A QR Code For Finding The Right CDMO
By Louis Garguilo, Chief Editor, Outsourced Pharma
If only there were QR codes to scan for help in locating the right CDMOs.
I’ve got those two-dimensional squares in mind as I write this during an extended stay in Tokyo. The QR code was invented in Japan, and today its leading city seems to run on them.
Regarding the search for CDMOs, in a recent conversation Ron Lewis, Sr. Director, Technical & CMC Operations, MEI Pharma, said:
“We can perform our due diligence, draft the right RFP to cover the scope of work that needs to be done – or at least what we think at the onset of the project needs to be done – and collect a good selection of CDMOs out there.
“What I see, though, is today they all come with a strong and similar pitch. They tell you what their best offerings are.”
“Unfortunately,” he finishing his thought, “this means you have a difficult job of vetting to determine which are really the right fit for your company and program.”
Pitch And Catch
First, Lewis does not buy into – nor is he particularly looking for – the “We do it all!” CDMO.
Even if you are a virtual biotech, you can’t just out to the outsourcing market looking for everything.
“You’ll probably end up with a mis-prioritized jumble of services,” he says.
Outsourced Pharma readers have certainly heard this (but hopefully not experienced it) before. Professionals over the years have told us outsourcing starts within, and buttoning down exactly why you are outsourcing, and precisely what it is you need to accomplish first.
No, this does not to imply you shouldn’t be planning ahead. In fact, looking out as far as possible is always recommended. Neither is this a blanket discouragement of the “full-service” model. If the model did not work more often than not, we would not continue to proliferate.
Nonetheless, “we need everything” is not an outsourcing strategy.
It’s a confession.
“If you have in fact clearly prioritized and identified what you need and why you need it, you can better decipher the all-services pitch should you be considering taking that route,” says Lewis.
An early question within that deciphering process is whether the initial capacity is a fit, and the equipment the right scope.
“Do they have the capabilities internally? Whether it be an analytical or synthetic chemist, project managers, their quality systems?” asks Lewis.
Some CDMOs may in fact be able to move you from early development to commercial, “but are they flexible enough to work with smaller companies?”
And many smaller companies remain small until the very endpoint of a buyout from a larger pharma, commercial success, or conversely, a program failure.
“Find out if your CDMO is bogged down in quality systems that don't allow them the flexibility you may need," Lewis advises,
If you discover too late they are, “then you’ll have to wade through these quality checks that can slow down progress as you're looking to quickly move your early-stage program through the stages.”
Lewis’ admonition:
“Because you get one big pitch from a service provider does not allow you to opt out of all the minutia you need to understand for elevating your chances of meeting timelines, and ultimate program and indeed business success.”
His prescription:
“Ideally, what we do internally is weigh a lot of those key attributes against each representative CDMO we bring to the table for consideration. On average, I'd say we're looking anywhere from three to eight CDMOs that claim to have the capabilities we're looking for.”
Is Everyone Happy
MEI Pharma enjoys what we might consider the good luck of being focused on small molecules.
This means it has relatively many choices in the service-provider ranks, compared to, for example, a gene- or cell-therapy sponsor.
But more choices doesn’t necessarily make for an easier ultimate determination of which is the best choice of CDMO.
“We go through a vetting process where we're scoring service providers, and leveraging our internal teams, to make sure there's alignment with all our different functions. These include synthesis, the formulation specialists, quality people … all the key functions that will be needed when it comes time to writing INDs or NDA documents,” says Lewis.
“We make sure the CDMO has the proper experience to be able to help all of us here.”
Once Lewis and team starts winnowing down to the final few CDMOs, they’ll then perform site visits to “kick the tires more rigorously on the quality and regulatory systems, and make sure everybody's happy internally before nailing down a final pick and begin to transfer projects.”
There may be a second, more rigorous onsite visit before a final determination, says Lewis, “and that should be with all our involved SMEs, whether it be drug substance or product, quality ... and information technology folks would definitely be involved.”
IT?
IT today needs to be involved, Lewis explains, “in terms of the data integrity aspect,” and confirming the CDMO has the proper protocols and systems in place, and that they are accurately utilized.
“These professionals will do their own diligence to ensure the CDMO has the proper digital infrastructure, particularly given the emphasis from the FDA on data security and integrity today,” says Lewis.
“And with so much risk now due to cybersecurity issues, the IT professionals must be convinced the proper safeguards are in place to protect all data and communications, including IP, any patient data, and all related information.”
With the increasing sophistication of equipment systems and their implementation, and for example, visualization technology being added to facilities, Lewis says the information technology specialists at the CDMO "need to befriend the IT folks at the sponsor.”
And while they're at it, maybe the two sides can come up with some helpful QR codes.