Biotherapeutics discovery teams now have a free, structured tool for deciding whether an early-stage program should advance, pause, or stop. Catherine Cifuentes-Rojas, Director and Lead for Genetic Medicines and Biologics at Ginkgo Bioworks, has released a five-question go/no-go checklist built from more than 15 years of experience moving programs from target discovery toward the clinic.
The checklist is not tied to any company's pipeline or software platform. It is a set of plain questions meant to slow a team down at the moment momentum tends to speed it up, according to the announcement. Teams answer the five questions in writing before a program moves to the next stage of investment.
The questions ask whether a primary assay result replicates in a second, independent system; whether the team has tried to kill its hypothesis rather than just confirm it; what the in vivo data says rather than the in vitro data; who outside the generating team reviewed the work; and what would change the team's mind, and whether that has happened yet. The final question requires teams to record disconfirming evidence in advance so they cannot quietly redefine success after the fact.
The checklist matters because early program decisions carry significant financial and human stakes. Cifuentes-Rojas said a no-go call made early and backed by real data protects capital and protects people, and is just as much a success as a program that clears every stage. Her stated concern is that without a structured process, decisions can rest on gut feel or seniority in the room rather than evidence.
She 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. A checklist, she argued, takes the argument out of the room: either the box is checked with evidence, or it is not.
The tool is designed to sit at defined decision points, including 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 answers recorded and revisited at the next decision point. It works as a shared document filled in by whoever owns the program, with dissenting views recorded rather than smoothed over.
For discovery biologists, computational scientists, and automation engineers who each see a different slice of a program's data, a shared checklist offers a common reference point instead of requiring every debate to start from scratch, she said. The checklist's broader implication is that it gives smaller and earlier-stage teams access to a decision discipline often associated with larger, more resourced organizations, without requiring any purchase or platform adoption.
Cifuentes-Rojas 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.
