The Serious Business Of Working With CDMOs At Phase 2
By Louis Garguilo, Chief Editor, Outsourced Pharma
During six years as a consultant, between full time positions – always involved in CMC and working with CDMOs – Anthony Grenier, Sr Director CMC at Reunion Neuroscience, says, “I was usually coming in at times when things were not going as expected. Rarely did I start a project when most everything was on track.”
He’s not complaining.
Those experiences, and the more pleasant ones stemming from positions at Big Pharma and virtual drug developers, have provided him with a wealth of CMC experience.
Since December 2022, he’s brought all that to Reunion Neuroscience, which is developing “innovative, patented, FDA-approved serotonergic psychedelic therapeutic solutions for underserved mental health disorders, beginning with postpartum depression (PPD).”
Reunion’s lead candidate, RE104, is “a patented, clinical-stage drug candidate designed as a safe, fast-acting, short-duration therapy for patients with underserved mental health disorders.”
RE104, the only 4-OH-DiPT prodrug in clinical development, is being evaluated in the RECONNECT Phase 2 clinical trial.
We’ll learn more about Reunion subsequently, but let’s first get some advice from Grenier on working with CDMOs.
Phase 2, The Start Of “Business”
In short, Grenier compares Phase 1 with Phase 2 (and beyond) by saying that in that initial phase, product is often made relatively “quick and dirty, and rather easily.”
The external partner to do that initial work, even today, may not be the correct one to then take you farther. Often, he says, that first provider has come via word-of-mouth with less forethought than might be expected.
It’s a situation he'd rather avoid. “When you make your decision initially for a partner, you should try to make it once for all time,” he believes, particularly for virtual companies (such as Reunion).
Nonetheless, when an initial CDMO selection necessitates the move to another for scale ups and clinical/commercial material for larger clinical trials, the key is then “look at an optimally robust partner.”
For that, he says, from the beginning of the outreach process, make all efforts to put things in great internal order, “working in an efficient fashion to craft a nice RFP.”
Every project and product is different, he says, but there are commonalities when approaching CDMOs.
“You can in fact anticipate way ahead what all the CDMOs will be asking,” he said. So get ready early.
That preparation is a role he’s played throughout his career, and today at Reunion.
“I've worked with brilliant people – physicians, psychiatrists, PhD chemists – but many are not business oriented to manage this strategic relationship with the CDMO, nor are they able to find the right partner.”
Grenier guides sponsors by bringing “internal structure and project management implementation and skills,” and a strong business acumen.
And notwithstanding the tribulations of company formation, this move to later phases and new relationships is where the science and technology turns towards the business realm of the biopharma industry.
Test Your CDMO Hypotheses
It’s not unusual that after Phase 1, a biotech will have some idea about who they may like to turn to next for partnership.
Stop right there, says Grenier.
You may have an idea or two regarding your next CDMO, “but you have to predefine an internal team that will be involved.”
He says he’s not necessarily speaking about CEO review (yet). Rather, “focusing hard on your key internal experts to map prerequisites.”
Do these CDMOs under consideration have everything needed so the sponsor can in fact expect full responses to the well-thoughtout RFPs Grenier mentions above?
He stresses that despite such pressures, the goal is not to get a “quick quote,” which often leads to multiple changes of scope and iterations. He's looking for answers.
“I'm trying to capture in a most comprehensive fashion their full scope of work, and avoiding time lost to administrative back and forth, and revised quotes and RFPs.”
Always of consideration is current and anticipated capacity at CDMOs. However, Grenier has experienced that “most of the time the sponsors are rate limiting, because they're not providing comprehensive RFPs or a complete picture of their project, or they are disorganized internally."
External-facing project management at the sponsor, we might then say, starts here with the CDMO selection process.
Considering today’s virtual sponsors, with extraordinarily specific science and technologies, this may, conversely, come with a comprehensive lack of understanding of what that development process should look like.
It’s advisable, then, to hire in development/tech-transfer expertise, or employ consultants. These resources can be of great assistance to your CDMO.
A knowledgeable team can serve as better representatives to the CDMO, attaining a mutual grasping of how to proceed.
“What is the actual onboarding process? Are we all comprehending the quality agreement? are questions I ask well ahead of any activity, and the sooner we ask the better,” says Grenier.
What Kind Of CDMO?
Finally for now, Grenier says it’s a must-have to ensure you understand how your CDMO operates.
For example, in light of so many recent consolidations and other factors, you may end up working with a Big CDMO, one that advertises its stable of project managers.
That’s good, but do some poking around.
Grenier says at times the CDMO’s technical assets may be doubling as project managers – and shared with other projects. This can work at times, but it’s worth investigating whether it’ll work in your case.
“It’s certainly not the same working with a global CDMO or a smaller API manufacturer,” Grenier says. Uncovering nuances can help you to adapt your strategy to a preferred CDMO.
In fact, to some degree, both sides often need to take on “an adaptive approach.” This includes "administrative considerations," such as the sharing of documents for CMC applications on the science side, and payments on the business side.
So while the transition to later stage development phases is indeed invigorating, both from a science and business perspective, “little administrative items end up bugging people,” says Grenier.
"We're excited by our science, the hope for patients, but we must anticipate even mundane items that grease the outsourcing wheels on the way to developing new products, and profitable pursuits."