when you say okay you are you building actively buffer send in your schedule. Um I think that there is some buffer that needs to be discussed before time with the leadership and this is part of the governance discussions and we do incorporate that but I'm just talking about uh some unforeseen circumstances that you can have at personal level uh that sometimes are a 00:06:14 : little bit harder like you know, we have some some strange circumstances that I can disclose. Um, but it's it just comes down to having access to the equipment and things like this that can sometimes u be overlooked. Um, so there are certain buffers that for sure are implicit sometimes because there have been a standard practice that is carried over from uh from other projects and there are explicit buffers that require the dedicated discussion as mentioned. You wanted to say something that looked We can go to the next question. That's okay. No, just continue saying what you thought about it. The confidence and the trust. Yeah. Building. So, when I when I first started at Edwards, I used all of my past project management experience and drove all of the project planning down to the lowest level of detail possible. And the project teams aligned with that. They were okay with that. that was they were getting used to it and over the years we saw two transitions. One was at the very beginning, no matter how much detail we had, our leadership, they didn't even want to say the word buffer, right? 00:07:26 : And so when we set our annual goals, they'd ask, "Well, what's the project plan for that goal?" We'd say, "August." And they'd say, "Okay, then you have till June." And they would, right, as a challenge. After a few years of not hitting a single one of those objectives, they finally started asking, "How much buffer do you have in that?" Let me say August and they'd say how about we give you the goal is September, right? All of a sudden there was this shift. Meanwhile, at the project level, we started shifting in this level of trust. We started shifting away from tracking them at every single task to much higher level almost the tactical estimates that were made because we were doing much stronger resource management. And it got to the point where as long as the project manager, the functional manager and the person that owned the work package were all aligned, we would give them highle time frames and then they would have to operate to that. And as soon as they proved that we couldn't trust them at that level, we'd start getting into more detail. 00:08:32 : Yeah. And and we see also that I can only agree with you and see also that basically the schedule what you once established and what we've heard also in all the different talks is basically it's not budgeted. It's it's we have to track that and we have to adapt that and I think that coming also to the role of the project manager I see for us it's so important to communicate not only with the team but also with the management and do let's say proactive scenario planning and also a risk assessment and see like from the beginning um where are your potential bottlenecks and can you do something already to mitigate before you execute this just to mitigate certain significant delays which could happen biasing a machine for analytics. Yeah, have a better plan. Basically, I think risk management looking early what could go wrong and decide when do I need to implement a plan B is important and as well. say that we have some kind of team. we have communicated that cannot move or that we can extremely that's the value creation for the company to to them and here in the to be really clear on what was the assumption that we made what are the risks that we took and if there is any change obstacles Coming to moving away from Edwards, 00:10:21 : we go into every those level of detail to more of a level of trust. Do you decide in your plans? You have trigger points based on when you assess your plan more in detail. How do you decide points? Yeah, for every what one thing that we did is we started getting our leadership away from looking at, hey, why are you going to miss that objective in three years, right? We got them to look at one year at a time. And then we would take every single objective that we set for each year and break that into mile markers is what we called it. Kind of like as you're traveling along a road, you see where you're at and you make an assessment. How much longer will it take us? So, we guide ourselves by those mile markers and as long as we're achieving the success at each one of those, which is usually every two to three months, then you're demonstrating that you're on track and it's as simple as that. And then we're tracking status in the co or you want to add and before you said I invite everyone else here to raise questions you want to raise otherwise we can just make it objective. 00:11:39 : Yeah, just wanted to build a little bit with the team was articulating. So I think there is a quite standard practice for us in terms of the uh quarterly reviews. So what we started doing is making sure in the internet that there is a time to make sure communications the assumptions revision is also part of the discussion. So it's not just what's the risk status and has there been any evolution on the mitigation plans but just on on the assumptions because sometimes um external factors competitors development might impact as well your assumptions. So making sure that's part of the conversation frequency. Yeah. Thanks. And just observation just personal experience as humans people use the time that's you know when I see people that say I try to experience destinations. So you're doing for example trial there's a study start up there's the enrollment time okay there's a study close up you got the bies you have monitors you patients there's a lot of certainty so we would model what is the how confident are we certain is it 20% confidence is 70% so we also had you know different teams using the same methodology confidence I'm curious are you using silver be your companies or is it more qualitative approach confidence. 00:13:16 : I can just address that real quick. Um we started following the theory of constraints and we started using two estimates for every task. We would have the lowrisk task which is knowing what you know and all the extended work that you have to do. How long would it take to do that? Someone's going to say well it's going to take me three weeks. The second one is the focus duration. Say, how long would it take you if you did nothing else? They say, "Oh, I can get that done in two days." They don't get the five. They don't get the three weeks. That buffer goes to the end milestone of all that, which might be a year and a half later. What they get is the two days, but the entire team gets the buffer at the end. No one in no worker gets any buffer. No function gets any buffer but the entire project does. Out of curiosity for biotech no I mean delays which become visible and have impact on financing is even more critical. 00:14:28 : How do you plan for buffers? We don't have buffer. We are just trying to to bl between realistic andistic and um and I think that's the concept is more to we have really review of where we stand. So for us it's really more of the issue that we react as early as we can. So adding delay onto our recruitment uh extremely early try to find solution one to an engagement that for sure cost but for us is more critical. sometime decisions and and generally what we can also see is that sometimes take a bit too much time decision that yeah it's a way time and what are solution to that and so I think that it's a bit of the mindset to be sometimes extremely innovative the way that and that's also part of the of our role as program directors to say okay there is different options but there is also if we don't get additional here is the consequence of not taking for initiatives any of that to be sure that um any decision that we take because of lack of really supports everyone to all the either just something others. 00:16:40 : they found a new impurity and need additional time for testing etc. So having these uh trust on the team that you communicate really as soon as something or even there is a risk that something happened and then also communicating to management say okay can we do already something or that they say oh maybe we accept this risk and we are delaying this program by three months or four months or saying oh no we cannot but then we would put some in so I think I think this communication aspect gets strong especially at big farmer more more important that avoiding blaming also at the end talks projects coming in just the best people are moved to the next project and you you have less. So how easy is it to communicate to management that you either need more resources which are much not available or you're delayed by half a year. I think it's very important easy to communicate that message I think. Yeah. But I think it's very important in an appropriately mutually and uh maybe also with a solution potential difference analy coming up I think that's for me but I wanted to come back to an point the other point I think regarding the predictability of certain things for me also what I've heard also before is the people aspect so I think if you have someone very experienced I think might be able to do things in a different way be much much faster have 00:18:33 : someone else. But for me that's also a big big um point and I think it's more spoken about management that are always extremely opinion risk and risk they can It just is think is something that is needed for next steps. I think that's something that's also as the expert is outside because sorry I think an important point to the mention earlier about more projects coming on on top and some the team is already assigned Um it's important that um there there can be this upfront approach to consider that the team allocated to this project we are generally um especially lately in a very volatile environment. Um so if there is a consideration that there can be a new project coming up in the next quarter or in the next six months. Um, is management having these discussions or are we able to promote these discussions of can we make sure that maybe the priority for this project is not 100% tied so that we know that there are changes that are going to be coming and we are not creating tension up front. 00:20:35 : Um so the priority of the project may deeply speaking before we're giving the individual contributors the optimistic time estimate that they're providing but maybe there can be discussions prompted to make conscious decision of okay they could do it in two days but if that task is planned four months from now is that going to be realistic or is it smarter to say okay we're going to give you a 50% allocation to this project. So it would be a little bit of a a longer test. So this is something that we are trying uh because we do see especially with the with the impact of AI that there are other teams that may be coming to us. We know that this very high kitchen environment. We already have a VAU. So this is something that um we have started to discuss. It's not been implemented yet but at least we we do have the approach of this additional flexibility. Just wondering how is governance um dealing with this. So do they let you work until you come they suddenly feel your boss did this. 00:22:01 : She invited uh her four direct reports. I was one of them. And her colleagues on our leadership. She said to all four of you in the essence that it's so difficult for us. Now what do we have to do to fix it? And we had to take on the persona of the person that she assigned to us. The result was remarkably simple. We're now going to send out a status update. An email every Friday only to our leadership team. There's no obligation, but when you have a status, you better communicate it. All the squirrel and all of the communication problems that we had just vanished. And that one governance step, we started that three years ago. To this day, no one can ever say, "Why didn't you tell me?" Right? Even if it's bad news, we put it in there and say, "Hey, you need to management. We can raise challenges. relief like we can also uh up the support that we need to address them and it is really like where we have close connection and for decision making then you speaking about governance then on the monthly weekly but we have on decision of course we have also regular reporting reporting requirements uh but the directors central to ask you also how how program 00:23:57 : management it's basically this link between the team and takes pressure sometimes also from the team if cannot be escalated or be Great. All this questions maybe a question again from the startup side. So there's a lot of and you do give a timeline for your cosm of course there's the liability factor because you assume that they have incorporated their own buffers but when you present this do you add your own buffer on top of it or do you go exactly by their just this example I think you have to do an analytics externally we're waiting for the results submission basically they are delayed by by more than so we haven't had any buffer so basically it has huge impact to We work with them to be sure that that needs I hear yeah um there's also the aspect of projects have been involved more related with technology and implementation of AI um we do timelines and sorry was saying but one thing that's important is sometimes challenging the timelines is not going to change the output so we end up having to do is these discussions around agreeing on revising their requirements and revising our definition of the minimum viable outcome that we expecting for that milestone. 00:26:16 : So um often we do not get um to bring up this agreement that the tenants can be compressed but we can kind of get the approval for a revised scope that's still delivering the critical value at the right time uh even if it's not the full scope and it sometimes also depends if you practice let's say basis she I'm just laughing because I've also seen that and then their internal timelines already don't you have at some point in time a joint meeting where you discuss times etc. appropriate timeline where you have all parties sitting at the same table and be like okay I need this much time I need this much time how do we combine all this time together yes we can individually create our timelines and see how it fits but usually you have joint to see the interdependencies between the different partners but I think here the panel was more about schedule time. So that basically you develop your schedule with your team all the independencies that this schedule what you have developed as your team but then let's say external factors your sponsor management comes and say hey I want to see that half a year faster so basically I don't what Tim said basically oh I don't accept August you have to deliver in June try to do that go back and come visit Then basically who owns the critical is yeah and since we are working in 00:28:20 : a regulated requirement so I think is it QA basically who owns them the critical no I think it's at the end it's the sponsor who has the resources one last question just perhaps I can I think that there is also this discrepancy and yes we are forecasting we are thinking that will take so long but sure in partnership with external v we fix the timelines together but for sur ... [transcript truncated]