This concept of “Operationalizing the Quality Agreement” comes from my background. I’m an attorney in addition to being an engineer. I’ve done a lot of contract work. The challenge with contracts is they’re full of either individual or mutual obligations. They’re put in a textual environment. There just are things that you can do, that you can’t do, things to expect, responsibilities, etc. The challenge with those, it’s not a very friendly tool to use to actually then effectuate the relationship.
So, really a starting point for Operationalizing the Quality Agreement is to what I call “decompose the agreement into its constituent elements.” It’s kind of like doing a regulatory decomposition where you look the regulation you call out, “what are the discrete requirements?” So, you create these discrete requirements and obligations and responsibilities and expectations, and you just basically pull them out in separate line items, and then you have to aggregate them and create a management model, typically using computer-based tools. I wouldn’t call it digitization, but certainly communication tools and cadence such that those responsibilities, mutual responsibilities, those predecessor elements, are all very clearly identified, they’re owned, and they’re managed. There also should have governance framework over the operationalized activities that flow from the decomposition of the contractual elements such that a company has a clear view of what the what the CDMO / CMO was responsible for, and that they’re actually performing their duties in accordance with their agreements and that the Sponsors are doing what they need to do to provide the information the oversight the governance to the CDMOs. People need to own those responsibilities on both sides of those agreements. They should be part of a company’s of at least the Sponsor companies but also the CMO CDMO companies’ management review process such that we are we are fully implementing and adhering to the terms of our Quality Agreement which in theory defined the activity set that will make this an effective relationship for the development, commercialization, commercial manufacturing of the product from the Sponsor.
So, this operationalization we’ve used this approach it’s really it’s a decomposition, and then a roll up into an ability to manage in just a regular operational context. Get away from the legal agreements. Leave that to the lawyers. Now, you should have… to get to that agreement, there should have been an understanding of where all those things are. Often in the operationalizing context you may find things that you actually may need to tweak, because if you haven’t really looked at it from a day-to-day activity perspective, a week to week a month-to-month activity perspective, then you may have some surprises. There are benefits to keeping the agreement such that it is actually reflective of what you want to accomplish.