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Ep 33 - “We Can’t Just Discover, We Have to Deliver”: The Real Work of Scaling U.S. Biotechnology
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Ep 33 - “We Can’t Just Discover, We Have to Deliver”: The Real Work of Scaling U.S. Biotechnology

Chapter 2 of the NSCEB Final Report
a black and white photo of a building with pipes

The United States has no shortage of good ideas.

Biotech breakthroughs are still born here. They still spin out of our national labs, our university incubators, our startup accelerators, and the brains of some truly ridiculous graduate students with wild hair and whiteboards covered in dreams.

But too often, those good ideas don’t go anywhere.

They stall in a regulatory maze. They fail to raise capital. They never scale. Or worse, they scale in someone else’s country, using someone else’s infrastructure, backed by someone else’s industrial policy.

Chapter 2 of the NSCEB Final Report is about this exact problem. It’s a call to action, not to invent more, but to build better. Not just to “lead in biotech,” but to make sure that American innovations actually become American industries.

And if we want to do that, we need to do five things at once:

  1. Simplify how we regulate.

  2. Unlock private capital and de-risk scale-up.

  3. Build physical infrastructure to manufacture what we discover.

  4. Protect our supply chains and digital systems.

  5. Stop losing to brute force economics from countries who are playing for keeps.

This is not a casual to-do list. It’s a survival guide.

So let’s walk through the core recommendations in Chapter 2. No jargon. No fluff. Just what it says, why it matters, and what we need to do.


The podcast audio was AI-generated using Google’s NotebookLM.

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1. Simplify Regulation for American Biotechnology Companies

(Section 2.1 – Recommendations 2.1A & 2.1B)

If you’ve ever tried to bring a biotech product to market in the U.S., you know it’s a choose-your-own-adventure story with 15 federal offices, three lead agencies (FDA, EPA, USDA), and no map.

Recommendation 2.1A says: if something is familiar, safe, and well-understood, stop regulating it like it’s a radioactive alien. Products that could’ve been made conventionally (like non-browning apples or nitrogen-fixing microbes) should not have to repeat the entire review process just because they used biotech to get there.

Recommendation 2.1B is the other side of the coin. If a product is novel, especially if it behaves like a living system (gene drives, programmable microbes), then yes, give it a hard look. But build a system that’s actually built to do that well. The current patchwork is too slow, too vague, and doesn’t help anyone.

So what’s the fix?

  • Empower the National Biotechnology Coordination Office (NBCO) to map clear regulatory pathways.

  • Build a regulatory sandbox, a place to test new approaches safely.

  • Give agencies the ability to exempt familiar products.

  • Make digital tools, timelines, and review steps transparent.

This doesn’t mean deregulation. It means functional regulation.

And if we don’t fix it? Startups will continue to launch here… and commercialize somewhere else.

black traffic light

2. Attract and Scale Private Capital to Support Biotechnology

(Section 2.2 – Recommendations 2.2A–2.2D)

Here’s the hard truth: venture capital doesn’t scale bio. Not the kind we need. Not fast enough. And not for national security use cases.

Recommendation 2.2A says it clearly, create an Independence Investment Fund. A real one. Not a grant program dressed up in VC clothes. This fund would sit inside the Department of Commerce, be run by private investment professionals, and focus on one thing: getting biotech companies from prototype to scale-up without dying on the vine.

And it would do something even more important: signal to the market that biotech matters. That we’re serious. That we’re willing to put public capital at risk in strategic technologies like we did with semiconductors and microelectronics.

Recommendation 2.2B goes one level deeper: get the government to be the first customer. Through advance market commitments (AMCs) and offtake agreements, agencies like DOE and HHS can create reliable demand.

That might mean guaranteeing purchase of:

  • Biobased lubricants for hydro turbines,

  • Vaccines for emerging pathogens,

  • Enzymes for waste breakdown in defense facilities.

AMCs are not about picking winners. They’re about proving there’s a buyer. In biotech, that makes all the difference.

Recommendation 2.2C is more technical, but vital: restore full R&D expensing. The 2017 tax law change that phased it out hurt early-stage companies the most. If you can’t write off what you’re building, you’re not going to build it here.

Recommendation 2.2D calls for modernization of SBIR/STTR programs. Right now they’re siloed, rigid, and often disconnected from the commercial path. The fix? Increase funding, speed up award timelines, align them with scale-up stages, and make them relevant to national biotech goals.

Taken together, these four recommendations rebuild the middle of the capital stack. They help companies survive the valley of death.

And they send a message: we want you to build here.

U.S. dollar banknote with map

3. Scale U.S. Innovations

(Section 2.3 – Recommendations 2.3A & 2.3B)

This might be the most ambitious part of Chapter 2.

Recommendation 2.3A says: build a national network of pilot-scale biomanufacturing facilities. Think of it like a constellation of testbeds, places where startups can take their 5-liter lab recipe and scale it to 5,000 liters without having to raise $50 million or ship their process overseas.

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The model is clear:

  • Precommercial.

  • Modular.

  • Regionally distributed.

  • Fee-for-use, like Belgium’s Bio Base Europe Plant.

Every facility would support different feedstocks, fermentation methods, and products. Some would focus on food-grade production. Others on defense-relevant materials. Some on advanced therapeutics.

And each would be interoperable, with data infrastructure that ties into a national Web of Biological Data.

Recommendation 2.3B adds another piece: a biopharmaceutical manufacturing center of excellence. This is where we figure out the future of medicine-making, continuous manufacturing, modular biologics platforms, cell-free synthesis. And where we train the workforce to run it.

If we want bio to be a major industrial base, this is how we build the factories.

brown cardboard box near gray tanks

4. Protect Critical Biotechnology Infrastructure

(Section 2.4 – Recommendation 2.4A)

We’ve spent decades protecting our digital infrastructure. But we haven’t extended that protection to our biotech systems, the physical labs, the DNA databases, the critical suppliers and contract manufacturers.

Recommendation 2.4A is blunt: Congress must direct the Department of Homeland Security to classify biotechnology as critical infrastructure.

That means:

  • Including it in the Cybersecurity and Infrastructure Security Agency (CISA) sector list.

  • Creating a national protection plan for bio data (genomic, phenotypic, proprietary).

  • Standing up the same kind of playbooks we already have for energy, banking, and telecom.

This isn’t speculative. There have already been cyberattacks on ag facilities, hospitals, and pharma supply chains. And we haven’t even seen what a truly bio-specific attack could look like.

The longer we wait, the harder this gets.

teal LED panel

5. Fight Back Against China’s Brute Force Economic Tactics

(Section 2.5 – Recommendations 2.5A–2.5D)

Here’s the quiet part said out loud: China is using unfair economic tactics to dominate biotech. And it’s working.

Recommendation 2.5A: Require public companies to disclose supply chain choke points in countries of concern.

Recommendation 2.5B: Prohibit national security contractors and HHS partners from using Chinese biotech suppliers with known risk (like BGI or WuXi AppTec).

Recommendation 2.5C: Reform CFIUS to actually screen for strategic biotech investment, not just controlling stakes or post-hoc cleanups.

Recommendation 2.5D: Direct the International Trade Commission to investigate biotech dumping by Chinese firms.

This is not about xenophobia. It’s about leveling the field. Because right now, Chinese firms are backed by state subsidies, loose IP enforcement, and ambiguous concern for ethics. U.S. firms can’t compete on price if the price is national security.

We don’t need to out-China China. We need to out-America them with transparency, strength, and a system that actually values what we build.

Final Word: This Is the Hard Part

It’s easy to write “innovate.” It’s harder to build factories. It’s harder to reform regulation. It’s harder to convince Congress to fund precommercial fermentation tanks and multilateral data standards.

But this is the hard part of leadership. The boring part of the revolution. The necessary part of making biotechnology not just a promise but a pillar of American prosperity and security.

The United States has always done big things when it mattered. This is one of those moments.

Chapter 2 doesn’t hand us the moon. But it does give us a ladder.

And if we climb it, we don’t just discover new things, we deliver them to the world.

Cheers,

-Titus

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