Phacilitate is launching a dedicated training offering for the cell & gene therapy sector in direct response to recent calls from the industry we serve – from your perspective as a prominent consultant in the space, where do you see the greatest needs currently for ATMP-specific education?
The issue I see is that most of the training that has been targeted at the sector over the last decade has come in the form of workshops, so there’s been a series of external experts speaking for maybe up to an hour on a particular topic, for example. The problem with that is that it’s just simply not in-depth enough. That sort of workshop is built on the assumption that we all have the grounding and the understanding, and no offense to the industry, but there is a lack of deep understanding of process development.
A lot of the developers in this area have come out of universities and small biotechs - they don’t have those years of experience and in-depth systems in place for biotech products where it’s all tried and tested, as large pharma companies do.
So I think the real issue is the lack of depth, and one hour to cover a topic like comparability is very little time. I do comparability training for biotech companies and invariably, I either do it as a one-day or as a whole two-day course. And in fact, even a day is barely enough to get into the nitty-gritty of a topic like comparability. The in-depth courses to date have been more in the area of GMP, and there I think they have been more practical. But certainly in the area of quality, I'm not seeing that sort of course readily available currently.
One of the key issues is that the current workshops tend to present information to passive listeners. So one of the major elements that is missing, which I do include in my more formal training, is exercises. An exercise is based on the nature of the topic - trying to use things that look like real-life scenarios and get the audience to work in groups to try and work through a problem that’s related to the topic of discussion. That helps to reinforce the lessons from the lecturing aspects of the course. Again I don’t see this approach much in the training that is available today.
Your session in Berlin focuses on navigating the ICH Common Technical Document – can you tell us a bit about why you chose this particular topic, and why now?
While it is rather a mechanistic subject - not as interesting as potency or comparability where there’s a lot of science - it is an area that has frustrated me in my consulting practice for a very long time. It’s very clear to me from a lot of the documentation I see that the basic idea and purpose of the Common Technical Document is misunderstood, or just simply not understood at all! It is really there as a tool and actually has a lot of benefits, but I understand that the headings can perhaps be a little ambiguous, for one thing.
The other issue is that the regulators themselves would never give feedback on the Common Technical Document. As long as the data is there somewhere, they’ve found it and they can understand it, they are not going ask the question - they are not going to send you a message that, “This shouldn’t be in this section, it should be in a different section” because that is really not the purpose of what they do. But if you can get it right, this is a document that is accepted by a growing number of agencies, including almost every agency that developers in this sector would want to submit to right now. So having a better understanding of exactly how it’s supposed to be used could bring a lot of benefits.
What form will the session take on the day? In your experience, what works in terms of formats for this type of session?
This is a tricky one, because as I said, with other forms of training one of the really critical aspects to doing it well is to include an exercise. I also tend to include case studies, but not of the positive things that went well, which is what most people tend to do when they give talks - I tend to try and pick negative things out to reinforce what can go wrong if you do make a mistake. But with the CTD, it’s not something that really lends itself to that approach.
I've been using mind-mapping software for a number of years, and I suddenly realised that this could lend itself well to talking about a structured document and how to use it. Working towards this workshop, I will be developing a detailed mind -map and will present from it in order to more easily provide links as to how dottier sections interconnect. It also allows you to pull back to see the big picture, as well as zooming in to look at the detail.
It also allows a lot more flexibility and interaction with the audience, much more so than you would get with a very structured PowerPoint presentation. From feedback I have received, people say that the simple format of the software makes it less daunting upon opening, before you move down into the detail, and thus much more digestible than if you were immediately faced with a complex map.
The plan is for this to be the first in an ongoing series of Phacilitate Training for the cell & gene therapy space – what other topic areas would you personally like to see us cover in this type of format?
Some of the most popular topics for ATMP training are things like comparability and stability. Other areas that I think are in desperate need or attention include aspects of process development, and particularly at the process control end of process development. There’s a lot of discussion, interest, talks and conferences around choosing bioreactors and various bits of equipment, but what isn’t discussed in any great detail is the overall process control strategy. So discussing that in detail over a training course would be good, although at present that is just one potential topic in my mind.
Analytics is also well worth covering. I cover it to some degree in potency and comparability because obviously it’s key to them. However, a separate course looking at metrology aspects and the validation of complex analytical methods we use is definitely needed. Process validation is also an area that is generally difficult and that would benefit from some dedicated training.
Finally, can you sum up for us 5 key benefits that the participants in your ICH Common Technical Document training course will receive?
- Better understanding the nature of the data or information that is required in each dossier section
- Better understanding the relationship between the sections. (This is often very badly misunderstood!)
- Understanding how the sections support each other. This is subtly different from point 2 but important: so for example, how data from one section (such as characterisation, batch analysis, etc.) support the setting or specifications which are described in another section.
- You will receive tips on how to keep the sections clear and simple. (I identify whether a section actually requires data, or whether it is a simple discussion, for example).
- And then there will be some considerations, hints and tips on life-cycle management considerations.