Carlos Martin, Strategic Advisor, Rocket Pharmaceuticals

Like humans, biotechnology startups begin small. When they are born, they’re bold and the sky is the limit. Yes, they are small and still need to be nurtured, but at a young age they’re already focused on a big idea built around discovery that could have real impact on the world.

In the earliest of days, it’s all about focus and going deep on complex topics. First steps in R&D and early-stage financing with limited clinical evidence or no proof of concept (POC). Challenges are steep, with nearly half of clinical trials failing to progress beyond Phase I,¹ costing an average of $7.1 million (I would challenge this is low by today’s standards) and lasting as long as two years. Even when companies reach the market, hurdles persist, with only 28% of first-time biotech product launches exceeding analysts’ pre-launch forecasts, compared to nearly 50% for experienced companies.² Furthermore, about 90% of biotech startups end up failing,³ making the commercialization journey especially daunting. A strong foundation is critical.

The focus shift: From depth to depth and breadth

In early R&D stages, a high level of depth and focus is critical to succeed. Clinical and research teams dive deeply into the science, solving new problems daily. In a successful discovery process, quality wins over quantity. They need to ensure precision in the entire R&D process while keeping the big picture of how “wonder science” will be applied in day-to-day medicine. Before you know it, you go from “keeping this baby alive” to dealing with a toddler and then a teenager in search of their own identity and hungry for autonomy. As the saying goes: Little kids, little challenges; Big kids, big challenges.

Once a biotech company delivers a POC, part of bringing it to life will depend on how key elements of commercialization are integrated and if they’re integrated early enough in the clinical development and manufacturing process. Delayed focus on strategy—dosing, patient profiling, market fit—can jeopardize a promising drug’s future. As Keith Woods, chief operating officer at Scholar Rock explains, “Clinical teams need to work side-by-side with peers from early commercialization strategy teams, ensuring that science fits realistically into clinical practice, health systems, how it reaches patients, and how it aligns with payers, providers, and regulators.”

At this stage, financial stability becomes even more crucial. In 2023, biotech bankruptcies reached a10-year peak,⁴ highlighting the industry’s financial volatility and the challenges many companies face in sustaining operations long enough to reach commercialization.

Overnight, the teenager is out of college, and her world suddenly expands with opportunities and complexities. Vital decisions need to be made (where to live, what to become in a few years). A biotech at this stage, private or public, will grow exponentially in size, complexity, and capital requirements. Its risk and opportunity profile shifts from success in science to success in future science and commercial P&Ls.

While science should remain at the heart of the company, the opportunity to reach patients on a commercial scale and generate its own revenue is where true transformation takes shape.

In the same way parents guide their kids to unleash their full potential, company leaders and boards of directors need to drive change and evolution for a biotech company to deliver on its promise to patients, healthcare providers, employees, other stakeholders, and shareholders.

This is a moment of truth, and not all companies are able or willing to embrace the opportunity to evolve. Purist scientists have a tendency to “fall in love” with inventions they’ve spent years nurturing– rightfully so.

As a father of a wonderful teenage daughter, Violeta, I can assure you that it is not easy to see them grow and leave the “nest.” It’s a deeply emotional journey for both the kid and the father, but you know, letting go is critical for their growth.

Speed: From clinical research to clinical practice

R&D operates under a different sense of urgency and scale. Clinical trials are always a simplified and partial view of clinical practice. The company is in full control with protocols in place; they are meticulously planned, they know when patients are showing up days in advance, and progress is measured in years. Precision and patience are key.

Commercialization moves at the speed of life—patients, providers, and competitors won’t wait. Once approved, the company operates 24/7, with patient demands and compliance hurdles requiring agility, and many organizations struggle to adapt quickly. Moving from a deliberate, controlled setting to a more proactive, fast-moving, and uncertain environment requires a mindset change starting at the top. David Epstein, chairman and CEO of Ottimo Pharma says, “For biotech companies, the transition from an R&D-focused organization to a commercial entity is one of the deepest, most challenging yet rewarding transformations in the industry.

Control: Letting go while staying grounded

One of the most jarring changes during this transition is the loss of control. In R&D, you are the one steering the ship. You design clinical trials, control the environment, and interact with a small circle of stakeholders.

The arrival of early commercialization strategy teams should not dramatically change the script if the “voice of the customer” was included in the early days. Woods notes, “Once the product is approved, the market dictates its use—payers, prescribers, patients, and policymakers are in the driver’s seat.” This shift is a major hurdle faced by nearly half of the surveyed professionals,¹ making reimbursement and patient access unpredictable. The increased complexity and perceived randomness can feel overwhelming for companies accustomed to the precision of R&D alone.

A path forward? Learning to regain control in new ways. It’s about building trust with external stakeholders, creating robust processes, and being proactive rather than reactive. Thriving in uncertainty becomes a skill—and a necessity.

Leadership: Growing up at the top

The success of this transformation hinges on leadership. Epstein adds, “moving from R&D to commercial isn’t just a shift in operations—it’s a cultural transformation if it was not already considered in the early stages. Organizations risk misallocating resources or failing to meet critical regulatory milestones without strategic leadership and a cohesive development strategy. Strategy, vision, and decision-making all evolve.”

More often than not, companies wait too long to bring in the right leadership. Founders, who are often brilliant scientists, may struggle to move from two-variable equations (science and funding) to more complex organizations. Leading and running an R&D-focused organization requires a different mindset and skillset than leading a cross-functional commercial operation.

Successful biotech companies recognize this early on. They recruit experienced leaders and build teams capable of bridging science and business, and foster cultures that encourage collaboration and innovation.

The growing pains are worth it

The R&D-to-commercial transition is messy, tough, fascinating, challenging—and fun. It’s what turns an early spark of innovation into something real—something that changes lives at scale and over time. However, the reality remains that only a fraction of biotech companies⁵ successfully bring their first product to market, reinforcing the importance of strategic leadership, financial discipline, and early commercial planning.

Getting a product to market is just one part of the transition. The true goal is to build a resilient organization—one that can sustain innovation, deliver value, and leave a lasting impact.

The journey from lab to market isn’t a “stroll in the park,” and meaningful growth rarely is. It’s about embracing change and opportunity, learning from challenges, and growing into what’s next. And in biotech, that next step can change the world in magical but very real ways, just like science.

Carlos Martin is a Strategic Advisor for Rocket Pharmaceuticals

References

1. Early Phase Challenges for Biotechs. ICON. https://www.iconplc.com/sectors/biotech/early-phase-challenges-biotechs

2. Making the Leap from R&D to Fully Integrated Biotech for First Launch. McKinsey & Company. February 15, 2023. https://www.mckinsey.com/industries/life-sciences/our-insights/making-the-leap-from-r-and-d-to-fully-integrated-biotech-for-first-launch

3. Thornewood, R. How Often do Startups Fail? Fisheriesalliance.eu blog. August 12, 2024. https://fisheriesalliance.eu/how-often-do-startups-fail/

4. Armstrong, A.; Mason, G. Biotech Bankruptcies Hit 10-Year Peak in 2023. Fierce Biotech. February 12, 2024. https://www.fiercebiotech.com/special-reports/biotech-bankruptcies-break-10-year-record-2023?utm_source=chatgpt.com

5. First-Time Launchers in the Pharmaceutical Industry. McKinsey & Company. February 12, 2021. https://www.mckinsey.com/industries/life-sciences/our-insights/first-time-launchers-in-the-pharmaceutical-industry