Five Maxims For Outsourcing Success
By Louis Garguilo, Chief Editor, Outsourced Pharma
Without further ado, here they are:
- Outsourcing is really about positioning your CDMO to your competitive advantage.
- Transfer the competitive advantages of your CDMOs to your organization.
- Guide from afar rather than drive from close range.
- Work hard at positioning your CDMO to form unified best-in-class solutions.
- For outsourcing collaborations to work, leaders must emerge.
Over the years, I’ve heard a fair share of aphoristic statements on how biopharma organizations should approach CDMO relationships.
The first in our list above ranks among the most intriguing — and potentially powerful if put into practice.
You might call it the maximum maxim for drug development and manufacturing outsourcing.
I consider the other four – as important as they are on their own – as building blocks to accomplish the first.
All five are creations of Lisa Wyman, SVP Technical Operations, Acceleron Pharma, via a conversation from her home just outside Boston.
So how do you so position your CDMOs?
Transforming Tech Transfer
Wyman starts here:
“That’s accomplished by understanding CDMOs today are also under a significant amount of pressure to adapt, evolve, and innovate, so there’s an opportunity for both sides to take advantage of this dynamic.”
She knows this through personal experience, having worked at a CDMO (Lonza), Big Pharma (Wyeth/Pfizer), a consultancy (ValSource), a fast-growing biopharma-outsourcing pioneer (Shire, now Takeda), and, since January 2019, a Boston-based midsize biopharma (Acceleron).
“CDMOs have seen many successful – and not so successful – clinical and commercial manufacturing campaigns,” Wyman says.
“Positioning your organization to make use of that knowledge enables both sides to flourish.”
Wyman, also an Outsourced Pharma Editorial Advisory Board member, explains such positioning requires starting with “reflection and analysis of your own company, departmental capabilities, capacity, core competencies, and your long-range plan as an organization.”
With that understanding in hand, she advises discussing with your CDMO how they can best become an extension of your organization. Drug sponsors shouldn’t consider CDMOs as separate entities, but rather as an integrated component able to deliver you a competitive advantage.
And then, aphorism number two:
Transfer the competitive advantages of your CDMOs to your organization.
“When I think about Acceleron,” Wyman says, “our core capabilities are discovery and process development in early-stage clinical manufacturing. But we’ve had a fruitful pipeline pushing us toward late-stage clinical/commercial manufacturing under compressed timelines.
“What we have done is empower our CDMOs to guide that process. For example, we’ve leveraged the CDMOs’ streamlined modeling to accelerate tech transfer and scale-up in their manufacturing facilities.”
She adds:
“I’ve been in organizations where we felt the need to make our partners adapt or adopt to us.
“At Acceleron, we let CDMOs run their own shop, while we provide oversight and technical support. In this current case, it has enabled additional process optimization with our downstream purification steps, resulting in better quality attributes and yield. Their input helps drive our decisions.
“It is collaborative; we own oversight and the product, but we give them a lot of freedom and flexibility – and trust – to run our process within their program.”
Wyman describes this latest point as aphorism number three:
Guide from afar rather than drive from close range.
“The wisdom in this philosophy was magnified in the COVID-19 pandemic situation,” she says.
“We didn’t have access to the CDMO’s facilities. It was a kind of blessing that we had taken our approach early on, providing the CDMO autonomy to operate.
“Today we’re in the midst of a significant drug-substance manufacturing scale-up campaign, with zero person-in-plant oversight or on-site technical SME support. We wouldn’t have been as effective, or kept our program timelines, if we did not already have this relationship in place.”
To be clear, Wyman in no way advocates for a form of abdication of responsibility or oversight.
In some ways, just the opposite: You can’t enact her strategy for positioning a CDMO as an integral part of your team if you don’t precisely come to know what they are capable of — their strengths and weaknesses — and work closely in a form of co-execution.
“Without clearly defined oversight of programs and processes at your sponsor site,” she explains, “leveraging your CDMO as your competitive advantage falls apart. What you need are high-level guiding principles and established best practices.
“Nothing is too detailed in a procedure that either side, with enough mutual insight and communication, can’t apply and adopt. It’s hard for the CDMO when a customer asks them to deviate from their infrastructure, processes, and technologies to accommodate your special requests.
“That’s a huge ask.”
Two To Go
We’ll cover Wyman’s final two “sentences for success” in part two:
4. Work hard at positioning your CDMO to form unified best-in-class solutions.
5. For outsourcing collaborations to work, leaders must emerge.
A sneak peek suggests she believes a mindset for leveraging the capabilities and capacities of CDMOs is predicated on the drug sponsor’s appetite for adaptability and flexibility.
But when it comes to drug development and manufacturing outsourcing overall, enlightened leadership must reside on both sides of the equation.
To fully enact a strategy of positioning for competitive advantage to which Wyman is devoted, it requires individuals imbued with that aptitude for flexibility as much as anything else.
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This two-part editorial is adapted from my original feature with Wyman, published in the Life Science Leader CMO Leadership Awards Supplement.