Is Your "Preferred Provider List" Legacy-Heavy?
By Louis Garguilo, Chief Editor, Outsourced Pharma
Ron Lewis of MEI Pharma refers to his as a “legacy list” that includes over a dozen external service providers.
Much of it was in place when he joined the company five years ago. Now, as Senior Director, Technical & CMC Operations, he’ll admit to having added to the list as well.
Why the less than positive vibes for what many in the industry consider a key tactical component for sponsors outsourcing drug development and manufacturing?
Doesn’t an approved or preferred service provider list facilitate partner selection?
“Well, as you evolve as a company,” he starts his explanation, “I believe you should look to trim these lists down, if they’ve been built up over time. It probably makes sense in most cases to streamline.”
Historically, he says, CDMOs can remain as approved vendors well past their expiration date, so to speak. Your needs may change; their operations/service may also.
Lewis believes in including your quality teams specifically to identify which CDMOs you should move forward with. He also believes in moving others, and those you haven't worked with for a number of years, "off your books."
“That’s a process,” he says. One all serious outsourcing professionals should take on.
As we saw in the first part of our discussion with Lewis, a primary determination in such a process is to look at the current “relevancy” of the service providers you are working with today, and of those you may be considering.
“Sometimes a lot of these CMOs you have as approved are legacy vendors, and you really need to think more strategically,” he says. “Are they going to help you with what you need going forward?”
If not, start taking them off your lists. “I think all companies have to deal with this in terms of who really are your preferred vendors today, and then ensuring you are picking the right ones from your updated lists.
Who’s In? Who’s Out
Approved provider lists can carry the names of CDMOs that made the initial cut, and when given the opportunity started out well, only to have them fade off in their quality of services or other areas.
With those companies finally removed as approved options, Lewis says you can better identify new CDMOs to investigate, and approve if deemed worthy in terms of quality and service.
Naturally, the stage and of progression at a sponsor – or perhaps a change in therapeutic or modality direction; new financial investments that allow for some internal build out, etc. – can eliminate the need for certain partners.
The point is none of this happens of its own. Lists need to be maintained and looked at as living documents.
Currently, of the dozen or so on the preferred list Lewis inherited, MEI Pharma works with about six vendors at any one time.
So who is on the list?
The answer to that question will reveal much about past outsourcing strategy and needs. If it reads more like a historic document than an explanation of the present and map to the future, it could be the wrong service providers.
Regarding strategy, for example, does Lewis see a lot of smaller CDMOs listed? And today would he lean in one direction over another when it comes to partner size as his company moves through phases and adds drug candidates?
“I think for smaller biotechs and biopharma companies, the level of specialized services from smaller, more boutique CMOs is more amenable,” he says. “We have pursued that.”
“There's a certain suite of activities and capabilities that the smaller boutiques have. The level of attention you receive may be increased, versus being a small biopharma working with one of the larger CDMOs. With the larger CDMOs, where things may start off well, as you progress you can see shifts in the level of attention your programs receive."
Another category to consider is domestic versus international service providers. Being a San Diego-based U.S. company, MEI Pharma is relatively closer to Asia than other biotechs in the U.S. may be.
If there has been a tendency at your organization to go offshore, has it been China more than India as a suitable location? If so, with today’s geopolitical ramifications, might that get reversed? Or has a bigger focus domestically become the prudent risk-aversion strategy? Or Europe?
Lewis says you won’t really know until you take the time to seriously assess who is and ought to be on your list against where you are currently and what the future looks like at this point.
Of course the adjustments – if any are needed – will vary from company to company.
“How do I best put this?” he asks, then replies: “The level of tolerance or risk acceptance is definitely different for each sponsor. In previous lives, I've worked with companies in China or India (see part one), and not thought twice about it.”
“But now having moved to smaller sponsors, I understand in relative terms there may be a heighted concern for IP, for example, that instills some reluctance to work with companies located in certain regions of the world.
“The preference may very well be to work with U.S. or European-based CDMOs, where there’s a little more sense of comfort.”
Conversely, he says, no CDMO should feel overly comfortable once they have been added to a sponsor's preferred list. They need to work to keep the designation as more sponsors track CDMO key performance indicators (KPIs) as part of their vendor management programs. It's a relationship that should be continually assessed.
A Final Thought
Sponsors try hard, and spend considerable resources, building preferred provider lists. CDMOs may work just as hard to get listed.
And people, projects and companies change.
I ask Lewis if anything has surprised him during his career, which started in research at a service provider, moved through Pfizer, and then on to smaller biotechs.
One registers foremost.
“Here’s what has really hit home while making my transition from discovery and the service side, to development and manufacturing and the sponsor side – the importance of professional relationships, between the quality, regulatory and the CMC groups, for ensuring there’s a solid understanding of goals and objectives across your enterprise and at external partners.
“We're all focused on doing what's right for the patients. To make sure what we're manufacturing is going to be safe and of high quality, everybody must have a voice at the table.
“To remain nimble, be able to move fast and push a new project through, you cannot be handicapped by what went on in the past or who you have worked with before. You have to stay aligned, right-sized, and phase appropriate.”
And check that partner list.