By Louis Garguilo, Chief Editor, Outsourced Pharma
“You’re an 18-year veteran of our industry, and currently have a critical job at a CDMO as a validation manager. Why are you doing this on the side?”
“I’d rather describe it as a thorn in my side.”
That thorn has spurred Layth Ujam to his dissertation stage, the final requirement for receiving a Master’s Degree from the Technological University Dublin, in Pharmaceutical Validation Technology.
His research includes Outsourced Pharma, specifically editorials and articles on the sub-topic of tech transfer. Ujam asked if I’d speak to him on what I’ve ascertained from that content.
In return, he’s presenting our readers with some gems he’s gleaned through industry surveys, and multiple interviews with CEOs and frontline workers in the biopharma industry.
Here’s the start of our conversation.
What Are We Transferring?
Ujam: “I'm a biochemical engineer by education; my postgraduate research was in downstream purification at the University of Cambridge. For the last 18 years, I've been working my way through biopharma and medical device companies in R&D, cGMP manufacturing, engineering, and validation roles.
About two years ago, I realized ‘validation’ doesn't have a formal qualification associated with it. People learn on the job. I thought it would be great to get a recognized qualification. I’ve successfully completed the two years of courses, and I'm finishing up the writing of my dissertation. The main theme, and my long-time interest, is biopharma-CDMO tech transfer.
I've looked through your columns and found recent articles about tech transfer – notably the McKinsey article, your piece with Jana Spes, and Mark Witcher’s talk about ‘eradicating’ tech transfer.
Is this topic of tech transfer top-of-mind in the industry today? What are you hearing and seeing?
Humble Editor: “When I started as chief editor six years ago, it was quite a hot topic. Then to an extent other topics gained importance, and it faded a bit. Now – and obviously further induced by the remarkably fast transfers of COVID-19 vaccines to manufacturing platforms– the industry has turned its attention here again. I’d say specifically to the productivity of the transfer activities.
However, we haven’t really quantified ‘tech transfer productivity.’ How much should it cost? Do we utilize too many or too few resources? Is it accomplished fast enough? Are we aligned the right way?
A lot of this questioning is also timed to the growth of the virtual biotech. These start-ups are entrepreneurial, and driven by investors. They're looking very closely at how to do these project transfers to CDMOs.
Some years ago it was all about ‘communication.’ For example, when I was interviewing a head of CMC, or even CEO, I would preface the conversation by saying, “We're going to talk about tech transfer, but you can't use the word ‘communication.’ You’ve got to give me something more than that.
So what do they then say? They are looking for some type of proven, formalized process. And I like this definition of tech transfer I saw somewhere: ‘A formalized process for moving the development or manufacture of a drug from one location to another, one scale to another, one part of the life cycle to another.’
So when you think about that, you're always doing tech transfers. It’s not this nebulous activity you get into when you pick a CDMO, and then move on from there. It’s part of your entire life cycle. I think that's an important part that people miss, or at least used to miss.
The thought was: ‘It’s at the CDMO. We got that done.’ But the next thing they know, following our definition above, they are transferring again, even if it's to a different part of the same CDMO, or from development to scale up to a pilot plant.
“I’d just add something I first heard at one of our conferences, and then wrote an editorial on. It’s the idea that we used to rely on a lot of documents. Now it’s, ‘Forget documents, we have these massive data dumps to deal with!’ The old way was here're the SOPs; now it’s here's the data transfers.
“However, what remains the same is this: Whether data or documents, they transfer information. But more importantly, you need skilled people to transfer knowledge. That hasn’t changed. And of course that brings us back to communication!”
Four Thorns In Everyone’s Sides
Ujam: “Agreed. I conducted a random survey recently and I had 50 responses, which I didn't think is too bad for a Master’s dissertation. Let me tell you communication is still the issue. People are still talking about it as a problem. It’s as if we haven’t learned much.
The second biggest issue cited was project management. Apparently project managers don't do a great job.
The third problem was managing expectations – essentially poor expectation management from start to finish.
Then fourth is collaborating effectively within the sponsor-CDMO relationship that has been established. And these last three can be seen as a coefficient of the first, communication.
So interestingly, the science and the capability of the CDMO were actually low down the list of issues. People felt that the science almost handles itself.
And that points back to that definition of the transfer as knowledge management, doesn’t it? It's those four aspects in transferring a process that people are still talking about. They feel let down by their tech transfers.
I then asked them, with those issues in mind, how could we improve? The biggest solution – or requirement – was ‘shared ownership,’ what Jana Spes was talking about in your column with her.
This was mirrored by the individual CEOs I interviewed. They felt it truly has to be a two-way process. Neither side [sponsor or CDMO] dictating. A culture and one-team approach. Professionals today really want to improve on this.
Another solution is looking at how to facilitate tech transfer earlier – the sponsor and CDMO coming together a lot sooner in the drug program. Hence that's why we’ve seen CMOs take on the development part and offer those services and support to the customer.
The trend is to facilitate development services to help tech transfers. Companies are using operational excellence to drive continual improvements, often through more data analysis and Six-Sigma-type tools.
However, I’ve talked to a few other companies who want to expedite tech transfer, but the only way they can think to do that is either throw more people at it, or look to employ risk management strategy – to basically try and manage the risk out of the process.”
To be continued.
EDITOR’S NOTE: Layth Ujam’s views above are his own, and do not represent that of any of his previous or current employers. Our dialogue here is slightly edited and abridged for clarity and flow.