By Barbara Berglund, COO, CMC Turnkey Solutions
You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.
It might be that the project manager (PM) is a pleaser and tells you what you want to hear to make you happy with his work and the organization instead of relaying issues which might upset the project team dynamic. Worse yet, you may be doing business with an organization that operates in an overpromise, under-deliver paradigm.
There are some signs to watch for if the issue is related to the PM but is not pervasive in the organization. This PM does not want to give you bad news, and that typically runs both ways, so he also does not want to communicate your issues up the chain. You may find, for example, that your business development representative did not know your fill dates were changed or that the regulatory commitments have not been made transparent to the CMO management team. The PM who is a pleaser tends to prefer being an intermediary and spends much of his time on relationship-oriented activities. This PM is often outgoing, likable, and celebrates good news in the update meetings. However, issue resolution can be challenging.
If this is the case, there are some opportunities to improve the dynamic and return your project to realistic time predictions. Sometimes, you or a project member on your side can coach the PM into understanding what is needed. On your side, you can provide tools for project reporting so the PM is able to provide you with appropriate updates, even if this means the PM operates outside his comfort zone. If these are not options, escalation from management team to management team may be able to provide the CMO PM with the tools and support to improve communication. You can then advise your internal team of realistic timelines and perhaps even stop or reverse timeline slippage.
An organization operating in an overpromise, under-deliver paradigm is a larger issue. Some organizations do this temporarily so they can fill up the manufacturing schedule; this may justify an increased head count, provide justification for expansion, or perhaps enhance marketing efforts with a boon in new products or customers. Other organizations have a pervasive culture of over-promise and under-deliver.
Whatever the cause of this organizational paradigm in the CMO, detecting the issue is not always easy. You may find the organization is reluctant to put commitments in writing and timelines are always in broad strokes; for example, at the outset of the program, you lay out your plan and indicate you need three fills in the 3rd quarter and five fills in the 4th quarter. The initial project timeline simply lists items to be completed by “end of 3rd quarter” and “end of 4th quarter.” Attempts to get hard date commitments for document completion, validation activities, equipment qualification, and manufacturing are met with vague estimations. The fill dates and task completions are listed as “target dates” instead of “confirmed dates.” When you ask for firm dates, you may find the PM offers excuses or consistently delays discussions until key people are present, but then is unable to get the key people into meetings. You may also find the PM becomes irritable when you ask for follow-up or status reports. Also, when you escalate issues to the CMO management team, you get a good conversation but no follow-up and no changes in the routine project team meetings. It sometimes takes months or even a year to realize the depth of the cultural issue, and it may cause considerable pain to your own organization by then.
Depending on the depth of the issue, there may be steps you can take to alleviate the problem. If the situation is a temporary one in the CMO, strong communication to the management team and guidance on the regulatory commitments you have may be enough for the CMO to relay to its PM the criticality and urgency of your program. This means your own team needs to be very alert and able to detect time slippage and behaviors and maintain a strong dialogue with the CMO. Also, some CMOs might respond well to reservation fees, which make them much less likely to change fill dates. These CMOs may prioritize clients that bring more money to the table or have a more lucrative forecast, so up-front deposits can assure a smaller program is securely scheduled.
If the CMO has a deep cultural paradigm of overpromise and under-deliver, there may not be a constructive way to alleviate the issue. Extreme oversight, including putting a representative in the plant on a regular basis, may be effective, as avoidance by the CMO is more difficult. Hard contractual discussions and constant follow-up and pressure make a project stressful, but might help. Ultimately, it may be that options such as considering alternate CMOs are the only way to provide agencies with meaningful commitments.
In the end, it is often difficult at the onset of a project to distinguish between normal operations at a well-operating CMO and a poorly operating one. It is critical that the team can detect timeline risk and attempt to solve the issues. Some issues may be as simple as PM styles, or they may be as complicated as organizational culture. The success of your program depends heavily on commitment from both sides of the table.
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.
Berglund has an undergraduate degree in chemistry and postgraduate degrees in chemistry and pharmacological and physiological science. She received her PMI PMP certification in 2007 and her ASQ CQA and ASQ CMQ/OE certifications in 2015.