In her work with startups as founder and CEO of Agile Consulting Group, Stella Vnook has a front-row seat for the stumbling blocks that prevent companies from getting their innovations to market. Failure often has little to do with the science and is more related to a clear commercial direction, she said.
“It’s actually tragic to see good potential assets [fail] because there's no clarity. Or maybe clarity is there, but it's not articulated in the right way,” she said. “Having clarity from the beginning is going to enable the company to understand not only the timeline, but the funding.”
This hurdle can keep innovations from reaching patients.
“All the gaps that we're experiencing in that process is exactly the reason we don't have more treatments that are available,” she said.
Vnook’s mission is to close that gap by helping startups navigate the path from discovery to commercialization.
Avoiding early-stage mistakes is especially important now, as investors increasingly favor the safer bet of later-stage assets, according to a recent J.P. Morgan report. Seed and series A capital in 2025 fell to its lowest level this decade, with only $8.7 billion in total investment and a deal count of 191, while funding for companies seeking series B or later reached $16 billion.
After spending more than a decade in business development at Merck & Co., Vnook jumped into the biotech world, building more than $500 million in portfolio and deal value while leading the formulation and drug delivery company Likarda as CEO. Here, Vnook shares the early mistakes that can sink even the most promising biotech startups.
Not understanding their core asset
There’s more to the story of a core asset than how it targets a specific disease or leverages a mechanism of action. Yet, when Vnook asks inventors or entrepreneurs to describe their core asset through the lens of commercialization, “usually they cannot,” she said.
“Investors want to make sure they invest in something that is ownable,” she said.
With that in mind, fledgling biotech companies should be able to answer questions like: Is it a product or a platform? Who owns the intellectual property? Has the data been published elsewhere? Is the asset patentable? Who else owns something similar?
“You'd be surprised,” Vnook said. “It's a simple question, but a lot of times [startups] don't have the answer.”
Failing to identify the indication and regulatory pathway
Identifying the exact indication and regulatory pathway is crucial for generating sufficient preclinical data to present to the FDA to get clearance for clinical trials. That means figuring out whether the asset might fall under special pathways like the fast track or breakthrough therapy designations.
“Even if somebody launched a product five years ago, it does not mean it's going to follow the same pathway,” she said.
While plotting the asset’s regulatory course, companies should also determine clinical protocols, whether they plan to work with contract research or manufacturing organizations, and how they plan to scale past phase 1.
Forgetting they’re trying to win investors, not a grant
Grants are typically tied to research-based milestones. But investors want more.
“Things that were OK for grant submissions would not meet a lot of the investors' criteria,” Vnook said. “If we're looking for investors, how do we de-risk our path to commercialization? Because at some point, we need to translate the company from the grant strategy.”
In addition to the science, investors want to see that potential biotechs have a clear strategy for their asset, including ownership, as well as the right leaders in place, an understanding of the competitive landscape, the asset’s valuation, insights into possible reimbursement and a vision for the patient journey.
Not putting a team in place
Building a successful biotech is about more than the person who made or owns a discovery. It’s also about building what Vnook calls a “clean infrastructure” of leaders, advisors and decision makers.
“It starts with understanding that not everybody can do everything,” Vnook said. “Let's put a team together that has the right commercial vision, regulatory vision and the right authority to do what's right for the company.”
Once a team is settled, each member needs delegated authority within their area of expertise, as well as a clear understanding of who will own which decisions — from clinical milestones to competitive assessment.
Biotechs also need “a clear IP” and to make sure the asset they’re working with “falls within the IP parameters,” Vnook said.
