They say that the things you like most about your partner at the beginning become the things that annoy you most later on in life....
In Pharma, thank god, we don’t keep going “till death do us part”.
When the scale is insufficient, or the program reaches the next level of maturity, we oftentimes decide to transfer our manufacturing operations to another site.
It could be from the lab to a CDMO, or from one CDMO to another, or in-house out, or outsourced in….
Either way- this is a feature, not a bug.
Tech Transfer is considered a natural phase within the product lifecycle and all guidelines tell you that.
So why is everyone so surprised when the time comes to switch over?
I always tell my clients that the best day to start preparing for a Tech Transfer is when the project begins.
This might sound extreme, but the reality is that we will spend many years with this supplier.
There will be ups and downs, countless development studies, batch releases, regulatory filings, and whatnot.
We should always keep in mind where all this knowledge goes, because, as I said, one day, it will have to be transferred.
In fact, the Technology is the easiest “thing” to transfer. The real complexity is transferring the knowledge, know-hows and infinite nuances that follow along with it.
Add to the mix the fact that the people involved in the project are not married to it just the same and WILL change places, and you got yourself a sure recipe for a headache down the road (or much worse).
Don’t wait until the actual transfer begins because who knows how the waters will be (and sometimes they are rough) and where the people will be.
So what to do?
Remember to capture project knowledge in a way that will be easy to transfer - use systems, habits, and culture, ingrained in the daily activities of the project
Ask yourself- will this piece of data be accessible and clear to the person staring at my cloud one day?
Assign a Knowledge officer to the project- that keeps track of all the new knowledge that is produced, and makes sure it is being captured as intended
Make habits of quick “knowledge shares” across teams- for example, start every multidisciplinary meeting with a 3-minutes talk by a rotating group representative to teach the other teams a new lesson learned in their domain.
I could go on and on, but people tell me I write too much- so passing the mic to you- any tips and tricks to keep your company’s knowledge alive and accessible to everyone?
Would love to hear about it in the comments…
Bypass the algorithm!