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Few transitions in the life science lifecycle are more consequential — or more perilous — than the jump from a clinical-stage organization to a commercially capable one.
To explore why this moment is an existential pivot for biotechs and what separates those who scale successfully from those who stall, The FDA Group’s Nick Capman sat down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs at SAB Biotherapeutics.
Carlos has guided INDs, BLAs, NDAs, and CTAs across major markets, built inspection-ready systems, led multinational teams, negotiated expedited pathways like Fast Track and Breakthrough, and delivered both small and large molecule programs from Phase 1 through launch.
He joined the podcast to break down:
Why the clinic-to-commercial transition has become harder and riskier.
The operational, cultural, and strategic pitfalls that derail first launches.
How biotechs should sequence investments, evaluate external partners, and build regulatory and quality systems that can withstand scrutiny.
What a realistic commercial-readiness roadmap actually looks like.
How leaders must evolve their mindset from “guardians of science” to “stewards of sustainability.”
If you lead a clinical-stage organization, support one, or advise one, this is the playbook to follow heading into 2026.
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Carlos’ key insights: What biotechs must understand before attempting a first launch
The clinic-to-commercial transition is not a milestone. It’s a survivability test. Carlos is blunt here: moving from a clinical program to a commercial organization is an existential inflection point. It’s where companies must “build the plane while flying it,” and the consequences of missteps are severe, from delayed market entry to outright value destruction.
He outlines the forces raising the stakes:
Biotechs now own two-thirds of the R&D pipeline, especially in oncology, neurology, and rare disease. Competitive pressure is enormous.
Investor tolerance for mistakes is shrinking. Speed to market is expected; capital is impatient.
Accelerated and breakthrough pathways compress timelines, leaving little room to build infrastructure later.
Even a one-month launch delay can destroy hundreds of millions in revenue in some therapeutic areas.
Global regulatory and payer divergence requires sophisticated evidence and negotiation strategies early — often before companies are structurally ready.
This is why Carlos tells leadership teams: “Commercial readiness is not what you do after approval. It’s what determines whether you ever get there.”
Common pitfalls and how to avoid them
Carlos sees the same patterns repeatedly when companies stumble. Below are the major failure modes he cites.
Insufficient market and payer preparation. Many teams underestimate how quickly pricing, access, HTA assessments, and payer expectations can derail even strong clinical programs. Even with compelling efficacy, uptake collapses without early market preparation.
Overestimating physician readiness. Companies assume physicians will immediately shift entrenched treatment habits. They rarely actually do. Even products with excellent pivotal-trial data can face slow adoption if clinicians aren’t educated and prepared early.
Underdeveloped internal functions (regulatory, QA/QC, CMC, supply chain, IT). Carlos stresses that science alone does not get products approved or sustained. QA and QC cannot be split into separate reporting lines. Doing so creates conflicts of interest and has directly resulted in 483s at companies he has supported. Common gaps include:
Regulatory teams not prepared for global filings or accelerated pathways.
Fragmented governance across clinical, regulatory, CMC, and commercial.
QA/QC viewed as a “late-stage bolt-on,” leaving systems not inspection-ready.
Tech transfer failures and inadequate cold-chain planning.
Supply chains built on brittle single-source dependencies.
IT systems adopted without part 11/Annex 11 validation, cybersecurity, or data governance.
Over-reliance on CROs, CDMOs, and consultants without oversight. External partners are essential — but only when the sponsor maintains control. Carlos cites real examples where:
Weak vendor oversight caused data-integrity issues.
Sponsors “outsourced the brain” instead of the execution.
Vendors’ SOPs were assumed to be sufficient, leaving internal controls absent.
Cultural resistance to commercialization. Scientists and R&D teams may view commercialization as a dilution of innovation. If leadership doesn’t actively manage this cultural transition, morale suffers and alignment fractures.
How to evaluate and integrate external partners without losing control
For emerging biotechs, external partners are essential — but Carlos emphasizes that they can only become true force multipliers when the sponsor maintains disciplined control. He outlines a structured, pragmatic approach that prevents the common failure mode of “outsourcing accountability.”
The evaluation process should begin with a targeted vendor search, not an open-ended one. Carlos recommends reviewing three to five vendors — no fewer, no more — to ensure diversity of thought without overwhelming the selection process. From there, teams should scrutinize each candidate’s therapeutic-area experience, their ability to handle real-world scenarios, and concrete examples of how they have navigated comparable challenges. He stresses that glossy capability decks are meaningless without proof.
Once a partner is chosen, the working relationship must be shaped around aligned incentives. For small companies where every month of delay carries enormous financial and competitive cost, Carlos warns against fee structures based on hours or headcount. Instead, contracts should reward speed, quality, and delivery — the metrics that matter most for companies racing toward pivotal milestones.
Governance is equally critical. Carlos advocates establishing joint governance committees that ensure visibility into ongoing work, provide structured escalation pathways, and facilitate cross-functional risk planning. These mechanisms prevent the drift, miscommunication, and silent project failures that often occur when governance is left informal.
Quality must also be embedded into every aspect of the relationship. Sponsors often assume vendor SOPs are adequate, but Carlos is explicit: vendor procedures are not your procedures. QA needs to review, integrate, and approve workflows to maintain compliance and protect the sponsor’s license.
On the digital side, companies must design audit-ready data flows from the start. Audit trails, reporting capabilities, and data custody can’t be afterthoughts or outsourced assumptions. If the data will eventually support a filing, inspection, or validation exercise, the sponsor must own its integrity.
Finally, Carlos highlights the importance of documenting knowledge and decisions. Vendor turnover is inevitable; consultants leave; programs evolve. Without strong documentation, institutional memory evaporates and compliance gaps emerge just when companies need clarity most — typically during inspection or late-stage regulatory interactions.
His core message is simple: Partners amplify capability, not responsibility. Sponsors decide whether vendors become assets or liabilities.
Commercialization planning must begin earlier
Regulatory expectations are dynamic, data-driven, and increasingly commercial in nature. Carlos says companies most often stumble because they treat regulatory as a hurdle at the end. Instead, they must:
Build regulatory roadmaps as early as Phase 2.
Integrate CMC early and secure agreed comparability protocols.
Ensure readiness for real-world evidence requirements.
Prepare digital, decentralized, or data-integrity-sensitive trial designs.
Stay agile as guidances evolve during multi-year development.
Build lifecycle plans and post-approval commitments into the roadmap itself.
How to avoid compliance gaps that can derail approval or launch
Compliance is not a checklist — it is the foundation of credibility. Carlos’ strategies:
Continuous gap assessments. Bring in external auditors before every major milestone, especially for teams new to commercialization.
Commercial simulations early. Don’t wait until engineering batches. Stress-test systems long before PPQ. If you’re using a CDMO, stress-test them too.
Data integrity by design. Embed ALCOA principles from the outset. They are your defense during inspection.
Active oversight of partners. CMOs and CROs are extensions of your license. Treat them accordingly.
Validated digital systems. Do not rely on vendor validation alone. Implement internal part 11/Annex 11–compliant controls.
Train staff for unannounced inspections. You cannot scramble your way to readiness.
Treat CAPA as part of your launch plan. Not as a post-approval repair mechanism.
Prioritizing investments: what to build, what to outsource, when to scale
In resource-constrained biotech environments, sequencing is everything. Carlos’ guidance:
Build only what you must for the current phase.
Outsource until scale demands internal capability.
Prioritize non-negotiables first: regulatory infrastructure, supply chain reliability, digital backbone.
Avoid homegrown systems — they cannot keep pace with the ecosystem and will become a liability.
Scenario-plan for scale early.
Use modular, flexible systems wherever possible.
One thing to take back to your team
Pick one upcoming milestone — a submission, tech transfer, vendor selection, or inspection — and map the cross-functional risks, dependencies, and required governance around it. Then validate whether your systems, people, and partners are aligned. If they aren’t, better to know now than during inspection or launch.
Carlos Carrillo, PhD, MSc, is the Senior Vice President of Regulatory Affairs and Quality Assurance at SAB Biotherapeutics and one of the most seasoned regulatory leaders operating at the intersection of biologics innovation, CMC strategy, and global product development. Over 28 years, he has held progressively senior roles spanning Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, guiding programs from early development through launch across small- and large-molecule modalities.
Carlos has a long track record of leading FDA interactions—from pre-IND and pre-NDA/BLA meetings to ANDA and Type B/C/D discussions—as well as scientific and regulatory engagements with authorities across Europe, the UK, and Australia. He has authored and overseen major submissions, including INDs, IMPDs, CTAs, CTRs, BLAs, and MAAs, and has secured key expedited designations such as Fast Track and Breakthrough Therapy.
His therapeutic portfolio spans infectious diseases, autoimmune disorders, cardiology, endocrinology, and oncology, supported by hands-on experience in solid dosage forms, terminally sterilized products, lyophilized products, and biologics manufacturing. He is also certified in Lean Manufacturing, Six Sigma Green Belt, and PMP methodologies.
At SAB Biotherapeutics, Carlos additionally serves as Interim Chief Compliance Officer, overseeing regulatory strategy and quality systems, shaping policy engagement with federal and state stakeholders, managing inspection readiness, and supporting the regulatory pathway for SAB’s Tc bovine–derived polyclonal antibody platform.
Connect with him on LinkedIn here.
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