Does Diversity At CDMOs Matter?
By Louis Garguilo, Chief Editor, Outsourced Pharma
“That's a really interesting question,” replies Sara McCutchan, cofounder, and Director, Regulatory Affairs and Quality, Aristea Therapeutics, during a conversation we had a few months ago.
Unfortunately, in the intervening time between our conversation and the publication of this editorial, San-Diego based Aristea announced it would dissolve after unsatisfactory safety findings in the Phase 2 clinical trials of its lead compound (RIST4721).
McCutchan said in an email she’s proud of the “top-notch team” at Aristea, and to have had “this experience of trying to bring a new drug to patients.”
This time, the question that prompts the initial reply above is if she’d be happier if there were more women at the CDMOs she works with.
“I've actually seen very diverse representation at our CDMOs, which is great,” she says.
“Maybe traditionally it wasn't that way, but I think we will see an increased focus on diversity and inclusion over the coming years and beyond.” She believes this will become “an expectation, integral to corporate success, and interwoven in the fabric of growth.”
“Sponsor companies, and certainly regulators, are not only looking for diversity in one’s internal operations, but also with partnerships. This is not only a critical concept from a clinical trial perspective – ensuring that trials include underrepresented populations.”
“Hopefully, this continues as a key focus throughout our industry.”
Diversity Reflected
It has been a focus for McCutchan and me.
In the spring of 2020, I featured her in two editorials (A Path To Biotech For Young Women, and Shared Responsibility: A Millennial’s Outsourcing Strategy).
We also worked together on an article for the December 2022 issue of our sister publication Life Science Leader (also published here at Outsourced Pharma.)
During that conversation, I returned her to the topic of women in outsourcing, and added this question:
“If you're visiting a CDMO you are considering for the first time, and you get there and note little diversity among the workforce, would you be concerned? Does all this go to that level?”
“I think it should go to that level,” she replies.
“When you select a CDMO, you're looking at a variety of different aspects. Quality is typically highest on the list. Can this CDMO deliver a high-quality product we can trust and rely on?”
“Beyond that, and among other aspects,” she continues, “knowing the team that is working on your project at the CDMO is important – not only their professional background and skill set, but overall background and personal qualities will continue to become part of the decision-making process.”
“That is one prerequisite for me personally. I think it will become more of a prerequisite for engagement in all companies – this sense that potential partners are inclusive and diverse across the board.
“It says something about them.”
McCutchan says a drug development company with a core value to be inclusive – and equitable – should be looking for partner organizations “to align with and reflect similar values.”
One From Many
As expressed so often in these pages by biopharma executives, each organization also manifests its own company culture and, we might add, self-awareness as an independent, working unit.
CDMOs have always needed the ability to match up with divergent customers and their equally diverging work ethics, cultures, and focuses. That “customer-facing agility” needs to keep pace with the biotechs (and evolving pharma) emerging around the world today, and the emphasis these customers place on the theme of inclusivity.
“It's really a search for balance in how this is approached,” says McCutchan.
“It’s critical to understand the inherent benefits and importance of aligning strategic goals for inclusion in the organization, rather than focusing on the potential downsides to not having a diverse organization. That’s where the focus should be.”
“Diversity of perspective, opinion, and experience,” she concludes here, “builds a foundation for innovation.” In the clinical development setting, she adds, this carries through to diverse and inclusive clinical trial design as well.
What’s Next?
As McCutchan and Aristea have experienced just recently, in our industry even the organizations with the highest aspirations for its workforce, outsourcing partners, and the patients they are trying to help, may not succeed.
When that happens, the members of that effort will spread the knowledge learned to further pursuits and often other organizations.
Drug and therapy discovery, development, and manufacturing are all endeavors with high-hurdle challenges. But all are worth the pursuit, and there’s learning in setbacks.
Will McCutchan join – or again cofound – a biotech that exhibits the ideals she has neatly expressed for us over the past few years?
Along with her quality oversight and management of CDMOs, she has also led strategic and operational regulatory aspects for Aristea’s clinical trials. Options, we suspect, are many.
In all our conversations, she has pulled the thread of inclusion and diversity through the entire drug development continuum, including partnering with diverse CDMOs and clinical-trial partners.
For her, it all fits together. Looking forward to what fits best for her.