Speed, Discipline, and the New Rules of Biotech Development: Q&A with Stella K. Vnook, PhD, Kaida BioPharma and Aviva Ventures

A confluence of declining NIH funding, large pharma's pivot toward later-stage assets, and a global operating environment demanding faster, leaner paths to proof-of-concept data is forcing early-stage biotechs to fundamentally rethink how they allocate capital and sequence development decisions.

To explore this further, Applied Clinical Trials spoke with Stella K. Vnook, PhD, CEO and executive chair of Kaida BioPharma and founder and CEO of Aviva Ventures, about which risks are most underappreciated in the current environment, how commercialization strategy is moving upstream into trial design, and what founders should be asking before signing on with an accelerator, incubator, or venture studio.

ACT: How is the current funding environment changing which clinical programs move forward and how sponsors are prioritizing them?

Vnook: The environment has changed quite a bit in the past 12 to 24 months, and what's really driving this is a trifecta of pressures. There are significant changes in NIH funding, which has traditionally funded early clinical programs. There's also a cliff in large pharma—they're seeking assets, but later-stage assets. And third, the global ability to get a clinical trial done and get that proof-of-concept human data has really motivated all of us to rethink our development plans, our regulatory strategy, and our patient population.

Maybe four years ago, we were much more interested in very creative science and interesting approaches. Now we're focused on going really fast, utilizing less capital to get to inflection points, and getting to first patient in as soon as we can. This trifecta is forcing a much higher level of discipline, rigor, and agility in how we move forward.

ACT: What are the most significant risks facing early-stage and rare disease programs right now?

Vnook: Scientific failure has always been the core risk—what happens at the next inflection point—and that will never change. That's just part of science. But what has changed, again because of what I mentioned in the first answer, is the lack of NIH funding. Are we going to be able to get to the next inflection point with the funding we have, and what are the sources of that funding? If money is moving toward later-stage phase one and phase two, do we still have the infrastructure to cover pre-clinical?

The most significant risk is not seeing the potential of real assets because we don't have enough funding to get there. The other risk is not selecting the right indication. We now have more analogs and AI models that are allowing us to be smarter in predicting the optimal indication for a mechanism of action. But we still operate on trade-offs—who is the right patient, what is the right endpoint, what is the right trial design. A lot of great assets fall behind because they made the wrong decisions along those paths.

ACT: How has the relationship between commercialization readiness and clinical development strategy shifted?

Vnook: It's a lot more joined now. We've always done commercialization readiness much later—end of phase two, maybe beginning of phase three—and that's probably too late. Now we have to think earlier about how we will commercialize a product, how it will be integrated into prescribing or coverage, in order to make the right decisions around indication selection, trial design, and site strategy.

It doesn't mean you need a full-blown commercial team in pre-clinical or phase one. But it does mean having the right consultants or partners doing the right surveys to understand what the end looks like, so you can create a better, smarter clinical trial design with the right endpoints.

ACT: What does a leaner, more strategic development model actually look like operationally for biotech today?

Vnook: When I hear "leaner," I always think "under-resourced," and maybe that's sometimes true—but it's not about cutting corners. It's about being mindful of where we spend money, because as I mentioned earlier, the goal is getting to an inflection point as fast as possible on limited dollars. The key is not the size of the team; it's the quality of the advice, whether from partners or advisors.

Instead of hiring a full-blown team as soon as you get seed funding, think about how to use the team fractionally or partner strategically. That has really been a game changer for a lot of companies that have been successful in the past two years.

ACT: Where do you see the greatest strategic opportunities for biotechs willing to adapt their development models?

Vnook: Structure is really what's governing the greatest strategic opportunities, and I get asked this all the time. If I were a first-time founder today, I would be very confused about how to get support. There's a lot out there—consulting companies, advisors, accelerators, incubators, venture studios—and I would have no idea what any of it means.

I'm glad there's more support, but we need to distinguish between branding and substance. An incubator is usually a space with mentoring and early support. An accelerator needs to show it can prove traction; it provides a program and curriculum, maybe investor introductions, and hopefully clinical trial and regulatory experts. A venture studio is a company-building group with real operational expertise and a track record. We need to start asking questions: what have you accelerated, what have you incubated, what are the success stories, what are the exits? A lot of people are using these names as branding, and it can be very confusing for someone who truly needs help.