Development And Commercial: 2 Supply Chains For An Ideal Future

By Louis Garguilo, Chief Editor, Outsourced Pharma

For Thierry Bilbault, Senior VP, Tech Ops, at Ardelyx, Inc., the “ideal outsourcing future” is attained individually, by each organization’s ultimate manifestation – commercial acceptance of its drug or therapy, “and thus the need to establish a de-risked commercial supply chain.”

But it takes some effort – at times Herculean – to get to that nirvana.

Bilbault’s career includes prior roles at Alcon, Pfizer, Novartis, and other biotechs. He has achieved the “future” he describes below, and it is manifesting yet again at Ardelyx, which he joined in March of 2023.

Getting The Chain Started

Perhaps prosaic as statement, but professionals at start-up biotechs and established pharma alike pursue in one way or another the ultimate approval of your programs, and attaining the critical objective of ensuring timely availability to patients.

“Oh, and you’d also like to drive commercial success to fund future endeavors,” says Bilbault with a smile. “That’s a function of supply chain as well. Together, this is the ultimate goal, your ideal future.” 

In his personal quest to revisit that future – you can return to it if you are fortunate – after working years at Big Pharma and other biopharma organizations, Bilbault recently took on the new challenge at Ardelyx, Inc.

The company has two commercial drugs: just-approved (October) XPHOZAH (tenapanor), the first and only phosphate absorption inhibitor for adults with certain chronic kidney disease (CKD) conditions, and IBSRELA® (tenapanor), a first-in-class therapy for the treatment of adults with irritable bowel syndrome with constipation (IBS-C)).

“My new role is similar to those in the past in CMC and supply chain,” he says, and adds he looks forward to once again facing the challenges this brings.

The challenge for small organizations who are dependent on CDMOs and CPOs [commercial packaging organizations] “is how do we ensure we can transition the complexity of multiple partners globally – when each of them has had a different part to play in the overall supply chain – to a streamlined commercial solution?"

Those initial supply chains may have taken years to get you from point A to product launch, but need to be changed for commercial. "From this standpoint," says Bilbault, "you can argue outsourcing is actually not the ideal scenario.”

But it’s the scenario we have, and the benefits (e.g., early-phase flexibility, less upfront expenditures, additive skillsets and experience) when weighed against more intense in-house reliability, make outsourcing an industry-enabling ecosystem.

Bilbault has devoted his career to smoothing out rough patches in an organization’s transition to commercial supply chains within that ecosystem.

Important to note, he does value mitigating, as much as possible, the risks presented during that later supply-chain transition, by for example, carefully selecting "a manageable number of external partners" with the capabilities necessary in the R&D stages.

And despite the potential for added complexity, Bilbault is a big believer of going wherever in the world the most suitable CDMO for your specific needs is located.

Therefore, throughout the product life cycle, he advises, keep at least one eye focused on your approaching commercial-stage consolidation. Start working on your consolidation strategy “way in advance,” he advises.

Two key questions, according to Bilbault:

• As you are nearing launch, but still within your initial supply-chain scenario, how do you ensure you can manage the complexity at the time of filing for approval?
• How do you begin to plan for commercial quantities when you need to anticipate the demand of the product – with different partners – often years in advance?

I dare to offer him an answer for both.

If working with multiple partners through R&D (and often through the clinic) is suboptimal, why not select one of the larger “all-in-one,” multi-service providers from the get-go?

That is a potential option, he replies.

However, he stresses that “earlier stages often require working with smaller and flexible external partners with specialized skills and capacity.”

It’s not until you're actually moving to those later stages and need escalated manufacturing volumes that the optimal option is to find a partner who can offer you a variety of services and streamlined options.

Risk Sharing

Let’s put the two supply chains together.

 “As part of the supply strategy for a small organization, you should look for nimble partners initially, and ensure you minimize approval risks with those partners, even though they may not be your long-term solution,” Bilbault explains.

But once you are nearing or have approval, transition to a streamlined commercial-supply strategy (you’ve ideally set in place well ahead of time).

Bilbault does, though, clarify one point.

“As part of ensuring commercial supply continuity, you do look for dual sourcing.” This is to stave off “a number of potential vulnerabilities,” including he says, geopolitical risks.

“You want those partners [first and second source manufacturers] to be more end-to-end solution providers, able to procure your raw materials, get those to your drug-system manufacturer and to your tablet-pressers or other partners, and then to packaging and distribution. Now your goal is that end-to-end partner with some redundancy within their plants or networks.”

The Best Part

Masterminding supply-risk reduction, says Bilbault, is the role he most relishes.

He considers the greatest contributions he’s made in a decades-long career has been aided by his ability to "implement supply risk reduction and mitigation, coupled with effective cost management, as a component of long-term planning for commercial activity.”

Again, that’s certainly not to say this isn’t complicated. Sponsors will need commercial launch quantities ready at launch, but they may not need nor desire more significant amounts of available capacity – perhaps for the first few years.

Key is finding those vendors who will work collaboratively for both present and potential future quantities, “most importantly to enable you at maximum sales potential to reach all the patients in need.”