You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.

First of all, you are being pressured to sign something you haven’t seen; further, you didn’t even know it was a requirement. Next, you are being told your scheduled run is at risk, which may impact your entire program. Also, you are concerned: why wasn’t this brought up in a previous meeting or communicated by email or other means? What other “invisible” tasks are out there?

As you ask questions and understand why the CMO needs to run this test, you uncover several other documents and actions that will be required prior to your run, but that had not been actively discussed. The project manager on the other side knows just what’s going on and does not let timelines slip, but the way he is managing the project makes many tasks invisible to you. You suddenly feel like your project is like an iceberg and you have only seen the part above the water. The project manager explains that the project can seem overwhelming if he hits you with all of the necessary tasks, but he assures you things are on target. Your fill will happen on time.

Now, you have a few problems. For the immediate issue, you need to find the right reviewers and coordinate timing on your side. You also need explanations, clarifications, and changes from your CMO. The bigger-picture issue is that you also need to figure out how to come together with your CMO on project management.

There is project management on both sides of the table, and there are tasks and roadblocks which are not shared across the table. For example, a clinical-trial program manager might not share with the CMO a funding issue that has arisen; he also might not immediately share a delay in the timeline for a trial, because he might think the CMO will deprioritize the run behind another client’s. The CMO might not share an issue with internal documents that need approval prior to creating client-specific documents, or the project manager might not know about a timeline shift for another client until it is in conflict with his own project. The project manager on each side is tracking events that don’t necessarily need to be brought into the project.

So, how do you come together to track all the right tasks and documents without including information the other side of the project does not need?

Ideally, part of the kickoff meeting at the beginning of the project includes a meaningful project-management discussion. Within that topic, an understanding of what each side expects is made clear. Further, the tools used are discussed and described. The CMO project manager may provide a presentation and even examples of the tools to be used and how. The presentation may include:

  • a Gantt chart indicating the critical path and assigning responsibilities
  • an action-item spreadsheet with current information and a record of closed items and dates
  • a document list with detailed responsibilities, signature requirements, and deadlines.

What may be even more critical are the expectations, not only of the tools used, but of what is contained within the project information. Quite often, during the course of running a project, team members change, including leadership and project management; expectations may change as well.

If the project is in full swing and the project expectations were already set down, perhaps by predecessors, call a project management meeting for both sides. Make a list of preferences and expectations, and see if the two sides can agree; restart at the next meeting with a refreshed agenda. It may take two or three meetings before the changes are evident, and the changes might make the meeting longer or more difficult. Always check in to see if the meetings are effective.

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Whether the project is just kicking off or in progress, there are some common issues to resolve. The overall timeline needs to meet both the needs of the client and the capacity of the CMO; further, the individual task timelines need to be realistic on both sides. For example, a single-document review time of two days might be possible, but it is not unusual to have more than 50 documents required for a typical commercial-transfer project, including complex protocols and master batch records. Also, a technical review may require reliance on experts, sometimes consultants, who may need advance notice. Many tools can track these activities: a Gantt chart, which shows not only timelines but responsibilities, or a tracking list with status bars that provides details for both partners and visibility of at-risk timelines.

The project tools need to include an escalation plan. On each side, routine communication includes meetings with the project team and the management team and providing updates to the executive management team. A critical-path item that is delayed and potentially puts filling dates at risk needs to be communicated on both sides so the impact may be understood and decisions can be made at a leadership level. Using best practices, this pathway is communicated at the kickoff meeting or during the project execution when a risk is identified. For example, a standard paper or electronic form allows the project manager to describe and escalate a specific issue to either or both management teams.

Another key aspect of the overall project is a deep analysis of its scope. If the project-communication tools were not used to determine the entire scope, sometimes gaps are found while in progress. For example, the original scope may have included the use of a validated test procedure which would be transferred to the CMO, and the timeline may have simply put in a placeholder for “lab transfer.” However, if the project tools do not include details of this, common issues may not be raised in time to plan effectively. The transfer of a validated procedure typically consists of a feasibility study, a gap analysis on the validation which was performed, construction and approval of a protocol to measure appropriate performance parameters, execution of the work, creation and approval of a report, and creation and approval of the routine test procedure within the systems. For complex test procedures, this may require several weeks and procurement of specialized equipment, reagents, and standards. Neither the client nor the CMO wants to find out months into the project that a specialized piece of equipment was ordered on time, but the timeline did not include equipment qualification in advance of being used.

Project management styles and expectations do not always match up, but in the end both sides are looking for success. Open communication and planning help to ensure that success.

About The Author:

Barbara Berglund is COO of CMC Turnkey Solutions, where she applies over 20 years of experience in finished pharmaceutical, API, and medical-device manufacturing. In particular, she has direct experience with quality assurance and manufacturing of commercial and clinical-trial sterile liquid and lyophilized parenterals, microencapsulated products, intravitreal products, suspensions, and solid dosage forms. She has held strategic leadership positions in quality assurance, quality control, sterile manufacturing, and project management and has a particular interest in technical transfers both of processes and analytical procedures.

Barb has an undergraduate degree in chemistry and postgraduate degrees in chemistry and pharmacological and physiological science. She received her PMI PMP (Project Management Institute Project Management Professional) certification in 2007 and her ASQ CQA (American Society for Quality Certified Quality Auditor) and ASQ CMQ/OE (Certified Manager of Quality and Operational Excellence) certifications in 2015.

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