Sana CEO Steve Harr actively questions whether the company's groundbreaking science can translate into a scalable, commercially viable therapy. This internal pressure focuses the team on solving not just the scientific challenges ("does it work?"), but also manufacturing ("can you scale it?") and the commercial model required for a true cure.

While processes are essential for scaling, excessive rigidity stifles the iterative and experimental nature of innovation. Organizations must balance operational efficiency with the flexibility needed for creative breakthroughs, as too much process kills new ideas.

Pendo's CPO warns that scaling isn't just about replicating processes for more teams. Leaders must simultaneously build coordination systems (design reviews, clear communication) while fighting to maintain the "maniacal focus on the customer" and rapid innovation that characterize small teams.

A biotech transitioning from a small, 'fit-for-purpose' R&D team to a large commercial organization gets a rare chance to create a new culture. Madrigal treated its rapid growth from ~100 to over 500 people as an opportunity to establish fresh core values for the newly-formed enterprise.

Ron Cooper credits his success not to being a "scaling guy" at Bristol-Myers Squibb, but the "fix-it guy." Being deployed to turn around struggling business units across different geographies and therapeutic areas provided the multicultural, problem-solving toolkit essential for navigating the constant challenges of leading a biotech startup.

Unlike most biotechs that start with researchers, CRISPR prioritized hiring manufacturing and process development experts early. This 'backwards' approach was crucial for solving the challenge of scaling cell editing from lab to GMP, which they identified as a primary risk.

CEO Ron Cooper likens a biotech startup to a fire needing three elements in sync: science (the log), people (the spark), and money (oxygen). An imbalance, such as science outpacing funding, will destroy value by forcing compromised decisions.

Moving from a science-focused research phase to building physical technology demonstrators is critical. The sooner a deep tech company does this, the faster it uncovers new real-world challenges, creates tangible proof for investors and customers, and fosters a culture of building, not just researching.

Developing a new medicine is 'the toughest team sport,' requiring hundreds of people across diverse disciplines over many years. In this context, culture isn't a perk; it's the fundamental 'glue' that enables these disparate teams to work in concert and succeed. Without it, even the best individual players will fail.