At CDMO Live Europe 2026, Giulio Cavalli, Principal Lead External Manufacturing, J&J Innovative Medicine; Neil Stevenson, Director, CMC Logic Consultancy; Marine Joly Battaglini, Founder, PharmDev; and Susan Reasoner, Chief Commercial Officer, BioDuro, examined how early-stage biotechs can avoid common selection mistakes, manage capacity concerns, and build CDMO relationships designed to last beyond Phase 1.
Choosing the Right Partner
The CDMO shortlist gets shorter the moment a program moves beyond standard modalities. Neil Stevenson, Director of CMC Logic Consultancy, identified the single most common cause of poor early shortlisting: a narrow network. “As a biotech, you get a lot of spam,” he said. “Sometimes that shortlisting is only coming about because the CEO had a short chat with somebody at a random conference, and then all of a sudden that’s lodged in their mind.” He recommends bringing in an independent consultant early to pressure-test the decision before it becomes a commitment.
Marine Joly Battaglini, Founder of her own CMC consulting firm, PharmDev, flagged a structural issue with how many startups approach Chemistry, Manufacturing, and Controls (CMC). The “D” in CDMO, she said, is often underweighted. For a startup that lacks in-house CMC expertise, the development partner effectively becomes an extension of the team. Two conditions must be met before proceeding: the CDMO must have the specific skill sets the project requires, and it must demonstrate genuine interest in the program. “If you already start with having these two key ingredients, you’re already going in the right direction.”
On spotting authentic expertise during a site visit, Giulio Cavalli, Principal Lead , External Manufacturing at Johnson & Johnson Innovative Medicine, said things should not look staged. He looks for openness beyond the scope of the formal visit, willingness to discuss how the CDMO handles difficulties, and early signals of a collaborative working approach. “When we are on site, things don’t need to look fake.” Susan Reasoner, Chief Commercial Officer at BioDuro, added that the most convincing moments happen when scientists speak candidly about how they have handled similar chemistry in the past, including where it did not go well and what they did to recover.
Capacity and the Small Biotech Problem
The concern that smaller clients get deprioritized when larger clients compete for the same slots is real but manageable, according to Cavalli, who has worked on both sides. His prescription involves three things:
- A solid contract with agreed milestone-based protections before the relationship starts
- A well-documented value stream map that makes priorities visible to the CDMO project team
- Agility that biotechs can use to their advantage. Where big pharma brings complexity and slow turnaround on documentation, a biotech can move fast and make itself attractive to work with.
Reasoner framed the same dynamic from the commercial side. Biotechs tend to need genuine development partners rather than vendors, which creates more strategic opportunity than a large pharma account. “When you have success in their programs, that really creates that sticky customer.” The downstream effects, she argued, include multi-year agreements, referrals, and access to the broader portfolio.
Planning Beyond Phase 1
Battaglini acknowledged the commercial reality: most startups are too focused on getting to the clinic to think much further. But she described a shift underway. Complete response letters from the FDA increasingly cite CMC deficiencies, and the industry is starting to notice. “We’re like firefighters in an emergency, whereas you really need to anticipate on your CMC activities.” Her advice is not to overload a startup with a 10-year commercial plan, but to ask a targeted question at Phase 1 selection: is this CDMO capable of accompanying the program through later phases, or is a planned transfer already inevitable? If transfer is likely, benchmarking the next partner early costs nothing and saves time when the decision becomes urgent.
Cavalli described how J&J’s separation of early-phase and commercial external manufacturing teams is designed to address exactly this. Clinical teams optimize for speed and flexibility; commercial teams optimize for volume and supply chain resilience. What holds it together is a horizontal view across the value stream so that decisions made at the first stage gate are understood in terms of their downstream consequences. The risk is steeper for small biotechs, he noted, because they lack the internal development infrastructure that large organizations can rely on when scale-up problems emerge.
Making the Relationship Work
Reasoner reduced the practical requirements for a functional CDMO-biotech relationship to three things: setting clear expectations, aligning priorities early, and maintaining transparent, regular communication. Without those, she said, any partnership will drift.
Stevenson pointed to a gap that contracts cannot fill: the difference between what is agreed in writing and how it is delivered. Hard deliverables, timelines, and specifications can all be specified. What often goes unstated is the working style, the frequency and quality of communication, and the flexibility expected on both sides. “How we want to deliver that is just as important. It’s crucial to that success.” When the two sides start to diverge on those softer dimensions, the relationship deteriorates faster than any commercial disagreement would suggest.
Takeaways
- Bring a consultant before finalizing any CDMO shortlist. A single independent review can expose gaps a CEO’s personal network cannot.
- Treat the site visit as an evaluation tool, not a formality. Watch for transparency, not polish.
- Establish milestone-based contract protections before the relationship starts to protect against deprioritization.
- Biotechs should use their agility deliberately. Fast document turnaround and clear priorities make smaller clients more attractive to CDMO project teams than the account size alone would suggest.
- Ask at Phase 1 whether a planned transfer later is the right strategy. Beginning to benchmark the next CDMO early is cheaper than scrambling at stage gate.
- Define how the relationship will operate, not just what it will deliver. The soft deliverables, communication cadence, and working style need to be agreed, not assumed.
