A new, freely available checklist from Catherine Cifuentes-Rojas aims to give biotherapeutics discovery teams a structured way to decide when to advance or halt early-stage programs. Cifuentes-Rojas, who has spent more than 15 years moving biotherapeutic programs from target discovery toward the clinic, released the five-question tool to address a persistent gap in how teams make high-stakes decisions.
The checklist is not a proprietary framework tied to any company's pipeline. Instead, it consists of plain questions designed to slow teams down at the exact moment momentum tends to speed them up. The questions must be answered in writing before a program moves to the next stage of investment. They ask whether a primary assay result replicates in a second, independent system; whether the team has tried to kill its hypothesis rather than merely confirm it; what in vivo data show, as opposed to in vitro results; who outside the generating team has reviewed the work; and what evidence would change the team's mind, and whether that evidence has appeared yet.
The implications for the biotherapeutics industry are significant. Drug discovery is capital-intensive, and programs that advance on weak or unreplicated data consume resources that could be directed elsewhere. Cifuentes-Rojas said a no-go call made early, backed by real data, protects capital and protects people, and is just as much a success as a program that clears every stage. The checklist is intended to reduce reliance on gut feel or seniority in the room when making that call.
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, because either the box is checked with evidence or it is not.
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.
Teams are meant to use the checklist 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 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. No particular software or platform is required.
The broader significance lies in the checklist's potential to standardize early-stage decision-making across discovery teams. By requiring written answers, independent review, and pre-specified disconfirming evidence, the tool could help organizations avoid the sunk-cost pressures that often keep weak programs alive. The goal is not to slow science down, Cifuentes-Rojas said, but to make sure the fast decisions are the right ones, and the slow ones are worth the time they take.
Cifuentes-Rojas 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.
