Expert’s Opinion

Biotech’s Great Reset: Smart Capital and Smarter Manufacturing Converge

The intersection where science meets production is where real value is created.

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By: Audrey Greenberg

Chair of Business Development

After decades in private equity, biotech services, and venture creation, I have seen cycles of exuberance and contraction, but what we are experiencing today is something different. This is not a downturn. It is a realignment. The industry is moving from speed at all costs to precision with purpose. That shift will define the next generation of biopharma success.

Capital has become discerning. The inflated valuations of 2021 have given way to a more disciplined environment where investors prize translation over promise and platform over pipeline. Public markets have cooled, and private investors now expect clear evidence of manufacturability and patient impact before they commit. That may feel constraining to some, but in truth it is a gift. It forces rigor. It rewards those who can balance innovation with execution.

For service providers and manufacturing partners, this moment demands reinvention. The CDMO landscape was built for scale, but the future belongs to those who can deliver flexibility, data driven precision, and scientific partnership. Manufacturing is no longer an operational afterthought. It is a strategic differentiator. The smartest biotechs are rethinking their outsourcing models entirely, seeking partners who can design, analyze, and adapt alongside them from discovery through commercial readiness.

The areas of whitespace are clear. Delivery systems that lower cost of goods while improving precision and reducing off target effects are among the most valuable assets in development today. Lipid nanoparticles, polymeric carriers, and nonviral gene delivery technologies are reshaping how we think about therapeutic logistics. The winners will be the teams that can align delivery innovation with manufacturability and supply chain reliability early in the process. That intersection, where science meets production, is where real value is created.

We are also seeing a deeper convergence between biology and data. Traditional endpoints no longer tell the full story. Biomarkers, digital readouts, and adaptive trial models are becoming the new standard for evaluating therapeutic success. They generate continuous feedback loops that feed both research and manufacturing intelligence. The same data that drives clinical insight can inform batch control, yield optimization, and process scalability. It is a shift from episodic measurement to continuous learning.

Artificial intelligence is the backbone of this transformation. In the lab, AI helps identify targets and predict molecular behavior. In manufacturing, it monitors process parameters in real time, forecasting deviations before they occur. In the clinic, it correlates biomarker trends with manufacturing variables to close the loop between discovery, development, and delivery. In commercial operations, it manages logistics, inventory, and quality data across global networks. The organizations that treat AI as a structural element rather than a side experiment will move faster, spend less, and fail smarter.

The implications extend beyond technology. They touch capital, collaboration, and culture. Investors are no longer chasing novelty. They are chasing proof of scalability. Pharma companies are seeking fewer transactional relationships and more strategic alliances with service providers that can share data, insight, and accountability. Public private partnerships and academic collaborations are filling early-stage gaps, blending scientific depth with financial discipline. The value chain is becoming less linear and more networked, with AI serving as the connective tissue.

From my vantage point, the most resilient companies are those that design for manufacturability and patient access from day one. They are pragmatic about risk. They are disciplined about capital. And they partner early with organizations that can provide data integrity, process design, and regulatory foresight.

This is also a moment for introspection within the services sector. The CDMOs that succeed in the coming years will be those that think beyond capacity. They will act as architects of innovation ecosystems, building modular facilities, embedding digital control systems, integrating analytics, and supporting clients from the earliest stages of development. They will not wait for demand to arrive. They will create it by solving the problems no one else wants to touch.

The convergence of smart capital and smarter manufacturing is not a slogan. It is a framework for enduring growth. Biotech has always thrived at the intersection of science and audacity. Today it must thrive at the intersection of science and discipline. The industry’s reset is building a stronger foundation, one rooted in data, efficiency, and accountability. Those who align science, manufacturing, and capital will define the decade ahead. Those who do not will serve those who do.

Innovation will always be biotech’s currency, but execution will be its multiplier. This is the era of intelligent build, strategic partnership, and continuous learning. It is not about doing more with less. It is about doing better with purpose. And for those who can combine scientific vision with operational excellence, the future has never looked brighter.

Audrey Greenberg

Audrey Greenberg is Chair of Business Development and a Venture Partner at Mayo Clinic. She has raised more than $1.5 billion in capital and built multiple category-defining ventures, including the Center for Breakthrough Medicines, acquired by SK pharmteco. She brings deep expertise in biotech, manufacturing, and finance, serving on boards across healthcare, biotechnology, real estate and economic development.  

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