NCI SBIR podcast: Experts lay out commercialization-plan essentials for cancer startups

Billy Bozza, a program director with the NCI SBIR Development Center, hosted an episode of the Innovation Lab podcast in which two company founders offered practical steps for writing commercialization plans for Phase II SBIR awards.

Sid Selvaraj, CEO of Arima Genomics, said entrepreneurs should start by identifying a clear unmet need — a problem that customers will act on, such as paying for a service or changing clinical practice — and then demonstrate there are enough customers to make a viable market. "What is the unmet need?" Selvaraj asked, adding that founders must show who the customer is (patients, researchers, labs or clinical-trials staff) and why they would act.

Selvaraj outlined five core elements investors commonly look for in commercialization plans: a defined unmet need, a quantifiable market size, a clear understanding of where value resides in the ecosystem, a strategy (the set of activities to capture that value), and a realistic plan for execution. He emphasized repeated customer interviews to refine hypotheses into a coherent story for reviewers and investors: "Talk to customers. A lot of them again and again and again," he said.

For diagnostic companies, Selvaraj warned that timelines are often longer and that founders must demonstrate demand and reimbursement pathways. He suggested non-dilutive funding or early niche revenue to "buy time" while building evidence and cautioned that intellectual property alone may not be sufficient to protect a small company from larger competitors.

Manisha Goldberg, identified by the host as CEO of Prevost Technologies, focused on the operational and regulatory pieces for therapeutics. She advised assembling a team, consulting key opinion leaders (KOLs) to define unmet medical needs, and contacting contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) for scale-up and clinical-trial estimates, ideally under a confidentiality agreement. "You need regulatory experts to provide guidance on FDA requirements," Goldberg said, and urged applicants to be explicit about how they will meet CMC and IND requirements if pursuing a therapeutic.

Goldberg recommended preparing a storyboard or flow diagram that illustrates the path to early commercialization, collecting support letters from KOLs and investors, and being transparent with reviewers about known gaps and plans to address them. She also advised modeling pricing and reimbursement using an approved product in the same space and seeking redacted marketing-plan examples from business advisers.

The hosts closed by directing listeners to sbir.cancer.gov for funding opportunities and commercialization resources and provided contact information for general inquiries.

This episode compiles founders' practical steps that applicants can reference when drafting commercialization plans for NCI SBIR applications; it does not announce any new NCI policy or change in funding rules. The podcast includes contact information for further SBIR resources.