The further along we go down the development line, the deeper the knowledge we accumulate on the product. This translates to lower risk and higher value.
The very high costs in Pharmaceutical development drive startups (and not only!) to outsource their most intimate assets- like the case of the Manufacturing process, which is handed over to CMOs (Contract Manufacturing Organizations).
Over the years, many of those CMOs have adopted another D for Development (CDMOs) and they now offer a one-stop shop service that enables even virtual companies the ability to develop and make their exploratory drug.
Everyone benefits from this economy of scale- first, the startups instantly gain access to top-notch technologies, trained personnel, and facilities, as well as the vast knowledge and Know-how OF those CDMOs. The CDMOs benefit from the accumulated manufacturing experience (and BIG DATA) on a multitude of products of a similar modality- so overall it’s a win-win situation.
What startups oftentimes neglect is the sheer magnitude of data (and knowledge) they “leave behind” when these operations are outsourced. This applies to all outsourced services- manufacturing, clinical development, regulatory affairs, and even quality- some companies are tiny, holding a huge network of service providers, and managing knowledge in this situation is a challenge.
Startups and service providers are separate entities that might have conflicting interests at some point. This becomes more of an issue the closer the project gets to the market. The lack of internal knowledge and know-how within the startup might be a risk- and as such, must be managed.
In the world of AI and Big data, the looming question above all this is: Who owns the data? (and do they have access to it?)
I am happy to share with you daily leaves from my personal tree, which revolves around Pharmaceutical Development and CMC.
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