LifeSciVC 09月29日 10:49
生物技术产业面临范式转变
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文章探讨了生物技术行业正经历一场深刻的范式转变,这种转变不仅限于技术层面,更受到全球政治经济格局变化的影响。贸易紧张、供应链中断以及地缘政治因素正在重塑行业赖以生存的全球化基础。文章指出,政策制定者正将生物技术视为战略基础设施,国家利益成为考量投入成本、监管路径和合同可行性的新视角。从资本流动、新药研发到政府战略投资,都显示出生物技术正步入一个更加注重稳定、部署和国家韧性的新时代,强调“部署能力”而非仅是“发现新颖性”,并提出“稳定性即服务”(Stability as a Service)的概念,以应对全球化碎片化带来的挑战,最终实现生物技术的全球普惠和可持续发展。

🌍 **全球供应链的重塑与战略化:** 文章指出,生物技术行业过去高度依赖全球化供应链,但当前的地缘政治和贸易紧张局势(如对WuXi AppTec的审查)正使其变得不稳定。各国政策制定者正将生物技术视为与半导体、能源同等重要的战略基础设施,国家利益成为影响行业发展的关键因素,这意味着“自由贸易”不再是默认前提,行业需要适应新的政治经济现实。

🚀 **从“发现新颖性”到“部署能力”的转变:** 传统的生物技术评估框架正被更新。文章强调,未来的行业价值将更多地体现在“部署能力”上,即不仅要能发现突破性疗法,更要能实现其在全球范围内的稳定、快速和可靠的交付。这包括了对药物研发的模块化、可扩展性、快速响应能力以及在不同环境下的适应性的重视,例如ARPA-H资助的注重转化速度和技术风险的项目。

💡 **“稳定性即服务”(Stability as a Service)的兴起:** 面对RNA等先进疗法在冷链、制造和递送方面的脆弱性,文章提出了“稳定性即服务”(SaaS)的概念。SaaS旨在开发模块化能力,使核酸疗法能在极端条件下(如高温、复杂物流、地缘政治不确定性)得以部署,这包括开发冻干制剂、非低温递送系统和适应分散式分发的包装。SaaS不仅关乎制剂问题,更是实现全球公平、国防准备和气候适应性的战略手段。

🏗️ **基础设施层面的创新与投资:** 文章通过Comanche Biopharma(开发耐热RNA递送系统)、Isomorphic Labs(AI驱动的药物发现平台)和Tierra Biosciences(按需蛋白质合成)等公司案例,说明了行业正从单一产品研发转向构建更具弹性和可扩展性的系统。Resilience(构建GMP制造能力平台)和Laronde(开发长效RNA平台)等公司则通过构建基础设施来推动行业发展,表明生物技术的未来成功可能更多地取决于系统架构和部署能力,而非单纯的科学发现。

By Jason Campagna, CMO of Q32 Bio, as part of the From The Trenches feature of LifeSciVC

We’re entering a phase shift in biotech—one that extends beyond molecules, pipelines, or even platforms. Tariff escalations, supply chain fractures, and a reassertion of industrial policy are reshaping the terrain beneath us. The scrutiny and legislative backlash against WuXi AppTec—one of the world’s largest CDMOs—has brought into public view what many in the industry have long navigated quietly, that biotechnology’s foundational reliance on globally integrated supply chains is no longer politically or operationally stable.

The WuXi case is not an outlier—it’s a signal. U.S. policymakers are now treating biotech the way they’ve come to treat semiconductors and energy: as strategic infrastructure. Input costs, regulatory pathways, and even contractual viability are being reinterpreted through the lens of national interest. In this context, “free trade” is no longer a default assumption.

From my perch within the Atlas ecosystem, and through conversations across its portfolio companies, I’m seeing clear signs of transition. Biologics pipelines increasingly feature bispecifics, trispecifics, and ADCs built not only for biological sophistication but for differentiated deployment—exemplified by Pheon Therapeutics, which recently raised $120M to advance next-generation ADCs into the clinic. At the same time, Chinese-origin NMEs are flowing into U.S. portfolios at a striking pace. Hercules, a spinout of Hengrui Pharmaceuticals backed by Atlas and others, raised $400M in one of the largest cross-border biotech launches to date.

And while these capital movements accelerate, state-aligned instruments—such as the Department of Defense’s Office of Strategic Capital—are treating biotechnology with the same strategic framing once reserved for semiconductors or defense platforms. The terrain is shifting, and the signals are becoming harder to ignore. ARPA-H’s decision to locate its Investor Catalyst Hub in Cambridge, Massachusetts further underscores this shift—placing national strategic infrastructure for health innovation directly within one of biotech’s most active ecosystems. It reflects a broader reality: the government is no longer just a funder of innovation. It is becoming a platform builder, aligning capital and geography to accelerate translation and resilience.

Biotech’s Infrastructure Moment

Change is already underway—but our frameworks for value, relevance, and readiness haven’t fully caught up. Biotech has traditionally been framed as a domain of therapeutic innovation: a source of breakthrough medicines, investor returns, and occasionally, public-private collaboration. But that framing is incomplete for the decade ahead. We are shifting from a world that valued therapeutic novelty in isolation to one that prioritizes stability, deployment, and sovereign readiness.

Just as the CHIPS Act reframed semiconductors as infrastructure, and the IRA did the same for energy systems, we are now witnessing the early architecture of what might become the bio-industrial policy era. Agencies like BARDA, ARPA-H, and CEPI are not simply funding science—they are funding capabilities. The core question is shifting: not just what can you discover, but what can you deploy?

We’re already seeing this play out. Nimbus Therapeutics has leveraged modular drug discovery and computational chemistry platforms that align with DARPA- and BARDA-style interests in scalable, rapid-response therapeutic development. Meanwhile, Moderna’s ongoing CEPI partnerships—including pre-pandemic commitments to rapidly produce mRNA vaccines in LMICs—demonstrate how platform readiness, not just innovation, is being treated as public health infrastructure. And through ARPA-H, we’re beginning to see a new funding model that prioritizes translational velocity and technical risk: programs like NITRO (Novel Innovations for Tissue Regeneration and Organoids) or the use of rapid manufacturing hubs are explicitly designed to create deployable biotech toolkits—not just advance single-asset R&D.

These emerging funding models share a common thesis: that the value of a biotech platform lies not only in its novelty, but in its readiness—its ability to scale, deploy, and operate under constraint. But in practice, many of the most promising therapeutic modalities—particularly RNA-based platforms—remain fragile and logistically intensive. This creates a strategic blind spot: we are investing in innovation faster than we are building the systems to reliably deliver it. What’s missing is a capability layer beneath the molecule. A kind of infrastructure that enables biologics to function not just in ideal settings—but in conflict zones, LMICs, and heat-stressed geographies.

Think of it as a capability stack: at the top sits the therapeutic innovation itself—the siRNA, mRNA, or biologic payload. Beneath that lies formulation science, packaging design, and delivery hardware. And at the foundation are the supply chain dynamics: how therapies are stored, transported, and accessed across geographies. When any layer is unstable, the entire stack is vulnerable. Today, too much of biotech is built on assumptions that only hold in centralized, well-resourced environments. If we want RNA and advanced biologics to fulfill their global promise, we need to invest in the foundational layers that make them operable under stress.

Stability as a Service: A Missing Layer

RNA-based therapeutics exemplify this new duality. mRNA, siRNA, and related modalities have massive potential, but remain constrained by cold-chain fragility, complex manufacturing, and delivery limitations.

That constraint is an opportunity. What we need is a new operational layer: “Stability as a Service” (SaaS). SaaS, in this context, is the development of modular capabilities that enable nucleic acid therapeutics to be deployed under stress—heat, logistics, time, and geopolitics. These include lyophilized formulations, non-cryogenic delivery systems, and packaging designed for decentralized distribution.

SaaS is not just a formulation problem—it’s a strategic lever:

We are approaching a world where the “formulation layer” becomes just as strategic as the API itself.

Three Signals, Three Layers of the Stack

If biotech’s next phase will be shaped not just by what we discover, but by how we deploy it, then the strategic advantage will lie in mastering a new capability stack. Several companies already signal the growing importance of this architecture:

Together, these companies signal a broader redefinition of biotech—not just as a generator of novel molecules, but as a builder of resilient, scalable systems. The future may depend not only on discovery—but on the structures we build beneath it.

From Signals to Structure: Two Case Studies

If the companies above suggest where the field is heading, the next examples make the path and direction explicit. These aren’t signals—they are structural commitments. Both Resilience and Laronde have moved beyond singular product ambition and are actively building the infrastructure that could define biotech’s next operating system. Each embodies a distinct philosophy: one focused on manufacturing sovereignty, the other on platform endurance. Taken together, they highlight the emerging belief that biotech’s long-term relevance may depend as much on systems architecture as on scientific novelty.

Resilience and the Productization of Capacity

Resilience, backed by ARCH Venture Partners, is perhaps the clearest example of biotech’s infrastructural turn. Rather than focusing on therapeutics, Resilience builds distributed, modular GMP manufacturing capacity as a platform. In doing so, it reframes biomanufacturing as a service layer—akin to AWS for biotech—where scale, speed, and sovereign flexibility become core capabilities. It is a vivid demonstration that infrastructure itself can be a strategic asset, not just a supporting function.

Laronde and the Challenge of Sustained RNA

Flagship Pioneering’s Laronde is developing “endless RNA” (eRNA), a programmable RNA platform with extended durability. But the promise of persistent, systemic expression raises a fundamental question: how do we deliver and control such a molecule across diverse clinical and logistical environments? The technology is bold—but its success may hinge not only on the biology, but on the infrastructure that surrounds it. Laronde illustrates that as RNA therapeutics evolve in sophistication, their dependency on robust deployment systems only intensifies.

Why Now

This isn’t an abstract forecast. Recent policy developments are clarifying the stakes. The next wave of tariffs and trade policy—particularly around China—will implicate APIs, excipients, reagents, and packaging materials essential to biotech manufacturing. Add to this the rising scrutiny around CMO geography, sovereign biomanufacturing, and dual-use technology, and the message becomes clear: biotech is entering the strategic domain once occupied by energy and defense. And with that shift comes opportunity: for access to new pools of capital, for advanced market commitments, for blended public-private partnership models that reward infrastructure alongside innovation.

Why Me

I don’t write this as an academic observer or policy analyst—I write as someone who, like many in this field, has spent years inside the system, leading development efforts while navigating firsthand the intersections of infrastructure, geopolitics, and clinical urgency. These experiences don’t make me unique—but they’ve made the patterns harder to ignore.

Earlier in my career at The Medicines Company (MDCO), I wasn’t just involved in product development—I was part of an effort to build a scalable operating model for how innovation could be embedded into high-acuity health systems. MDCO’s ambition extended beyond launching therapies like Angiomax or Cleviprex. The company sought to solve the diffusion problem in modern therapeutics: how to institutionalize change, not just individual prescriptions. Through strategic frameworks like the “nine-box model,” modular rollout strategies, and global playbooks tailored to hospital behavior, we aimed to make therapeutic adoption as programmable as therapeutic discovery.

Ironically, the company’s name—“The Medicines Development Company”—wasn’t about molecules alone. It reflected a vision for drug development as a platform discipline: repeatable, systems-aware, and built to scale under constraint. That experience reshaped how I see the field today. Formulation, delivery, and integration aren’t downstream of innovation—they are innovation. And whether in antibiotics or RNA, it’s often the infrastructure, not the science, that determines reach. This essay reflects that shift—not from the outside in, but from the inside out.

Conclusion: The Opportunity of Convergence

The infrastructure layer of biotech is no longer secondary. It’s becoming the stage on which scientific, economic, and geopolitical pressures collide. Tariffs, trade restrictions, and the fracturing of long-assumed global supply routes are accelerating—not hypothetically, but right now.

None of this diminishes the core value of biotech’s traditional model: founding and funding therapeutics, advancing human health, and delivering breakthrough science. That work remains essential—and in this regard, Atlas has consistently backed companies that push the frontier of science with rigor, focus, and a deep understanding of what it takes to bring a therapeutic to life. But the context around that excellence is changing.

What does this mean for our industry? For how we build companies in the next decade? For the types of founders, funders, and platforms that will define the next era? These aren’t rhetorical questions—they’re live ones. And they’re thrilling to consider.

This essay has raised the possibility that companies who invest early—into stability, logistics, and delivery—won’t just lead clinically. They’ll be the ones still standing when the context shifts, the ones partners and policymakers turn to when deployment becomes the bottleneck. This isn’t about speculative preparedness. It’s about staying relevant in a world that is reorganizing beneath our feet. And that moment is already here.

 

The post Strategic Infrastructure in a Fragmenting World: Biotech in the Transition Zone appeared first on LifeSciVC.

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生物技术 供应链 战略基础设施 地缘政治 部署能力 稳定性即服务 Biotechnology Supply Chain Strategic Infrastructure Geopolitics Deployment Capability Stability as a Service
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