Catherine Cifuentes-Rojas releases a free early-stage go/no-go checklist for biotherapeutics teams
Dr. Cifuentes-Rojas, Director of Genetic Medicines and Biologics at Ginkgo Bioworks, is publishing a working checklist that R&D teams can use to decide, with data rather than momentum, whether an early program should advance.
BOSTON, MA, October 31, 2026 -- Catherine Cifuentes-Rojas has spent more than 15 years moving biotherapeutic programs from target discovery toward the clinic, first in academic labs at Massachusetts General Hospital and Harvard Medical School, then at Sail Biomedicines, and now at Ginkgo Bioworks. Across that span she has sat in the room for dozens of go/no-go calls on RNA therapeutics, cell therapies, and biologics candidates.
She is now releasing a short checklist, built from that experience, that any discovery team can apply to their own early-stage programs. It is not a proprietary framework tied to one company's pipeline. It is a set of plain questions meant to slow a team down at the exact moment momentum tends to speed them up.
What the checklist asks
The list has five questions, meant to be answered in writing before a program moves to the next stage of investment:
Does the primary assay result replicate in a second, independent system? A single strong data set is not evidence. A repeated one is.
Have we tried to kill the hypothesis, not just confirm it? Cifuentes-Rojas asks teams to name the experiment most likely to disprove their favored mechanism, then run it before celebrating.
What does the in vivo data say, not the in vitro data? Candidates that perform well in primary cell assays can lose stability entirely once tested in a living system. The checklist asks teams to weigh in vivo results above earlier, easier signals.
Who reviewed this outside the team that generated it? A second set of eyes, ideally from a different technical background, is required before a program clears the checklist.
What would change our mind, and has it happened yet? Teams write down their own disconfirming evidence in advance, so they cannot quietly redefine success after the fact.
"A no-go call made early, backed by real data, protects capital and protects people," Cifuentes-Rojas said. "It is just as much a success as a program that clears every stage. The checklist exists so a team does not have to rely on gut feel or seniority in the room to make that call."
Why she is publishing it now
Cifuentes-Rojas said the idea came from watching junior scientists hesitate to raise disconfirming data in front of more senior colleagues, not because the data was weak, but because no one had given them a structured way to bring it forward.
"If the only tool in the room is confidence, the most confident person wins the argument," she said. "A checklist takes the argument out of it. Either the box is checked with evidence, or it isn't."
She pointed to her own experience directing cross-functional teams at Ginkgo Bioworks, where discovery biologists, computational scientists, and automation engineers each see a different slice of a program's data. A shared checklist, she said, gives those groups a common reference point instead of requiring every debate to start from scratch.
How teams can use it
The checklist is meant to sit at defined decision points: after initial target validation, before committing to in vivo studies, and before a program moves toward IND-enabling pre-clinical work. Cifuentes-Rojas designed it to take under an hour to complete as a group, with the answers recorded and revisited at the next decision point.
She is not asking teams to adopt any particular software or platform to use it. It works as a shared document, filled in by whoever owns the program, with dissenting views recorded rather than smoothed over.
"The goal isn't to slow science down," Cifuentes-Rojas said. "It's to make sure the fast decisions are the right ones, and the slow ones are worth the time they take."
Catherine Cifuentes-Rojas, Ph.D., is Director and Lead for Genetic Medicines and Biologics at Ginkgo Bioworks in Boston, Massachusetts. She holds a Ph.D. in Genetics from Texas A&M University and completed postdoctoral research and a faculty appointment at Massachusetts General Hospital and Harvard Medical School. Her work on long non-coding RNAs earned the National Academy of Sciences Cozzarelli Prize in Biological Sciences in 2020. She previously served as Associate Director of Discovery Biology and Interim Head of In Vivo Pharmacology at Sail Biomedicines.
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She is now releasing a short checklist, built from that experience, that any discovery team can apply to their own early-stage programs. It is not a proprietary framework tied to one company's pipeline. It is a set of plain questions meant to slow a team down at the exact moment momentum tends to speed them up.
What the checklist asks
The list has five questions, meant to be answered in writing before a program moves to the next stage of investment:
Does the primary assay result replicate in a second, independent system? A single strong data set is not evidence. A repeated one is.
Have we tried to kill the hypothesis, not just confirm it? Cifuentes-Rojas asks teams to name the experiment most likely to disprove their favored mechanism, then run it before celebrating.
What does the in vivo data say, not the in vitro data? Candidates that perform well in primary cell assays can lose stability entirely once tested in a living system. The checklist asks teams to weigh in vivo results above earlier, easier signals.
Who reviewed this outside the team that generated it? A second set of eyes, ideally from a different technical background, is required before a program clears the checklist.
What would change our mind, and has it happened yet? Teams write down their own disconfirming evidence in advance, so they cannot quietly redefine success after the fact.
"A no-go call made early, backed by real data, protects capital and protects people," Cifuentes-Rojas said. "It is just as much a success as a program that clears every stage. The checklist exists so a team does not have to rely on gut feel or seniority in the room to make that call."
Why she is publishing it now
Cifuentes-Rojas said the idea came from watching junior scientists hesitate to raise disconfirming data in front of more senior colleagues, not because the data was weak, but because no one had given them a structured way to bring it forward.
"If the only tool in the room is confidence, the most confident person wins the argument," she said. "A checklist takes the argument out of it. Either the box is checked with evidence, or it isn't."
She pointed to her own experience directing cross-functional teams at Ginkgo Bioworks, where discovery biologists, computational scientists, and automation engineers each see a different slice of a program's data. A shared checklist, she said, gives those groups a common reference point instead of requiring every debate to start from scratch.
How teams can use it
The checklist is meant to sit at defined decision points: after initial target validation, before committing to in vivo studies, and before a program moves toward IND-enabling pre-clinical work. Cifuentes-Rojas designed it to take under an hour to complete as a group, with the answers recorded and revisited at the next decision point.
She is not asking teams to adopt any particular software or platform to use it. It works as a shared document, filled in by whoever owns the program, with dissenting views recorded rather than smoothed over.
"The goal isn't to slow science down," Cifuentes-Rojas said. "It's to make sure the fast decisions are the right ones, and the slow ones are worth the time they take."
Catherine Cifuentes-Rojas, Ph.D., is Director and Lead for Genetic Medicines and Biologics at Ginkgo Bioworks in Boston, Massachusetts. She holds a Ph.D. in Genetics from Texas A&M University and completed postdoctoral research and a faculty appointment at Massachusetts General Hospital and Harvard Medical School. Her work on long non-coding RNAs earned the National Academy of Sciences Cozzarelli Prize in Biological Sciences in 2020. She previously served as Associate Director of Discovery Biology and Interim Head of In Vivo Pharmacology at Sail Biomedicines.
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