Curated News
By: NewsRamp Editorial Staff
October 31, 2026
Ginkgo Bioworks Scientist Releases 5-Question Checklist for Biotech Go/No-Go Calls
TLDR
- Ginkgo Bioworks director Catherine Cifuentes-Rojas releases a five-question checklist to help discovery teams make better go/no-go decisions and protect capital.
- The checklist requires written answers to five questions at defined decision points, including replication, disconfirmation, in vivo data, external review, and pre-committed change criteria.
- Cifuentes-Rojas's checklist promotes early no-go calls backed by data, protecting capital and people while giving junior scientists a structured way to raise concerns.
- Cifuentes-Rojas's checklist includes a question asking teams to name the experiment most likely to disprove their favored mechanism, then run it before celebrating.
Impact - Why it Matters
This news matters because early-stage biotherapeutic programs often advance on optimism and momentum rather than hard evidence, leading to costly late-stage failures. Cifuentes-Rojas’s checklist offers a simple, low-cost way for teams to stress-test their assumptions, document disconfirming data, and make more disciplined decisions. By democratizing access to a structured go/no-go framework, it could reduce wasteful spending, accelerate the demise of weak programs, and ultimately bring better therapies to patients faster. It also addresses a cultural issue in science: giving junior researchers a formal mechanism to raise concerns without being overruled by seniority.
Summary
After more than 15 years steering biotherapeutic programs from target discovery toward the clinic, Catherine Cifuentes-Rojas, Ph.D., has distilled her go/no-go experience into a concise checklist that any discovery team can apply to early-stage programs. Currently Director and Lead for Genetic Medicines and Biologics at Ginkgo Bioworks, Cifuentes-Rojas has held roles at Massachusetts General Hospital, Harvard Medical School, and Sail Biomedicines, where she sat in on dozens of critical decisions about RNA therapeutics, cell therapies, and biologics. The checklist, now publicly released, is not tied to any company’s pipeline but consists of five plain questions designed to slow teams down at the moments when momentum can outpace rigor.
The questions require written answers before a program advances: Does the primary assay replicate in an independent system? Have we tried to kill the hypothesis rather than just confirm it? What does the in vivo data say, not the in vitro data? Who outside the generating team reviewed the work? What would change our mind, and has it happened yet? Cifuentes-Rojas emphasizes that a no-go call backed by real data protects both capital and people, and that structured checklists remove reliance on gut feel or seniority. The idea arose from watching junior scientists hesitate to present disconfirming data to senior colleagues, and from her experience directing cross-functional teams at Ginkgo Bioworks, where biologists, computational scientists, and automation engineers each see different slices of a program. The checklist is meant to be used at defined decision points—after target validation, before committing to in vivo studies, and before IND-enabling preclinical work—and can be completed in under an hour as a group, with dissenting views recorded rather than smoothed over.
By sharing this tool, Cifuentes-Rojas aims to make fast decisions the right ones and slow decisions worth the time, without requiring any specific software or platform. The checklist is available as a shared document that any team can adopt to bring structure and accountability to early-stage biotherapeutic development.
Source Statement
This curated news summary relied on content distributed by 24-7 Press Release. Read the original source here, Ginkgo Bioworks Scientist Releases 5-Question Checklist for Biotech Go/No-Go Calls
