Regulatory submissions are an inherent part of drug development.
They are often considered as an “event” that a project goes through when looking for approval or advice.
In small startups, these events are so far apart that it doesn’t make sense to hold an in-house function for it, and consultants like me step in as needed, to fill in the gaps.
Writing habits
What is oftentimes neglected is the hidden benefit of the writing process itself.
Drug development is a knowledge-seeking endeavor, and writing crystalizes knowledge.
Not only does it force us to reflect- writing makes us collect all the pieces together into a coherent space, and in heavily outsourced operations so common for startups- this becomes a central issue.
Startup teams run fast to the next experiment or the next urgency, and more often than not, don’t take the time to write down their findings.
There is a false sense of knowledge preservation because we DO write all the time- we have lab notebooks, E-mails, meeting minutes, draft reports, and batch records… and worst case- the raw data is backed up on the cloud and “we’ll figure it out later”.
But when “later” comes, and the team needs to prepare a regulatory submission (or a potential investor comes knocking on the door asking questions)- the painstaking process of collection and recollection begins- of data, of conclusions, of knowledge…
Some of it is gone forever.
Some of it takes too long to extract from the original sources.
Some people have already left and some connections untied.
Knowledge is inevitably lost this way, even when the best consultants are hired to clean up the mess.
Single source of truth
I advocate for treating knowledge with the same respect as we treat risk- as the two are tightly interwoven.
One way to do it is to make a habit of treating key documents as a single source of truth and maintaining them “alive” at all times.
They don’t have to be submission-ready- but they must be able to reflect the company’s knowledge clearly, and they can serve as a good framework to work through a predefined long-term plan.
CTD Module 3 Workshop
Module 3 of the CTD is one such document, where we (eventually) communicate the entire CMC Development portfolio to the authorities.
CMC (Chemistry, Manufacturing and Controls) is the aspect of making quality pharmaceutical products, and is a central pillar of drug development.
Right after the holidays, we will start another cohort of the “CTD Module 3 Workshop”- where we will create together a working copy of your project’s Module 3, and by doing it- create a single source of truth for the entire CMC Development workplan and product quality knowledge.
If your project hasn’t reached the point of submitting a Module 3 quite yet- this is your opportunity to do it in-house and cut down future costs and time to initiate clinical trials.
If you already have a submitted copy and want to learn how to streamline regular updates into your daily work without taking too much of your time- join us!
Very limited spots are available, as the workshop combines private sessions with me, as well as weekly group meetings.
More details and registration here: https://form.jotform.com/233451883967470
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