What Strategies Can Biotech Executives Use To Effectively Prioritize And De-Risk Development Programs During Tough Economic Times?

IN THE CELL THERAPY SETTING WHERE FUNDERS REWARD DATA, NOT IND FILING EVENTS, our remit is to obtain data expeditiously and in a cost-effective manner. To maximize the potential for value-creating opportunities, we anticipate and plan for positive, negative, and middle of the road clinical outcomes. What next steps can be executed or progressed when the data reads out, to capture and enhance value?

Development risks can be lowered by leveraging validated technologies, modalities, and targets, and perhaps combining them in novel ways to create a platform, which in turn enables proof of concept before exploring higher-risk targets. We manage development costs and make modest, stage-gated investments to arrive at milestone decisions. To manage operational costs, we work with reputable contract partners unless one has the tremendous benefit of a GMP pilot lab and associated fit for purpose QMS that can enable first-in-human studies. Planning with an eye toward future clinical (e.g., country), operational (e.g., testing), and commercial (e.g., scale, COGM) expectations minimizes spending and development timelines. Comparability matters. Developing a process change evolution strategy maximizes the number of highly similar batches across the development history and the likelihood of using the full complement of clinical data for the registrational filing.

CHARLENE BANARD is the chief technical officer at Atara Biotherapeutics.