Forget Tech Transfer. You Need A Cognitive Connection

By Louis Garguilo, Chief Editor, Outsourced Pharma

Cognitive transfer is a concept widely studied in educational psychology. It has growing relevance within the context of our industry’s ever-increasing number of technology transfers.

Our tech transfers are understood in the main as moving development and/or manufacturing processes/technologies from one stage to the next, one location to another, one organization – as when utilizing CDMOs – to another.

In outsourcing particularly our first batch of attention is reserved for the physical transfer and operations to an external partner, related precisely to facilities, instrumentation/equipment, materials acquisition, operating protocols, timelines, and documentation.

However, for these past years, we have more intently zeroed in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation.

This is where cognitive transfer enters our portal.

No, this is not about mind-melding. (But gets us closer.)

It is a step up in extending personal (and institutional) knowledge, skills and aptitudes to analyze developments gained through experience, and also relaying contextualized strategies to perform tasks and solve challenges.

A more cognitive focus, if you will,  further ensures that decision-making frameworks and nuanced understanding of the technology developed by scientists and engineers is successfully conveyed to the receiving organization.

This touches on a fundamental insight. Drug development and manufacturing knowledge is not a static entity transmitted like a commodity. Instead, these activities are actively constructed and transformed through human (and nowadays AI) cognition, and professional interaction.

Clearly, this suggests processes cannot be transferred entirely via batch records, prior data sets, nor strict analytical results.

But let’s pause here. For two reasons.

Fist, before our more data-derived readers begin to bail on us, this by no means diminishes the value of statistical knowledge or documented physical attributes, as noted by author Jackson Lears in Animal Spirits.

Instead, it is the recognition “that while statistics [data, batch records, et al.] can provide invaluably precise description, they can easily be overvalued and misused as tools of interpretation and prediction.” (emphasis mine)

Such as when a whole batch goes awry not specifically due to any misreading of instruction or protocols, but means of a complete reliance on “interpreted interaction by operators.”

An engineer might put it this way: “You mean that wasn’t how this was supposed to be done? It says it right here in the batch record…”

The second reason to pause here is for those readers who say, “Frankly, we don’t have much accumulated data or knowledge, and that’s why we’re outsourcing.” The response to that takes up the following section.

Learning As We Teach

A benefit of integrating the concept of cognitive transfer into tech transfer processes is the back-and-forth flow of knowledge as it is being acquired. This then enhances alignment of mental models of operation and behavior going forward.

Cognitive transfer focuses on a two-way answering of the “why” behind certain steps in a process, as well as the “how.”

Mutually considering why a specific purification method is selected over another can help CDMO engineers perform more effectively, as they now appreciate the foundational scientific rationale. Sponsors, open to this type of knowledge transfer, benefit immensely from this knowledge loop.

Who is teacher and who is student becomes irrelevant. Practically and mutually, CDMOs and sponsors discover how to speed up process validations and improve scale-up in new phases. This flow of in-time knowledge helps reduce the risk of errors from, as mentioned above, misinterpretation or oversimplification of procedures and “physical transfer” focuses.

Cognitive transfer, then, fosters a culture of continuous improvement, enhanced process optimization, and reciprocal knowledge-share.

But as stated above, no mind-melding here.

Cognition is still gained through our more typical (although unevenly applied) practices of PIP (persons in plant), and facility visits and audits for in-person talks (when possible).

Even (Gasp!) structured mentoring/coaching programs, where experienced scientists and engineers from the biotech and CDMO teams learn together, is worth the attempt. Again, who is mentoring/coaching whom is irrelevant.

How about scheduled “workshops” to go along with project or oversight meetings? Everyone is busy, but joint discussions utilizing today’s array of digital platforms to facilitate sharing insights in real time is worth considering.

Look at this narrative-driven, co-learning as a road to mutual technical comprehension through the promotion of critical thinking.

Long-Term Cognition

Briefly mentioned above, cognitive transfer plays a pivotal role in risk management.

In our regulated industry, adherence to quality and safety standards is paramount. By ensuring cognitive aspects of process knowledge are effectively communicated, the biotech and the CDMO better anticipate potential regulatory challenges.

For instance, if CDMO personnel understand the critical control points of a process from a cognitive perspective, they can more effectively implement quality assurance measures and design risk-mitigation strategies.

Both sponsor and provider organizations benefit from an enriched knowledge ecosystem that can drive innovation cycles, improve regulatory compliance, result in more robust manufacturing processes, and the more profitable commercialization of products.

Which means as relationships grow, the professionals at your CDMO will better anticipate situations and complications. And so will the drug sponsor.

Relationships will prove more effective and thus enduring when embedding cognitive transfer into tech transfer protocols.

Something to cogitate over.