December 30, 2011

Nature of the Beast

Posted in General at 9:10 PM by Solutions2Projects, LLC

I’ve been in biotech long enough to know that the likelihood of organizational success is challenging due to regulatory hoops and the general economics. Fortunately, people and investors continue to chase the dream in hopes of finding the ‘billion dollar drug.’ The reality is that most don’t make it.

We are usually brought into smaller organizations (30-300 people) pre-commercialization or pre-IPO to put in the systems to bring them closer to their organizational goals. For the pre-IPO companies, we help them select and implement systems and IT controls to meet Sarbanes-Oxley requirements. For the pre-commercialization companies, we help them with all of their other system needs including ERP/MRP, document management, complaint handling, NCMR/CAPA, serious adverse events, clinical trial management, calibration/maintenance, and QC systems to name a few. This includes system selection, implementation and validation.

The companies we work with are small and have limited resources (financial and human) and need to work within various constraints. Every project is a challenge (no one likes change!) but the constraints make it even more challenging but not impossible. Due to the resource constraints, we often step in to fill gaps and work so closely with the employees that we become truly invested in their success. This makes it all the more difficult when companies encounter significant challenges because we want them to succeed. We want to celebrate their successes.

What we are seeing is that due to the limited resources, companies are having to make tough decisions about where to spend money and invest human resources. This means they may be waiting until the very last minute to invest in the systems to support commercialization and may not be allowing for sufficient time to effectively implement the required systems. When FDA comes in to inspect, they need to see that the systems and processes have been in place to support the filing and are in place to support commercial release of the product. This creates a dilemma for organizations on the cusp. It becomes a chicken/egg dilemma.

Crystal balls are murky and unreliable. FDA is unpredictable. Resources are limited. What’s the real answer? I wish I knew. I’ve been a part of two biotech layoffs for organizations that are no longer, have helped companies that have been acquired and reorganized, and recently had a client issue a WARN letter to all of its employees. I felt a bit unlucky until I reflected on all of the factors influencing biotech companies and realized it’s egotistical to think it’s me when it’s just the nature of the beast.


December 9, 2011

The Rhythm of Projects and Half Marathons

Posted in General tagged , , , , at 11:52 AM by Solutions2Projects, LLC

I recently ran my first half marathon after training for nine weeks and realized that the rhythm of a computerized system implementation project (for me at least) mimicked the rhythm of running a half marathon.
At the start of a race, similar to the start of an implementation, there is excitement, apprehension, jostling for position, and general anxiety. Project team members are excited about solving an existing problem with a new system but are uncertain about how their respective jobs will be impacted by the changes that will be made which causes anxiety. In order to alleviate that anxiety, folks in an organization jockey for position to ensure that they can positively influence the changes or avoid them entirely. Some may put themselves in positions of leadership and control or find a way to avoid completely.
As you move from the starting gate and begin to establish your own pace, you feel a sense of relief that it’s finally underway and a bit of a thrill that it’s finally happening. On a project, the (seemingly endless) planning is behind you and there’s finally progress toward the actual goal. There is cheering from the executive sponsor (similar to my family cheering me on at mile 2) and the project moves on.
Eventually, the excitement and relief fade as you pass the first few mile markers. Yes, there’s been some accomplishment but then there is the realization that there is quite a bit more to go. At this point, it’s extremely important for the project manager to keep the team motivated, focused on the overall objective, and give team members a sense of accomplishment. It also helps to have some cheering from the sidelines to reinforce the importance of the project and provide a sense of appreciation from outside the project team. This is a great time for rewards (even small tokens help) and cheering from the business sponsor similar to the cheering from the sidelines from friends, family members, or complete strangers. The boost takes you through a couple more miles and a couple more deliverables on a project.
A few more miles tick by and you feel like you are in the home stretch. Some of the big miles or milestones have been accomplished and it feels good. You get a renewed sense of energy and purpose and realize that it’s actually possible to meet your goal. It actually becomes possible to visualize the end even though you can’t see the finish line.
And then it gets hard again. For me it was at 10.5 miles. I was thrilled at how far I’d run and impressed I’d made it that far. But then I did some math and realized I still had 2.6 miles to go. I hadn’t trained beyond one 9 mile run and two eight mile runs. I wasn’t going to stop but I knew it was going to be hard. I put my head down and focused on completing the run…one step, one quarter mile, one half mile at a time. I broke it down into manageable chunks and gave myself kudos for every quarter mile. I closely monitored my progress to remind myself of how little there was left to meet my goal.
I do the same with a project team. The project team is tired at this point. While they know the end is near, the finish line seems so far away because of all of the little things left at the end of a project and none of them are fun. This includes data clean up and migration, data set up, work instruction and procedure finalization, training, and closing out documentation. At this point, the little deliverables don’t give much of a sense of accomplishment but it takes the project team closer to the go live date one step at a time. As a project manager, it’s critical to keep the project team members focused on checking these off and not getting distracted by what seems to be an endless list. Cheering from the business sponsor is helpful here, too.
As with every project I manage, once I see the finish line, I pick up the pace and use every last bit of energy to push across the finish line. Sometimes I have to push and pull the project team members along me but we must all cross together. We started as a team and we will finish as a team.
The elation you feel crossing the finish line lasts for a brief period of time before the letdown begins. There’s no longer a focused sense of purpose associated with a project. After the race, I looked back and said to myself, ‘well, now what?’ I walked back to the hotel to meet up with my family and we resumed the day. It is similar on a project. Once the project is over, most project team members return to their day jobs and work to get into a new comfort zone now that the new system is in place. It’s often uncomfortable and takes some time to get used to. Things will not be the same as they were.
At Solutions2Projects, LLC we recognize that computerized system implementations are not easy and that change is uncomfortable for most people. For most implementations, we recommend having incentives, rewards and project tracking and love to center them around a theme. On one project, our theme was ‘around the world in 88 days.’ To keep the company informed (and provide the team with a sense of progress) we had a map with marked destinations and as we reached milestones, we marked them on the map. Each milestone was in a different country and had a reward associated with that company. The rewards were small but the gesture appreciated by the team members. We celebrated the project completion with an America-themed end of project party since our destination was the Bay Area.
As a project manager, recognizing that there are going to be hills and valleys during an implementation helps to remove the surprise associated with the downs. This will provide you with the power to manage through the phases knowing that there is an easier time coming up and that eventually, there will be a finish line. I suppose that’s the great thing about projects…there’s always a beginning, a middle, and an end. At the end there should always be a celebration as the process to get there is never easy. And, once the project is over, as with this race, it’s time to find another one!